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液体制剂如大输液、针剂、液体喷剂和口服液等,被广泛用于治疗多种疾病。其成分含量的准确性对于治疗有效与否甚至对患者的生命安全至关重要。在药品生产实践过程中,由于液体制剂的成分含量单位和工艺过程控制单位的不同,以及工艺过程中温度的变化,溶液混合过程中各组分的量总是困扰着工程师和操作人员。以某一实际工艺生产为例,运用溶液混合的基本原理,对不同的产品浓度要求下,溶液配制工艺中的组份在不同单位与温度下进行了计算。此计算与讨论理清了一些易混淆的概念,为制定配制工艺中各组份的质量控制标准提供参考。
Liquid preparations such as infusion, injection, liquid spray and oral liquid, etc., are widely used to treat a variety of diseases. The accuracy of the content of its ingredients is very important for the patient’s life safety even if the treatment is effective or not. In the process of pharmaceutical production, due to the difference of the unit content of the liquid preparation and the control unit of the process, and the change of the temperature in the process, the amount of each component in the solution mixing always bothers the engineers and operators. Taking an actual process as an example, the basic principles of solution mixing are used. For different product concentration requirements, the components in the solution preparation process are calculated in different units and temperatures. This calculation and discussion clarified some confusable concepts and provided references for the formulation of quality control standards for each component in the formulation process.