{"id":50996,"date":"2018-09-24T01:00:00","date_gmt":"2018-09-26T02:14:17","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/%e5%8e%9f%e6%96%99%e8%8d%af%e5%b7%a5%e8%89%ba%e7%a0%94%e5%8f%91%e4%b8%8e%e6%8e%a7%e5%88%b6-qbd%e4%b8%8e%e8%b4%a8%e9%87%8f%e9%a3%8e%e9%99%a9%e7%ae%a1%e7%90%86\/"},"modified":"2018-09-26T10:14:21","modified_gmt":"2018-09-26T02:14:21","slug":"%e5%8e%9f%e6%96%99%e8%8d%af%e5%b7%a5%e8%89%ba%e7%a0%94%e5%8f%91%e4%b8%8e%e6%8e%a7%e5%88%b6-qbd%e4%b8%8e%e8%b4%a8%e9%87%8f%e9%a3%8e%e9%99%a9%e7%ae%a1%e7%90%86","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/50996\/","title":{"rendered":"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236 QBD\u4e0e\u8d28\u91cf\u98ce\u9669\u7ba1\u7406"},"content":{"rendered":"
\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

1 \u5236\u9020\u5de5\u827a\u5f00\u53d1<\/span><\/strong><\/p>\n

1.1 \u539f\u6599\u836f\u5236\u9020\u5de5\u827a\u5f00\u53d1\u7684\u76ee\u7684\uff1a<\/span><\/p>\n

1.1.1 \u5efa\u7acb\u4e00\u4e2a\u80fd\u591f\u6301\u7eed\u751f\u4ea7\u51fa\u7b26\u5408\u9884\u671f\u8d28\u91cf\u539f\u6599\u836f\u7684\u5546\u4e1a\u5236\u9020\u5de5\u827a\u3002<\/span><\/p>\n

1.1.2 \u5173\u952e<\/span><\/p>\n

\u00d8 \u6301\u7eed\uff1a\u7a33\u5b9a\u3001\u53ef\u63a7<\/span><\/p>\n

\u00d8 \u9884\u671f\u8d28\u91cf\uff1a\u5b89\u5168\u3001\u6709\u6548 <\/span><\/p>\n

\u00d8 \u5546\u4e1a\u5316\uff1a\u89c4\u6a21<\/span><\/p>\n

1.2 \u4f20\u7edf\u65b9\u5f0f<\/span><\/p>\n

1.2.1 \u4e0e\u539f\u6599\u836f\u6709\u5173\u7684\u6f5c\u5728\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u786e\u7acb\u4e00\u4e2a\u5408\u9002\u7684\u5236\u9020\u5de5\u827a<\/span><\/p>\n

1.2.2 \u786e\u7acb\u4e00\u4e2a\u5408\u9002\u7684\u5236\u9020\u5de5\u827a<\/span><\/p>\n

1.2.3 \u786e\u7acb\u4e00\u4e2a\u63a7\u5236\u7b56\u7565<\/span><\/p>\n

1.3 \u52a0\u5f3a\u65b9\u5f0fQBD<\/span><\/p>\n

1.3.1 \u8bc4\u4f30\u7406\u89e3\u548c\u7ec6\u5316\u751f\u4ea7\u5de5\u827a<\/span>
<\/p>\n

\u00d8 \u8fa8\u8bc6\u7269\u6599\u5c5e\u6027\u548c\u5de5\u827a\u53c2\u6570<\/span><\/p>\n

\u00d8 \u786e\u5b9a\u7269\u6599\u5c5e\u6027\u53ca\u5de5\u827a\u53c2\u6570\u4e0eCQA\u7684\u5173\u7cfb<\/span><\/p>\n

1.3.2 \u7ed3\u5408\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u5efa\u7acb\u66f4\u4f18\u7684\u63a7\u5236\u7b56\u7565\uff0c\u5982\u8bbe\u8ba1\u7a7a\u95f4\u7684\u5efa\u8bae<\/span><\/p>\n

2 \u4ec0\u4e48\u662fQBD<\/span><\/strong><\/p>\n

2.1 Quality by Design (QbD): ICH Q8\u7684\u5b9a\u4e49\uff1a<\/span><\/p>\n

A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.<\/span><\/p>\n

\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff0c\u662f\u4e00\u79cd\u7cfb\u7edf\u7684\u7814\u53d1\u65b9\u6cd5\uff0c\u5176\u4ee5\u9884\u5148\u8bbe\u5b9a\u76ee\u6807\u4e3a\u8d77\u59cb\uff0c\u57fa\u4e8e\u53ef\u9760\u7684\u79d1\u5b66\u548c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\uff0c\u5f3a\u8c03\u5bf9\u4ea7\u54c1\u548c\u751f\u4ea7\u8fc7\u7a0b\u7684\u7406\u89e3\uff0c\u53ca\u5bf9\u5de5\u827a\u7684\u63a7\u5236\u3002<\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

<\/span>\u7cfb\u7edf\u7814\u7a76\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n

\n

\u4ee5\u59cb\u4e3a\u7ec8\uff0c\u5148\u8bbe\u5b9a\u76ee\u6807\u518d\u884c\u52a8<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u9884\u5148\u8bbe\u5b9a\u76ee\u6807<\/span><\/p>\n<\/td>\n

\n

\u8bbe\u5b9a\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5\uff08QTPP<\/span>\uff09\u786e\u5b9a\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span>(CQA)<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4ea7\u54c1\u4e0e\u5de5\u827a\u7684\u7406\u89e3<\/span><\/p>\n<\/td>\n

\n

\u786e\u5b9a\u5173\u952e\u7269\u6599\u5c5e\u6027\uff08CMA<\/span>\uff09\u53ca\u5173\u952e\u5de5\u827a\u53c2\u6570<\/span>(CPP)<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u8fc7\u7a0b\u63a7\u5236<\/span><\/p>\n<\/td>\n

\n

\u5efa\u7acb\u9002\u5b9c\u63a7\u5236\u7b56\u7565<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53ef\u9760\u7684\u79d1\u5b66<\/span><\/p>\n<\/td>\n

\n

\u5229\u7528\u79d1\u6280\u6587\u732e\u3001\u5148\u8fdb\u77e5\u8bc6\u7b49<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u8d28\u91cf\u98ce\u9669\u7ba1\u7406<\/span><\/p>\n<\/td>\n

\n

\u98ce\u9669\u8bc4\u4f30(ICH Q9)<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/span><\/p>\n

3 \u4ec0\u4e48\u662fQBD\u7cfb\u7edf<\/strong><\/span><\/p>\n

\uff081\uff09\u786e\u5b9a\u76ee\u6807\u4ea7\u54c1\u7684\u7279\u6027\uff0c\u5236\u5b9a\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u3002<\/span><\/p>\n

\uff082\uff09\u8bbe\u8ba1\u6ee1\u8db3\u4ea7\u54c1CQA\u7684\u7269\u6599\u548c\u5de5\u827a\u6d41\u7a0b\u3002<\/span><\/p>\n

\uff083\uff09\u6301\u7eed\u76d1\u63a7\u548c\u66f4\u65b0\u5de5\u827a\u786e\u4fdd\u7a33\u5b9a\u7684\u8d28\u91cf\u3002<\/span><\/p>\n

\uff084\uff09\u786e\u5b9a\u548c\u63a7\u5236\u7269\u6599\u53ca\u5de5\u827a\u4e2d\u53d8\u5f02\u7684\u6765\u6e90\u3002<\/span><\/p>\n

\uff085\uff09\u4e86\u89e3\u7269\u6599\u5c5e\u6027\u548c\u5de5\u827a\u53c2\u6570\u5bf9\u4ea7\u54c1CQA\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

4 QBD\u7684\u5173\u952e\u8981\u7d20<\/strong><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5<\/span><\/p>\n

\uff08QTPP)<\/span><\/span><\/p>\n<\/td>\n

\n

\u4e3a\u7406\u60f3\u5730\u5b9e\u73b0\u836f\u7269\u9884\u671f\u8d28\u91cf\uff08\u6027\u80fd\uff09\u7684\u524d\u77bb\u6027\u603b\u7ed3<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u98ce\u9669\u8bc4\u4f30(Risk<\/span><\/span><\/p>\n

