The concept of a medicinal substance and a medicinal product,
A strict distinction between the concepts of drug, substance and poison cannot be made.
You know very well how dangerous the bites of poisonous snakes are. However, painkillers are made from cobra venom medicines, in small doses, these poisons have a calming effect on the c.n.s. The poisons of most snakes from the viper family have a hemostatic effect. A hemostatic drug, lubetox, was obtained from gyurza venom. What is poison?
The general biological and toxicological definition of the concept of poison - poison is any chemical substance that, when interacting with a living organism, causes the pathological process on the part of the latter, sometimes ending in death.
Paracelsus Definition - Everything is poison, nothing is poisonous. The dose is only invisible. Really. All of you are well aware of such a matter as NaCl, without which animal organisms cannot do. However, salt is very often the cause of poisoning of animals, especially birds and pigs. And at the same time, such strong poisons as strychnine, atropine, scopolamine, strophanthin are widely used in veterinary practice as medicinal substances.
A medicinal substance is a separate chemical substance that interacts with the receptors of human or animal cells, providing a targeted therapeutic or prophylactic effect.
A medicinal product is a pharmacological preparation authorized by the authorized body of the respective country in the prescribed manner for use in order to treat, prevent and diagnose a disease in humans and animals. A drug may include several drugs.
A medicinal product is a medicinal product in the form of a specific dosage form.
Dosage form - given to a medicinal product or medicinal plant material, a condition convenient for use that provides the necessary therapeutic effect.
Dosage forms are divided into several groups:
1. solid or dense (powder, tablet, dragee, granule, bolus, pill, suppository, collection, briquette, patch, etc.).
2. soft - ointment, liniment, paste, porridge.
3. liquid - solution, potion, emulsion, suspension, infusion, decoction.
4. gaseous dosage form - spray can.
5. galenic and newgalenic preparations. Preparations of complex chemical structure, obtained from raw materials of animal and vegetable origin as a result of technological treatments (tinctures, extracts, syrups, water, soaps, alcohols). Novogalenovye preparations - extracts that are maximally, and sometimes completely freed from ballast substances.
By force of action, medicinal substances are divided into 3 groups:
1. “Yenena” - poisonous substances. Indicated by the letter “A”.
2. “Heroica” - strongly acting. Indicated by the letter “B”.
3. “Yaria” - others or the general list.
Medicinal substances are stored in their respective group membership. Group A substances require strict accounting and storage in a safe under lock and seal, under the responsibility of a qualified specialist. The inscription “Yenena” or “A” is hung on the safe door. A list of toxic substances is displayed on the inside of the door, indicating the highest single doses.
Group B substances are stored separately in lockers.
In addition, all drugs are stored taking into account their physical and chemical properties.
The chemical and pharmaceutical industry produces a huge number of therapeutic and prophylactic drugs. However, pharmacologists and chemists are faced with the task of constantly searching and creating new, more effective therapeutic and prophylactic agents.
Classification helps to characterize individual phenomena, facts, depending on belonging to a particular group, allows us to anticipate still unknown or unexplored phenomena and objects. However, it should be borne in mind that any classification is conditional, therefore, its further improvement is possible.
There are two generally accepted classifications of drugs:
- Classification of drugs by origin.
- Classification of drugs by the strength of pharmacological activity.
Classification of drugs by origin
By origin, drugs are divided into two main groups:
- Primary raw materials of mineral, vegetable, and animal origin that have undergone primary processing (purification from impurities, drying, sorting). These include: medicinal mineral raw materials - baking soda, activated carbon, sludge therapeutic mud, etc .; medicinal plant materials represented by various morphological groups - collections, leaves, herbs, flowers, fruits, seeds, roots, rhizomes, bark, etc .; medicinal raw materials of animal origin - glands of internal secretion of domestic animals.
- Medicinal substances of synthetic or semi-synthetic origin, obtained as a result of processing of natural raw materials or targeted synthesis.
