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在清凉油的菌检中,我们采用文献报道(卫生部药品生物制品检定所:药品卫生检验方法,2页,1980)的不溶于水的软膏或乳膏制剂供试品的乳化方法(下称原法),发现该法存在所用乳化剂西黄蓍胶灭菌不完全,操作不便等问题。为此,我们对该法进行了改进。一、改进方法取不溶于水的软膏或乳膏制剂样品5g,放在乳钵中,加5ml无菌吐温-80(灭菌采用10磅20分钟),研磨均匀,然后加入少量加温至45℃的磷酸盐缓冲液或生理盐水,边加边研磨,使成100ml乳剂,移至三角瓶中即为1:20供试液。此液需在45℃水浴中保温备用。
In the test of the cool oil, we use the water-insoluble ointment or cream preparation reported in the literature (Ministry of Health Pharmaceutical and Biological Products Institute: Pharmaceutical Hygiene Test Method, 2 pages, 1980) for the test sample emulsification method Act), found that the law there is the use of emulsifier tragacanth sterilization is not complete, inconvenient operation and other issues. To this end, we have made improvements to the law. First, the improvement method Take water-insoluble ointment or cream preparation sample 5g, placed in a mortar, add 5ml sterile Tween -80 (sterilized using 10 pounds 20 minutes), grinding evenly, and then add a small amount of warming to 45 ℃ phosphate buffer or saline, while adding edge grinding, make into 100ml emulsion, move to the flask is 1:20 for the test solution. This solution needs to be kept in 45 ℃ water bath.