二黄通便胶囊的制备和质量标准研究

Preliminary Study of the Quality Standard of Erhuang Tongbian Capsules

目的初步确定二黄通便胶囊的制备工艺并拟定质量控制标准。方法采用传统水煎煮提取、浓缩制备成胶囊;用薄层色谱法(TCL)对制剂中大黄进行了定性鉴别实验;参照"中药新药稳定性试验要求"中胶囊剂项下稳定性试验项目进行性状、鉴别、水分、崩解时限等各项考核。结果工艺合理,疗效确切,质量可控;薄层色谱中样品色谱斑点显色清晰,分离度好;性状、鉴别、水分、崩解时限、微生物限度等各项考察指标均符合相关规定。结论该制剂制备工艺合理,所建立的方法准确可行,专属性强,重现性好,质量可控,稳定性良好,有利于对二黄通便胶囊的质量控制作进一步研究。

Objective To determine preliminarily the preparation technology of erhuang tongbian capsules and implement the quality control standards. Methods The traditional water decoction extraction and concentration were adopted to prepare the capsules. The thin layer chromatography（TLC） was applied to have the qualitative identification experiment of rhubard in the preparation. In reference to the stability test project of the capsule item in New Medicine Stability Test Requirements of Chinese Herbal Medicine, the properties, identification, moisture content, disintegration time and the others were checked. Results It was found that the processing was applicable, the effect was definite and the quality was controllable. TLC discov ered that the chromatogram spots of the sample were clear and was good in separation. The inspection indica tors were all in line with the relevant provisions, such as properties, identification, moisture content, disinte gration time and microbial limit. Conclusion The study results indicate that this preparation technology is applicable. The established method is accurate and feasible, characterized as high specificity, good reproduc ibility, controllable quality and good stability. A further study on the quality control of erhuang tongbian cap sules is required.