This group is divided into the following subgroups:
- Chemicals. By their nature, these are individual chemicals, and by their origin they are synthesis products or purified natural substances that are medicinal substances, for example, sodium chloride, sodium sulfate, silver nitrate, hydrochloric and sulfuric acids, sodium bicarbonate, potassium permanganate, sodium thiosulfate, etc. .d.
- Chemical and pharmaceutical preparations. By their nature, they are also individual chemicals resulting from a very complex organic synthesis. These drugs include: sulfa drugs (streptocide, norsulfazole), anti-TB drugs (phthivazide), hypnotics and anesthetics, anti-malarials (bigumal). The subgroup of chemical pharmaceutical preparations also includes biologically active substances isolated in pure form from raw materials of plant and animal origin (alkaloids and glycosides). A separate group is represented by preparations of radioactive isotopes, for example, preparations of radioactive iodine.
- Antibiotic drugs. Antibiotics are vital products of various microorganisms *! obtained as a result of biological synthesis during the cultivation of microorganisms on nutrient special media. Microbial antibiotics are widely known (penicillin, streptomycin, biomycin, gramicidin). Some of the antibiotics are synthetically produced (methicillin, oxacillin). A wide spectrum of antibacterial action is possessed by antibiotics of the cephalosporin group.
- Vitamin preparations. Among them are both individual chemical synthetic substances (ascorbic acid, thiamine, nicotinic acid, cyanocobalamin, etc.), as well as complex complexes of substances (concentrates, extracts, syrups).
- Organizational preparations. Obtained from organs, tissues and juices of the animal body. They are complex complexes of substances containing hormonal substances as biologically active compounds. Some of them were able to isolate in its pure form (for example, adrenaline). A number of hormones are synthetically produced (sex hormones). Enzymes (pepsin) also belong to organ preparations.
- Vaccines and serums. These are immunobiological preparations produced by vaccine and serum institutes, institutes of epidemiology, microbiology and hygiene, as well as a number of sanitary epidemiological stations.
- Primary processing products of medicinal raw materials. These include: essential oils, fats, and fatty oils derived from parts of plants and animals.
- Galenic preparations. These include preparations of complex chemical composition, extracted from natural medicinal raw materials of plant and animal origin and containing biologically active substances (BAS). These are different extracts, tinctures, some syrups, fragrant waters, etc. Novogalenny preparations (extracts and tinctures), which are pure preparations freed from ballast substances, constitute a special subgroup.
Medicines - chemical compounds of natural or synthetic origin and their combinations, used for the treatment, prevention and diagnosis of human and animal diseases. Medicines also include drugs to prevent pregnancy.
Medicinal substances Organic Raw materials for the synthesis of organic preparations are natural gas, oil, coal, shale and wood. Oil and gas are a valuable source of raw materials for the synthesis of hydrocarbons, which are intermediates in the production of organic medicines. Inorganic Raw materials for inorganic preparations are rocks, ores, gases, water from lakes and seas, and waste from chemical industries.
All modern medicinal products are grouped according to the following basic principles: Therapeutic groups drugs for the treatment of inflammation lowering blood pressure antimicrobials Pharmacological action, that is, the effect caused by vasodilators vasodilator vasodilator spasmolytics vascular spasm analgesics reduce pain irritation Chemical structure of salicylates a strictly defined asthma disease with COROLLARY for the treatment of myocardial infarction and others.
Groups: Agents acting on the central nervous system. Agents acting on the peripheral nervous system. Agents acting on the sensitive nerve endings. Agents acting on the cardiovascular system. Agents that enhance urination and inhibit the formation of urinary stones. Drugs that improve liver function Drugs that affect the muscles of the uterus Metabolism-controlling drugs Drugs that affect the immune system Antioxidants Antimicrobial, antiviral, antifungal drugs Drugs used in the treatment of cancer Diagnostic drugs Other drugs of various pharmacological groups
Aspirin It can not be taken to people with uncontrolled high blood pressure, as well as in violation of blood coagulation. It is not recommended for people with asthma, ulcers, or those with a sensitive stomach or allergy to aspirin for such drugs. You can not take aspirin for children under 12 years of age: at a young age, aspirin can provoke the development of a deadly disease in a child, known as Re-ye syndrome.
