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剂型筛选是研究中药新制剂的重要内容之一,因为药物制剂的剂型是影响中药制剂质量稳定性、有效成分溶出和吸收、药物显效快慢强弱的主要因素,与临床疗效密切相关。1 剂型与药物疗效的关系药物剂型的不同,其稳定性有显著差异。《新药审批办法》规定对新制剂要作较长时间的稳定性考察,且不同剂型其稳定性考核项目不同,考核时间各异。所以对临床疗效有所不同。
The dosage form screening is one of the important contents of the new Chinese medicine preparations, because the dosage forms of the pharmaceutical preparations are the main factors that affect the quality stability of the Chinese medicine preparations, the dissolution and absorption of active ingredients, and the speed and effectiveness of the drugs. They are closely related to clinical efficacy. 1 The relationship between the dosage form and the therapeutic effect of the drug The stability of the drug has a significant difference. The “Approval Methods for New Drugs” stipulates that the stability of the new preparations should be examined for a longer period of time. Different types of formulations have different assessment items for their stability, and their assessment time varies. Therefore, the clinical efficacy is different.