Evolution of China Pharmacopoeia

After the founding of People's Republic of China (PRC), the Party and the government were very concerned about people's medical and health work. At that time, the Ministry of Health convened relevant medical experts in Beijing to discuss the compilation of Pharmacopoeia. From 1950 to 65438+ year 10, the Ministry of Health was responsible for setting up the China Pharmacopoeia Compilation Committee and the meeting of officials who handled the daily work of Professor Meng Mude, a Shanghai pharmaceutical expert, to plan and compile the new China Pharmacopoeia.

1950 In April, a pharmacopoeia symposium was held in Shanghai to discuss the principles and recommended varieties of the pharmacopoeia. According to the instructions of the Ministry of Health, it was proposed to compile a new edition of China Pharmacopoeia based on the national conditions and the principles of nationalization, scientificity and popularization. Subsequently, the Ministry of Health hired 49 members of the Pharmacopoeia and divided them into eight groups: nouns, chemicals, preparations, plant medicines, biological products, animal medicines, pharmacology and dosage, and hired 35 communication members to set up the first China Pharmacopoeia Compilation Committee. Li Dequan, Minister of Health, is the chairman.

195 1 The first plenary meeting of the first China Pharmacopoeia Compilation Committee was held in Beijing from April 24th to 28th. The meeting made a decision on the name, varieties, proper nouns, weights and measures and format of Pharmacopoeia. According to the opinions discussed in the plenary session, the director will revise the draft pharmacopoeia. After the draft was submitted by the Ministry of Health to the the State Council Municipal Commission of Culture and Education for approval at the end of 1952, the Ministry of Health published the first edition of China Pharmacopoeia 1953.

The Pharmacopoeia 1953 contains 53 kinds of drugs, including 2 kinds of chemicals, 65 kinds of plants and oils, 2 kinds of animals, 2 kinds of antibiotics, 25 kinds of biological products and 2 kinds of preparations. After the publication of Pharmacopoeia, the first supplement of Pharmacopoeia of China was published in 1957. From 65438 to 0955, the Ministry of Health established the Second Pharmacopoeia Committee, with 49 members and 68 correspondence members, but the Committee failed to carry out its work for some reasons. 1957, the third pharmacopoeia Committee was established and 80 members were hired. Professor Tang Tenghan, a pharmaceutical expert, is the chairman of the Committee (no communication Committee). The first meeting of all members was held in Beijing from July 28th to August 5th of the same year. Li Dequan, Minister of the Ministry of Health, pointed out in his report on the work of Pharmacopoeia that the first edition of China Pharmacopoeia did not include traditional Chinese medicines commonly used by ordinary people, which is a big defect. On the basis of summing up the work, the meeting adopted the principles of formulating pharmacopoeia, discussed the nature and function of pharmacopoeia, and revised the articles of association of the Committee. The meeting agreed to include qualified Chinese medicines in the Pharmacopoeia. On August 27th, the Ministry of Health approved the establishment of six special committees and terminology groups on pharmacology and medicine, chemicals, pharmaceuticals, biochemical drugs, raw materials and biological products. The Pharmacopoeia Committee set up a standing committee, and the daily work organization was renamed the secretarial office. 1958 After being studied by the Standing Committee and reported to the Ministry of Health for approval, eight Chinese medicine experts and three Chinese medicine experts were hired to form a Chinese medicine professional committee, and Chinese medicine experts from relevant provinces and cities were organized to draft the standards of Chinese medicine and Chinese medicine prescriptions (i.e. Chinese patent medicines) according to the theory and experience of Chinese medicine.

1959 From June 25th to July 5th, the second plenary meeting of this committee was held in Beijing, mainly to review the draft of the new Pharmacopoeia and determine the varieties to be collected. After the draft was revised and supplemented, it was reviewed and approved by the special committees respectively. The draft has been submitted to the State Council for approval and then issued. 1On October 26th, the Ministry of Health published the Pharmacopoeia of China 1963, and issued a notice and implementation measures.