Paracetamol Paracetamol, less than aspirin, irritates the stomach. If you take paracetamol for a long time and regularly, your kidneys and liver will suffer. An overdose of paracetamol is also dangerous for the liver, which can lead to death. To cause the death of this important organ, it is enough to drink g (20-30 tablets) of the drug. You can not take paracetamol to people with liver diseases, as well as to those who constantly drink. Even small doses of alcohol in combination with paracetamol are a deadly threat.
Analgin Analgin is the most popular pain medication, they “treat” migraines, bad teeth, menstrual pain, and a hangover. But in most Western countries, analgin has not been used for a long time. In the USA, Norway, Great Britain, Sweden, Holland, he was expelled from the Pharmacopoeia in the 1970s. Even one tablet of dipyrone is enough to cause significant damage to the body. Analgin is especially dangerous for children, pregnant and lactating mothers. This medicine suppresses bone marrow activity, which leads to a decrease in the production of white blood cells, which protect the body from infections. An overdose of analgin can lead to death. Analgin is cheap and known to everyone, so many girls and women drink it in handfuls to get rid of headaches and discomfort in the “critical days”. Few of them realize that WHO experts have long and persistently offered the world to abandon this dangerous medicine.
Rules for taking medications 1. You must strictly follow the instructions. This is especially true for the ratio of medication to food. Not only the effectiveness of treatment, but also the state of the digestive and excretory systems will depend on strict compliance with this requirement. After all, drugs that need to be taken on an empty stomach practically do not exist. 2. Self-medication is not allowed. Most patients consider themselves the best doctor. Naturally, they are treated themselves, taking medications on the recommendation of friends.
3. Take your medicine at regular intervals. It is known that the concentration of drugs in the blood is greatest after taking the drug, then, with every hour, it gradually decreases. If you arrange large intervals between doses of drugs, then there will come a period when the blood concentration of the drug will be very low. Therefore, they need to be taken 2, 4, 6 times a day, and the intervals between doses should be uniform.
4. What time of day is it best to take medicine? Pain is most felt at night, so pain medication is very important to take in the evening. Vasodilating drugs should be taken in the morning. Indeed, during this period, the danger of myocardial infarction reaches a peak. But in the evening, the doses of these drugs can be reduced without health consequences. Anti-rheumatic drugs should also be taken in the evening. This will reduce joint pain and improve their mobility after sleep. Also in the evening, but late, it is necessary to take anti-allergic drugs, since it is at night in the body that the least amount of the hormone is produced, which inhibits allergic reactions. Given that gastric juices are very aggressive at night, it is most advisable to take drugs against stomach ulcers and duodenal ulcers in large doses shortly before bedtime.
5. If several medications are prescribed, they must be taken separately. Even the most harmless drugs for the body during salvo administration, i.e., the simultaneous administration of several drugs, will give a large load on the stomach and liver. So, taking medications must be diluted in time so that the interval between doses is at least 30 minutes.
6. Medicines must be washed down. Even miniature tablets need to be washed down, since a high concentration of the active substance can harm the stomach. It is best to drink the medicine with warm boiled water. It is not allowed to drink with juices, carbonated water, milk (unless this is provided for in the instructions), kefir, etc. After all, milk and kefir, even fat-free, contain fat that is enveloped by the tablets, preventing them from being completely and without delay.
