The Chinese Pharmacopoeia in the hplc method of system applicability of the experimental content of what

1, the theoretical plate number of the column

2, separation

3, repeatability

4, tailing factor

In the system suitability test of high performance liquid chromatography (HPLC), there are four commonly used parameters: separation, column efficiency, repeatability and tailing factor.

Separation and column efficiency are the two most important and practical parameters.

Separation is the degree to which two substances are separated in a method, and although it is related to column efficiency, the first emphasis should be on separation when measuring the suitability of the system, and only when there is only one peak in the chromatogram or the determination of trace amounts of the components, then the stipulation of the column efficiency has its special importance.

Repeatability and drag factors, respectively, impose requirements for reproducibility and peak shape of chromatographic peaks. Reproducibility ensures the reproducibility of the method, the requirements of the column efficiency, column aging, collapse, tailing factor is difficult to meet the requirements

High performance liquid chromatography, also known as "high-pressure liquid chromatography", "high-speed liquid chromatography", "High separation liquid chromatography", "modern column chromatography" and so on.

High-performance liquid chromatography is an important branch of chromatography, using liquid as the mobile phase, using high-pressure infusion system, a single solvent with different polarity or different proportions of mixed solvents, buffers, and other mobile phases are pumped into the column equipped with a stationary phase, and the components are separated within the column, and then entered into the detector for detection, so as to realize the analysis of the specimen.

This method has become an important application of separation and analysis technology in the fields of chemistry, medicine, industry, agronomy, commodity inspection and forensic inspection.

Extended information:

China has ****promulgated 8 editions of Chinese Pharmacopoeia since the founding of the country

Chinese Pharmacopoeia History

On October 1, 1949 after the founding of the Chinese People's Republic of China, the Party and the government cared a lot about the people's medicine and health care, in November of that year, the Ministry of Health convened a meeting of the relevant medical experts in Beijing to discuss the compilation of the Pharmacopoeia. 1950, the Ministry of Health in January of the Pharmacopoeia of the Pharmacy experts from Shanghai to transfer the Meng Meng purpose is responsible for the establishment of the Chinese Pharmacopoeia Codification Committee and the handling of the day-to-day work of the Board of Directors. In January 1950, the Ministry of Health transferred Professor Meng Mu, an expert in pharmacology from Shanghai, to set up the Chinese Pharmacopoeia Codification Committee and a committee to deal with the day-to-day work.

A symposium on the pharmacopoeia was held in Shanghai in April 1950 to discuss the principle of including varieties in the pharmacopoeia and the recommended varieties to be included, and, according to the instructions of the Ministry of Health, to propose that the new Chinese pharmacopoeia should be combined with the national conditions to compile a pharmacopoeia with nationalization, scientification, and popularization. Subsequently, the Ministry of Health hired 49 members of the Pharmacopoeia.

Divided into eight groups, namely, nomenclature, chemical drugs, preparations, botanical drugs, biological products, animal drugs, pharmacology, and dosage, and 35 corresponding members, the first Chinese Pharmacopoeia Codification Committee was established. Li Dequan, Minister of Health, served as the chairman of the committee.

The first plenary session of the first Chinese Pharmacopoeia Codification Committee was held in Beijing from April 24 to 28, 1951, at which decisions were made on the name of the Pharmacopoeia, the varieties to be included, the special terms, the issues of weights and measures, and the arrangement of formats. The committee revised the draft pharmacopoeia according to the opinions discussed in the plenary session.

The draft was submitted to the Ministry of Health at the end of 1952 for approval by the Council of Culture and Education of the State Council, and the first Chinese Pharmacopoeia, the 1953 edition, was published by the Ministry of Health.

The 1953 edition of the Pharmacopoeia*** contained 531 kinds of medicines, including 215 kinds of chemicals, 65 kinds of botanicals and oils, 13 kinds of animal medicines, 2 kinds of antibiotics, 25 kinds of biological products, and 211 kinds of preparations. After the publication of the Pharmacopoeia, the first supplement to the 1953 edition of the Chinese Pharmacopoeia was published in 1957.

In 1955, the Ministry of Health set up the second Pharmacopoeia Committee, employing 49 members and 68 corresponding members, but this committee failed to work for some reasons. 1957, the third Pharmacopoeia Committee was established, employing 80 members, and Professor Tang Teng-han, an expert in pharmacy, was the chairman of the committee (without corresponding members).

