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目的:研制氨来呫诺鼻用温敏凝胶喷雾剂,建立其质量控制方法。方法:采用冷法工艺制备氨来呫诺鼻用温敏凝胶喷雾剂,以泊洛沙姆407和泊洛沙姆188为基质,并以胶凝温度与成胶前黏度为考察指标,采用星点设计-效应面法对两种基质的用量进行考察;采用HPLC法测定氨来呫诺的含量,参照《中国药典》2010年版相关规定,对氨来呫诺鼻用温敏凝胶喷雾剂的外观、p H、黏度、含量、装量、每瓶总喷次和每喷主药含量进行测定。结果:泊洛沙姆407和泊洛沙姆188的最佳配比为17.0%和0.9%;凝胶中氨来呫诺含量测定的平均回收率为98.8%,RSD为1.7%(n=9);制备的3批样品各项质量指标均符合规定。结论:氨来呫诺鼻用温敏凝胶喷雾剂处方和制备工艺合理可行,质量可控,可进一步研究开发。
OBJECTIVE: To develop a thermosensitive gel spray for amlodipine nasal spray and establish its quality control method. Methods: The cold gel process was used to prepare the variola gel with poloxamer 407 and poloxamer 188 as matrix. The gel temperature and the viscosity before gel formation were used as indexes to study the effect of temperature on gel permeation. - effect surface method to examine the amount of the two substrates; HPLC method for the determination of amloxan content, with reference to “Chinese Pharmacopoeia” 2010 edition of the relevant provisions of amloxannoyen temperature sensitive gel spray appearance, p H , Viscosity, content, loading volume, total spray volume per bottle and main content of each spray were measured. Results: The best ratio of poloxamer 407 and poloxamer 188 was 17.0% and 0.9%. The average recovery of amiloxanil in gel was 98.8% and the RSD was 1.7% (n = 9) The quality indexes of 3 batches of samples prepared were in accordance with the regulations. Conclusion: The prescription and preparation process of amloxanide nasal thermosensitive gel spray are reasonable and feasible, the quality of which is controllable and can be further studied and developed.