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目的:研究一种治疗寻常痤疮的外用制剂处方、设计制备工艺、建立制剂的含量测定方法、并对制剂进行临床疗效观察。方法:处方中选用盐酸克林霉素和替硝唑为主药,新型药用辅料卡波姆为基质,用HPLC法测定含量,结果可靠。结果:通过临床验证认为疗效确切,无刺激性,处方配伍合理,质量可控。结论:该制剂配制、含量测定方法可靠,临床疗效较好,值得推广应用。
OBJECTIVE: To study the prescription of topical preparation for the treatment of acne vulgaris, design and preparation of the preparation, and to establish the method for determination of the content of the preparation. The clinical efficacy of the preparation was also observed. Methods: Clindamycin hydrochloride and tinidazole were selected as the prescriptions. The new pharmaceutical excipient carbomer was used as the matrix. The content was determined by HPLC and the results were reliable. Results: The clinical validation that the curative effect is exact, non-irritating, prescription compatibility reasonable, quality controllable. Conclusion: The preparation of the preparation, content determination method is reliable, the clinical curative effect is good, it is worth popularizing and applying.