Part
1
1.1
参比制剂遴选、发布政策沿革
1.2
已公示参比制剂品种
Part
2
2.1
落选品种的公示批次
表1 落选化学仿制药参比制剂的批次及品种规格
2.2
落选品种未通过审评的原因
表2 落选化学仿制药参比制剂的落选原因
2.3
落选品种的剂型
表3 落选化学仿制药参比制剂的剂型
Part
3
3.1
避免安全性、有效性数据不足
3.2
仿制药或“三改”品种参比制剂的注意事项
3.3
参比制剂用法用量、处方及工艺
3.4
参比制剂的来源
Part
4
参考文献
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撰稿人 | 刘冬、韩鸿璨、安娜、李芳、王骏
责任编辑 | 胡静
审核人 | 何发
2024-08-17
2024-09-02
2024-08-19
2024-08-15
2024-08-28
2024-09-04
2024-09-23
为提高生产效率、降低能源消耗,使药材受热均匀,有效成分更好地得到保留,本文对小柴胡颗粒连续逆流动态提取进行研究。以浸膏收率、黄芩苷鉴别、甘草鉴别、小柴胡鉴别、黄芩苷含量等为考察指标,采用 L9(34)正交试验优选小柴胡颗粒连续逆流动态提取工艺。结果显示优选的动态逆流提取连续生产工艺为:粗碎粒径 8mm、浸润时间 30min、加料转速 6rpm、饮用水流量 100L/h、提取转速 7rpm、提取时间 180min、提取温度 100℃,浸膏收率、黄芩苷鉴别、甘草鉴别、小柴胡鉴别、黄芩苷含量等均符合质量标准。因此,优选小柴胡颗粒连续逆流动态提取工艺重现性好,有效成分转移率高,为中药应用连续逆流动态提取提供了参考依据。
作者:石朝阳、姜许帆、张文标、乔晓芳
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