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我院自1974年开始,用双花、黄芩、连翘3种中药制成双黄连注射液用于临床,至今已有9年的历史。本制剂主要治疗小儿肺炎、上呼吸道和泌尿道感染,收到较为满意的疗效。根据我院儿科的观察,对小儿肺炎的有效率达92.5%,治疗率达80.8%。每年约需生产数万支供临床使用。自开展中西医结合工作以来,有些单方或复方中药制剂改成注射液,不少品种取得了良好的效果。然而,由于中药成分复杂,有效成分往往不清楚,一般多用提取精制方法制备注射液,工艺不够稳定,又加上无可靠的质量控制方法,因此制剂的稳定性和疗效均不易恒定。鉴于上述情况,我们对双黄连注射液的制备和质量控制方法进行了研究,现在报告如下:
Since our hospital began in 1974, Shuanghuanglian Injection has been used in the clinical application of Shuanghua, Huangqi, and Forsythia. It has a history of 9 years. The preparation mainly treats children with pneumonia, upper respiratory tract and urinary tract infection and has received satisfactory results. According to the pediatric observation in our hospital, the effective rate for children with pneumonia was 92.5%, and the treatment rate was 80.8%. Each year about tens of thousands of production are required for clinical use. Since the launch of the integration of traditional Chinese and western medicine, some unilateral or compound Chinese medicine preparations have been changed into injections, and many varieties have achieved good results. However, due to the complex composition of traditional Chinese medicines, the active ingredients are often unclear. In general, extraction and refining methods are generally used to prepare injections. The process is not stable enough, and there is no reliable quality control method. Therefore, the stability and efficacy of the preparations are not always constant. In view of the above, we studied the preparation and quality control methods of Shuanghuanglian Injection. The report is as follows: