基于合理给药时间的口服植物药制剂的临床药学调研

Clinical Pharmacy Study of Oral Botanic Medications Based on Rational Dosing Time

关键词:  植物药制剂  临床药学  给药时间  口服生物利用度  合理用药

Key words:  botanic medications  clinical pharmacy  dosing time  oral bioavailability  rational drug use

摘要:

目的 促进口服植物药制剂的临床合理使用和科研工作。方法 查阅药品说明书和检索新编临床用药参考软件,找出注明食物-药物相互作用或对服药时间由特殊要求的信息。检索CNKI和PubMed有关进食与植物药制剂疗效或有效成分生物利用度关系的文献。结果 说明书明确要求空腹服用的进口植物药制剂有4种,包括草木犀流浸液片、桃金娘油肠溶胶囊、帕歌斯片和非洲臀果木提取物胶囊。说明书明确要求空腹服用的国产植物药制剂有10种。空腹服用对植物药生物利用度影响的文献涉及绿茶提取物制剂(空腹吸收更好)、齿叶乳香树脂提取物制剂、四物汤和知母皂苷B-II(餐后吸收更好)。植物药有效成分的生物利用度可能与脂溶性大小、胃酸中稳定性以及系统前肠道代谢有关。有12种中成药的服药有时辰要求。结论 植物药制剂说明书中有关食物-药物相互作用信息的标注率低,植物药正确服药时间(特别是空腹还是餐后)还没有引起临床医务人员和科研人员足够的重视,有必要在该领域加强临床药学和科研工作。

Abstract:

OBJECTIVE To promote the rational use of oral botanic medications and relevant academic research. METHODS By retrieving the package inserts and New Clinical Drug Reference Database, relevant food-drug information was identified. Literatures on the influence of dosing conditions (fasted or after meal) on oral bioavailability of botanic medications were reviewed by CNKI and PubMed search (Jan 1989-March 2013). RESULTS There are four imported botanic medications which require administration at the fasted status, i.e., Melilotus extract tablets, Myrtol standardized enteric coated soft capsules, Pagosid tablets and Pygeum African extract capsules. There are 10 domestic prepared traditional Chinese medicines (TCMs) which require administration with the empty stomach. Botanic medications whose bioavailability could be influenced by meal involved Polyphenon E capsules (fasted >non-fasted), frankincense extract formulation, Samul-tang and Timosaponin B-II (together with a standardized high-fat meal >fasted state). Bioavailability of some active ingredients of botanic medications were related to lipophilicity, stability in acidic conditions and presystem loss due to biotransformation. There were 12 prepared TCMs with requirements of circadian rhythm. CONCLUSIONS There is a very poor information on food-drug interaction in current package inserts of botanic medications and poor awareness of special dosing time (fasted or non-fasted) among physicians, nurses and pharmacists. It is necessary to strengthen clinical pharmacy and research in this respect in order to warrant clinical efficacy and avoid toxicity.