摘要
目的:以煎剂和丸剂2种剂型为代表,研究中药制剂等量性,为等效性评价奠定基础。方法:以龙胆苦苷、栀子苷含量和水溶性浸出物为指标,考察龙胆泻肝汤煎剂与丸剂的等量性。结果:以含量为指标,煎剂的日服用量是丸剂的6.39倍;以浸出物为指标,煎剂的日服用量是丸剂的4.02倍。结论:适当增大丸剂目前日服用量方可达到与煎剂相同剂量。增大程度,需结合药理、临床等研究成果定论。
OBJECTIVE : To investigate the equivalence of preparations of traditional Chinese medicines with decoction and pill as the representative dosage forms so as to lay a foundation for the evaluation of equivalence.METHODS:Taking the contents of gentiopicroside and geniposide and water soluble extractive as indexes to investigate the equivalence between decoction for Longdan xiegan tang and Longdan xiegan pills.RESULTS: Evaluated by the indexes of contents of gentiopicroside and geniposide, the current daily oral dosage of the decoction was 6.39 times superior to the pill;taking water soluble extractive as index, the decoction was 4.02 times superior to the pill .CONCLUSION: To be equivalent to the decoction, the current daily oral dosage of the pill should be increased appropriately.The degree of increase should be based on the final results of pharmacological and clinical studies.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第6期429-431,共3页
China Pharmacy
关键词
龙胆泻肝汤
龙胆泻肝丸
等量性
龙胆苦苷
栀子苷
Longdan xiegan tang
Longdan xiegan pills
Equivalence
Gentiopicroside
Jasminoidin