摘要
目的制备乳康口服液并建立其质量控制标准。方法根据碘化钾性质合理设计处方并制定生产工艺，选取性状、鉴别、pH值、含量测定作为内控质量检查项目，采用银量法对碘化钾进行含量测定。结果碘化钾在3．5525～35．525mg范围内呈良好线性关系，r=0．9999；平均回收率为100．05％，RSD为0．51％（n=6）。结论乳康口服液处方合理，制备工艺简单；质量控制方法简便，结果准确可靠。可用于乳康口服液的质量控制。
OBJECTIVE To prepare rukang oral liquid and establish its quality standard.METHODS The prescription and production technology of rukang oral liquid were instituted according to the properties of potassi- um iodide with the character, identification, pH content determination as the examination items of quality control; and the content of potassium iodide was determined by Silver measuring method. RESULTS Potassium iodide presented a good linear relation within a range of 3. 5525 - 35. 525mg （r = 0. 9999）. The average recovery was 100.05 % and RSD was 0.51% （n = 6）. CONCLUSION The prescription of rukang oral liquid is reasonable with a simple production technology, and the quality control method is simple, sensitive and accurate, which can be used for quality control of rukang oral liquid.
出处
《海峡药学》
2011年第7期25-26,共2页
Strait Pharmaceutical Journal
关键词
乳康口服液
质量控制
碘化钾
银量法
Rukang oral liquid
Quality control
Potassium iodide
Silver measuring method
