僵蚕药材质量现状及对2025年版《中国药典》的建议  

Quality status of Bombyx Batryticatus and suggestions for Chinese Pharmacopoeia(2025)

作　　者：杨永泓 王梅 种叶敏 邓红梅 蒋孟莲 杨转珍 颜雨豪 齐景梁 李敏[1] 苟琰 YANG Yong-hong;WANG Mei;CHONG Ye-min;DENG Hong-mei;JIANG Meng-lian;YANG Zhuan-zhen;YAN Yu-hao;QI Jing-liang;LI Min;COU Yan(State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy/School of Modern Chinese Medicine Industry,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;National Medical Products Administration Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices),Chengdu 611731,China)

机构地区：[1]成都中医药大学药学院/现代中药产业学院省部共建西南特色中药资源国家重点实验室,四川成都611137 [2]四川省药品检验研究院(四川省医疗器械检测中心)国家药品监督管理局中成药质量评价重点实验室,四川成都611731

出　　处：《中国中药杂志》2023年第15期4087-4096,共10页China Journal of Chinese Materia Medica

基　　金：国家药品监督管理局中成药质量评价重点实验室项目(中成药-2022-KFKT-001)。

摘　　要：为了解目前僵蚕药材的质量现状和养殖情况,笔者于2016—2018年分别收集不同主产地及五大中药材市场共102批僵蚕药材,测定断面丝腺环性状和质量,以明确不同产地与市场僵蚕药材的质量现状,另以2019—2022年的35批僵蚕药材验证修订后的断面丝腺环情况;同时于家蚕4~5龄不同龄期分别接种白僵菌,规范化养殖至僵死,测定其僵死率和质量,明确不同龄期僵蚕药材的差异,探讨2020年版《中国药典》僵蚕感染龄期制定的合理性。结果发现102批僵蚕药材断面丝腺环合格率低,总灰分超标严重,白僵菌素含量差异较大;35批僵蚕断面性状合格率仅为47.49%,若将丝腺环规定为2~4个,合格率提升至73.00%;不同感染龄期的僵蚕僵死率差异较大,质量参差不齐,总体以5龄第1天接种药材得率较高,质量较好。因此结合僵蚕质量及实际生产,对2025年版《中国药典》僵蚕项下提出修订建议,断面性状修订为“有2~4个亮棕色或亮黑色的丝腺环”,修订后既能保障药材质量,也体现“辨状论质”的科学性;增订含量测定指标“白僵菌素含量不得少于0.017%”,增强僵蚕药材质量可控性;同时将感染龄期修订为“5龄第1天”,缩小龄期跨度,更能结合实际生产,保证药材质量。To understand the current quality status and rearing situation of Bombyx Batryticatus,the authors collected 102 batches of Bombyx Batryticatus from different main producing areas and five major Chinese medicine markets from 2016 to 2018,and measured the properties and quality of the silk gland,to clarify the quality status of Bombyx Batryticatus from different producing areas and markets.In addition,35 batches of Bombyx Batryticatus from 2019 to 2022 were used to verify the silk gland after revision.Moreover,Beauveria Bassiana was inoculated in the silkworm of 4-5 instars,and standardized rearing was carried out until they die.The death rate and the quality of Bombyx Batryticatus were measured to determine the differences in Bombyx Batryticatus of different instars,and explore the rationality of the infection age of Bombyx Batryticatus in Chinese Pharmacopoeia(2020).The results revealed that in the 102 batches of Bombyx Batryticatus,the qualification rate of silk gland was low;the content of total ash far exceeded the standard;the content of beauvericin varied greatly.The qualification rate of the silk gland of the 35 batches of Bombyx Batryticatus was only 47.49%,which could be increased to 73.00%if the number of silk gland was 2 to 4.The death rate of Bombyx Batryticatus at different infection ages was quite different,with uneven quality.Generally,the yield of Bombyx Batryticatus inoculated on the first day of the fifth instar was high with good quality.Therefore,in combination with the quality and actual production of Bombyx Batryticatus,the following suggestions were proposed for revision of Bombyx Batryticatus in Chinese Pharmacopoeia(2025):The number of silk gland should be revised as 2-4 bright brown or bright black silk glands,after which,the quality of Bombyx Batryticatus could be guaranteed,and the"quality identification based on character"could also be reflected scientifically;the content determination index that the content of beauvericin shall not be less than 0.017%should be added to better control

关 键 词：僵蚕 质量现状 丝腺环 总灰分 白僵菌素 感染龄期 

分 类 号：R282.74[医药卫生—中药学]