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在1981年4月1日公布了第10版日本药典(JPX)。本版主要修订了如下五个方面: (1)更精密仪器的引进; (2)制剂均一性的提高(溶出试验、含量均一性试验); (3)制剂中异物和微生物的规定(注射剂、滴眼剂和眼膏剂等); (4)试剂安全性的保证; (5)规格的完备。现按三个问题分述如下。一、药典制剂的变迁和制剂技术的进步第10版药典同第9版,总则没有大的变化,共收载了26类制剂。对于同一类制剂的规定,其内容也随着时代的推移而有所变化。例如,日本药典各版中,片剂从湿制片剂,经干制片剂,发展到
The 10th edition of the Japanese Pharmacopoeia (JPX) was published on April 1, 1981. This edition mainly revised the following five aspects: (1) the introduction of more sophisticated instruments; (2) the improvement of the uniformity of the preparation (dissolution test and content homogeneity test); (3) the provisions of foreign substances and microorganisms in the preparation (injection, Eye drops and eye ointment, etc.); (4) Reagent safety assurance; (5) Complete specifications. Now according to three questions are as follows. First, the pharmacopoeia preparation and preparation technology changes Progress 10th Edition Pharmacopoeia with the 9th edition, there is no major changes in the general, a total of 26 types of preparation. For the same type of preparation requirements, its content also changes with the passage of time. For example, in each edition of Japanese Pharmacopoeia, tablets are developed from wet tablets, dried tablets