Assessment)<\/span><\/p>\n<\/td>\n

\n

\u5728\u98ce\u9669\u7ba1\u7406\u8fc7\u7a0b\u4e2d\u7ec4\u7ec7\u76f8\u5173\u4fe1\u606f\u4ee5\u652f\u6301\u98ce\u9669\u51b3\u7b56\u7684\u7cfb\u7edf\u5316\u8fc7\u7a0b<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/p>\n

(CQA)<\/span><\/p>\n<\/td>\n

\n

\u6307\u67d0\u79cd\u7269\u7406\u3001\u5316\u5b66\u3001\u751f\u7269\u5b66\u6216\u5fae\u751f\u7269\u5b66\u7684\u6027\u8d28\uff0c\u5e94\u5f53\u6709\u9002\u5f53\u9650\u5ea6\u3001\u8303\u56f4\u6216\u5206\u5e03\uff0c\u4fdd\u8bc1\u9884\u671f\u7684\u4ea7\u54c1\u8d28\u91cf<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5173\u952e\u7269\u6599\u5c5e\u6027<\/span><\/p>\n

(CMA)<\/span><\/p>\n<\/td>\n

\n

\u6307\u67d0\u79cd\u7269\u6599\uff08\u8d77\u59cb\u539f\u6599\u3001\u4e2d\u95f4\u4f53\u3001\u8bd5\u5242\uff09\u7684\u7269\u7406\u3001\u5316\u5b66\u3001\u751f\u7269\u5b66\u6216\u5fae\u751f\u7269\u5b66\u7684\u6027\u8d28\uff0c\u5e94\u5f53\u6709\u9002\u5f53\u9650\u5ea6\u3001\u8303\u56f4\u6216\u5206\u5e03<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5173\u952e\u5de5\u827a\u53c2\u6570(CPP)<\/span><\/span><\/p>\n<\/td>\n

\n

\u662f\u6307\u8be5\u5de5\u827a\u53c2\u6570\u7684\u53d8\u5f02\u4f1a\u5bf9\u4ea7\u54c1\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u4ea7\u751f\u5f71\u54cd\uff0c\u4ece\u800c\u9700\u8981\u76d1\u6d4b\u6216\u63a7\u5236\u4ee5\u786e\u4fdd\u8be5\u5de5\u827a\u751f\u4ea7\u51fa\u9884\u671f\u7684\u8d28\u91cf<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u63a7\u5236\u7b56\u7565(Control<\/span><\/span><\/p>\n

Strategy)<\/span><\/p>\n<\/td>\n

\n

\u662f\u6307\u4ece\u76ee\u524d\u7684\u4ea7\u54c1\u548c\u8fc7\u7a0b\u7684\u7406\u89e3\u6d3e\u751f\u51fa\u7684\u63a7\u5236\u8ba1\u5212\u7684\u8bbe\u7f6e\uff0c\u4ee5\u786e\u4fdd\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n

5 QBD-KEY ELEMENTS\u5173\u952e\u8981\u7d20 <\/strong><\/span><\/p>\n

6 \u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5<\/strong><\/span><\/p>\n

QTPP\uff08Quality Target Product Profile)<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

6.1 \u5bf9\u4e8eAPI\u6765\u8bf4\uff0cQTPP\u4e00\u822c\u4e3a\u5173\u6ce8\u4ee5\u4e0b\u51e0\u70b9\uff1a<\/span><\/p>\n

6.1.1 \u4e0eAPI \u5316\u5b66\u6027\u8d28\u76f8\u5173<\/span><\/p>\n

\u00d8 \u6742\u8d28\uff1a\u6709\u673a\u6742\u8d28\u6b8b\u7559\u6eb6\u5242\u6b8b\u7559\u8bd5\u5242<\/span><\/p>\n

\u00d8 \u5927\u4e8e\u5b9a\u91cf\u9650\u7684\u6742\u8d28\uff0c\u4e0d\u80fd\u9ad8\u4e8e\u539f\u7814<\/span><\/p>\n

6.1.2 \u5176\u4ed6\uff1a\u7b26\u5408\u65e2\u5b9a\u836f\u5178\u6216\u8005ICH\u8981\u6c42<\/span><\/p>\n

6.1.3 \u542b\u91cf\uff1a98.0~102.0% <\/span><\/p>\n

6.1.4 \u5176\u4ed6\u6307\u6807\uff1a\u5916\u89c2\u3001\u9274\u522b\u3001\u91cd\u91d1\u5c5e\u3001\u6c34\u5206\u3001\u5e72\u71e5\u5931\u91cd\u3001\u70bd\u707c\u6b8b\u6e23\u3001\u7b49\u7b49\u3002<\/span><\/p>\n

7 \u5efa\u7acb\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5\u7684\u57fa\u7840<\/strong><\/span><\/p>\n

7.1 \u539f\u6599\u836f\u7684\u5408\u6210\u76ee\u7684\uff1a<\/span><\/p>\n

\u4e3a\u5236\u5242\u63d0\u4f9b\u8d28\u91cf\u7a33\u5b9a\u7684\u539f\u6599\u836f\uff0c\u4ee5\u4f7f\u5176\u80fd\u751f\u4ea7\u51fa\u7b26\u5408\u9884\u671f\u8d28\u91cf\u8981\u6c42\u7684\u5236\u5242\u4ea7\u54c1\u3002<\/span><\/p>\n

7.2 ICH (Q11):<\/span><\/p>\n

\u786e\u7acb\u539f\u6599\u836f\u7684\u9884\u671f\u8d28\u91cf\u65f6\uff0c\u5e94\u8003\u8651\u539f\u6599\u836f\u5728\u5236\u5242\u4e2d\u7684\u7528\u9014\uff0c\u5373\u660e\u786e\u548c\u7406\u89e3\u5bf9\u5236\u5242\u4ea7\u54c1\u7814\u53d1\u4ea7\u751f\u5f71\u54cd\u7684\u7269\u7406\u3001\u5316\u5b66\u3001\u751f\u7269\u4e0e\u5fae\u751f\u7269\u5c5e\u6027\u6216\u7279\u6027\uff08\u4f8b\u5982\uff0c\u539f\u6599\u836f\u7684\u6eb6\u89e3\u6027\u53ef\u80fd\u5f71\u54cd\u5242\u578b\u7684\u9009\u62e9\uff09\u3002<\/span><\/p>\n

8 \u5173\u952e\u8d28\u91cf\u5c5e\u6027-\u6982\u5ff5<\/strong><\/span><\/p>\n

\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u662f\u4e00\u4e2a\u7269\u7406\u3001\u5316\u5b66\u3001\u751f\u7269\u5b66\u6216\u5fae\u751f\u7269\u5b66\u5c5e\u6027\u6216\u7279\u5f81\uff0c\u5728\u67d0\u4e2a\u5408\u9002   \u7684\u9650\u5ea6\u3001\u8303\u56f4\u6216\u5206\u5e03\u5185\u624d\u80fd\u786e\u4fdd\u6240\u9700\u7684\u4ea7\u54c1\u8d28\u91cf\u3002<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

9 <\/span>\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span> \u2013\u5982\u4f55\u5b9a\u4e49\u539f\u6599\u836f\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/strong><\/span><\/h1>\n

9.1\u5982\u4f55\u5b9a\u4e49\u539f\u6599\u836f\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff1a<\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

10 <\/span>\u4e0e\u836f\u54c1\u6709\u5173\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/strong><\/span><\/h1>\n\n\n\n\n\n\n\n\n
\n

