中药炮制辅料胆汁质量标准研究

Study on the Quality Standard of Bile for Processing Excipients of Traditional Chinese Medicine

目的:建立胆汁辅料质量标准,为提高和稳定胆汁制中药饮片质量和临床疗效提供参考。方法:收集不同批次的牛、猪、羊胆汁,对其进行质量分析,包括性状、理化和薄层鉴别,异性胆汁、相对密度、异性有机物和水分检查及总胆酸含量测定,制订胆汁辅料标准。采用胆汁发酵天南星,按照2020年版《中华人民共和国药典》对胆南星饮片进行质量检测从而评价辅料胆汁质量。结果:胆汁呈具有一定黏度的棕黄色至黄绿色或至绿褐色、半透明液体,气微腥,味极苦,含有胆汁酸类成分且均含有胆酸。薄层和显微检查表明样品中均无异性有机物掺入。胆汁相对密度为1.020~1.430,水分为86.53%~94.00%,紫外-可见分光光度法测得总胆酸含量为5.20~75.16 mg/mL。胆汁发酵后的胆南星饮片质量符合《中华人民共和国药典》规定。结论:初步建立了中药炮制辅料胆汁质量标准,可为中药炮制辅料胆汁质量标准制订提供依据。

Objective:To establish the quality standard of bile excipients,and to improve and stabilize the quality and clinical efficacy of traditional Chinese medicine prepared with bile.Methods:Different batches of bile from cattle,pigs and sheep were collected for quality analysis,including character,physicochemical and thin layer identification,heterosexual bile,relative density,heterosexual organic matter and water content,and total cholic acid content determination.The standard of bile excipients was formulated.The bile fermented Tiannanxing(Arisaematis Rhizoma)was used to evaluate the quality of the auxiliary bile by performing quality inspection on the decoction pieces of dannanxing according to the 2020 edition of Pharmacopoeia of the People's Republic of China.Results:Bile was a brown yellow to yellow green or green brown,translucent liquid with certain viscosity,slightly fishy and bitter taste,containing bile acids and bile acids.Thin layer and microscopic examination showed that there was no foreign organic matter in the samples.The relative density of bile was 1.020~1.430,the moisture was 86.53%~94.00%,and the total cholic acid content measured by UV visible spectrophotometry was 5.20~75.16 mg/ml.The quality of Dannanxing(Bile Arisaema)slices after bile fermentation meets the requirements of the Pharmacopoeia of the People's Republic of China.Conclusion:The quality standard of bile for processing excipients of traditional Chinese medicine has been preliminarily established,which can provide a basis for formulating the quality standard of bile for processing excipients of traditional Chinese medicine.