Licensed Pharmacists-Pharmaceutical Analysis-Chapter 1 Pharmacopoeia-Checking Knowledge Points. Drug analysis accounts for about 40% of the "Pharmaceutical Professional Knowledge I" of the licensed pharmacist qualification examination, with many scores. Some students said that there are many knowledge points in the course of drug analysis, which is troublesome to review and can't be remembered. Personally, I think that the review of pharmaceutical analysis needs to systematically sort out the knowledge points first, and then memorize the knowledge points in each chapter. It shouldn't be a problem to score more than 30 points in the 40-point exam. Let's work together! Section 1: Overview of requirements of national drug standards: (1) Composition and effectiveness of national drug standards; (2) Knowledge points of formulation principles of national drug standards: 1. National drug standards include People's Republic of China (PRC) Pharmacopoeia, drug standards and drug registration standards. National drug standards are promulgated by the US Food and Drug Administration. 3. The agency responsible for formulating and revising national drug standards is the National Pharmacopoeia Committee. Drugs must meet the national drug standards, and it is illegal to produce, sell and use drugs that do not meet the national drug standards. 5. The quality standards of drugs and drugs always come into being at the same time. The principles to be followed in formulating standards are: (1) The formulation of inspection items should be targeted; (2) The selection of inspection methods should be scientific; (3) The boundaries of standards should be reasonable; (6) The selection principle of inspection method is: accurate, sensitive, simple and fast. Section II Requirements of China Pharmacopoeia Outline: (1) Basic structure of China Pharmacopoeia (2) Main contents of typical cases (3) Main contents of text (4) Main contents of appendix knowledge points: 1, and English name of China Pharmacopoeia is Ch. P, compiled and revised by the National Pharmacopoeia Committee; Promulgated by the US Food and Drug Administration. 2. The first Pharmacopoeia after the founding of New China was 1953. 3. China Pharmacopoeia (version 1963) is divided into two parts. 4. The English version of China Pharmacopoeia 1985 appeared; China Pharmacopoeia 1990 was published separately; China Pharmacopoeia 1995 Latin was cancelled and two foreign languages were renamed English; China Pharmacopoeia (2005 edition) began to divide it. 8. China Pharmacopoeia consists of Part I, Part II, Part III and Appendix; The content includes: example, text, appendix and index. 9, every example is the basic principle of the correct use of Pharmacopoeia drug quality verification, is a unified regulation of * * *. 10, the specification refers to the weight (or titer) or content (%) or loading capacity of the main drug contained in each tablet, tablet or other unit preparation. For example, "1 ml: 1 0mg" means that1ml contains the main drug10mg. 1 1, avoiding light means opacity; Sealed means that the container is sealed; Sealing is to seal the container; 12, the yin refers to no more than 20 degrees and the yin does not exceed 20 degrees; Cold place 2- 10 degrees; Normal temperature 10-30 degrees. 13. If the upper limit of the content of raw materials is above 100%, it refers to the possible value when determined by the analytical method specified in the Pharmacopoeia. If the upper limit is not specified, it means that the standard substance used for identification, inspection and content determination is a reference substance, and the standard substance does not exceed 10 1.0% 14. The reference material used for bioassay, content or potency determination of antibiotics or biochemical drugs is the reference material. Unless otherwise specified, the standard sample is calculated according to the titre unit, and the reference sample is calculated according to the dry product before use. 15, with a weight of "0. 1g" indicating a weight of 0.06-0.14g; Weighing 2g means1.5-2.5g; Weight of 2.0g means weight1.95-2.05g; Weight of 2.00g means weight1.995-2.005g; 16, accurate weighing means that the weight should be accurate to one thousandth of the weight; Weighing means accurate to 1% of the weighed weight; About refers to the amount shall not exceed the specified amount of plus or minus10%17, constant weight refers to the weight of the sample after two consecutive drying or burning, and the weight difference is below 0.3mg; The second and subsequent weighing after drying to constant weight shall be carried out after drying for 65438 0 hours under specified conditions; Ignition in 30 minutes. 18. The names of drugs in the national drug standards include: Chinese names, pinyin of Chinese names, and English names; Chinese names are named according to the names and naming principles recorded in CNDN of China. Unless otherwise specified, the English names all adopt the international generic drug name INN 19, and the test temperature: water bath means 98-100℃; Hot water 70-80℃; Warm water or mild temperature of 40-50℃; Room temperature10-30℃; Cold water 2-10℃; Ice bath 0℃. 20. Unless otherwise specified, the temperature during the test refers to 25 2℃ at room temperature. 2 1, test water, unless otherwise specified, refers to purified water; The water used for pH check refers to the water that is newly boiled and cooled to room temperature. 22. Extremely soluble means that the solute 1g( 1ml) can be dissolved in a solvent less than 1ml; Almost insoluble or insoluble means that the solute 1g( 1ml) is not completely dissolved in the solvent 10000ml. 23. The appendices of China Pharmacopoeia mainly include: general principles of preparations, general detection methods and guiding principles.
Part III: Main Pharmacopoeia Abroad
Outline requirements: 1. USP。
Full name, abbreviation and basic structure II. British pharmacopoeia
Full name, abbreviation and basic structure. European pharmacopoeia
Full name, abbreviation and basic structure. Japanese pharmacy prescription
Full name, abbreviation and basic structure knowledge points: 24. English abbreviation USP USP; The National Formulary of the United States (NF) consists of examples, texts, appendices and indexes. The latest version of USP 33-NF28 (released in April 2065438+00, effective in 10/0) 25. Abbreviation of British Pharmacopoeia: BP26, JP27 of Japanese Pharmacy Bureau Fang Yingwen, and Ph.Eur or EP of Euro-China Pharmacopoeia.