196565438+1On October 26th, the Ministry of Health published the Pharmacopoeia of China 1963. This edition of Pharmacopoeia is divided into two parts. One part contains commonly used Chinese herbal medicines and traditional Chinese medicine prescriptions, and the other part contains chemicals and their preparations. These two parts have their own examples and appendices. The first part records the "functional indications" of drugs, and the second part adds the "functions and uses" of drugs.
The third part of China Pharmacopoeia was promulgated on June 4, 1979, and it is the Pharmacopoeia of China (version 1977). It was implemented on June 4, 1980, 1. This edition of Pharmacopoeia is still divided into two parts. One part contains Chinese herbal medicines (including minority medicines), Chinese herbal medicine extracts, plant liposuction, some single medicinal preparations and prescription preparations (including minority medicines), and the other part contains chemicals and biological products.
China Pharmacopoeia (version 1985) has been implemented since 1 April, 9861day. The first part of this edition of Pharmacopoeia still includes the collection and arrangement of Chinese herbal medicines, vegetable oils and fats, single-taste preparations and traditional Chinese medicine prescriptions, and the second part includes chemicals and biological products. Matching with this edition of Pharmacopoeia, 1988 compiled and published the first English edition of Pharmacopoeia of China (1985), and also published two selected notes of Pharmacopoeia in the same year.
China Pharmacopoeia 1990 has been implemented since July 199 1 year/day. This edition of China Pharmacopoeia is also divided into two parts, including 175 1 drug. The infrared absorption spectra of related varieties are included in the "Infrared Spectra of Drugs" and will be announced separately. The Pharmacopoeia of China (version 1990) has been compiled and published one after another, including two annotations, Annotations Compilation of Medical Education Network, Color Atlas of Traditional Chinese Medicine, Color Atlas of Thin Layer Chromatography of Traditional Chinese Medicine, Instructions for Clinical Use and General Names of Drugs in China. The English version of China Pharmacopoeia 1990 was also published in July 1993.
China Pharmacopoeia (version 1995) has been implemented since 1 April 19961day. Part I and Part II of this edition of Pharmacopoeia contain 2375 kinds of drugs. Obviously different from the previous editions of Pharmacopoeia, the Chinese names of the two drugs in this edition only contain generic names of drugs, and no sub-names are listed; The foreign names of drugs were changed from Latin names to English names. The first volume of Infrared Spectra of Drugs (version 1995) was also published.
China Pharmacopoeia 2000 was officially implemented on July 1 2000. This edition of Pharmacopoeia has greatly increased the number of varieties, with a total of 269 1 piece, of which one part contains 992 kinds of Chinese herbal medicines and Chinese herbal prescription preparations, and the other part contains 1699 kinds of chemicals, antibiotics, biochemical drugs, radioactive drugs and biological products. The Basic Physiology and Medical Education Network collects and sorts out the drug standard structure with the National Pharmacopoeia as the main body. In order to ensure that the appendix is more rigorous, perfect and standardized, the appendix of this edition of Pharmacopoeia has been improved and perfected. The second appendix also contains six guiding principles for the first time, such as the Guiding Principles for Verification of Analytical Methods of Drug Quality Standards and the Guiding Principles for Drug Stability Tests. In addition, according to international practice, this edition of Pharmacopoeia cancels the items such as "dosage" and "precautions" and moves the relevant contents to the book "Instructions for Clinical Use". The Chinese and English versions of this edition of Pharmacopoeia have been published simultaneously. The second volume (2000 edition) of Infrared Spectra of Drugs was also published.
The current edition of China Pharmacopoeia is the 2005 edition, which was officially implemented on July 1 2005. China Pharmacopoeia (2005 edition) is divided into three parts. In the first part, Chinese herbal medicines and decoction pieces, vegetable oils and extracts, prescription preparations and simple preparations were collected and sorted out. The second part includes chemicals, antibiotics, biochemical drugs, radioactive drugs and their preparations, and pharmaceutical excipients. China Pharmacopoeia (2005 edition) listed biological products as a separate part for the first time, and the original China Biological Products Specification was incorporated into the Pharmacopoeia as the third part. China Pharmacopoeia (2005 edition) Part III included 10 1 biological products.
China Pharmacopoeia (2005 edition) pays more attention to the safety of drugs. The determination methods of harmful elements such as lead, cadmium, arsenic, mercury and copper are added. The harmful elements in drugs were determined by atomic absorption spectrometry and inductively coupled plasma mass spectrometry, and the limit of harmful elements was specified. In the second part, the insoluble particle test was added to multiple intravenous injections, and the bacterial endotoxin test method for more than 100 varieties was collected and revised by Medical Education Network. The inspection of residual solvents in drugs is also carried out in accordance with international harmonized standards.
Among the eight pharmacopoeias published and used in China, modern analytical techniques are used more and more, such as high performance liquid chromatography, which has been adopted from the five-year edition of China Pharmacopoeia 198 Medical Education Network to the 2005 edition of China Pharmacopoeia, and has been greatly increased. This method is mainly used to determine antibiotics and hormones. New instrumental analysis methods, such as capillary electrophoresis, thermal analysis and mass spectrometry, have also appeared in the appendix of China Pharmacopoeia (2005 edition).