During the storage process, there are a number of medicinal herbs, in addition to the external air, water, sunlight, temperature, microbes and other factors, it itself will also produce a series of chemical changes, constantly changing the ingredients. For example, hollyhine, Polygonum cuspidatum, etc. contain a large amount of tannins, which can be continuously oxidized under the action of enzymes and polymerized to form other substances, thereby reducing the efficacy. Another example is Boziren, peach kernel, Yu Liren, Chinese angelica, gardenia, etc. They contain a lot of fatty oil, sticky sugar and other ingredients, these herbs are easy to "go oil." In addition, peppermint, perrin, musk, sandalwood, orange peel and other volatile ingredients containing herbs, stored for too long, because the aroma does not affect the quality and reduce efficacy. On the contrary, there are also some herbs that need to be stored for a certain period of time so that their components can be naturally decomposed to reduce their toxicity, or to make them volatile and “obscene.†Such as frankincense, myrrh, ejiao and other varieties of gum and dried tangerine peel.
In short, the length of storage time of Chinese herbal medicine can not be generalized. It depends on the nature of various medicinal materials and storage conditions. However, from the perspective of safe and effective medication, it should not be too long. Herbs (including leaves and flowers) generally do not exceed two years; woody plants (including roots, stems, and skins) do not exceed 3 years; fruits and seeds do not exceed 4 years; minerals do not exceed 10 years.
API Powder is fully defined in ICH Q7A as any substance or mixture of substances intended for use in the manufacture of pharmaceutical products and, when used in pharmaceutical products, as an active ingredient of pharmaceutical products. Such substances have pharmacological activities or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the body. The active ingredient of a medicine. Only when an API is processed into a pharmaceutical preparation can it become a medicine for clinical application.
According to its source, apis are divided into chemical synthetic drugs and natural chemical drugs.
Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (very few are elements), such as aluminum hydroxide and magnesium trisilicate for the treatment of gastric and duodenal ulcer, etc. Organic synthetic drugs are mainly made of basic organic chemical raw materials, through a series of organic chemical reactions and drugs (such as aspirin, chloramphenicol, caffeine, etc.).
Natural chemical drugs can also be divided into biochemical drugs and phytochemical drugs according to their sources. Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. In recent years, a variety of semi-synthetic antibiotics are the combination of biosynthesis and chemical synthesis products. Among apis, organic synthetic drugs account for the largest proportion of variety, yield and output value, which is the main pillar of chemical pharmaceutical industry. The quality of the API determines the quality of the preparation, so its quality standards are very strict. All countries in the world have formulated strict national pharmacopoeia standards and quality control methods for the widely used APIS.
Specific API after processing -- pharmaceutical preparations
The term API is used mainly in relation to the finished product. Mainly raw materials obtained by chemical processing means, supply raw materials for the production of finished drugs. For example, cefpirome sulfate for injection is a drug, then cefpirome sulfate is an API
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