The first plenary meeting was held in Beijing from July 28 to August 5 of the same year, and Minister Li Dequan of the Ministry of Health made a report on the work of the Pharmacopoeia, pointing out, in particular, that the first edition of the Chinese Pharmacopoeia did not contain Chinese medicines used by the general public, which was a great defect. On the basis of summarizing the work, the meeting adopted the principles for the formulation of the Pharmacopoeia, discussed the nature and role of the Pharmacopoeia, and revised the constitution of the committee.

The meeting agreed that eligible Chinese medicines should be included in the Pharmacopoeia. 27 August, the Ministry of Health approved the Committee to set up pharmacology and medicine, chemicals, pharmaceuticals, biochemical drugs, biopharmaceuticals, biological products and six specialized committees and nomenclature group, the Pharmacopoeia Committee to set up a Standing Committee, the day-to-day work of the institution renamed the Secretary's Office.

In 1958, after the Standing Committee's study and the approval of the Ministry of Health, 8 Chinese medicine experts and 3 Chinese medicine experts were recruited to form the Specialized Committee on Chinese Medicine, which organized Chinese medicine experts from the relevant provinces and cities to draft the standards for Chinese herbal medicines and Chinese medicines (i.e., proprietary Chinese medicines) in accordance with the theories and experiences of traditional Chinese medicines.

The second plenary session of this committee was held in Beijing from June 25 to July 5, 1959, which mainly considered the draft of the new pharmacopoeia and determined the varieties to be included. The draft was revised and supplemented, respectively, by the specialized committees to validate the draft in 1962 to complete the draft for review, reported to the State Council for approval after printing, January 26, 1965, the Ministry of Health announced the Chinese Pharmacopoeia 1963 version.

The 1963 edition of the Pharmacopoeia*** contains 1310 kinds of medicines, divided into two parts, each with its own general rules and relevant appendices. The first part contains 446 kinds of Chinese herbal medicines and 197 kinds of Chinese prescription preparations commonly used in traditional Chinese medicine; the second part contains 667 kinds of chemical drugs. In addition, a record of the "function and main treatment" of drugs, the second part of the "role and use" of drugs.

1966 due to the "Cultural Revolution" turmoil, the Pharmacopoeia Committee work came to a standstill. 1972 April 28, the State Council replied to the Ministry of Health, "agreed to restore the Pharmacopoeia Committee, the four ministries (the Ministry of Health, the Ministry of Fuel and Chemical Industry, the Ministry of Commerce, the Ministry of Health of the People's Liberation Army) to participate, led by the Ministry of Shengsheng". The Ministry of Health, the Ministry of Commerce, the PLA General Logistics Department of Health to participate, led by the Ministry of Shengsheng".

Accordingly, the same year, May 31 to June 10 in Beijing held a working meeting of the preparation of a new national pharmacopeia, the meeting was attended by the provinces (autonomous regions and municipalities directly under the Central Government) of the drug testing, pharmacological management, as well as relevant.... The meeting was attended by representatives of drug testing, pharmacovigilance and related organizations from all provinces (autonomous regions, municipalities directly under the central government). The meeting focused on the preparation of the Pharmacopoeia of the guiding ideology, methods, tasks and requirements, exchanges of experience,

determined the preparation of the new Pharmacopoeia program, and division of labor to implement the drafting tasks.

In April 1973, the second National Pharmacopoeia Work Conference was held in Beijing to discuss some of the principles and requirements for the development of the Pharmacopoeia, as well as the standard samples of Chinese and Western medicines and the drafting of instructions, and adjusted the drafting tasks according to the main origins of the medicinal materials and production of medicines.

October 4, 1979, the Ministry of Health promulgated the Chinese Pharmacopoeia 1977 version since January 1, 1980, the implementation of.

The 1977 edition of the Pharmacopoeia*** contained 1925 medicines. The first part contains 882 kinds of Chinese herbal medicines (including minority medicines), herbal extracts, vegetable oils and some single-flavored herbal preparations, 270 kinds of prescription preparations (including minority medicines), and 1,152 kinds of ****; the second part contains 773 kinds of chemical drugs and biological products.

In 1979, 112 members were hired by the Ministry of Health to form the fourth Pharmacopoeia Committee, with Minister of Health Qian Xinzhong as the chairman. The first plenary meeting of this session was held in Beijing from November 22 to 28 of the same year, and the meeting discussed and revised the constitution of the committee, the management of drug standards and work plans.

The committee is divided into 10 professional groups: Chinese medicine, traditional Chinese medicine, medicine and pharmacology, chemical drugs, biochemical drugs, pharmaceuticals, antibiotics, biological products, radioactive drugs and terminology. Recommended by the relevant professional groups, respectively, the new Pharmacopoeia contained varieties, Chinese medicine professional group is responsible for reviewing the development of a range of varieties contained; medicine and pharmacology professional group is responsible for reviewing the development of the range of varieties contained in the second;

by the main place of origin of the province (autonomous regions, municipalities directly under the Central Government) Drug Inspection Institute and the relevant units are responsible for the drafting of the standard, Pharmacopoeia Commission Office of the organization of the cross-checking, and some of the projects to form a special topic. Collaborative group drafted through experimental research, the draft standard by the relevant professional group members and invite representatives of the relevant drug testing laboratories and pharmaceutical companies to discuss and consider the approval of the Ministry of Health.

The 1985 edition of the Chinese Pharmacopoeia was published in September 1985, and was implemented from April 1, 1986 onwards. This edition of the Pharmacopoeia*** contains 1489 kinds of medicines. A collection of Chinese herbal medicines, plant oils and fats and single-flavored preparations 506 kinds, 207 kinds of Chinese medicine prescription, *** 713 kinds; the second part of the collection of chemical drugs, biological products, such as 776 kinds.

July 1, 1985 "People's Republic of China *** and the State Drug Administration Law" formally implemented, which provides that "drugs must comply with the national drug standards or provincial, autonomous regions and municipalities directly under the Central Drug Standard. It is clear that the "Chinese People's Pharmacopoeia" and drug standards promulgated by the health administrative department of the State Council are the national drug standards.

"The Pharmacopoeia Committee of the health administrative department of the State Council is responsible for organizing the formulation and revision of national drug standards". Further defined the statutory nature of the drug standard and the task of the Pharmacopoeia Committee.

1986 the Ministry of Health in accordance with the statutes of the Pharmacopoeia Committee to hire members of the 150 people to form the fifth Pharmacopoeia Committee, by the Ministry of Health Cui Yue Li, Minister of the head of the Committee, the permanent office was changed to the Secretary-General system. May 5 to 8 of the same year, held the first meeting of the fifth session of the Committee of the Whole, discussed the revision of the Committee's statutes, adopted the "Seventh Five-Year" period of standard work envisaged.

Determining the guiding ideology and principle requirements for the preparation of the 1990 edition of the Chinese Pharmacopoeia.

In November 1987, the 1985 edition of the Chinese Pharmacopoeia was published, with 23 new varieties, 172 revised varieties and 21 appendices.

In October 1988, the first English version of the 1985 edition of the Chinese Pharmacopoeia was officially published.

In October 1988, the first English version of the 1985 edition of the Chinese Pharmacopoeia was officially published, and in the same year, a selection of the second annotations of the Pharmacopoeia was published.

In December of the same year, the Pharmacopoeia Committee Chairman, Vice Chairman and heads of professional groups held an enlarged meeting in Beijing for deliberation, reported to the Ministry of Health for approval and then printed.

On December 3, 1990, the Ministry of Health promulgated the "Chinese Pharmacopoeia," the 1990 version of the July 1, 1991 onwards.

This edition of the Pharmacopoeia is divided into two parts, **** contains 1751 species.

The first part contains 784 species, of which 509 species are Chinese herbal medicines, vegetable fats and oils, and 275 species are Chinese medicinal formulas and single-flavored preparations; the second part contains 967 species of chemical drugs and biological products. Compared with the 1985 edition of the Pharmacopoeia, 80 new species were added to the first part and 213 new species were added to the second part (including 5 species transferred from the first part of the 1985 edition of the Pharmacopoeia); and 25 species were deleted (3 species from the first part and 22 species from the second part).

The names of medicines have been appropriately revised according to the actual situation. Pharmacopoeia two species under the provisions of the "role and purpose" and "usage and dosage", were changed to "category" and "dose". In addition, a book entitled "Notes on Clinical Use of Drugs" was compiled to guide clinical use of drugs. The infrared absorption spectra of the relevant species, collected in the "infrared spectra of drugs set" published separately, the version of the Pharmacopoeia Appendix is no longer published.

1991 the formation of the sixth Pharmacopoeia Committee, hired by the Ministry of Health members **** 168 people, the Ministry of Health Minister Chen Minzhang concurrently served as chairman. May 16 to 18 of the same year, held the first meeting of all members, discussed and adopted the constitution of the Committee and the preparation of "Chinese Pharmacopoeia" 1995 version of the design program, and set up by the chairman, deputy chairman and experts *** 11 people composed of the Standing Committee.

