盐酸米诺环素膜剂的溶出度检测与质量控制

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	英文篇名：Dissolution Detection and Quality Control of Minocycline Hydrochloride Film 作者：李敏 ; 叶霞 英文作者：Li Min;Ye Xia; 关键词：盐酸米诺环素 ; 膜剂 ; 溶出度 ; 质量控制 英文关键词：minocycline hydrochloride;;membrane;;dissolution;;quality control 中文刊名：WGTX 英文刊名：Chemical Engineering Design Communications 机构：浙江尖峰药业有限公司; 出版日期：2019-07-28 出版单位：化工设计通讯 年：2019 期：v.45;No.205 语种：中文; 页：WGTX201907152 页数：2 CN：07 ISSN：43-1108/TQ 分类号：239-240

摘要

目的 :探讨分析盐酸米诺环素膜剂的溶出度检测与质量控制。方法 :按照《中国药典》中关于溶出度的检测方法,检测盐酸米诺环素膜剂的溶出度,并且通过高效液相色谱法对样品含量进行测定,计算溶出度,检验各项参数的相关性。结果:在不同批号膜剂内,组间溶出度均无显著性差异,P>0.05。结论 :盐酸米诺环素膜剂的处方设计满足标准要求,且制备工艺科学合理,质量安全性和可靠性较高。
        To investigate the dissolution and quality control of minocycline hydrochloride membrane.Methods :According to the detection method of dissolution in Chinese Pharmacopoeia,the dissolution rate of minocycline hydrochloride membrane was detected,and the sample content was determined by high performance liquid chromatography to calculate the dissolution degree and test the correlation of various parameters.Sex.RESULTS :There was no significant difference in dissolution between groups in different batches of membranes,P>0.05.Conclusion :The formulation design of minocycline hydrochloride membrane meets the standard requirements,and the preparation process is scientific and reasonable,and the quality safety and reliability are relatively high.

引文

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