\u836f\u54c1\u76ee\u6807\u8d28\u91cf\u6982\u51b5<\/span><\/p>\n<\/td>\n

\n

API\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/span><\/p>\n<\/td>\n

\n

\u6d4b\u8bd5\u9879\u76ee<\/span><\/p>\n<\/td>\n

\n

\u5173\u952e\u6216\u4e0d\u5173\u952e<\/span><\/p>\n<\/td>\n

\n

\u539f\u7406<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9274\u522b\/<\/span>\u542b\u91cf<\/span>\/<\/span>\u5747\u4e00\u6027<\/span><\/span><\/p>\n<\/td>\n

\n

\u5916\u89c2\u63cf\u8ff0<\/span><\/p>\n<\/td>\n

\n

\u76ee\u89c6\u68c0\u6d4b<\/span><\/p>\n<\/td>\n

\n

Q6A\u51b3\u7b56\u6811<\/span><\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

\u9274\u522b<\/span><\/p>\n<\/td>\n

\n

UV\/IR\/HPLC<\/span><\/p>\n<\/td>\n

\n

\u5173\u952e<\/span><\/p>\n<\/td>\n

\n

\u6b63\u786e\u7684API <\/span>\u5206\u5b50\u7ed3\u6784<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u542b\u91cf<\/span><\/p>\n<\/td>\n

\n

\u542b\u91cf\u68c0\u6d4b<\/span><\/p>\n<\/td>\n

\n

\u5173\u952e<\/span><\/p>\n<\/td>\n

\n

\u836f\u54c1\u6709\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6742\u8d28\u542b\u91cf<\/span><\/p>\n<\/td>\n

\n

API\u6742\u8d28\u8c31<\/span><\/span><\/p>\n<\/td>\n

\n

\u6709\u673a\u6742\u8d28\uff08\u542b\u624b\u6027\u6742\u8d28\uff09<\/span><\/p>\n

\u65e0\u673a\u6742\u8d28\u91cd\u91d1\u5c5e\u6b8b\u7559\u6eb6\u5242<\/span><\/p>\n<\/td>\n

\n

\u5173\u952e<\/span><\/p>\n<\/td>\n

\n

\u836f\u54c1\u5b89\u5168\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6eb6\u51fa\u5ea6\/ <\/span>\u7a33\u5b9a\u6027<\/span><\/span><\/p>\n<\/td>\n

\n

\u6676\u578b\/<\/span>\u9897\u7c92\u5ea6<\/span><\/span><\/p>\n<\/td>\n

\n

DSC\/XPRD\/PSD<\/span><\/p>\n<\/td>\n

\n

Q6A\u51b3\u7b56\u6811<\/span><\/span><\/p>\n<\/td>\n

\n

\u836f\u54c1\u751f\u7269\u7b49\u6548\u6027\uff1b\u7a33\u5b9a\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

11 <\/span>\u5173\u952e\u5de5\u827a\u53c2\u6570<\/span><\/strong><\/span><\/h1>\n

11.1 \u5b9a\u4e49<\/span><\/h2>\n

\u5de5\u827a\u53c2\u6570\u7684\u53d8\u5316\u5f71\u54cd\u8d28\u91cf\u5c5e\u6027\uff0c\u56e0\u6b64\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u9700\u8981\u63a7\u5236\u8fd9\u4e9b\u53c2\u6570\u4ee5\u4fdd\u8bc1\u8fbe\u5230\u9884\u671f\u7684\u8d28\u91cf\u3002\u4e00\u4e2a\u5173\u952e\u5de5\u827a\u53c2\u6570\u5373\u4f7f\u53d7\u63a7\u4e5f\u4ecd\u7136\u662f\u5173\u952e\u7684\u3002\u56e0\u6b64\uff0c\u5173\u952e\u5de5\u827a\u53c2\u6570\u662f\u6307\u90a3\u4e9b\u5df2\u8bc1\u5b9e\u5bf9\u539f\u6599\u836f\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u6709\u5f71\u54cd\u7684\u53c2\u6570\u3002<\/span><\/p>\n

11.2 \u5de5\u827a\u53c2\u6570\u4e4b\u95f4\u5173\u7cfb<\/span><\/h2>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

<\/span> 11.3 \u53c2\u6570\u4e4b\u95f4\u5173\u7cfb<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

11.4\u64cd\u4f5c\u5173\u952e\u53c2\u6570\u5904\u7406<\/span><\/p>\n

11.4.1 \u4e00\u65e6\u5b9a\u4e49\u4e3a\u64cd\u4f5c\u5173\u952e\uff0c\u9700\u8981\u91c7\u53d6\u4ee5\u4e0b\u63aa\u65bd\uff0c\u6700\u597d\u5c06\u64cd\u4f5c\u6807\u51c6\u504f\u5dee\u964d\u4f4e\uff0c\u4ee5\u6ee1\u8db3\u975e\u64cd\u4f5c\u5173\u952e\u7684\u8981\u6c42\uff1a<\/span><\/p>\n

\u00d8 \u66f4\u65b0\u8bbe\u5907<\/span><\/p>\n

\u00d8 \u589e\u52a0\u81ea\u52a8\u5316\u63a7\u5236<\/span><\/p>\n

\u00d8 \u5bf9\u4eba\u5458\u8fdb\u884c\u57f9\u8bad\uff0c\u63d0\u9ad8\u64cd\u4f5c\u6280\u80fd<\/span><\/p>\n

\u00d8 \u4e13\u4eba\u64cd\u4f5c<\/span><\/p>\n

\u00d8 \u589e\u52a0\u53cc\u4eba\u590d\u6838<\/span><\/p>\n

\u00d8 \u589e\u52a0IPC\u76d1\u63a7<\/span><\/p>\n

\u00d8 \u3002\u3002\u3002<\/span><\/p>\n

12   CMA,CPP,CQA\u4e4b\u95f4\u7684\u5173\u7cfb<\/span><\/strong><\/p>\n

<\/span><\/strong><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

<\/span><\/strong><\/p>\n

\u5982\u679c\u4e00\u79cd\u8f93\u51fa\u7269\u6599\u6210\u4e3a\u53e6\u4e00\u64cd\u4f5c\u5355\u5143\u7684\u8f93\u5165\u7269\u6599\u65f6\uff0c\u5b83\u8f93\u51fa\u65f6\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5c31\u53ef\u80fd\u53d8\u6210\u8f93\u5165\u65f6\u7684\u5173\u952e\u7269\u6599\u5c5e\u6027<\/span><\/p>\n

13 <\/span>\u8bbe\u8ba1\u7a7a\u95f4\uff08<\/span>ICH Q8<\/span><\/strong>\uff09<\/span><\/strong><\/span><\/h1>\n

\u00b2 <\/span>\u5b9a\u4e49\uff1a\u4e0e\u4fdd\u8bc1\u8d28\u91cf\u76f8\u5173\u7684\u8f93\u5165\u53d8\u91cf\uff08\u5982\u7269\u6599\u5c5e\u6027\uff09\u548c\u5de5\u827a\u53c2\u6570\u7684\u591a\u79cd\u7ec4\u5408\u53ca\u5176\u76f8\u4e92\u4f5c\u7528\u3002<\/span><\/span><\/p>\n

\u00b2 <\/span>\u5728\u8bbe\u8ba1\u7a7a\u95f4\u8303\u56f4\u5185\u7684\u64cd\u4f5c\u4e0d\u4f5c\u4e3a\u53d8\u66f4\uff08\u5728\u65e5\u5e38\u7684\u76d1\u7ba1\u4e2d\u4e0d\u518d\u8fdb\u884c\u5ba1\u6279\uff09\u3002\u5728\u8bbe\u8ba1\u7a7a\u95f4\u8303\u56f4\u4e4b\u5916\u8fdb\u884c\u7684\u64cd\u4f5c\u90fd\u7b97\u4f5c\u53d8\u66f4\uff0c\u4e00\u822c\u9700\u7531\u76d1\u7ba1\u90e8\u95e8\u8fdb\u884c\u5ba1\u6279\u3002<\/span><\/span><\/p>\n

