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该品是我市涂山药厂八五年申报批准生产的,中国药典七七年版450页收载了盐酸利多卡因注射液但无收载此规格。批准依据七七年版药典,为此提出该品的含量测定方法需加以改进的二点。 1.七七年版规定取样相当于盐酸利多卡因0.4g按规定取样量应200ml,这样操作不方便。误差大,改为取样50ml(相当于盐酸利多卡因0.1g)。
The product is Tuyen pharmaceutical companies in our city to declare the production of approved in 1985, the Chinese Pharmacopoeia 1974 version of 450 pages containing lidocaine hydrochloride injection but no this specification. Approved based on seven or seven years Pharmacopoeia, to determine the content of the product determination method needs to be improved two points. 1. The seven seven-year edition of the provisions of the sample equivalent to 0.4g of lidocaine hydrochloride according to the provisions of the sample size should be 200ml, so the operation is not convenient. Large error, instead of sampling 50ml (equivalent to lidocaine hydrochloride 0.1g).