| 引用本文: | 盛凯丽,盛晓霞,唐勇,陶巧凤.缬沙坦胶囊处方工艺筛选及溶出度评价[J].中国现代应用药学,2017,34(6):864-867. |
| SHENG Kaili,SHENG Xiaoxia,TANG Yong,TAO Qiaofeng.Screening of Formulation for the Preparation of Valsartan Capsules and the Evaluation of Their Dissolubility[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(6):864-867. |
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| 摘要: |
| 目的 研制以诺华制药产品“代文”（规格：80 mg）为仿制目标的缬沙坦胶囊。方法 通过比较自制制剂和原研制剂的体外溶出数据，筛选处方和工艺。为了达到两者溶出曲线一致，分析不同厂家原料药对溶出的影响，并对处方内增溶剂用法和用量进行考察。结果 调整处方解决原料药难溶会降低溶出度的问题，采用f2因子法比较仿制胶囊和“代文”在多介质中的溶出曲线，体外两者溶出相似。结论 最终的处方和工艺具有可行性，仿制制剂和原研制剂体外溶出相似性可为体内两者质量一致提供一定依据。 |
| 关键词: 缬沙坦胶囊 处方工艺 溶出度 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.06.017 |
| 分类号:R944.5 |
| 基金项目: |
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| Screening of Formulation for the Preparation of Valsartan Capsules and the Evaluation of Their Dissolubility |
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SHENG Kaili1, SHENG Xiaoxia1,2, TANG Yong2, TAO Qiaofeng3
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1.Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology, Hangzhou 310014, China;2.Hangzhou SoliPharma Co., Ltd., Hangzhou 310018, China;3.Zhejiang Center for Drug and Cosmetic Evaluation, Hangzhou 310012, China
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| Abstract: |
| OBJECTIVE To develop generic valsartan capsules with Novartis' Dioan(80 mg) as a reference. METHODS Formulation of valsartan capsules was evaluated by comparison of in vitro dissolution profiles between generic drug and Dioan. Valsartan from different suppliers were evaluated and the application of solubilizer was optimized for consistent dissolution profile. RESULTS The similarity factor f2 was calculated to compare dissolution profile of generic drug and Dioan in different mediums. The in vitro drug release behaviors of generic drug and Dioan were similar. CONCLUSION The final formula and manufacturing process of generic valsartan capsules are feasible. The similarity in in vitro dissolution between generic drug and Dioan provides a high confidence in achieving equivalence in in vivo studies. |
| Key words: valsartan capsules formulation and process dissolution |
