People's Republic of China Pharmacopoeia( Anterior order)

《中华人民共和国药典》 （简 称 《中国药典》）2 0 1 5年版为第十版药典。按照第十届药典委员会成立大
The 2015 edition of the People's Republic of China Pharmacopoeia ("Chinese Pharmacopoeia") is the tenth edition of the Pharmacopoeia. In accordance with the tenth session of the Pharmacopoeia Committee
会暨全体委员大会审议通过的药典编制大纲所确立的指导思想、基本原则、任务目标及具体要求，在国家
The guiding ideology, basic principles, task objectives and specific requirements established in the outline of the compilation of the Pharmacopoeia of the plenary meeting of the plenary Committee of the general committee are in the state.
食品药品监督管理总局的领导下，在各级药检机构、科研院所和大专院校的大力支持和帮助下，以及各药
Under the leadership of the General Administration of food and drug administration, with the support and assistance of the drug inspection agencies, scientific research institutes and colleges and universities at all levels, and the various drugs
品生产企业的积极参与和配合下，经过全体委员和常设机构工作人员的辛勤工作和不懈努力，顺利完成了
With the active participation and cooperation of the production enterprises, the hard work and unremitting efforts of all the members of the Committee and the staff of the permanent institutions have been successfully completed.
《中国药典》2 0 1 5年版编制任务。2 0 1 5年 2 月 4 日，第十届药典委员会执行委员会全体会议审议通过了本
The Chinese Pharmacopoeia (China Pharmacopoeia) was compiled in the 2015 edition. In February 4, 2015, the tenth session of the Executive Committee of the Pharmacopoeia Committee examined and passed this
版药典，2 0 1 5年 6 月 5 日由国家食品药品监督管理总局批准颁布，自 2 0 1 5年 1 2 月 1 日起实施。
The edition of Pharmacopoeia was approved by the State Administration of food and Drug Administration in June 5, 2015 and was implemented since December 1, 2015.
《中国药典》2 0 1 5 年版由一部、二 部 、三部和四部构成，收 载 品 种 总 计 5 6 0 8 种 ，其 中 新 增 1 0 8 2种 。
The 2015 edition of the Chinese Pharmacopoeia was made up of one, two, three and four parts, with a total of 5608 varieties, of which 1082 were added.
一 部收载药材和饮片、植物油脂和提取物、成方制剂和单味制剂等，品 种 共 计 2 5 9 8种 ，其 中 新 增 4 4 0 种 、
A total of 2598 species of herbs and pieces, vegetable oils and extracts, formulation preparations and single flavors were added, including 440 new species.
修 订 5 1 7 种 ，不 收 载 7 种 。二部收载化学药品、抗 生 素 、生化药品以及放射性药品等，品 种 共 计 2 6 0 3种 ，
517 kinds are revised, 7 kinds are not collected. Two kinds of chemicals, antibiotics, biochemical drugs and radiopharmaceuticals, including 2603 varieties, were carried out.
其中新增 4 9 2 种 、修 订 4 1 5 种 ，不 收 载 2 8 种。三部收载生物制品 1 3 7 种 ，其 中 新 增 1 3 种 、修 订 1 0 5 种 ，
There are 492 new types and 415 kinds of revision, and 28 kinds are not collected. There were 137 kinds of biologics in three, of which 13 were added and 105 were revised.
不收载 6 种 。为解决长期以来各部药典检测方法重复收录，方法间不协调、不 统 一 、不规范的问题，本版 # 药典对各部药典共性附录进行整合，将原附录更名为通则，包括制剂通则、检定方法、标准物质、试剂试
6 kinds are not collected. In order to solve the long-standing harmacopoeia duplication detection method included, not coordinated and unified and standard methods, this version of # Pharmacopoeia to integrate the various common Pharmacopoeia appendix, the original appendix was renamed general rules, including the rules of preparation, test method, standard materials, test reagent
药和指导原则。重新建立规范的编码体系，并首次将通则、药 用 辅 料 单 独 作 为 《中国药典》四部。四部收 * 载通则总计3 1 7 个 ，其中制剂通则3 8 个 、检 验 方 法 2 4 0 个 、指 导 原 则 3 0 个 、标准物质和试液试药相关通
The principles of medicine and guidance. The standard coding system was reestablished, and the general principles and medicinal materials were used as the four part of the Chinese pharmacopoeia for the first time. Four department general * load of a total of 317, 240, 38 of which the rules of preparation of test methods, principle 30, standard material and reagent solution related links
则 9 个 ；药 用 辅 料 2 7 0 种 ，其 中 新 增 1 3 7种 、修 订 9 7 种 ，不 收 载 2 种 。
9, 270 kinds of medicinal excipients, of which 137 were added, 97 were revised, and 2 kinds were not collected.
