ABSTRACT
Objective:To establish microbial limit test methods for three Hospital Preparations: the Jianer Granule, Anti-inflammatory and anti-itching Liquor and Baicao Lotion. Methods:According to the four general principles of the Chinese Pharmacopoeia (edition 2015), to test the applicability for three kinds of hospital preparations with microbial count method using outine method, medium dilution method, membrane filtration method and neutralizer combined membrane filtration method. The applicability test of control bacteria test for three kinds hospital preparations was carried out by routine method, membrane filtration method and neutralizer combined with membrane filtration method. Results:The microbial limit test of Jianer Granule was tested by routine method. The microbial limit test of Anti-inflammatory and anti-itching Liquor was tested by membrane filtration method. The microbial limit test of Baicao Lotion was tested by neutralizer combined with membrane filtration method. Conclusions:Established the methods of microbial limit test for three kinds hospital preparations which are accurate and reliable.
ABSTRACT
Objective To establish the quality standard of Wuji-Jianwei granules. Methods The contents of Bupleuri Radix, Codonopsis Radix, Paeoniae Radix Alba, Corydalis Rhizoma in Wuji-Jianwei granules were identified by using the thin layer chromatography (TLC) method. The contents of peoniflorin was determined by the high performance liquid chromatography (HPLC) method. Results The TLC had strong specificity and high separation, negative control without interference. The linear range was 0.124 8-0.748 8 μg for peoniflorin (r=0.999 6). The average recovery was 94.42% (RSD=1.46%) and the content of peoniflorin was 0.725 3 mg/g. Conclusions The method is accurate and reasonable, and can be used for the quality control of Wuji-Jianwei granules.