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目的建立复方丹参喷雾剂的制备方法及质量控制标准,并观察其临床疗效。方法用不同浓度的乙醇及水混合提取丹参和三七,回收乙醇,浓缩,加冰片和适量辅料制成喷雾剂。建立性状、鉴别、检查、含量测定等质量标准。用本制剂治疗不稳定型心绞痛患者,观察临床效果。结果建立了该制剂的制备工艺和质量控制方法。经临床观察112例患者,总有效率94.6%。结论该制剂制备工艺可行,质量控制方法可靠,临床疗效确切。
Objective To establish a preparation method and quality control standard of compound Danshen spray and observe its clinical efficacy. Methods Different concentrations of ethanol and water were mixed to extract Salvia miltiorrhiza and Panax notoginseng, ethanol was recovered, concentration, borneol and appropriate excipients were used as sprays. Establish traits, identification, inspection, content determination and other quality standards. Treating patients with unstable angina with this preparation, observe the clinical effect. As a result, the preparation process and quality control method of the preparation were established. After clinical observation of 112 patients, the total effective rate was 94.6%. Conclusion The preparation process is feasible, the quality control method is reliable, and the clinical curative effect is exact.