\u00b2 <\/span>\u8bbe\u8ba1\u7a7a\u95f4\u662f\u7531\u7533\u8bf7\u4eba\u63d0\u51fa\uff0c\u5e76\u63d0\u4ea4\u7ed9\u76d1\u7ba1\u90e8\u95e8\u8fdb\u884c\u8bc4\u4f30\u548c\u5ba1\u6279\u3002<\/span><\/span><\/p>\n

14 <\/span>QBD\u7406\u5ff5\u7684\u5173\u952e\u2014\u2014<\/span><\/span><\/strong>\u8bbe\u8ba1\u7a7a\u95f4<\/span><\/strong><\/span><\/h1>\n

\u8bbe\u8ba1\u7a7a\u95f4\uff08Design space\uff09<\/span><\/p>\n

\u662f\u5df2\u88ab\u8bc1\u660e\u6709\u8d28\u91cf\u4fdd\u969c\u4f5c\u7528\u7684\u7269\u6599\u53d8\u91cf\u548c\u5de5\u827a\u53c2\u6570\u7684\u591a\u7ef4\u7ec4\u5408\u548c\u4ea4\u4e92\u4f5c\u7528<\/span><\/p>\n

\u77e5\u8bc6\u7a7a\u95f4\uff1aCQAs\u4e0e\u7269\u6599\u5c5e\u6027\u548c\u5de5\u827a\u53c2\u6570\u7684\u5173\u7cfb<\/span>
<\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

15 <\/span>\u8bbe\u8ba1\u7a7a\u95f4\u7684\u786e\u5b9a<\/span><\/strong><\/span><\/h1>\n

15.1 \u5148\u7533\u8bf7\u539f\u5219<\/span><\/h2>\n

\u7ed3\u5408\u5b9e\u9a8c\u6570\u636e\u548c\u5316\u5b66\u3001\u7269\u7406\u3001\u5de5\u7a0b\u7b49\u673a\u7406\u5bf9\u4ea7\u54c1\u6027\u80fd\u8fdb\u884c\u6a21\u62df\u548c\u9884\u6d4b<\/span><\/p>\n

15.2 \u7edf\u8ba1\u8bbe\u8ba1\u7684\u5b9e\u9a8c<\/span><\/h2>\n

\u7528\u6765\u786e\u5b9a\u591a\u53c2\u6570\u7684\u5f71\u54cd\u548c\u5b83\u4eec\u4e4b\u95f4\u76f8\u4e92\u4f5c\u7528\u7684\u6709\u6548\u65b9\u6cd5<\/span> <\/span><\/span><\/p>\n

15.3 \u89c4\u6a21\u5316\u5173\u7cfb<\/span><\/h2>\n

\u4e00\u4e2a\u534a\u7ecf\u9a8c\u7684\u65b9\u6cd5\uff0c\u7528\u4e8e\u5728\u4e0d\u540c\u89c4\u6a21\uff08\u4ef6\uff09\u8bbe\u5907\u4e4b\u95f4\u8f6c\u5316\u64cd\u4f5c\u6761\u4ef6<\/span><\/p>\n

16 <\/span>\u8bbe\u8ba1\u7a7a\u95f4<\/span>Design Space<\/span><\/strong><\/span><\/h1>\n

\u67d0\u4e2a\u6700\u7ec8\u4ea7\u54c1\u5355\u6742A\u7684\u8d28\u91cf\u6807\u51c6\u4e3a\u22640.20%<\/span>\uff0c\u6765\u6e90\u4e8e\u7c97\u54c1\u4e2d\u5355\u6742 A<\/span>\uff0c\u4f46\u5728\u7cbe\u5236\u8fc7\u7a0b\u4e2d\u53ef\u4ee5\u53bb\u9664\u4e00\u90e8\u5206\uff0c\u4e3b\u8981\u8d77\u4f5c\u7528\u7684\u662fpH<\/span>\u503c\uff0c pH<\/span>\u503c\u8d8a\u4f4e\uff0c\u53bb\u9664\u7684\u80fd\u529b\u8d8a\u5f3a\uff0c\u4f46\u4ea7\u54c1\u6536\u7387\u8d8a\u4f4e\uff0c\u5982\u4e0b\u8868\u6240\u793a\uff1a<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u7c97\u54c1\u5355\u6742A %<\/span><\/span><\/p>\n<\/td>\n

\n

\u7cbe\u5236\u4e2dpH<\/span>\u503c<\/span><\/span><\/p>\n<\/td>\n

\n

\u7cbe\u54c1\u5355\u6742A %<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.3<\/span><\/p>\n<\/td>\n

\n

6.00<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.4<\/span><\/p>\n<\/td>\n

\n

5.80<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.5<\/span><\/p>\n<\/td>\n

\n

5.65<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.6<\/span><\/p>\n<\/td>\n

\n

5.50<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.7<\/span><\/p>\n<\/td>\n

\n

5.41<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.8<\/span><\/p>\n<\/td>\n

\n

5.30<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0.9<\/span><\/p>\n<\/td>\n

\n

5.25<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1.0<\/span><\/p>\n<\/td>\n

\n

5.20<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1.1<\/span><\/p>\n<\/td>\n

\n

5.15<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1.2<\/span><\/p>\n<\/td>\n

\n

5.10<\/span><\/p>\n<\/td>\n

\n

0.20<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span>u <\/span>\u5982\u679c\u91c7\u7528\u4f20\u7edf\u65b9\u5f0f\uff1a\u5355\u7eaf\u7684\u5c06\u4e24\u4e2a\u8f93\u5165\u53d8\u91cf\uff08\u7c97\u54c1\u5355\u6742\uff09\u548c\u5de5\u827a\u53c2\u6570\u56fa\u5b9a\u5316\uff0c\u5982\u7c97\u54c1\u5355\u6742\u5b9a\u4e49\u4e3a\u2264<\/span>0.80%<\/span>\uff0c\u4e3a\u4e86\u4fdd\u8bc1\u7cbe\u54c1\u4e2d\u5355\u6742<\/span>A <\/span>\u2264<\/span>0.20% <\/span>\uff0c\u7cbe\u5236\u4e2dpH\u503c\u5b9a\u4e49\u5c31\u8981\u5c0f\u4e8e5.30<\/span>\uff0c\u8fd9\u6837\uff0c\u51fa\u73b0\u4e24\u4e2a\u95ee\u9898\uff1a<\/span><\/span><\/p>\n

\u00d8 <\/span>\u5bf9\u4e8e\u7c97\u54c1\u5355\u6742<\/span>A<\/span>\u5c0f\u4e8e<\/span>0.8%<\/span>\u7684<\/span>pH<\/span>\u503c\u7684\u8fc7\u4f4e\u5bfc\u81f4\u6536\u7387\u964d\u4f4e\u5f88\u591a<\/span><\/span><\/p>\n

\u00d8 <\/span>\u5bf9\u4e8e\u7c97\u54c1\u5355\u6742<\/span>A<\/span>\u5927\u4e8e<\/span>0.8%<\/span>\u7684\uff0c\u4ece\u6ce8\u518c\u6cd5\u89c4\u7684\u89d2\u5ea6\u8bb2\u6ca1\u6709\u529e\u6cd5\u5904\u7406\uff0c\u56e0\u4e3a\u5f53\u521d\u7533\u62a5\u7684\u7c97\u54c1\u5355\u6742\u4e3a\u22640.8%<\/span>\u3002<\/span><\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

u <\/span>\u5982\u679c\u91c7\u7528\u8bbe\u8ba1\u7a7a\u95f4\u6982\u5ff5\uff1a\u4e0d\u518d\u5c06\u8f93\u5165\u53d8\u91cf\uff08\u7c97\u54c1\u5355\u6742\uff09\u548c\u5de5\u827a\u53c2\u6570\u56fa\u5b9a\u5316\uff0c\u800c\u662f\u6839\u636e\u7c97\u54c1\u5355\u6742A\u7684\u60c5\u51b5\u8c03\u8282\u7cbe\u5236\u5de5\u827a\u4e2d<\/span>pH\u503c\uff0c\u4ece\u800c\u4fdd\u8bc1\u7cbe\u54c1\u4e2d\u5355\u6742<\/span>A\u2264<\/span>0.20%\u3002<\/span><\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

