Quality Testing Of Bezoar Inflammatory Capsules

Bezoar inflammatory Capsules is composed by artificial bezoar,realgar,skullcap,gardenia,turmeric,borneol,cinnabar,buffalo horn concentrated powder,gypsum,mother of pearl berberine eleven herbs.lt is processed by the extraction of traditional Chinese medicine.Has anti-inflammatory,fever,Tongqiao,sedatiion,buck nerves efficacy for the treatment of viral influenza,upper respiratory tract infection,pneumonia,bronchitis,high fever caused by other bacterial and viral infections subside embolism.Now contained in the "Ministry of Health standards for traditional Chinese medicine prescription preparations",as set out in this standard have not received any determination of the project,only the mother of pearl,cinnabar,realgar,bezoar berberine five kinds components were identified,respectively,and therefore the quality of the existing standards can not effectively control the quality of medicines.Based on the original quality standards,access to the extensive literature on its qualitative identification and determination,The main purpose is in accordance with national regulations,to improve the quality standards of the compound to explore research,provide a basis for quality control.Details are as follows:(1)To establish the TLC method for qualitative identification of gardenia,turmeric,skullcap,borneol in bezoar inflammatory capsules.The results showed that the test and reference substance corresponding position was the same color spots and the same shape,negative control without interference.(2)To establish the HPLC method to determine the content of baicalin in bezoar inflammatory capsules.Get the linear regression equation was Y=42.685X-23.450,the correlation coefficient R is equal to 0.9999,baicalin within 19-94μg/ml range,showed a good linear relationship;six groups of bezoar inflammatory capsules recoveries were 97.7%,103.1%,98.6%,98.8%,99.2%and 100.6%,the relative standard deviation was 1.93%and the average recovery was 99.7%;According to the regulations of the pharmacopoeia,sample content limit should not be less than the minimum content of 80%,baicalin content measured between 1.54mg/tablets and 1.72mg/tablets,minimum was 1.54mg/tablets,so tentative bezoar inflammatory capsules in baicalin not less than 1.54mg/tablets.(3)To establish the HPLC method to determine the content of Geniposide in bezoar inflammatory capsules.Get the linear regression equation was Y=20.838X+19.700,the correlation coefficient R is equal to 0.9997,the injection volume Geniposide within the range of 8-40μg/ml,showed a good linear relationship;six groups of bezoar inflammatory capsules recoveries were 98.6%,97.1%,101.1%,100.6%,96.9%,95.7%and relative standard deviation was 2.19%and the average recovery was 98.3%;According to the regulations of the pharmacopoeia,sample content limit should not be less than the minimum content of 80%,geniposide content measured between 0.664mg/tablets and 0.711mg/tablets,the minimum is 0.664mg/tablets,so tentative bezoar inflammatory capsules in baicalin not less than 0.664mg/tablets.The experiments were improved in the detection of targets,can more fully and effectively control the quality of the preparation,the proposed amendments to the existing standards.It not only ensure the safety quality,efficient,stable and controllable of bezoar inflammatory Capsules,but also provide guarantee and basis for the production,distribution,use and inspection.