There are 13 specialized groups, namely: Chinese Medicine, Chinese Materia Medica, Proprietary Chinese Medicines, Western Medicine, Pharmacology, Chemistry, Chemistry, Chemistry, Chemistry, Antibiotics, Biochemistry, Biologics, Radiopharmaceuticals and Pharmaceutical Nomenclature.

After the meeting, each specialty group held an enlarged meeting of specialty group members to arrange for the implementation of the tasks proposed by the plenary session.

1993 "Chinese Pharmacopoeia" 1995 edition, the first draft of the appendix sent to all parts of the drafting, revision of the main body of the standard basis. 1994 July around the basic completion of the drafting of the standard task, by the Pharmacopoeia Committee of the professional committees to organize the review of the draft work respectively.

On November 29, 1994, it was submitted to the expanded meeting of the Standing Committee for discussion and deliberation, and was adopted in principle and submitted to the Ministry of Health for approval and printing. The Ministry of Health approved the promulgation of the Chinese Pharmacopoeia 1995 edition from April 1996 l implementation.

This edition of the Pharmacopoeia contains 2,375 varieties. The first edition contains 920 varieties, including 522 varieties of Chinese herbal medicines and plant fats, 398 varieties of Chinese herbal medicines and single-flavored preparations, and the second edition contains 1,455 varieties, including chemicals, antibiotics, biochemicals, radiopharmaceuticals, biological products, and auxiliary materials. A new variety of 142 species, the second part of the new varieties of 4 "species.

The second part of the foreign name of the drug to use the English name, cancel the Latin name; Chinese name only contains the legal common name of the drug, no longer listed in the bylaws. Preparation and publication of the infrared spectral collection of medicines, Volume I (1995 edition).

The book "Notes on Clinical Use of Drugs" was revised and published at the same time as the 1995 edition of the Chinese Pharmacopoeia. Approved by the Ministry of Health, the "Indications" and "Dosage" parts of the book were used as a basis for the pharmacological and production departments to publicize the use and management of drugs.

This is the first time that a drug has been used in the United States.

In addition to completing the compilation of the 1995 edition of the Pharmacopoeia, this session of the Pharmacopoeia Committee also compiled and published the first and second supplements to the 1990 edition of the Chinese Pharmacopoeia in 1992 and 1993, as well as two annotations and a selection of annotations, a color atlas of Chinese medicines, a color atlas of Chinese medicine thin-layer chromatography, and a series of companion works on standards, such as the Chinese Common Names of Medicines.

The 1990 edition of the Chinese Pharmacopoeia was published in July 1993 in English.

In order to strengthen the work of national drug standards, the Ministry of Health decided on May 21, 1993 to separate the permanent organization of the Pharmacopoeia Commission from the China National Institute for the Control of Pharmaceuticals and Biological Products, as a unit directly under the Ministry of Health, which was a major reform in the history of the Pharmacopoeia Commission organization.

In May 1996, approved by the Ministry of Health, the seventh Pharmacopoeia Committee was established by the Ministry of Health to hire 204 members, including 18 honorary members, the Ministry of Health, Minister Chen Minzhang, who also served as chairman of the Committee. In September 1998, according to the Central Editorial Office (1998) 32: the Pharmacopoeia Committee of the Ministry of Health was renamed the State Pharmacopoeia Committee, and was transferred to the State Drug Administration as a whole.

Because of the changes in the management system and the death of Minister Chen Minzhang in March 1999, after obtaining the consent of the relevant leading departments, in accordance with the spirit of the statutes of the Seventh Pharmacopoeia Commission, by the December 1999 meeting of the Standing Committee of the Seventh Pharmacopoeia Commission unanimously agreed to the adjustment of the chairman and vice-chairman. This session of the Committee set up 16 professional committees ****. >Antibiotics Specialty Committee, Biochemical Drugs Specialty Committee, Radiopharmaceuticals Specialty Committee, Biological Products Specialty Committee.

The first meeting of the Standing Committee of the Seventh Pharmacopoeia Committee was held in 1996, which adopted the "Design Program for the 2000 Edition of the Chinese Pharmacopoeia" proposed by the Committee, and established a program of "highlighting the characteristics, based on the enhancement of the"

The second part of the program is the "Chinese Pharmacopoeia", which is the "Chinese Pharmacopoeia".