17 <\/span>\u63a7\u5236\u7b56\u7565<\/span><\/strong><\/span><\/h1>\n

17.1 \u5f00\u53d1\u63a7\u5236\u7b56\u7565\u7684\u8003\u8651\u4e8b\u9879\uff1a<\/span><\/h2>\n

\u00d8 <\/span>\u57fa\u4e8e\u5bf9\u4ea7\u54c1\u548c\u5de5\u827a\u7684\u7406\u89e3\uff0c\u4fdd\u969c\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf\u7684\u63a7\u5236\u65b9\u5f0f<\/span><\/span><\/p>\n

\u00d8 <\/span>\u63a7\u5236\u7b56\u7565\u5e94\u4fdd\u8bc1\u6bcf\u79cd\u539f\u6599\u836f\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5904\u4e8e\u9002\u5f53\u7684\u8303\u56f4\u3001\u9650\u5ea6\u6216\u5206\u5e03\u533a\u57df\u3002<\/span><\/span><\/p>\n

\u00d8 <\/span>CQA\u4e0e\u8d28\u91cf\u6807\u51c6\u4e4b\u95f4\u7684\u5173\u7cfb\u5982\u4e0b\uff1a<\/span> <\/span><\/p>\n

\u00fc <\/span>CQA<\/span>\u5168\u90e8\u5217\u5165\u8d28\u91cf\u6807\u51c6\uff0c\u901a\u8fc7\u5bf9\u6210\u54c1\u68c0\u6d4b\u786e\u8ba4<\/span> <\/span><\/span><\/p>\n

\u00fc <\/span>CQA<\/span>\u5168\u90e8\u5217\u5165\u8d28\u91cf\u6807\u51c6\uff0c\u4f46\u901a\u8fc7\u4e0a\u6e38\u63a7\u5236\u786e\u8ba4<\/span><\/span><\/p>\n

\u00fc <\/span>CQA<\/span>\u4e0d\u5217\u5165\u8d28\u91cf\u6807\u51c6\uff0c\u4f46\u901a\u8fc7\u4e0a\u6e38\u63a7\u5236\u786e\u4fdd<\/span><\/span><\/p>\n

\u00d8 <\/span>\u4e0a\u6e38\u63a7\u5236\u662f\u57fa\u4e8e\u5bf9<\/span>CQA<\/span>\u53d8\u5f02\u6765\u6e90\u7684\u8bc4\u4f30\u548c\u7406\u89e3<\/span><\/span><\/p>\n

\u00d8 <\/span>\u8fd8\u8981\u8003\u8651\u4e0b\u6e38\u56e0\u7d20\u7684\u5f71\u54cd\uff1a<\/span><\/span><\/p>\n

\u00fc <\/span>\u6e29\u5ea6\u53d8\u5316<\/span><\/span><\/p>\n

\u00fc <\/span>\u6c27\u5316\u6761\u4ef6<\/span><\/span><\/p>\n

\u00fc <\/span>\u5149\u7167<\/span><\/span><\/p>\n

\u00fc <\/span>\u76f8\u5bb9\u6027\u7b49<\/span><\/span><\/p>\n

\u00d8 <\/span>\u6839\u636e\u98ce\u9669\u548c\u5355\u4e00\u63a7\u5236\u80fd\u529b\uff0c\u5bf9\u7279\u5b9a\u7684<\/span>CQA<\/span>\uff0c\u5728\u5de5\u827a\u4e2d\u8bbe\u7f6e\u5355\u4e00\u6216\u591a\u4e2a\u63a7\u5236\u70b9\u3002<\/span><\/span><\/p>\n

\u00d8 <\/span>\u4e0b\u6e38\u7269\u6599\u63a7\u5236\u8981\u4e25\u683c\u4e8e\u4e0a\u6e38\u7269\u6599\u7684\u63a7\u5236<\/span><\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

<\/span><\/p>\n

1.\u786e\u5b9a\u6240\u6709\u53ef\u80fd\u5f71\u54cd\u751f\u4ea7\u5de5\u827a\u7684\u5de5\u827a\u53c2\u6570\u548c\u7269\u6599\u5c5e\u6027<\/span><\/p>\n

2.\u5229\u7528\u98ce\u9669\u8bc4\u4f30\u7684\u65b9\u6cd5\u786e\u5b9a\u9ad8\u98ce\u9669\u53c2\u6570\u548c\/<\/span>\u6216\u5c5e\u6027<\/span><\/p>\n

3.\u786e\u5b9a\u8fd9\u4e9b\u9ad8\u98ce\u9669\u53c2\u6570\u548c\u5c5e\u6027\u7684\u6c34\u5e73\u548c\u8303\u56f4<\/span><\/p>\n

4.\u91c7\u7528\u5408\u9002\u7684DOE<\/span>\u6765\u8bbe\u8ba1\u5b9e\u9a8c\u65b9\u6848<\/span><\/p>\n

5.\u5f00\u5c55\u5b9e\u9a8c\u7814\u7a76<\/span><\/p>\n

6.\u5206\u6790\u5b9e\u9a8c\u6570\u636e\uff0c\u786e\u5b9a\u54ea\u4e9b\u5de5\u827a\u53c2\u6570\u6216\u7269\u6599\u5c5e\u6027\u662f\u5173\u952e\u7684<\/span><\/p>\n

7.\u5f53\u4e00\u4e2a\u5de5\u827a\u53c2\u6570\u6216\u7269\u6599\u5c5e\u6027\u53d1\u751f\u5b9e\u8d28\u6027\u53d8\u5316\u5c31\u80fd\u5bfc\u81f4\u65e0\u6cd5\u6ee1\u8db3\u9884\u671f\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u65f6\uff0c\u8be5\u5de5\u827a\u53c2\u6570\u6216\u7269\u6599\u5c5e\u6027\u5c31\u662f\u81f3\u5173\u91cd\u8981\u7684<\/span><\/p>\n

8.\u5bf9\u4e8e\u5173\u952e\u53c2\u6570\u6216\u5c5e\u6027\uff0c\u5e94\u9650\u5b9a\u53ef\u63a5\u53d7\u7684\u8303\u56f4\uff08\u8bbe\u8ba1\u7a7a\u95f4\uff09\u3002\u800c\u5bf9\u4e8e\u975e\u5173\u952e\u53c2\u6570\u6216\u5c5e\u6027\uff0c\u5219\u53ef\u63a5\u53d7\u8303\u56f4\u5c31\u662f\u7814\u7a76\u8303\u56f4<\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u523617.2 QBD\u7406\u5ff5\u8d2f\u7a7f\u4e8e\u5de5\u827a\u5f00\u53d1\u5168\u8fc7\u7a0b<\/span><\/strong><\/span><\/p>\n

\u5de5\u827a\u8bbe\u8ba1\u9636\u6bb5<\/span><\/p>\n

\u2022 \u660e\u786e\u76ee\u6807\u5206\u5b50\u7684\u8d28\u91cf\u8981\u6c42<\/span><\/p>\n

\u2022 \u8bbe\u8ba1\u5408\u7406\u8def\u7ebf\u907f\u514d\u6742\u8d28\u7684\u751f\u6210\uff0c\u4fdd\u8bc1\u539f\u6599\u836f\u8d28\u91cf<\/span><\/p>\n

\u2022 \u9009\u62e9\u5408\u9002\u7684\u8d77\u59cb\u539f\u6599<\/span><\/p>\n

\u2022 \u51cf\u5c11\u5bf9\u73af\u5883\u6c61\u67d3\uff0c\u964d\u4f4e\u751f\u4ea7\u6210\u672c<\/span><\/p>\n

\u5de5\u827a\u786e\u8ba4\u9636\u6bb5<\/span><\/p>\n

\u2022 \u660e\u786e\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u548c\u5173\u952e\u5de5\u827a\u53c2\u6570<\/span><\/p>\n

