Verification of Quality Inspection Items for Hospital-prepared Yangwei Granules
Objective To verify the quality inspection items for Yangwei granules prepared by a mili-tary hospital.Methods Three batches of Yangwei granules were prepared according to the prescribed composition and process.The properties and physicochemical characteristics were identified.Such items for inspection as particle size,solubility,packing mass differences,moisture content,loss mass on drying,and microbial limits were studied.Results During the inspection of particle size of three batches of Yang-wei granules,the sum percentage of substances that failed to pass No.1 sieve and substances that passed No.5 sieve was(7.40±1.13)％.In the solubility inspection,the solutions were slightly turbid,but no foreign bodies or scorched debris were found.In the inspection of packing mass differences,no more than two bags of each batch exceeded the packing mass difference limit(±5％),and no bag exceeded the pack-ing mass difference limit by 200％.In the moisture content inspection,the moisture was(4.22±0.33)％.In the loss mass on drying inspection,the reduced mass was(1.60±0.38)％.The recovery ratios of Staphylococcus aureus,Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans,and Aspergillus niger of three batches of Yangwei granules ranged from 0.5 to 2.0.Escherichia coli was detected in the test group rather than in the negative control group.Conclusion The test results for particle size,solubility,packing mass differ-ences,moisture content,loss mass on drying,and microbial limits for the three batches of Yangwei granules all met the requirements stipulated in Chinese Pharmacopoeia(2020 Edition,Part 4).The plate method is applicable to the determination of the total count of aerobic bacteria,molds and yeasts in Yangwei granules,while the conventional method is preferable for the determination of E.coli in Yangwei granules.
万方数据
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