1963 Pharmacopoeia contains 13 10 drugs, which are divided into two parts, each with its own examples and related appendices. One volume contains 446 kinds of Chinese herbal medicines commonly used in traditional Chinese medicine, and Chinese herbal medicine prescription preparation 197 kinds; The second part contains 667 chemicals. In addition, one part recorded the "functions and indications" of drugs, and the other part added the "functions and uses" of drugs.

1966 due to the turmoil of the cultural revolution, the work of the pharmacopoeia Committee came to a standstill. 1972 on April 28th, the State Council gave a reply to the Ministry of Health "agreeing to resume the Pharmacopoeia Committee, with the participation of four departments (Ministry of Health, Ministry of Fuel Chemical Industry, Ministry of Commerce and Ministry of Health of the General Logistics Department of the People's Liberation Army), with the Ministry of Health taking the lead". Accordingly, from May 3 1 day to June 10 in the same year, a national conference on compiling a new edition of Pharmacopoeia was held in Beijing, with 88 representatives from drug inspection, drug administration and relevant units of all provinces (autonomous regions and municipalities directly under the Central Government) attending the conference. This meeting focused on the guiding ideology, methods, tasks and requirements of pharmacopoeia compilation, exchanged working experience, determined the compilation scheme of the new pharmacopoeia, and implemented the drafting task in a division of labor. 1973 in April, the second national pharmacopoeia work conference was held in Beijing, and some principles and requirements for formulating pharmacopoeia, as well as standard samples and drafting instructions of Chinese and western medicines were discussed, and the drafting tasks were adjusted according to the main producing areas of medicinal materials and drug production. China Pharmacopoeia 1979 1977 issued by the Ministry of Health has been implemented since 1980 10. 1977 edition of Pharmacopoeia contains 1925 kinds of drugs. The first part contains 882 kinds of Chinese herbal medicines (including minority medicines), Chinese herbal medicine extracts, vegetable oil and some single medicinal preparations, and 270 kinds of prescription preparations (including minority medicines), totaling 1 152 kinds; The second part contains 773 chemicals and biological products.

1979, the Ministry of Health hired 1 12 members to form the fourth Pharmacopoeia Committee, with Minister of Health Qian Xinzhong as the chairman. In the same year, 165438+ held the first plenary meeting in Beijing from 22 to 28 October on/kloc-0. The meeting discussed and revised the articles of association, management measures and work plan of the Drug Standards Committee. There are 10 professional groups under the Committee: traditional Chinese medicine, traditional Chinese medicine, medicine and pharmacology, chemical medicine, biochemical medicine, pharmacy, antibiotics, biological products, radioactive drugs and nouns. Relevant professional groups respectively recommend the varieties included in the new Pharmacopoeia, and the Chinese medicine professional group is responsible for reviewing and drafting the range of varieties included in the new Pharmacopoeia; The medical and pharmacological professional group is responsible for reviewing and formulating the range of varieties included in the second part; The drug inspection offices of provinces (autonomous regions and municipalities directly under the Central Government) where the main producing areas are located and relevant units are responsible for drafting standards, and the Office of Pharmacopoeia Committee organizes cross-review. Some projects were drafted by a special cooperation team after experimental research, and the draft standard was discussed and considered by members of relevant professional teams, and representatives of relevant drug inspection institutes and pharmaceutical factories were invited to participate, and then reported to the Ministry of Health for approval. China Pharmacopoeia 1985 was published in September. 1986 April. This edition of Pharmacopoeia contains 1489 kinds of drugs. One volume contains 506 kinds of Chinese herbal medicines, vegetable oils and single preparations, and 207 kinds of Chinese herbal medicines, totaling 765,438+03 kinds; The second part contains 776 chemicals and biological products.

