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目的:建立盐酸普萘洛尔凝胶的微生物限度检查方法。方法:利用氯化钙能与凝胶中的壳聚糖结合形成钙盐沉淀达到破胶目的的原理,用10%氯化钙溶液10 m L与盐酸普萘洛尔凝胶10 g混匀,加0.9%无菌氯化钠溶液至100 m L,得1∶10破胶供试液,取1 m L加0.9%无菌氯化钠溶液100 m L稀释后过膜,用300 m L 0.9%无菌氯化钠溶液分3次冲洗滤膜,每次100 m L,边冲洗边振摇,泵速为160 r/min。结果:经验证试验,采用上述方法加菌回收率均大于70%,盐酸普萘洛尔凝胶在此实验条件下无抑菌作用或抑菌作用弱。结论:盐酸普萘洛尔凝胶中的细菌、霉菌、酵母菌的检查可采用薄膜过滤法,控制菌检查可采用常规法,结果可靠。
Objective: To establish a microbial limit test for propranolol hydrochloride gel. Methods: Calcium chloride gel can be used in combination with the formation of calcium chloride precipitation gel to achieve the purpose of breaking the gel, with 10% calcium chloride solution 10ml and Propranolol hydrochloride gel 10g mixing, Add 0.9% sterile sodium chloride solution to 100 m L, 1:10 gel breaking test solution, take 1 m L plus 0.9% sterile sodium chloride solution 100 m L diluted membrane, 300 m L 0.9 % Sterile sodium chloride solution wash the filter 3 times, 100 m L each time, shaking while washing, pump speed 160 r / min. Results: The results of the validation test showed that the recoveries of the bacteria increased by more than 70% by the above method. Propranolol hydrochloride gel had no antibacterial effect or weak antibacterial effect under the experimental conditions. CONCLUSIONS: Bacteria, molds and yeasts in propranolol hydrochloride gel can be examined by membrane filtration method. The control bacteria can be checked by conventional method and the results are reliable.