\u2022 \u8fdb\u884c\u591a\u53d8\u91cf\u5206\u6790\uff0c\u8fdb\u884c\u5e73\u884c\u6b63\u4ea4\u8bd5\u9a8c<\/span><\/p>\n

\u2022 \u786e\u5b9a\u53c2\u6570\u53ef\u63a7\u5236\u8303\u56f4<\/span><\/p>\n

\u2022 \u5efa\u7acb\u7269\u6599\u53ca\u4ea7\u54c1\u8d28\u91cf\u6807\u51c6<\/span><\/p>\n

\u5de5\u827a\u9a8c\u8bc1\u9636\u6bb5<\/span><\/p>\n

\u2022 \u660e\u786e\u89c4\u6a21\u76f8\u5173\u53c2\u6570<\/span><\/p>\n

\u2022 \u8fdb\u884c\u89c4\u6a21\u653e\u5927\u8bd5\u9a8c\uff0c\u786e\u5b9a\u53c2\u6570\u8303\u56f4<\/span><\/p>\n

17.2.1 \u5de5\u827a\u8bbe\u8ba1\u9636\u6bb5<\/span><\/strong><\/h3>\n

\uff081\uff09\u660e\u786e\u76ee\u6807\u5206\u5b50\u7684\u8d28\u91cf\u6982\u51b5\uff08\u7ec8\u4ea7\u54c1\u7684\u8d28\u91cf\u63a7\u5236\u76ee\u6807\uff09\uff1a<\/span><\/p>\n

\u7eaf\u5ea6\u3001\u6742\u8d28\u3001\u5f02\u6784\u4f53\u3001\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u3001\u6b8b\u7559\u6eb6\u5242\u3001\u6676\u578b\u3001\u7c92\u5ea6\u7b49\u3002<\/span><\/p>\n

\u8bbe\u5b9a\u4f9d\u636e\uff1a<\/span><\/p>\n

\u00d8 <\/span>\u5df2\u4e0a\u5e02\u540c\uff08\u7c7b\uff09\u4ea7\u54c1\u8d28\u91cf\u63a7\u5236\uff0c<\/span>ICH<\/span>\u6307\u5bfc\u539f\u5219\uff0c\u524d\u671f\u7814\u53d1\u7ecf\u9a8c<\/span><\/span><\/p>\n

\u00d8 <\/span>\u6839\u636e\u5236\u5242\uff08\u6700\u7ec8\u4e0a\u5e02\u7684\u662f\u5236\u5242\uff09\u8d28\u91cf\u63a7\u5236\u8981\u6c42\uff0c\u52a0\u5f3a\u539f\u6599\u836f\u8d28\u91cf\u63a7\u5236<\/span><\/span><\/p>\n\n\n\n\n\n\n\n
\n

\u539f\u6599\u836f\u8d28\u91cf\u63a7\u5236<\/span><\/p>\n<\/td>\n

\n

\u4e0e\u5236\u5242\u8d28\u91cf\u7684\u76f8\u5173\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7c92\u5ea6<\/span><\/p>\n<\/td>\n

\n

\u5f71\u54cd\u5236\u5242\u6eb6\u51fa\u5ea6\uff0c\u4ece\u800c\u5f71\u54cd\u836f\u7269\u6709\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u542b\u91cf<\/span><\/p>\n<\/td>\n

\n

\u5f71\u54cd\u5236\u5242\u6548\u529b\u548c\u542b\u91cf\u5747\u5300\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6742\u8d28\uff1a\u6709\u5173\u7269\u8d28\u3001\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u3001\u6b8b\u7559\u6eb6\u5242\u3001\u6b8b\u7559\u91d1\u5c5e\u50ac\u5316\u5242\u7b49<\/span><\/p>\n<\/td>\n

\n

\u5f71\u54cd\u5236\u5242\u6742\u8d28\u548c\u7a33\u5b9a\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9274\u522b<\/span><\/p>\n<\/td>\n

\n

\u5236\u5242\u9274\u522b<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff082\uff09\u5de5\u827a\u8def\u7ebf\u7684\u8bbe\u8ba1\u548c\u9009\u62e9\uff1a<\/span><\/p>\n

\u00d8 <\/span>\u539f\u6599\u548c\u8bd5\u5242\u7684\u6709\u6548\u6765\u6e90<\/span><\/span><\/p>\n

\u00d8 <\/span>\u5408\u6210\u6b65\u9aa4\u7684\u6700\u5c11\u5316<\/span><\/span><\/p>\n

\u4e0e\u4ea7\u54c1\u7684\u8d28\u91cf\u5bc6\u5207\u76f8\u5173<\/span><\/p>\n

\u00d8 <\/span>\u53ef\u80fd\u5de5\u827a\u76f8\u5173\u6742\u8d28\u5206\u6790\uff08\u539f\u6599\u53ca\u4e2d\u95f4\u4f53\u6b8b\u7559\u3001\u526f\u4ea7\u7269\u3001\u91d1\u5c5e\u50ac\u5316\u5242\u3001\u6b8b\u7559\u6eb6\u5242\uff1b\u901a\u8fc7\u8def\u7ebf\u9009\u62e9\u548c\u8c03\u8282\u5c3d\u53ef\u80fd\u51cf\u5c11\u9700\u63a7\u5236\u7684\u76f8\u5173\u6742\u8d28\uff09<\/span><\/span><\/p>\n

\u00d8 <\/span>\u8bd5\u5242\u53ca\u4e2d\u95f4\u4f53\u7684\u9057\u4f20\u6bd2\u6027\u5206\u6790\uff08<\/span>FDA<\/span>\u53ca\u6b27\u76df\u76f8\u5173\u6307\u5bfc\u539f\u5219\uff0c\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u9700\u63a7\u5236\u5728<\/span>1.5ug\/<\/span>\u5929\u7684\u66b4\u9732\u91cf\uff0c\u9650\u5ea6\u8f83\u4e00\u822c\u6742\u8d28\u4e25\u683c\u5f88\u591a\uff0c\u901a\u8fc7\u8def\u7ebf\u9009\u62e9\u548c\u8c03\u8282\u5c3d\u53ef\u80fd\u907f\u514d\u5177\u6709\u9057\u4f20\u6bd2\u6027\u8bd5\u5242\u7684\u4f7f\u7528\u548c\u5177\u6709\u9057\u4f20\u6bd2\u6027\u4e2d\u95f4\u4f53\u7684\u4ea7\u751f\uff09<\/span><\/span><\/p>\n

\u00d8 <\/span>\u52b3\u52a8\u9632\u62a4\u53ca\u73af\u5883\u6c61\u67d3<\/span><\/span><\/p>\n

\u00d8 <\/span>\u624b\u6027\u4e2d\u5fc3\u7684\u5408\u7406\u5f15\u5165<\/span><\/span><\/p>\n

\u00d8 <\/span>\u6536\u7387\u548c\u6210\u672c\u7684\u6700\u4f18\u5316<\/span><\/span><\/p>\n

17.2.2 \u5de5\u827a\u786e\u8ba4\u9636\u6bb5<\/span><\/strong><\/h3>\n

\u786e\u5b9a\u6574\u4e2a\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\u4e2d\u7684\u5173\u952e\u63a7\u5236\u70b9\u53ca\u5173\u952e\u5de5\u827a\u53c2\u6570<\/span><\/p>\n

\u98ce\u9669\u5206\u6790\uff1a<\/span><\/strong>\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u786e\u5b9a\u5173\u952e\u6b65\u9aa4\uff0c\u5b9a\u4e49\u6f5c\u5728\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\uff0c\u5e76\u786e\u5b9a\u53c2\u6570\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u3002<\/span><\/span><\/p>\n

\u8bd5\u9a8c\u8bbe\u8ba1\uff1a<\/span><\/strong>\u8fdb\u884c\u591a\u53d8\u91cf\u5206\u6790\uff0c\u786e\u5b9a\u8bbe\u8ba1\u7a7a\u95f4\u6216\u5df2\u8bc1\u660e\u7684\u53ef\u63a5\u53d7\u8303\u56f4\u3002<\/span><\/span><\/p>\n