本版药典的特点主要体现在：
The characteristics of this edition of the Pharmacopoeia are mainly reflected in:
收栽品种显著增加。进一步扩大了收载品种的范围，基本实现了国家基本药物目录品种生物制品全覆
The cultivated varieties increased significantly. It has further expanded the range of the varieties of the collection, and basically realized the full coverage of the biologics of the national basic drug catalogue.
盖 ，中药、化药覆盖率达到9 0 % 以上。对部分标准不完善、多年无生产、临床不良反应多、剂型不合理的
Cover, the coverage rate of Chinese medicine and chemical medicine reached more than 90%. It is not perfect for some standards, no production for many years, more adverse clinical reactions and irrational dosage forms.
品种加大调整力度，本版药典不再收载2 0 1 0年版药典品种共计4 3 种 。
There are 43 kinds of pharmacopoeia in the 2010 edition of the Pharmacopoeia.
药典标准体系更加完善。将过去药典各部附录进行整合，归为本版药典四部。完善了以凡例为总体要
The standard system of pharmacopoeia is more perfect. The appendix of the Department of the past pharmacopoeia is integrated into the four edition of the Pharmacopoeia of this edition. In order to improve the overall explanatory notes to
求 、通则为基本规定、正文为具体要求的药典标准体系。首 次 收 载 “国家药品标准物质制备” “药包材通用
The standard system of the Pharmacopoeia which is the basic rule and the text as the specific requirement. "Preparation of national drug standard substances" for the first time "general drug package"
要求” 以 及 “药用玻璃材料和容器”等指导原则，形成了涵盖原料药及其制剂、药用辅料、药 包 材 、标准
Requirements "as well as" medicinal glass materials and containers "and other guiding principles, forming the form of material and its preparations, pharmaceutical excipients, pharmaceutical packages, standards
物质等更加全面、系统、规范的药典标准体系。
Materials such as a more comprehensive, systematic and standardized standard system for Pharmacopoeia.现代分析技术的扩大应用。本版药典在保留常规检测方法的基础上，进一步扩大了对新技术、新方法的
The expanded application of modern analytical technology. On the basis of retaining the conventional methods, the Pharmacopoeia further expanded the new technology and new methods.
应用，以提高检测的灵敏度、专属性和稳定性。采用液相色谱法-串联质谱法、分子生物学检测技术、高效液
The application is used to improve the sensitivity, specificity and stability of the detection. Liquid chromatography tandem mass spectrometry, molecular biological detection technology, high performance liquid
相色谱-电感耦合等离子体质谱法等用于中药的质量控制。采用超临界流体色谱法、临界点色谱法、粉 末 X 射
Chromatograph - Inductively coupled plasma mass spectrometry (ICP MS) is used to control the quality of traditional Chinese medicine. Using supercritical fluid chromatography, critical point chromatography, powder X injection
线衍射法等用于化药的质量控制。采用毛细管电泳分析测定重组单克隆抗体产品分子大小异构体，采用髙效
Line diffraction is used to control the quality of chemical drugs. Determination of recombinant monoclonal antibody products molecular size isomers by capillary electrophoresis, high efficiency
液相色谱法测定抗毒素抗血清制品分子大小分布等。在检测技术储备方面，建立了中药材D N A 条形码分子鉴
The molecular size distribution of antiserum antiserum products was determined by liquid chromatography. In the field of technical reserve, the D N A bar code molecular identification of Chinese medicinal materials is established.
定法、色素测定法、中药中真菌毒素测定法、近红外分光光度法、基于基因芯片的药物评价技术等指导方法。
Method, pigment determination method, determination of mycotoxins in traditional Chinese medicine method, near infrared spectrophotometry, based on gene chip technology to guide drug evaluation method.
