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近几年,随着医疗单位制剂的广泛开展,也暴露出了一些违反《药品法》规定、不合《医院制剂规范》的质量问题,特别是中药制剂的质量问题较为严重,应当引起重视。 1.协定处方制剂没有完备的质量标准 协定处方在医疗单位普遍存在,但是,协定处方制剂存在的较大的技术问题是缺少与其制剂效果相应的较为完备的质量标准和科学的工艺规程,特别是缺少质量标准中的鉴别和含量测定两项。近两年协定处方制剂中用量较大
In recent years, with the extensive development of medical unit preparations, some quality problems have been exposed that violate the provisions of the Drug Law and are not consistent with the “Hospital Preparation Regulations.” In particular, the quality of traditional Chinese medicine preparations is more serious and should be taken seriously. 1. Agreements There are no comprehensive quality standards for prescription preparations. Prescriptions exist in medical units. However, the major technical problems in the existence of prescription preparations are the lack of comprehensive quality standards and scientific procedures relating to their effectiveness. There is a lack of identification and content determination in the quality standards. In the past two years, a large amount of prescription preparations