CAJ | 학술논문

目的：评估医疗机构中药制剂安全性及使用风险，为医疗机构中药制剂的研发、注册申请、临床使用以及技术审评和监督管理提供参考依据。方法：通过收集2012-2014年四川省食品药品监督管理局审批的医疗机构中药制剂资料，筛选出21个由临床经验方开发的中药制剂，对其所含药材、配制工艺、急性毒性等数据进行统计分析。结果：21个中药制剂品种中共涉及中药材98种，药材用量均在2010版《中国药典》规定的范围之内；16个品种的配制工艺仅有水煎煮、粉碎等传统工艺，其余5个品种的配制工艺涉及了醇提或醇沉工艺。急性毒性实验数据均通过小鼠实验得到，制剂的临床使用量都远远小于最大耐受量（MTD）或半数致死量（LD50）。结论：临床使用的经验方开发的中药制剂具有较高的安全性。
목적：평고의료궤구중약제제안전성급사용풍험，위의료궤구중약제제적연발、주책신청、림상사용이급기술심평화감독관리제공삼고의거。방법：통과수집2012-2014년사천성식품약품감독관리국심비적의료궤구중약제제자료，사선출21개유림상경험방개발적중약제제，대기소함약재、배제공예、급성독성등수거진행통계분석。결과：21개중약제제품충중공섭급중약재98충，약재용량균재2010판《중국약전》규정적범위지내；16개품충적배제공예부유수전자、분쇄등전통공예，기여5개품충적배제공예섭급료순제혹순침공예。급성독성실험수거균통과소서실험득도，제제적림상사용량도원원소우최대내수량（MTD）혹반수치사량（LD50）。결론：림상사용적경험방개발적중약제제구유교고적안전성。
This study was aimed to provide a reference for the development, registration, and clinical use of hospital traditional Chinese medicine (TCM) preparations, in order to analyze and assess their safety and risk. It also provided a reference for the technical review and supervision of hospital TCM preparations. Through collecting review materials of hospital TCM preparations from 2012 to 2014 in the Sichuan Food and Drug Administration, 21 preparations developed by clinical experiences were screened out. Analysis was made on their ingredients, preparation process and acute toxicity data. The results showed that 98 kinds of Chinese herbal medicines were contained in 21 preparations. The dosages of herbs were in compliance with theChina Pharmacopoeia2010 Edition. Preparation processes of 16 preparations were made by water extraction, grinding and other traditional techniques. The preparation processes of the remaining 5 preparations were involved with alcohol extraction or alcohol precipitation. Acute toxicity test data were obtained with experimental data in mice. Clinical usages of preparation were much lower than MTD or LD50. It was concluded that these hospital TCM preparations developed by clinical experiences were with high safety.