On July 1985, the Drug Administration Law of People's Republic of China (PRC) was formally implemented, which stipulated that "drugs must meet the national drug standards or the drug standards of provinces, autonomous regions and municipalities directly under the Central Government". It is clear that "People's Republic of China (PRC) Pharmacopoeia and drug standards promulgated by the health administrative department of the State Council are national drug standards". Pharmacopoeia Committee of the State Council health administrative department is responsible for organizing the formulation and revision of national drug standards. The legal nature of drug standards and the task of Pharmacopoeia Committee were further clarified.

1986, the Ministry of Health hired 150 people to form the Fifth Pharmacopoeia Committee, with Cui Yueli, Minister of Health, as the chairman, and the permanent establishment changed to the secretary-general system. In the same year, the first plenary meeting of the fifth session was held from May 5 to 8, at which the articles of association of the Committee were discussed and revised, the standard work plan for the seventh five-year plan period was adopted, and the guiding ideology and principle requirements for compiling the China Pharmacopoeia 1990 edition were determined. Convene professional meetings on Chinese herbal medicine, Chinese herbal medicine prescription, chemical medicine, antibiotics, biochemical medicine and pharmacology respectively, and arrange drafting and scientific research tasks. China Pharmacopoeia 1987 1 1 was published in1October, with 23 new varieties, 72 revised varieties, and Appendix 2 1. 1988 10, the first English version of Pharmacopoeia of China 1985 was officially published. In the same year, the second edition of Pharmacopoeia was published. 1989 March, the first draft of 1990 Pharmacopoeia standard was basically completed, and the standing body of Pharmacopoeia Committee began to organize the review and editing work. In February of the same year, an enlarged meeting of the chairman, vice-chairmen and heads of various disciplines of the Pharmacopoeia Committee was held in Beijing, and it was reported to the Ministry of Health for approval before being issued. 1990 65438+On February 3rd, the Ministry of Health promulgated the Pharmacopoeia of China1990, which came into effect in July.

This edition of Pharmacopoeia is divided into two parts, including 175 1 variety. There are 784 species in the first part, including 509 species of Chinese herbal medicine and vegetable oil, 275 species of Chinese herbal medicine prescriptions and single-flavor preparations; The second part contains 967 chemicals and biological products. Compared with the varieties included in 1985 Pharmacopoeia, there are 80 new varieties in the first edition and 2 13 new varieties in the second edition (including 5 new varieties in the first edition); Delete 25 species (3 species in part and 22 species in two parts); According to the actual situation, the name of the drug was modified appropriately. The "Function and Usage" and "Usage and Dosage" stipulated in the second part of Pharmacopoeia were changed to "Category" and "Dosage" respectively, and a book "Guidance on Clinical Medication" was compiled to guide clinical medication. The infrared absorption spectra of related varieties will be published separately in the Collection of Infrared Spectra of Drugs, not in the appendix of this edition of Pharmacopoeia.

199 1 year, the sixth pharmacopoeia Committee was established. The Ministry of Health employs 168 members, with Minister of Health Chen Minzhang as the chairman. In the same year, the first meeting of all members was held from May 16 to May 18. The articles of association of the committee were discussed and adopted, the design scheme of China Pharmacopoeia 1995 was formulated, and a standing committee composed of 1 1 chairman, vice-chairmen and experts was established. There are 13 professional groups, namely: Chinese medicine, Chinese herbal medicine, Chinese patent medicine, western medicine, pharmacology, chemistry, chemistry, antibiotics, biochemistry, biological products, radioactive drugs and medical terms. After the meeting, each professional group held an enlarged meeting of professional group members to arrange and implement the tasks put forward by the plenary session.

1993 "China Pharmacopoeia" 1995 edition, the first draft of the appendix was sent to various places as the basis for drafting and revising the text standard. From June 65438 to July 0994, all localities basically completed the task of drafting standards, and the professional committees of the Pharmacopoeia Committee organized the review work respectively. 1994165438+129 October was submitted to the enlarged meeting of the Standing Committee for discussion and deliberation, which was approved in principle and reported to the Ministry of Health for approval and issuance. The Ministry of Health approved the promulgation of China Pharmacopoeia 1995, which will be implemented on 1 April, 9961day.

