« Technology pharmaceutical
preparates»
Introduction . Technology Medicinal forms as science. Technology medicinal Forms (LF) Base concepts.
Technology of medicinal forms as science.
The primary goals of pharmaceutical technology are:
Development of theoretical substantiations existing Methods of manufacturing of medicinal forms;
Perfection of old ways of manufacturing Medicinal forms and creation new on the basis Uses of modern achievements of adjacent sciences;
Creation of such medicinal forms in which it is maximum Is shown medical effect, minimal collateral Action and which are convenient at use by patients.
Technology of medicinal forms (LF) - science about Theoretical bases and productions Processings medical products in medicinal Preparations by giving by him certain medicinal Forms.
The basic base concepts.
The terms designating base, basic concepts Of technology of medicinal forms, are:
A medical product;
Medicinal substance;
The medicinal form;
A medical product.
According to ÌÂ64Ó-1-97:
Medical products - substances or their mixes Natural, synthetic or biotechnical Origins which are applied to prevention Pregnancy, preventive maintenance, diagnostics and treatment Diseases of people or for change of a status and functions An organism.
Substances concern to medical products; GLS (medicinal Preparations); homeopathist means; means which Are applied to diagnostics of activators of diseases, and Also struggle against activators of diseases or parasites; Medicinal cosmetic means and medicinal Additives to foodstuff.
On the origin medical products share On two basic groups:
I. Natural raw materials vegetative, animal And the mineral origin, past primary Processing (clearing of impurity, drying, sorting).
Concern: medicinal vegetative raw material - valerjanovyj a root, flowers of a camomile, a berry of a raspberry, gum (apricot gum), balms (terpentin); Medicinal raw material of an animal origin - zhelezy Internal secretion of domestic animals.
II. The medicinal substances received in result Of processing of natural raw materials or Of purposeful synthesis.
II group shares on the following groups:
Chemical preparations. By the nature it Individual chemical substances, and on the To an origin - products of synthesis or cleared natural Substances which are medicinal substances - Sodium chloride, sodium sulfate, silver nitrate, hydrochloric and Sulfuric acids, sodium a hydrocarbonate, kalija permanganate, Sodium tiosulfat, etc.
Himiko-pharmaceutical preparations. By the nature it Also individually chemical substances. Turn out in Result of organic synthesis, sometimes rather complex. Enter: sulfanilamidnye preparations (streptocide, norsulfazol), antitubercular means (ftivazid), Somnolent and anesthetizing substances, protivomaljarijnye Means (bigumal). To HFP the active substances selected in the pure state from raw Of materials of a vegetative and animal origin (alkaloidy And glikozidy) concern also biologically . Separate group preparations Radioactive isotopes, for example represent preparations Radioactive iodine.
Preparations of antibiotics. Antibiotics are products Abilities to live of various microorganisms also turn out As a result of biological synthesis at cultivation Microorganisms on nutritious special environments. Antibiotics of a microbic origin (penicillin, Streptomycin, biomitsin, gramitsidin) are widely known. Some from Antibiotics receive sinteticheski (metitsillin, oksatsillin). Antibacterial Actions possess a wide spectrum antibiotics of group tsefalosporinov.
Vitamin preparations. Among them there are as chemically Individual synthetic substances (ascorbic An acid, tiamin, a nicotinic acid, tsianokobalamin and Other), And complex complexes of substances (concentrates, Extracts, syrups).
Organopreparaty. Turn out their bodies, fabrics and juices An animal organism. Are complex complexes The substances, containing in quality biologically active Connections hormonal substances. From them It was possible to allocate some in the pure state (for example, adrenaline). A number of hormones receive sinteticheski (sexual hormones). To organopreparatam enzymes (pepsin) concern also.
Vaccines and wheys. It immunobiologicheskie preparations, Developed institutes of vaccines and wheys, Institutes epidemiologii, microbiology and hygiene, and Also number SES.
Products of primary processing medicinal raw material. Concern: radio oils, fats and fat oils, Received from parts of plants and animals.
Galenovye preparations. Preparations concern to them complex A chemical compound, prepared by extraction from Natural medicinal raw materials A vegetative both animal origin and containing BAV With other substances. These are different extracts, tinctures, Tinctures, some syrups, fragrant waters, etc. Special A subgroup representing extraction (extracts and tinctures), But released from ballast substances make novogalenovye preparations, .
According to MV 64Ó-1-97:
Medicinal substances (the substances,) - biologically active substances - biologically active Substances which can change a status and functions An organism or have working substances preventive, diagnostic Or medical action also are used for manufacture GLS.
The medicinal substance is a maintenance medicinal Means and the medicinal form, due to him LS and LF Are used with the medical purpose. However same The maintenance can have different forms, and in identical The different maintenance is possible to enclose forms. For example, Analginum (maintenance) can be in such medicinal Forms as powders, tablets, a solution, etc. One The medicinal form can include different medicinal Substances, for example tablets of analginum, streptocide, amidopirina, ftalazola and dr to receive The medicinal form, to medicinal substance give The form of a medical product, i.e. a material, Suitable for manufacturing LF.
The medicinal form is supplied medicinal To means a status convenient for application (a powder, A solution, an ointment, tablets) at which the necessary medical effect is reached . Manufacturing medicinal Means is usually accompanied by giving by him certain Geometrical forms. For example, tablets have the form Disks, a pill of balls, a candle - a cone, etc. And, The geometrical form is selected so that To provide the maximal action of a medical product And convenience of application.
Medical products for the medical purposes Are not appointed the patient, they are only initial material For manufacturing medicinal preparates.
A preparation is a medical product in A kind of the certain medicinal form. Earlier it The term was understood as widely known term "medicine", But as agreed with foreign countries the term "medical product" is accepted uniform .
The medical product is ready product (GLS), Which use with the medical or preventive purpose, I.e. prepare for medical products from medicinal Means, giving to them a convenient status for application (medicinal The form) in which it is reached necessary medical effect.