药品安全性保障进一步提高。完善了 “药材和饮片检定通则” “炮制通则” 和 “药用辅料通则”；新增
The safety of drugs was further improved. The "general rules for the verification of medicinal materials and pieces of medicinal herbs", "general rules of processing" and "general principles of medicinal materials" were perfected;
“国家药品标准物质通则” “生物制品生产用原材料及辅料质量控制规程” “人用疫苗总论” “人用重组单克
"General rule of national drug standard material" "standard for quality control of raw materials and excipients for the production of biological products" "general discussion on human vaccine" "human use recombinant single gram"
隆抗体制品总论”等 ，增订了微粒制剂、药品晶型研究及晶型质量控制、中药有害残留物限量制定等相关
Monoclonal antibody products general ", a new particle preparation, crystal type and crystal type of drug quality control, medicine and other related harmful residue limit set
指导原则。一部制定了中药材及饮片中二氧化硫残留量限度标准，建立了珍珠、海藻等海洋类药物标准中
Guiding principle。 One set up the limit of the limit of sulfur dioxide residue in Chinese herbal medicine and Chinese herbal medicine, and established the standard of marine drugs such as pearl, seaweed and so on
有害元素限度标准，制定了人参、西洋参标准中有机氣等1 6 种农药残留的检查，对 柏子仁 等 1 4 味易受黄
16 kinds of pesticide residues in ginseng and American ginseng were checked, and 14 flavors of Bai Ziren and other flavors were easily yellow.
曲霉毒素感染药材及饮片增加了 “黄曲霉毒素”检查项目和限度标准。二部进一步加强了对有关物质的控
The test and limit of aflatoxin infection are increased by aspergillus toxin and herbal medicine. The two further strengthened the control of the related substances.
制 ，增强了对方法的系统适用性要求，同时还 增 加 了 约 5 0 0 个杂质 的结构信 息；增加对手性杂质的控制;
It enhances the application of the system to the method, and increases the structure information of about 500 impurities, and increases the control of the adversary system.
静脉输液及滴眼液等增加渗透压摩尔浓度的检测，增加对注射剂与滴眼剂中抑菌剂的控制要求等。三部加
The concentration of osmotic pressure was added to the intravenous infusion and eye drops, and the control requirements for the bacteriostat in the injection and eye drops were increased. Three plus
强对生物制品生产用原材料及辅料的质量控制，规范防腐剂的使用，加强残留溶剂的控制；增加疫苗产品
Control the quality of raw materials and excipients for the production of biological products, standardize the use of preservatives, strengthen the control of residual solvents, and increase the vaccine product
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渗透压摩尔浓度测定，增订毒种种子批全基因序列测定，严格细菌内毒素检查限度。
Osmolality determination, determination of the virus seed batch gene sequence, bacterial endotoxin limit strictly.
药品有效性控制进一步完善。对检测方法进行了全面增修订。一部部分中药材增加了专属性的显微鉴
The control of drug effectiveness is further improved. The detection method has carried on the comprehensive revision. A part of Chinese herbal medicine increases the specificity of the microscopic examination
别检查、特征氨基酸含量测定等；在 丹 参 等 3 0 多个标准中建立了特征图谱。二部采用离子色谱法检测硫酸
No examination, determination of characteristic amino acid content, and so on; characteristic atlas was established in more than 30 standards of Salvia miltiorrhiza and so on. Two parts are used to detect sulphuric acid by Ion Chromatography
盐或盐酸盐原料药中的酸根离子含量；采用专属性更强、准确度更高的方法测定制剂含量；增修订溶出度
The content of salt ions or hydrochloride in raw medicine; the stronger specificity and higher accuracy method for the content determination of cefradine capsules; dissolution of revision
和释放度检査法，加强对口服固体制剂和缓控释制剂有效性的控制。
And the release degree examination method to strengthen the control of the effectiveness of oral solid preparation and slow controlled release preparation.