The second part establishes the guiding principle of "combining catching up with the national situation, and combining the advanced with the distinctive features". According to the design proposed by the committee, October 1996, the professional committees have held meetings to implement the design of the proposed tasks and division of labor to carry out the work. 1997 the end of the year, the first to complete the appendices and the general rules of the preparation of the revision, and sent to the drafting unit for comments.

The first draft of the Pharmacopoeia was completed at the end of 1998, and after further soliciting the opinions of all relevant parties in the country, by the end of October 1999, 16 professional committees were convened to finalize the draft.

The 2000 edition of the Chinese Pharmacopoeia was considered and approved by the Standing Committee of the Seventh Pharmacopoeia Committee in December 1999, and submitted to the State Drug Administration for approval and promulgation, and was published in January 2000.

The Eighth Pharmacopoeia Committee was established with the approval of the State Drug Administration (renamed State Food and Drug Administration in September 2003) in October 2002.

The Chinese Pharmacopoeia is the most comprehensive pharmacopoeia in the world. The eighth Pharmacopoeia Committee was established. It is composed of 312 members hired by the State Drug Administration, and there are no more honorary members.

Zheng Xiaoying, Director General of the State Drug Administration, was appointed Chairman. The former Standing Committee was renamed as the Executive Committee, authorized by the General Assembly to finalize the Chinese Pharmacopoeia and national drug standards on major issues. The Committee has set up 24 specialized committees***. On the basis of the previous committee, the Specialized Committee on Ethnopharmaceuticals (Preparation), the Specialized Committee on Microbiology, and the Specialized Committee on Pharmaceutical Packaging Materials and Excipients have been added; the former Specialized Committee on Biological Products has been expanded into the Specialized Committee on Blood Products, the Specialized Committee on Viral Products, the Specialized Committee on Bacterial Products, the Specialized Committee on Somatic Cell Therapy and Gene Therapy, the Specialized Committee on Recombinant Products, and the Specialized Committee on Biological Reagents for In Vitro Diagnostic Use. The Committee on Biological Reagents for In Vitro Diagnosis.

The General Assembly of the Eighth Pharmacopoeia Committee and the first meeting of the Executive Committee were held in October, 2002, and adopted the "Design Program for the 2005 Edition of the Chinese Pharmacopoeia" proposed by the current Pharmacopoeia Committee.

The design program clearly adheres to the policy of combining inheritance and development, theory and practice; establishes the principles of compilation of the Pharmacopoeia, such as "scientific, practical, and standardized";

decides to incorporate the "Chinese Biological Products Regulations" into the Pharmacopoeia and set up as the three parts of the Pharmacopoeia; and compiles the first "Clinical Instructions for the Use of Drugs" for proprietary Chinese medicines.

Since November 2002, the professional committees have held meetings to organize the tasks proposed in the design program and work separately. in July 2003, the first draft appendix was completed and sent to relevant units for comments.

In early 2004, the Pharmacopoeia appendices and varieties of the first draft is basically completed, additions and revisions to the National Pharmacopoeia Committee website for three months, to solicit the views of all relevant parties in the country. June to August, the professional committees have convened the finalization of the draft conference.

In September, the 2005 edition of the Chinese Pharmacopoeia was reviewed and approved by the eighth session of the Pharmacopoeia Committee, and in December, it was submitted to the State Food and Drug Administration for approval and promulgation, and was published in January 2005, and was formally implemented from July 1, 2005 onwards. This edition of the Pharmacopoeia contains a substantial increase in the number of species.

***There are 3214 species in the Pharmacopoeia, of which 525 are new. The first part of the Pharmacopoeia contains 1,146 varieties, of which 154 are new and 453 are revised; the second part of the Pharmacopoeia contains 1,967 varieties, of which 327 are new and 522 are revised; and the third part of the Pharmacopoeia contains 101 varieties, of which 44 are new and 57 are revised. The 2000 edition of the Chinese Pharmacopoeia contains 9 species that are not included in the current edition of the Pharmacopoeia***.

The 2000 edition of the Chinese Biological Products Regulations and the 2002 Supplement contains 123 species*** that are not included in the Pharmacopoeia.

This edition of the Pharmacopoeia contains 98 appendices in the first part of the Pharmacopoeia, of which 12 are newly added, 48 are revised, and 1 is deleted;

The second part of the Pharmacopoeia contains 137 appendices, of which 13 are newly added, 65 are revised, and 1 is deleted; and the third part of the Pharmacopoeia contains 140 appendices, of which 62 are newly added, 78 are revised, and 1 is deleted. One, two, three *** with the use of appendices to be included in the various departments, and harmonized.