\u63a7\u5236\u7b56\u7565<\/span><\/strong>\uff1a<\/span><\/strong>\u786e\u5b9a\u5173\u952e\u6b65\u9aa4\u3001\u533a\u5206\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08<\/span>CPP)\u3001\u91cd\u8981\u5de5\u827a\u53c2\u6570\uff08<\/span>KPP<\/span>\uff09\u548c\u975e\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08<\/span>NCPP<\/span>\uff09\uff1b\u786e\u5b9a\u76f8\u5173\u53c2\u6570\u7684\u63a7\u5236\u8303\u56f4\u3002<\/span><\/span><\/span><\/p>\n

17.2.3 \u5de5\u827a\u9a8c\u8bc1\u9636\u6bb5<\/span><\/strong><\/h3>\n

\u4ece\u5c0f\u8bd5\u89c4\u6a21\u5230\u4e2d\u8bd5\u89c4\u6a21\u518d\u5230\u5546\u4e1a\u5316\u89c4\u6a21\u9010\u7ea7\u653e\u5927\u8fc7\u7a0b\u4e2d\uff0c\u6839\u636e\u653e\u5927\u6548\u5e94\uff0c\u4e0d\u65ad\u8c03\u6574\u53c2\u6570\u63a7\u5236\u8303\u56f4\uff0c\u4ee5\u4fdd\u8bc1\u4ea7\u54c1\u7684\u5408\u683c\u7387\u3002<\/span><\/p>\n

<\/span>\u8bd5\u9a8c\u5ba4\u89c4\u6a21<\/span>\u2014\u2014\u4e2d\u8bd5\u89c4\u6a21\u2014\u2014\u8bd5\u751f\u4ea7\u89c4\u6a21<\/span><\/strong><\/span><\/p>\n

<\/span><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP)\u3001\u91cd\u8981\u5de5\u827a\u53c2\u6570\uff08<\/span>KPP<\/span>\uff09<\/span>
<\/p>\n

\u4e0e\u89c4\u6a21\u76f8\u5173\u7684\u5de5\u827a\u53c2\u6570<\/span><\/strong>
<\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236
<\/p>\n

17.2.4 QBD\u5728\u5de5\u827a\u653e\u5927\u548c\u9a8c\u8bc1\u4e2d\u7684\u4f18\u52bf<\/span><\/span><\/strong><\/span><\/h3>\n

\u00d8 <\/span>\u5de5\u827a\u53c2\u6570\u4e0e\u4ea7\u54c1\u8d28\u91cf\u7684\u76f8\u5173\u6027\u660e\u786e\uff0c\u53ef\u4f7f\u5173\u952e\u5de5\u827a\u53c2\u6570\u59cb\u7ec8\u63a7\u5236\u5728\u53ef\u63a5\u53d7\u7684\u8303\u56f4\u5185\uff0c\u63d0\u9ad8\u4ea7\u54c1\u8d28\u91cf\u5408\u683c\u7684\u5fc5\u7136\u6027\uff0c\u5c3d\u53ef\u80fd\u51cf\u5c11\u4e0d\u5408\u683c\u4ea7\u54c1\u7684\u4ea7\u751f\u7387\u3002<\/span><\/span><\/p>\n

\u00d8 <\/span>\u6839\u636e\u53c2\u6570\u76f8\u5173\u6027\u7684\u5206\u6790\uff0c\u4f7f\u5de5\u827a\u9a8c\u8bc1\u7684\u76ee\u6807\u6027\u66f4\u52a0\u660e\u786e\uff0c\u51cf\u5c11\u5927\u89c4\u6a21\u5de5\u827a\u9a8c\u8bc1\u7684\u6b21\u6570\uff0c\u5f97\u5230\u7406\u60f3\u7ed3\u679c\u3002<\/span><\/span><\/p>\n

\u00d8 <\/span>\u53ef\u5229\u7528\u56fd\u5916\u5148\u8fdb\u7684\u8f6f\u4ef6\u548c\u6a21\u578b\uff0c\u5bf9\u5173\u952e\u53c2\u6570\u7684\u53d8\u5316\u8fdb\u884c\u9884\u6d4b\uff0c\u6307\u5bfc\u5de5\u827a\u653e\u5927\u7814\u7a76\uff0c\u51cf\u5c11\u4ece\u8bd5\u9a8c\u5ba4\u89c4\u6a21\u5230\u5546\u4e1a\u5316\u89c4\u6a21\u4e4b\u95f4\u7684\u9010\u7ea7\u653e\u5927\u7684\u6b21\u6570\uff0c\u52a0\u5feb\u5f00\u53d1\u8fdb\u7a0b\u3002<\/span><\/span><\/p>\n

18 <\/span>\u63a8\u884c<\/span>QBD\u7684\u76ca\u5904<\/span><\/span><\/strong><\/span><\/h1>\n

1. \u597d\u7684\u4ea7\u54c1\u8bbe\u8ba1\u5c06\u51cf\u5c11\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u95ee\u9898<\/span><\/p>\n

2. \u51cf\u5c11\u4e0a\u5e02\u540e\u7684\u53d8\u66f4\u9700\u8981\u9012\u4ea4\u8865\u5145\u7533\u8bf7\u7684\u6570\u91cf\u2014\u4f9d\u9760\u8fc7\u7a0b\u548c\u98ce\u9669\u7684\u7406\u89e3\u548c\u98ce\u9669\u7f13\u51cf<\/span><\/p>\n

3. \u6709\u52a9\u4e8e\u5728\u4e0d\u9700\u76d1\u7ba1\u90e8\u95e8\u5ba1\u67e5\u7684\u60c5\u51b5\u4e0b\u5e94\u7528\u9ad8\u65b0\u6280\u672f\u6765\u4fc3\u8fdb\u751f\u4ea7<\/span><\/p>\n

4. \u6709\u52a9\u4e8e\u51cf\u5c11\u6574\u4f53\u5236\u9020\u6210\u672c\u2014\u51cf\u5c11\u6d6a\u8d39<\/span><\/p>\n

5. \u6709\u52a9\u4e8e\u6301\u7eed\u6027\u5730\u63d0\u9ad8\u6216\u6539\u8fdb\u4ea7\u54c1\u548c\u751f\u4ea7\u5de5\u827a<\/span><\/p>\n

6. \u6709\u52a9\u4e8e\u66f4\u597d\u5730\u4e86\u89e3\u539f\u6599\u836f\u548c\u8f85\u6599\u5bf9\u751f\u4ea7\u7684\u5f71\u54cd<\/span><\/p>\n

19 QB<\/span><\/strong>D<\/span><\/strong>\u7684\u76ca\u5904<\/span><\/strong><\/span><\/h1>\n

<\/span><\/strong><\/p>\n

\"\u539f\u6599\u836f\u5de5\u827a\u7814\u53d1\u4e0e\u63a7\u5236<\/p>\n

\u58f0\u660e<\/span><\/strong>\uff1a\u672c\u6587\u4ec5\u4f9b\u5206\u4eab\u4e4b\u7528\uff0c\u7248\u6743\u5c5e\u4e8e\u539f\u4f5c\u8005\u3002\u5982\u6d89\u53ca\u7248\u6743\u95ee\u9898\uff0c\u8bf7\u4e0e\u5c0f\u7f16\u8054\u7cfb\u6211\u4eec\u4f1a\u59a5\u5584\u5904\u7406\u3002<\/span><\/span><\/p>\n

