云南药监局回应云南白药安全性质疑 Yunnan, the administration's response to yunnan baiyao security question

　　针对近期有媒体对云南白药安全性及处方保密的质疑，按照国家食品药品监督管理局的要求，云南省食品药品监督管理局7日进行了回应说明，指出云南白药质量安全可靠，但需在医生指导下按说明书规定用药。

According to recent media to yunnan baiyao safety and prescription secret question,According to the state food and drug administration requirements,Yunnan food and drug administration that the 7 response,Pointed out that yunnan baiyao quality safe and reliable,But should be under the guidance of a doctor to follow directions drug regulation.

　　回应说，云南白药创制于1902年，是我国中医药传统品种。自1956 年以来，其配方、工艺被国家确定为国家秘密技术，严格保密。根据国家保密法律法规的有关规定，凡列入国家秘密的品种，其说明书、标签可不列成分项目。

Responded that,Yunnan baiyao created in 1902,Is China's traditional Chinese medicine varieties.Since 1956,The formula/Process by the state identified as the national secret technology,Strictly confidential.According to the national security the relevant provisions in laws and regulations,All listed in the national secret varieties,The specification/Labels don't listed component project.

　　回应指出，国家食品药品监督管理局批准的云南白药配方中含有乌头碱类物质的药材。乌头类药材(如附子、川乌、草乌)通过炮制，乌头碱水解成乌头次碱并进一步水解成苯甲酰乌头原碱，可使毒性大大降低。而经炮制后的乌头类药材大量应用在中药成方制剂中。

Response points out that,State food and drug administration approved yunnan baiyao formula containing aconitine class material medicinal materials.Aconitum kind of medicinal materials(Such as monkshood/Radix aconiti/Kusnezoff monkshood)Through the processing,Aconitine hydrolysis into aconitum time base and further hydrolysis into benzoyl aconitum original base,Can make the toxicity is greatly reduced.And the processing of aconitum kind of herbs used in traditional Chinese medicine drugs in preparation.

　　回应介绍，2008年11月云南白药(胶囊)技术改造被列入国家“十一五”科技重大专项，国家(浙江)新药安全评价研究重点实验室进行了毒理学方面的试验研究，从云南白药的急性毒性、长期毒性、遗传毒性、生殖毒性等各个方面进行了详细充分的实验研究，研究结果证明云南白药是安全的。经中国人民解放军总医院(301医院)、北京协和医院、北京同仁医院等全国共67家医院开展云南白药四期临床试验，共观察2802例，其中试验组1399例、对照组1403例。研究表明，云南白药在临床上按说明书应用是安全的。

Response to introduce,Yunnan baiyao in November 2008(capsule)Technical renovation was included in the country"11th five-year plan"Science and technology major projects,countries(zhejiang)New drug safety evaluation and research of the key laboratory of the toxicology test research,From yunnan baiyao acute toxicity/Long-term toxicity/Genetic toxicity/Reproductive toxicity, and other aspects of the fully detailed experimental research,Research results show that yunnan baiyao is safe.The Chinese people's liberation army general hospital(301 hospital)/Beijing union medical college hospital/Beijing tongren hospital and the national 67 hospitals in yunnan baiyao four phase of clinical test,A total of 2802 cases of observation,The treatment group 1399 cases/1403 cases of control group.Research shows that,Yunnan baiyao in clinical application according to the specification is safe.

　　云南省食品药品监督管理局提醒公众，云南白药为纯中药制剂，是处方药(散剂、胶囊剂)，需在医生指导下按说明书规定用药。如出现严重不良反应，应及时就医，并报告当地食品药品监管部门。

Yunnan food and drug administration to remind the public,Yunnan baiyao for pure traditional Chinese medicine preparation,Is a prescription drug(powder/capsule),Should be under the guidance of a doctor to follow directions drug regulation.If appear serious adverse reaction,Should be timely medical,And report to the local food and drug supervision department.

　　回应说，云南省食品药品监督管理局已多次约谈了企业有关负责人，要求企业在遵守国家法律的同时，加强上市产品的不良反应监测，确保公众用药安全。同时，云南食品药品监督管理局已对企业进行了专项检查，检查结果表明该企业严格按照国家药品监管部门批准的配方工艺以及药品生产质量管理规范(GMP)的要求组织生产，并实施严格的过程监控和出厂前检验，云南白药产品质量安全可靠。

Responded that,Yunnan food and drug administration has repeatedly interviewed the enterprise relevant person in charge,Requests the enterprise abide by the state laws and at the same time,To strengthen the market adverse reactions monitoring,To ensure the public safety drug.At the same time,Yunnan food and drug administration (fda) has the special inspection to the enterprise,Test results show that the enterprise in strict accordance with the national drug regulatory approval for the formulation of the process and the quality control standard for pharmaceutical production(GMP)Organize production requirements,And implement strict process monitoring and inspection before they leave the factory,Yunnan baiyao reliable product quality and safety.