从药品监管的角度分析打粉中药存在的问题

Analysis of the problem existed in Traditional Chinese medicine powder from the prospect of drug supervision

目的:为保证打粉中药的安全及质量可控,并有利于监管部门对该类药材的监管,同时为我省2015年版《中药饮片炮制规范》收载范围提供参考意见。方法:通过收集成都市目前市面上正在销售的部分打粉中药,对其生产企业所在地、是否有执行标准、用法用量等进行统计,并结合相关法规和文献对打粉中药存在的问题及质量不可控的原因进行分析。结果:所收集的样本33.3%的品种未标示执行标准,标示有执行标准的品种中有50%与标示标准有出入,有部分品种无生产许可证、GMP证书,只有少数品种说明了制法/加工方法和原药材产地。结论:药监部门对目前市面上正在销售的粉末类药材监管不完善,可通过将打粉中药收录入《中药饮片炮制规范》的方式来规范其生产,达到利于药监部门监管的目的。

Objective: To ensure the safety and quality control of traditional Chinese medicine powder, improve the supervision and put the reference for the inclusion range of 'Chinese Herbal Medicine Decoction Pieces Processing Norms'. Method: Chinese traditional medicine powder on market was partly collected in Chengdu. Statistics analysis was carried out including production enterprises, execution standard, usage and dosage. And the reason for the existed problem and uncontrolled quality was analyzed in combination with regulation and literature. Result: In the samples collected, no execution standard couldn’t be found in 33.3% of the samples. The labeled standard was not in accordance with the powder could be found in 50% of the samples. Some varieties had no pharmaceutical producer license and drug GMP certification. Only a few varieties had the indication of the processing method and the medicinal origin. Conclusion: The current supervision on selling powder by regulation department is not enough. It is suggested that TCM powder can be included in 'Chinese Herbal Medicine Decoction Pieces Processing Norms' for the production standardization and better supervision of TCM powder.