论文部分内容阅读
一些制剂规定要检查重量差异,其目的是要求产品的重量均匀,服用剂量比较正确。根据制剂的剂型、规定规格和工艺条件的不同,对各类制剂重量差异的检查规定也有所不同。1.对比标准不同:如片剂、粉针剂、胶囊剂等一般要在规格项下规定含主药若干量,所以规定要与平均重量相比。又如丸剂、散剂、冲剂一般在规格项下规定每丸(或每包)若干重,所以规定要与标示重量相比。2.许可差异限度不同:如片剂根据平均片重的重量规定差异限度为±5和±7.5%两种限度。丸剂根据
Some preparation requirements to check the weight difference, its purpose is to require the weight of the product evenly, taking the dose is more correct. According to the preparation of formulations, the specifications and process conditions of different, various preparations of weight differences in the inspection requirements are also different. 1. Comparison of different standards: such as tablets, powders, capsules and other general specifications to be included in the main drug containing a certain amount, so the provisions to be compared with the average weight. Another example is the pill, powder, granules in general specifications under the provisions of each pill (or per pack) a number of weight, so the provisions of the marked weight compared with. 2. Permissible differences in different limits: If the tablet according to the weight of the average sheet weight difference between the limits of ± 5 and ± 7.5% two limits. According to pill