7. It is not allowed to take medicines with an expired shelf life. The smallest thing that will result from this is the ineffectiveness of treatment, and the biggest is irreparable harm to health. The same applies to drugs that were stored incorrectly (temperature, humidity, light warnings were not respected). Due to the fact that drug products are alien and toxic to the body, their correct dosage is very important!
The most common international Anatomical Therapeutic Chemical Classification (ATC) . In Russia, dividing into Pharmacological groups . In addition, there is still Nosological classification.
Prescription and OTC Medicines
In world practice, there is the concept of “over-the-counter” and “prescription” drugs. The latter suggest a greater potential risk of over-the-counter use. the doctor . There is a constant struggle between “pharmaceutical” and “medical” lobby (respectively, for the expansion of the 1st or 2nd group of drugs and the corresponding business).
State regulation is designed to take into account the interests of the population ( dilemma “Accessibility” and / or “safety” of medicines), - without bias towards the interests of the pharmaceutical or medical business.
Homeopathic medicines
In a number of countries, these funds are regulated differently - either as the category “Medicines”, or as “Food products and additives”, or as “funds alternative medicine ". Currently, there is no established opinion of international organizations on this subject, agreed with national health authorities.
In the Russian Federation, homeopathic medicines are subject to the same legislative regulation as conventional medicines.
Legislative regulation
The circulation of medicines is regulated by law and by-laws, including regularly updating the list Essential and Essential Medicines (Vital and Essential Drugs), List of Narcotic Drugs, etc.
Economic consequences of legislative regulation
In Ukraine, there is a practice of returning the excise duty for use alcohol in the manufacture of drugs - only after their implementation.
Bodies of state control over the quality of medicines
The quality of medicines in Russia is controlled by the Federal Service for Supervision of Health and Social Development (Roszdravnadzor), subordinate to the Ministry of Health and Social Development of the Russian Federation.
In most large cities of Russia, there are drug quality control centers. Their main task is to check the organizations selling drugs (compliance with the numerous standards for the storage and sale of drugs), as well as selective (and in some regions total) drug control. Based on data from regional centers, Roszdravnadzor makes decisions on defective one or another drug.
That should be ideal. In practice, everything looks a little different.
Firstly, the vast majority of drug quality control centers are more than poorly equipped, and they are not able to conduct complex chemical analyzes of modern drugs. An even more difficult situation is with microbiological studies, which are either not carried out at all, or are carried out in a very reduced volume. As a result, often all, so to speak, studies are limited to assessing the appearance of the drug (are there any unacceptable deposits, are they cracked tablets whether the packaging, the curve label, etc., are correctly framed).
Secondly, according to the legislation in force in Russia, it is unacceptable to require an additional seller analysis if the drug already has an active certificate (declaration) of conformity. Thus, all additional studies should be carried out at the expense of the Centers for Quality Control of Medicines. In fact, this translates into additional costs for the seller.
Third, drug quality control centers should produce selective drug control. In many regions of Russia (for example, Stavropol , Tver region , Tatarstan) re-verification is total. This is generally illegal, but due to the lack of equipment in the laboratories, it is simply meaningless, which leads to a significant difficulty in selling not only counterfeit and poor-quality medicines, but also medicines in general.
As a result of the above, it can be said that most of the regional centers for drug quality control today do not fulfill their tasks, only creating the basis for bribes and unfair competition.
Rejected and falsified medicines are subject to seizure from the pharmacy network, information about them is available on the following sites:
Original medicines and generics
The original medicine is called the drug, which was first released by the developer. As a rule, the development and marketing of a new drug is a very expensive and lengthy process. Of the many known compounds, as well as newly synthesized, by enumeration, on the basis of databases on their properties and computer modeling of the expected biological activity, substances having the maximum target activity are identified and synthesized. After animal experiments, in the case of a positive result, limited clinical trials are conducted on groups of volunteers. If the effectiveness is confirmed, and side effects are insignificant - the medicine goes into production, and on the basis of the results of additional tests, possible features of the action are clarified, undesirable effects are revealed. Often the most harmful side effects It turns out precisely with clinical use.
