雄·阿嘎日-8显微、薄层鉴别和微生物限度方法验证

Thin layer microscopic identification and microbial limit test for Xiong·Agari-8

目的建立雄·阿嘎日-8质量的定性研究方法及微生物限度检查方法。方法以沉香、诃子、广枣、木棉为对照,观察供试样品中的纤维管胞、石细胞、内果皮石细胞、花粉粒显微特征;采用TLC法,对雄·阿嘎日-8进行定性研究;采用平皿法、薄膜过滤法对雄·阿嘎日-8进行微生物限度检查。结果供试样品中纤维管胞、石细胞、内果皮石细胞、花粉粒特征明显;在与对照品及对照药材相应的位置上,供试样品有相同的斑点,阴性样品无干扰;根据回收试验结果,试验菌回收率均在50%~200%,符合验证要求。3批样品需氧菌总数、霉菌和酵母菌总数、控制菌检查均合格。结论对雄·阿嘎日-8的显微特征进行了鉴别;建立的TLC法及微生物限度的检查方法,可用于雄·阿嘎日-8质量控制。

Objective To establish the qualitative method and microbial limit test method for Xiong ~ Agari-8. Methods The microscopic characteristics of eaglewood, chebulinic, Guangzao, and kapok were used as the controls to observe the microscopic characteristics of tracheid fibres, sclereid, and stone cells of endocarp and pollen grains in the sample. TLC method was used to identify Xiong · Agari-8 and membrane filtration method was used to determine the microbial limit. Results We observed obvious microscopic characteristics of tracheid fibres, sclereid, and stone cells of endocarp and pollen grains in the sample. The samples shared the same spots with references, and the negative samples had no interference. The recovery of test bacteria was between 50% and 200%, which met the verification demands. The total number of test bacteria （aerobic bacteria, mold, yeast and control bacteria） was all qualified. Conclusion The method can be used to control the quality of Xiong· Agari-8.