This edition of Pharmacopoeia contains 2375 species. One volume contains 920 kinds, including 522 kinds of Chinese herbal medicine and vegetable oil, 398 kinds of traditional Chinese medicine prescriptions and single-flavor preparations; The second part contains 65,438+0,455 species, including chemicals, antibiotics, biochemical drugs, radioactive drugs, biological products and accessories. There are 142 new varieties in the first part and 4 "new varieties" in the second part. The foreign names of two drugs were changed to English names, and the Latin names were cancelled; The Chinese name only contains the legal generic name of the drug, without listing the sub-names. The first volume (version 1995) of Infrared Spectra of Drugs was edited and published. The Instructions for Clinical Use and the Pharmacopoeia of China (version 1995) approved by the Ministry of Health were revised and published at the same time, and "indications" and "dosage" were taken as the basis for drug administration and production departments to publicize the use and management of drugs.

In addition to compiling the 1995 edition of the Pharmacopoeia, the current Pharmacopoeia Committee also compiled and published the first and second supplements, two notes and a selected note, Color Atlas of Traditional Chinese Medicine and Color Atlas of Thin Layer Chromatography of Traditional Chinese Medicine in 1992 and 1993 respectively. The English version of China Pharmacopoeia 1990 was also published in July 1993.

In order to strengthen the work of national drug standards, the Ministry of Health decided on May 2 1993 to separate the permanent organization of the Pharmacopoeia Committee from the China Institute for the Control of Pharmaceutical and Biological Products, which was a major reform in the institutional history of the Pharmacopoeia Committee.

In May, 1996 was approved by the Ministry of Health, and the Seventh Pharmacopoeia Committee, composed of 204 members hired by the Ministry of Health, was established, including honorary member 18, and Minister of Health Chen Minzhang served as the chairman. 1September, 1998, the Pharmacopoeia Committee of the Ministry of Health was renamed the National Pharmacopoeia Committee according to Document No.32 of the Central Organization Establishment Committee. Due to the change of management system and the death of Minister Chen Minzhang in March, with the consent of the relevant leading departments and in accordance with the spirit of the Constitution of the Seventh Pharmacopoeia Committee, In February, the Standing Committee of the Seventh Pharmacopoeia Committee unanimously agreed to adjust the chairman and vice chairman. There are 16 professional committees in this session, namely: Chinese Medicine Committee, First Committee of Chinese Medicine, Second Committee of Chinese Medicine, Third Committee of Chinese Medicine, Fourth Committee of Chinese Medicine, Medical Committee, Drug Terminology Committee, Appendix Committee, Preparation Committee, Pharmacology Committee, First Committee of Chemicals, Second Committee of Chemicals, Antibiotics Committee and Biochemical Medicine Committee.

1996 The first meeting of the Standing Committee of the Seventh Pharmacopoeia Committee was held, and the Design Scheme of China Pharmacopoeia 2000 Edition put forward by this Pharmacopoeia Committee was adopted. In the first part, the guiding ideology of "highlighting characteristics and basing on improvement" was established, and in the second part, the guiding ideology of "catching up with national conditions and catching up with advanced features" was established. According to the design plan put forward by the Committee, from June 1996 to June 10, all professional committees held meetings successively to implement the tasks put forward in the design plan and carry out their work in a division of labor. At the end of 1997, at first, the appendix and general rules for writing were revised and distributed to all drafting units for comments. At the end of 1998, the first draft of Pharmacopoeia was completed. By the end of 1999, a total of 16 professional committee meetings had been held to consider and pass the draft. China Pharmacopoeia (2000 edition) was examined and adopted at the meetings of the Standing Committee of the Seventh Pharmacopoeia Committee (1, 999, 12), and submitted to the State Pharmaceutical Products Supervision and Administration for approval and promulgation. It was published in June 2000 and officially implemented in July 2000.