In this case, the manufacturer patents this new drug. All other firms can produce synonyms (so-called generics), but using their own technology, if they prove bioequivalence preparations. Of course, they cannot use the name brand for this medicine, but only INN , or any new patented by them. Despite the new name, in their effect, such drugs can be similar, or very close.
Are the original medicines fully equivalent and generics ? From the point of view of chemistry, the active substance is one and the same. But the production technology is different, a different degree of purification is possible. There are other factors. For example, it is known that for a long time different firms could not achieve the same efficiency. acetylsalicylic acid (generic), like a company Bayer ag - manufacturer of the original drug " aspirin ". It turned out that it was not only the purity of the raw material, but also a special crystallization method, resulting in special, smaller crystals of acetylsalicylic acid. There may be many such nuances. The opposite result is also possible, when a generic is more successful than the original medicine.
In modern drugs, only one of isomers (enantiomers), the other may be weakly active, inactive or even harmful (see Bioavailability).
Illegal actions in the production and circulation of medicines
Counterfeiting drugs, counterfeit drugs
The pharmaceutical business is considered the third most profitable after the arms and drug trade. This attracts dishonest entrepreneurs to him.
In Russia, until 1991, the problem of falsification of drugs was practically absent.
Counterfeit
Counterfeiting is a conscious change in the formulation of a drug. Replacing expensive components with cheaper ones, or reducing the content (and in the worst case, completely lacking) of the necessary component of the drug. For example, replacing a more expensive cefazolin cheaper (and less efficient) penicillin . In addition, other violations during production are possible: violation of the time and sequence of the technological process, underestimation of the degree of purification, poor-quality packaging materials, etc.
Counterfeit
Counterfeit medicines are medicines manufactured without the permission of the patent holder - the developer.
The effectiveness of the drug is primarily determined by the active substance (but not only them, see bioequivalence) According to international law, the formula or composition of the active substance cannot be the secret of the company. But this information for some time (about several years) is closed to other manufacturers, which even under a different name can not produce this medicine without the permission of the patent holder.
Even at the end of the allotted time, other companies cannot use the name of the drug ( The brand) registered by the patent holder (the so-called patented form).
Manufacturers of drugs have the temptation, knowing the formula, to release drugs bypassing the patent holder. An example is the drug No-spa® (registered name brand) In fact, this is a fairly simple synthesized drug, active substance which has generic name « drotaverine ". However, for several generations of people have used No-Shpo and do not know anything about some drotaverine. Accordingly, the price of a branded drug is 10 (!) Times higher than the price of the drug that is exactly the same in composition, manufacturing technology and effect drotaverine . It is not surprising that in some factories that produce cheap domestic medicines during the day, the same medicines are packaged in foreign, branded packages at night. It should be added that this usually does not affect the quality of the medicine, since the counterfeit manufacturer is afraid to raise even the slightest suspicion from the inspection authorities.
Drug Trafficking
Narcotic substances are subject to more stringent rules of treatment than other drugs. However, due to the increased demand for them, situations arise in which officials neglect the proper performance of official duties.
- The flip side of toughening the requirements for the turnover of narcotic drugs is unreasonably difficult receipt by persons with direct indications for use (cancer, etc.).
see also
References
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See what "Medicinal substances" are in other dictionaries:
automated system for accounting applications for new drugs - System for the statistical evaluation of the results of phases 2 and 3 of the clinical trial of new drugs in the USA Biotechnology topics EN computer assisted new drug application ... Technical Translator Reference
MEDICINAL FORMS - MEDICINAL FORMS, that kind, in rum medicinal substances come to the use of the treated person (person, animal). NomenclatureL. f. changes with the development of technology and medicine; new L. f. occur (e.g. tablets introduced since 1872 have arisen ... ... Big Medical Encyclopedia