\n
\n
<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\n
\n
\n
\n
\n
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\u8fd1\u671f\u57f9\u8bad\u70b9\u51fb\u53f3\u4fa7\u4f1a\u8bae\u94fe\u63a5\u5373\u53ef\u9605\u8bfb\u539f\u6587 <\/span>  <\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\n
\n\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u5730\u70b9<\/span><\/th>\n\u65f6\u95f4<\/span><\/th>\n\u4f1a\u8bae\u94fe\u63a5<\/span><\/th>\n<\/tr>\n
\u9f50\u9f50\u54c8\u5c14<\/span><\/strong><\/span><\/td>\n9\u670827-29\u65e5<\/span><\/td>\n\u9f50\u9f50\u54c8\u5c14\u4e3e\u529e2018\u4e2d\u56fd\u5927\u5065\u5eb7\u80cc\u666f\u4e0b\u4e2d\u836f\u7c7b\u5065\u5eb7\u4ea7\u54c1\u5f00\u53d1\u4e0e\u521b\u65b0\u53ca\u4e2d\u836f\u8d44\u6e90\u7efc\u5408\u5229\u7528\u9ad8\u5cf0\u8bba\u575b<\/span><\/span><\/a><\/td>\n<\/tr>\n
\u676d\u5dde<\/span><\/strong><\/span><\/td>\n9\u670827-29\u65e5<\/span><\/td>\n\n

\u676d\u5dde-\u7b2c\u4e09\u5c4a\u5168\u56fd\u5e9f\u6c34.<\/span>\u5e9f\u6c14.<\/span>\u5371\u9669\u5904\u7406\u6280\u672f\u4ea4\u6d41\u4f1a<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n

\u676d\u5dde<\/span><\/strong><\/td>\n10\u670811<\/span>-13<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u676d\u5dde<\/span>-2018\u201ccGMP\u6587\u4ef6\u7f16\u5236\u89c4\u8303<\/span>\u201d<\/span>\u4e13\u9898\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u4e0a\u6d77<\/span><\/strong><\/td>\n<\/span>10\u670812<\/span>-14<\/span>\u65e5<\/span><\/span><\/strong><\/span><\/td>\n\n

\u4e0a\u6d77<\/span>–\u7b2c\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f<\/span>GMP<\/span>\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u6b66\u6c49<\/span><\/strong><\/td>\n10\u670819<\/span>-21<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u6b66\u6c49<\/span>\u201c\u836f\u4f01\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u5b9e\u65bd\u4e0e\u6539\u8fdb\u4e13\u9898\u57f9\u8bad\u73ed<\/span>\u201d<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u4e0a\u6d77<\/span><\/strong><\/span><\/td>\n10\u670819-21\u65e5<\/span><\/td>\n\n

\u4e0a\u6d77\u4e3e\u529e<\/span>\u201c\u5316\u5b66\u539f\u6599\u836f\u5236\u5907\u5de5\u827a\u5f00\u53d1\u5173\u952e\u63a7\u5236\u4e0e\u8d28\u91cf\u7814\u7a76\u5b9e\u8df5\u201d\u7814\u4fee\u73ed<\/a><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\u676d\u5dde<\/span><\/td>\n10\u6708<\/span>25-27<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u676d\u5dde<\/span>–\u7b2c\u4e8c\u671f<\/span>2018<\/span>\u836f\u4f01<\/span>oos\/oot<\/span>\u8c03\u67e5\u8bef\u533a\u4e0e\u6539\u8fdb\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

<\/span>\u5317\u4eac<\/span><\/td>\n10\u6708<\/span>24-26<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u5317\u4eac\u4e3e\u529e\u6ee1\u8db3\u6b27\u7f8e\u6807\u51c6\u7684\u4eff\u5236\u836f\u7814\u53d1\u4f53\u7cfb\u642d\u5efa\u7814\u8ba8\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u5357\u4eac<\/strong><\/td>\n10\u6708<\/span>25-27<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u5357\u4eac<\/span>–\u4e3e\u529e<\/span>\u2018<\/span>\u836f\u7269\u7814\u53d1\u8d28\u91cf\u7ba1\u7406\u8fd0\u884c\u4e2d\u7684\u96be\u70b9\u5b9e\u65bd\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269<\/span>GMP<\/span>\u5b9e\u65bd\u5173\u952e\u70b9\u63a7\u5236<\/span>\u2019<\/span>\u9ad8\u7ea7\u7814\u4fee\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u676d\u5dde<\/strong><\/span><\/span><\/td>\n10\u6708<\/span>25-27<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u676d\u5dde<\/span>2018\u5e74\u529f\u80fd\u98df\u54c1<\/span>.<\/span>\u539f\u6599\u521b\u65b0\u4e0e\u6d3b\u6027\u6210\u5206\u5e94\u7528\u6280\u672f\u4e3b\u9898\u5cf0\u4f1a<\/span><\/span><\/span><\/a><\/p>\n

<\/span><\/strong><\/span><\/td>\n<\/tr>\n

<\/span>\u4e0a\u6d77<\/span><\/td>\n10\u6708<\/span>26-28<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u4e0a\u6d77\u4e3e\u529e<\/span>2018\u836f\u4f01\u8d28\u91cf\u8c03\u67e5\u6280\u672f\u6307\u5bfc\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u6d4e\u5357<\/span><\/td>\n10\u6708<\/span>26-28<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u6d4e\u5357<\/span>–\u7b2c\u4e8c\u671f\u5b9e\u9a8c\u5ba4\u7814\u53d1<\/span>qc<\/span>\u89c4\u8303\u7ba1\u7406\u4e0e<\/span>lch<\/span>\u6307\u5357\u53ca\u836f\u5178\u6700\u65b0\u8fdb\u5c55\u7814\u4fee\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u5357\u4eac<\/strong><\/td>\n10\u6708<\/span>27-29<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u5357\u4eac<\/span>–\u5236\u836f\u4f01\u4e1a\u5982\u4f55\u5b9e\u73b0<\/span>gmp<\/span>\u6709\u6548\u8fd0\u8425\u6c9f\u901a\u9ad8\u7ea7\u7814\u8ba8\u4f1a<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u4e0a\u6d77<\/span><\/strong><\/td>\n10\u670812-14<\/span>\u65e5<\/span><\/strong><\/td>\n\n

\u4e0a\u6d77<\/span>–\u7b2c\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f<\/span>GMP\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u6b66\u6c49<\/span><\/strong><\/td>\n\n

10\u670819-21<\/span>\u65e5<\/span><\/strong><\/span><\/p>\n


<\/p>\n<\/td>\n

\n

\u6b66\u6c49<\/span>\u201c\u836f\u4f01\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u5b9e\u65bd\u4e0e\u6539\u8fdb\u4e13\u9898\u57f9\u8bad\u73ed<\/span>\u201d<\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

\u91cd\u5e86<\/span><\/strong><\/td>\n11\u67081<\/span>-3<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u91cd\u5e86<\/span>–\u836f\u54c1\u5236\u5907\u5de5\u827a\u5f00\u53d1\u4e0e\u5de5\u827a\u9a8c\u8bc1<\/span>\/<\/span>\u6301\u7eed\u5de5\u827a\u786e\u5b9a\u7814\u7a76\u4e0e\u5b9e\u65bd\u7814\u4fee\u73ed<\/span><\/a><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\u676d\u5dde<\/span><\/strong><\/td>\n11\u67081<\/span>-3<\/span>\u65e5<\/span><\/span><\/strong><\/td>\n\n

\u676d\u5dde<\/span>–\u4e3e\u529e<\/span>2018<\/span>\u533b\u836f\u5316\u5de5\u5b89\u5168\u751f\u4ea7\u4e0e\u5de5\u827a\u5b89\u5168\u7ba1\u7406\u7814\u8ba8\u73ed<\/span><\/span><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

1 \u5236\u9020\u5de5\u827a\u5f00\u53d1 1.1 \u539f\u6599\u836f\u5236\u9020\u5de5\u827a\u5f00\u53d1\u7684\u76ee\u7684\uff1a 1.1.1 \u5efa\u7acb\u4e00\u4e2a\u80fd\u591f\u6301\u7eed\u751f\u4ea7\u51fa\u7b26\u5408\u9884\u671f\u8d28\u91cf\u539f\u6599\u836f\u7684\u5546 […]<\/p>\n","protected":false},"author":1,"featured_media":50997,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/50996"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=50996"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/50996\/revisions"}],"predecessor-version":[{"id":51013,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/50996\/revisions\/51013"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/50997"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=50996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=50996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=50996"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}