Quality Evaluation of XiaoEr KeChuanLing Granules Based on Provincial Supervision and Sampling Inspection
OBJECTIVE To evaluate the quality of commercially available XiaoEr KeChuanLing granules based on provincial supervision and sampling inspection,and make suggestions for the revision of quality stand-ards.METHODS 37 batches of samples were tested and analyzed according to the current standard.At the same time,from the perspective of the effectiveness,authenticity and quality consistency,the exploratory research on the TLC identification of licorice and honeysuckle,the screening of Lonicerae japonicae Flos.adulterated with Lonicerae si-mnilis Flos.and the determination of ephedra content were carried out.RESULTS According to the current standard test,37 batches of samples all meet the requirements.The results of exploratory research showed that glycyrrhetinic acid and chlorogenic acid,the index components of licorice and honeysuckle,were detected by TLC in all batches of samples.Macranthoidin B,the characteristic component of Lonicerae similis Flos,was detected in one batch of samples from enterprise F.The content range of ephedra sinica was 0.13-1.9 mg·g-1 of which 4 batches were below the pro-posed limit of 0.35 mg·g-1.CONCLUSION The overall quality of XiaoEr KeChuanLing granules is general,the stability of production process needs to be improved.The current quality standards are too low to control the quality of drugs and need to be revised and improved urgently.
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