药用辅料标准水平显著提高。本版药典收载药用辅料更加系列化、多规格化，以满足制剂生产的需求, 增订可供注射用等级辅料2 1 种 。加强药用辅料安全性控制，如增加残留溶剂等控制要求。更加注重对辅料
The standard level of medicinal excipients has been greatly improved. This edition Pharmacopoeia medicinal materials series, more specifications, to meet production needs, the utility model can be used for 21 kinds of injection grade materials. Strengthening the safety control of medicinal excipients, such as increasing the control requirements of residual solvents. Pay more attention to the auxiliary materials
功能性控制，如增订多孔性、粉末细度、粉末流动、比表面积、黏度等检查项，并强化药用辅料标准适用
The function of control, such as the porosity, powder fineness, powder flow, surface area, viscosity and other inspection items, and strengthen the application of standard pharmaceutical excipients
性研究的要求。
The requirement of sex research.
进一步强化药典标准导向作用。本版药典通过对品种的遴选和调整、先进检测方法的收载、技术指导
Further strengthening the standard oriented effect of the Pharmacopoeia. This edition of the Pharmacopoeia through selection and adjustment of the varieties, the collection of advanced testing methods and technical guidance
原则的制定等，强化对药品质量控制的导向作用；同时，紧跟国际药品质量控制和标准发展的趋势，兼顾
The formulation of principles should strengthen the guiding role of drug quality control, and at the same time follow the trend of international drug quality control and standard development.
我国药品生产的实际状况，在检查项目和限度设置方面，既要保障公众用药的安全性，又要满足公众用药
The actual situation of the drug production in China, in the inspection project and the limit setting, should not only guarantee the safety of the public drug use, but also meet the public drug use.
的可及性，从而引导我国制药工业健康科学发展。
In order to guide the development of the health science of the pharmaceutical industry in China.
本版药典继续秉承保护野生资源和自然环境、坚持中药可持续发展、倡导绿色标准的理念，不再新增
This edition of Pharmacopoeia continues to uphold the concept of protecting wild resources and natural environment, persisting in the sustainable development of traditional Chinese medicine and advocating green standards.
处方中含豹骨、羚羊角、龙 骨 、龙齿等濒危物种或化石的中成药品种；提倡检测试剂中具有毒性溶剂的替
The prescription containing leopard, antelope horn, keel, dragon and other endangered species or fossils of proprietary varieties; advocate with toxic solvents in the detection reagent for
代使用，如取消含苯和汞试剂的使用，以减少对环境及实验人员的污染。
Use, for example, to eliminate the use of benzene and mercury reagents to reduce pollution to the environment and the laboratory personnel.
药典制定更加公开透明、规范 有 序 。本版药典编制工作始终坚持公 开 、公 平 、公正的原则。药典委员
The formulation of the pharmacopoeia is more open, transparent and orderly. The compilation of this edition of the Pharmacopoeia always adhered to the principles of openness, fairness and impartiality. Member of the Pharmacopoeia
会常设机构首次将I S 0 9 0 0 1质量管理体系引入药典编制全过程管理，通过持续改进和完善药典委员会的管
The I S 09001 quality management system was introduced to the pharmacopoeia for the first time by the permanent organization, and through continuous improvement and improvement of the management of the Pharmacopoeia Committee
理制度、规范药典编制工作程序，为保证药典编制工作质量保驾护航。国家药典委员会大力推进药品标准
In order to guarantee the quality of the compiling of the Pharmacopoeia, the system of the Pharmacopoeia and the code of Pharmacopoeia are compiled. The national pharmacopoeia commission vigorously promotes drug standards
提高科研工作，保证药典编制的进度和质量。严 格 执 行 “中国药典编制工作程序”、完善专业委员会间沟通
To improve the scientific research work and to ensure the progress and quality of the compilation of the Pharmacopoeia. Strictly implement the "Chinese Pharmacopoeia compilation work procedure" and perfect the communication between Specialized Committee
和协调、加强标准审核和公示环节工作，所有标准增修订内容均在国家药典委员会网站予以公布，并将反
And coordination, strengthen the standard audit and publicity aspects of the work, all the standard revised contents of the national pharmacopoeia committee website to be published, and will be back
馈意见的专家审核结果对外发布。
The results of the expert review are issued to the outside world.
本版药典在保持药典科学性、先进性和规范性的基础上，重点加强药品安全性和有效性的控制要求，
On the basis of keeping the Pharmacopoeia scientific, advanced and standardized, the Pharmacopoeia focuses on strengthening the control requirements of drug safety and effectiveness.
充分借鉴国际先进的质量控制技术和
Fully draw lessons from international advanced quality control technology and