The 2000 edition of Pharmacopoeia contains 269 1 drug, of which one contains 992 drugs and the other contains 1 699 drugs. There are 399 new varieties and 562 revised varieties in the first and second parts. The appendices of this edition of Pharmacopoeia have been greatly improved, with new appendices 10 and revised appendices 3 1 0. The second part has 27 new appendices and 32 revised appendices. For the first time, six guiding principles, such as verification requirements of drug standard analysis methods, were included in the appendix of the second part, which played a guiding role in unifying and standardizing drug standard inspection methods. Modern analytical techniques have been further expanded and applied in this edition of Pharmacopoeia. The 7th Pharmacopoeia Committee also completed the Pharmacopoeia of China (version 1995), version 1997, version 1998, General Names of Drugs in China (version 1998), Infrared Spectra of Drugs (Volume II) and. 1997, the English version of China Pharmacopoeia was completed. In order to strengthen international cooperation and exchange, the Seventh Pharmacopoeia Committee also decided to publish the English and Chinese versions of China Pharmacopoeia 2000 simultaneously.

The contents of "dosage" and "precautions" in previous editions of Pharmacopoeia are too simple to accurately reflect the actual situation of clinical medication. According to the suggestion of the Design Plan of China Pharmacopoeia 2000, the second edition of this edition of Pharmacopoeia cancelled these two contents, and the related contents were moved to the book "Clinical Drug Instruction" of China Pharmacopoeia 2000.

In 2002, the Eighth Pharmacopoeia Committee was established with the approval of the State Pharmaceutical Products Supervision Administration (renamed the State Food and Drug Administration in September 2003). It is composed of 365,438+02 members hired by the State Administration of Pharmaceutical Products, with no honorary members. Zheng Xiaoying, director of the State Administration of Pharmaceutical Products, is also the chairman. The former Standing Committee was renamed as the Executive Committee, and all members of the General Assembly authorized the examination and approval of major issues in China Pharmacopoeia and national drug standards. The Committee consists of 24 professional committees. On the basis of the last special committee, a special committee on ethnic medicine (to be established), a special committee on microbiology and a special committee on packaging materials and auxiliary materials have been added. The original specialized committee for biological products has been expanded to specialized committees for blood products, virus products, bacterial products, somatic cell therapy and gene therapy, recombinant products and biochemical reagents for in vitro diagnosis.

On June 5438+ 10, 2002, the 8th General Assembly of Pharmacopoeia Committee and the first meeting of the Executive Committee were held, and the "China Pharmacopoeia 2005 Edition Design Plan" put forward by the current Pharmacopoeia Committee was adopted. The design scheme clarifies the principle of adhering to inheritance and development and integrating theory with practice; The principles of pharmacopoeia compilation such as "scientific, practical and standardized" were determined. Decided to incorporate the Regulations of China on Biological Products into the Pharmacopoeia and make it the third part of the Pharmacopoeia; And compiled the first Chinese patent medicine "Clinical Instruction".

Since June+10, 2002, various professional committees have held meetings to arrange the tasks proposed in the design plan and carry out their work separately. In July 2003, the draft appendix was first completed and sent to the relevant units for comments. At the beginning of 2004, the appendix and the first draft of varieties of Pharmacopoeia were basically completed, and the additions and revisions were published on the website of the National Pharmacopoeia Committee for three months to solicit opinions from all relevant parties in the country. From June to August, various professional committees held meetings to review and approve the draft. The 2005 edition of China Pharmacopoeia was reviewed and approved by the Executive Committee of the Eighth Pharmacopoeia Committee in September 2005, and was submitted to the State Food and Drug Administration for approval and promulgation in June+February 2005, published in June+10, and officially implemented in July +0, 2005. The varieties included in this edition of Pharmacopoeia have greatly increased. A total of 32 14 species were collected, including 525 new species. There are 1 146 species in Pharmacopoeia I, including 154 new species and 453 revised species. There are 1967 species in the second part of Pharmacopoeia, including 327 new species and 522 revised species. The third part of Pharmacopoeia contains 10 1 species, including 44 new species and 57 revised species. There are 9 kinds of Pharmacopoeia of China (2000 edition), but there are none in this edition. There are 123 species in the 2000 edition of "Regulations of Biological Products in China" and the 2002 supplement, but there are no species in the Pharmacopoeia.

