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Analysis of Shenhuang Capsule using HPLC: Method Development, Validation, and Application
Current Pharmaceutical Analysis ( IF 0.7 ) Pub Date : 2022-04-28 , DOI: 10.2174/1573412918666220427135241 Yuankai Si 1 , Zhigui Wu 2 , Gu Li 1 , Hua Li 1 , Pei Ge 2 , Huan Liu 3 , Wenqiang Zhang 4 , Yanli Xu 4 , Yuanqiong Huang 4 , Meijuan Chen 1
Current Pharmaceutical Analysis ( IF 0.7 ) Pub Date : 2022-04-28 , DOI: 10.2174/1573412918666220427135241 Yuankai Si 1 , Zhigui Wu 2 , Gu Li 1 , Hua Li 1 , Pei Ge 2 , Huan Liu 3 , Wenqiang Zhang 4 , Yanli Xu 4 , Yuanqiong Huang 4 , Meijuan Chen 1
Affiliation
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Objective: Shenhuang (SH) capsule is a traditional Chinese medicine compound preparation containing rhubarb, coptis, scutellaria, salvia and Pueraria, used for diabetic nephropathy studied by our research group in the early stage. This study aims to develop the method of qualitative identification and content determination of the main active ingredients of SH capsules so as to establish the quality standard. Methods: HPLC method was used to determine the contents of rhein, Pueraria, and tanshinone in SH capsules. The determination method of SH capsules was established through the determination of specificity, regression equation, precision, repeatability, and recovery. The general quality standard of SH capsules was established by measuring water content, disintegration time, and microorganism. The contents of rhein, puerarin, and tanshinone IIA in SH capsules were determined by HPLC. Results: The precision was 1.10–3.00% and the reproducibility and recovery rates were 95.0– 105.7%. The moisture determination, disintegration time, and microorganism examination of SH capsule were all in line with the standard. Conclusion: The stable, feasible, simple, and reliable content determination method was established through the content determination of SH capsules and the general quality standard test.
中文翻译：
使用 HPLC 分析神黄胶囊：方法开发、验证和应用
目的：神黄胶囊是本课题组前期研究的用于治疗糖尿病肾病的中药复方制剂，主要成分为大黄、黄连、黄芩、丹参和葛根。本研究旨在建立SH胶囊主要活性成分的定性鉴定和含量测定方法，以建立质量标准。方法：采用HPLC法测定SH胶囊中大黄酸、葛根和丹参酮的含量。通过特异性、回归方程、精密度、重复性和回收率的测定，建立了SH胶囊的测定方法。SH胶囊的一般质量标准是通过测定水分含量、崩解时间和微生物来建立的。大黄酸、葛根素的含量，HPLC测定SH胶囊中丹参酮IIA和丹参酮IIA的含量。结果：精密度为1.10%～3.00%，重现性和回收率为95.0%～105.7%。SH胶囊的水分测定、崩解时间、微生物检验均符合标准。结论：通过SH胶囊的含量测定和通用质量标准试验，建立了稳定、可行、简便、可靠的含量测定方法。
更新日期：2022-04-28
中文翻译：
使用 HPLC 分析神黄胶囊：方法开发、验证和应用
目的：神黄胶囊是本课题组前期研究的用于治疗糖尿病肾病的中药复方制剂，主要成分为大黄、黄连、黄芩、丹参和葛根。本研究旨在建立SH胶囊主要活性成分的定性鉴定和含量测定方法，以建立质量标准。方法：采用HPLC法测定SH胶囊中大黄酸、葛根和丹参酮的含量。通过特异性、回归方程、精密度、重复性和回收率的测定，建立了SH胶囊的测定方法。SH胶囊的一般质量标准是通过测定水分含量、崩解时间和微生物来建立的。大黄酸、葛根素的含量，HPLC测定SH胶囊中丹参酮IIA和丹参酮IIA的含量。结果：精密度为1.10%～3.00%，重现性和回收率为95.0%～105.7%。SH胶囊的水分测定、崩解时间、微生物检验均符合标准。结论：通过SH胶囊的含量测定和通用质量标准试验，建立了稳定、可行、简便、可靠的含量测定方法。
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