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目的:确立氯诺昔康滴丸的最佳成型工艺和研究建立氯诺昔康滴丸的质量标准。方法:采用正交试验设计法,对药物与基质的用量,药料温度和冷却液上部温度进行了优选。采用高效液相色谱法对滴丸中氯诺昔康进行含量测定。结果:根据实验所确定的工艺,制备3批样品,符合中国药典关于滴丸的规定。氯诺昔康可以用HPLC法测定含量,氯诺昔康的线性范围在4.01μg/ml～16.03μg/ml(r=0.9999),平均回收率为99.9%,RSD%<2.0%(n=6)。结论:优选的制备工艺简便可行,所建立的质量标准能检测和确定制剂中氯诺昔康的含量,且方法简便、灵敏、快速、准确。
Objective: To establish the best molding process of lornoxicam dropping pills and study the quality standard of establishing lornoxicam dropping pills. Methods: Orthogonal experimental design was used to optimize the dosage of drug and matrix, the temperature of drug and the temperature of the upper coolant. Determination of lornoxicam in drip pills by high performance liquid chromatography. Results: According to the experimentally determined process, three batches of samples were prepared in accordance with the provisions of the Chinese Pharmacopoeia on dropping pills. The lornoxicam content was determined by HPLC. The linear range of lornoxicam ranged from 4.01μg / ml to 16.03μg / ml (r = 0.9999) with an average recovery of 99.9% and RSD% <2.0% (n = 6 ). Conclusion: The optimal preparation process is simple and feasible. The established quality standard can detect and determine the content of lornoxicam in the preparation. The method is simple, sensitive, rapid and accurate.