There are 98 appendices in this edition of Pharmacopoeia, including 12 newly added, 48 revised and 1 deleted. Pharmacopoeia II contains 137, of which 13 was added, 65 were revised and 1 was deleted. The Pharmacopoeia consists of three parts: 140, of which 62 parts were added, 78 parts were revised and 1 part was deleted. All departments collected and coordinated the appendices jointly adopted by the first, second and third departments.

This edition of pharmacopoeia pays more attention to the safety of drugs under the active advocacy of the chairman. The determination methods of harmful elements (lead, cadmium, arsenic, mercury and copper) are added to Pharmacopoeia I, and the limit of harmful elements is stipulated. Pharmacopoeia I also added the Guiding Principles for the Application of Safety Inspection Methods for Traditional Chinese Medicine Injection. There are 126 kinds of intravenous injections in the second part of Pharmacopoeia, and the insoluble particle test is updated, and the bacterial endotoxin test is changed to112; The internationally coordinated limit requirements of residual solvents were introduced in the determination method of residual solvents, and the residual solvents inspection of 24 APIs was updated. The second part of the Pharmacopoeia also added the guiding principles of drug impurity analysis and quality control of positron and technetium [99 mm TC] radiopharmaceuticals. In the third part of Pharmacopoeia, reverse transcriptase activity detection method and human serum albumin aluminum residue detection method were added, and the detection methods of bovine serum albumin residue and CHO cell protein residue were also improved. This edition of Pharmacopoeia, based on the current situation of China's pharmaceutical industry and the actual situation of clinical medication, revised the Rules and Standards for Clarity Inspection promulgated by the former Ministry of Health into the Law for Inspection of Visible Foreign Bodies, in order to strengthen the medication safety of injections and other drugs.

This edition of Pharmacopoeia adheres to the consistency principle of paying attention to environmental protection, and uses other solvents as far as possible to replace harmful solvents such as benzene in varieties. Based on the theory of syndrome differentiation and treatment of traditional Chinese medicine, this edition of Pharmacopoeia scientifically standardizes the functional indications of traditional Chinese medicine, which provides a guarantee for accurately understanding the functional indications of traditional Chinese medicine and promoting the healthy development of traditional Chinese medicine in the new period.

This edition of Pharmacopoeia III originated from the regulations of biological products in China. Since 195 1, six versions of the code have been promulgated and implemented, namely 195 1 and 1952 revised version, 1959 version, 1979 version and In 2002, the first English version of the Regulations of China on Biological Products (2000 Edition) was translated and published.

The Eighth Pharmacopoeia Committee also completed the China Pharmacopoeia 2000 Edition, the 2002 Supplement, the 2004 Supplement, the General Names of Drugs in China (2005 Edition), the Infrared Spectrum of Drugs (Volume III) and the Instructions for Clinical Use (the first edition of Chinese patent medicines and the fourth edition of chemical medicines). In 2005, the English version of China Pharmacopoeia 2005 was completed. In order to strengthen international cooperation and exchange, the first Sino-US Pharmacopoeia Forum was jointly held with the Pharmacopoeia Committee of the United States during this session.

In order to strengthen and improve the work efficiency and level of national standards, the permanent organization has completed the office automation and standard database construction, and realized the computer network retrieval and statistical analysis of published standards.