After extraction and purification, for injections made into the modern Preparation , Can be unilateral (single herb) and the compound injection, can also be effective injection site. TCM injections Package Including a small injection (usually each 2 ~ 20ml), infusion (generally bottle 50 ~ 100ml), frozen Dry powder Injection (usually a bottle of 0.2 ~ 0.5g). Advantages of TCM injections bioavailability, rapid onset for acute critically ill patients.
Although traditional Chinese medicine injection dosage form is a good, good preparation, but because of Chinese medicine complex, it is not easy to be developed. TCM injections most common problem is that impurities (proteins, tannins, resins, etc.) failed to produce turbidity or sedimentation, and so the solution color to deepen. The main reason these problems or the extraction and purification of inappropriate or improper molding process, and extraction and purification process or molding process with the Pharmacy Accessories Directly related to the choice. Excipients used improperly can not only extract the active ingredients of Chinese medicine, it is difficult to impurities (such as proteins, tannins, resins and other invalid component) divisible, in the molding process, the improper selection of accessories can also cause injection turbidity, precipitation or oxidation discoloration. Therefore, research and development of TCM injections, particularly important in the selection of pharmaceutical excipients.
1 Chinese extract , The choice of purification accessories
Development of traditional Chinese medicine injection and development of pharmaceutical excipients used injection chemicals vary greatly selection of accessories, development of Chinese medicine injection using excipients has its own characteristics, we must first select the appropriate Solvent Extracting active ingredients or parts, and then to select appropriate materials and production techniques were isolated and purified, to get a pure Extract ( Intermediate ), And finally the use of appropriate materials and production techniques molding. Therefore, the development of traditional Chinese medicine injection selection of accessories focused on extracting traditional Chinese medicine, the selection of accessories during purification, involving solvent extraction assisted Additives , Flocculation agent, absorbent, antioxidant and antioxidant synergist such use. Chinese molding accessories selection and the same chemical injection, involving solvent, cosolvent with increasing solvent, antioxidant and antioxidant synergist, pH, regulators, osmotic pressure regulator, leavening agent class selection of accessories .
1.1 Selection of auxiliary solvents
Solvent used in traditional Chinese medicine injection is divided into two major categories of water and non-water research and development of Chinese medicine injection solvents used can be divided into Chinese herbal medicines Active ingredients or part of extraction and purification process and molding process using solvents. Molding process used in traditional Chinese medicine and chemical injection solvent used in the same solvent, such as water for injection, ethanol, Glycerin , Propylene glycol , Poly Glycol -200, -300, -400, -600, Benzene Methanol , Aldehyde glycerin, polyethylene glycol ether Tetrahydro furfural, dimethyl acetamide, DMSO, ethyl acetate, ethyl carbonate, ethyl lactate, benzyl benzoate, vegetable oil, etc., but the most commonly used is water for injection, followed by ethanol, glycerol, propylene glycol and the compound solvent.
In research and development of TCM injections, Chinese herbal medicine in the active ingredients or parts of the extraction, separation and purification of solvents used are unique. Chinese extract water-soluble active ingredients or parts of general use ordinary water, a few cases using pure water, insoluble or poorly water-soluble active ingredients or parts, usually with different concentrations of ethanol, Acetone , Ethyl acetate, ethyl ether, petroleum ether solvent such as three or four, as far as possible without toxic benzene, chloroform, methanol, cyclohexane, n-hexane solvent such as a Class I and II. Crude extracts were isolated, should also follow these principles. Chinese herbal medicines or crude extracts, such as the need for fat processing, should be selected petroleum ether, ethyl ether, acetone and other solvents III and IV, and not use cyclohexane, hexane, chloroform and other toxic solvents in the second category Otherwise, traditional Chinese medicine injection residue limits should be established inspection standards, a lot of trouble. Are the components of the active ingredient of Chinese medicine extraction, separation and purification of excipients used are summarized below.
1.1.1 glycosides containing active ingredients herbal extraction, separation and purification of selected accessories
Glycosides (Glycosides) active ingredient according to the chemical structure of aglycone can be divided into coumarin glycoside, lignan glycosides, anthraquinone glycosides, flavonoids, glycosides and other indole, with its hydrophilic aglycones chemical structure, the types and number of sugar then more significant difference, but most strongly hydrophilic glycosides can be extracted water, different concentrations of alcohol can also be extracted. I am a professional writer from China Crafts Suppliers, which contains a great deal of information about fire exit sign , plastic handcuffs, welcome to visit!
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