论文部分内容阅读
C.P.为Chemical pure的縮写,即化学纯粹;A.R.为Analytical reagent的縮写,即分析試剂;G.R.为Guarranteed reagent的縮写,即保証試剂。它們是不同規格的供化学分析用的試剂药品,同时在瓶签上仍印有“本品未經药理試驗”的字样,这就說明化学分析用的試剂药品和药用的标准,不論在杂質的檢查項目、杂質的含量等方面的要求都是不同的。为了保証分析結果的正确可靠,分析用試剂中的某些杂質的含量規定远超过药典上的要求,如有的杂質不得超过10万分之几,有的甚至不得超过百万分之几,因此在制备上要求高,成本亦高。因为要求不同,药用和分析用的药品在杂質檢查的項目中也就不同。分析用試剂中所含的杂質以不影响分析結果的正确性为原則,而药用品的标准則以不影响疗效,对机体無毒且無不良的副作用者为原則,因此药用品在杂質的檢查中往往着重于药理試驗、砷鹽和重金屬的檢查,而分析用試剂药品檢查的重点並不一定在于这方面,甚至有不檢查的。因此我們認为,凡未经
C.P. is an abbreviation of Chemical pure, that is, chemical pure; A.R. is an abbreviation of Analytical reagent, that is, an analytical reagent; G.R. is an abbreviation of Guarranteed reagent, ie, a guaranteed reagent. They are different specifications of chemical reagents for the analysis of drugs, while the bottle is still marked with the label “This product without pharmacological test ” message, which shows the chemical reagents and pharmaceutical reagents used in the standard , Regardless of the inspection items in the impurities, the content of impurities and other requirements are different. In order to ensure the correctness and reliability of the analytical results, the content of some impurities in analytical reagents far exceeds the requirements of the Pharmacopoeia, if any impurity should not exceed 100,000 parts, and some even can not exceed several parts per million , So the preparation of high requirements, the cost is high. Because of the differences in requirements, medicinal and analytical drugs are also different in the item of impurity inspection. Analysis of impurities contained in the reagent does not affect the correctness of the analysis as the principle, and the standard pharmaceutical products without affecting the efficacy of non-toxic on the body and no adverse side effects of those who are principles, so pharmaceutical products in impurities Of the tests are often focused on pharmacological tests, arsenic salts and heavy metals inspection, and analytical reagents and pharmaceutical inspection does not necessarily lie in this area, or even not checked. Therefore, we think that all without