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Dissolution test is an important index to evaluate the formulation, production process and bioavailability of Chinese herbal medicine. Chinese herbal medicine oral solid preparation of medicinal powder or extract as raw material, its preparation, formulation, formulation and preparation process and the dissolution of the drug directly related. By choosing appropriate accessories and preparation process to improve the dissolution, release and dissolution, can increase the absorption of drugs in the body.
Factors that affect the dissolution of Chinese traditional medicine preparation, formulation and process
1, dosage form and drug dissolution of a close relationship
The researchers respectively with baicalin, berberine, chlorogenic acid and Total Anthraquinone as the index determination of bezoar detoxification pills and Niuhuang Jiedu Tablets dissolution. The results showed that the dissolution rate of pill, more than sugar coated slow 2/3. Obviously, the bezoar detoxification pills converted into Niuhuangjiedu, is conducive to the release of the drug. But not all the pills are the dissolution of tablets is small. Such as Yinqiaojiedu pills and Huanglianshangqing pill pill by restructuring into tablets, the release rate slowed down 2/3. And hairy holly root dry capsule extract two minutes of release is equivalent to the release of sugar coated tablets 30 minutes of. 50 minutes capsules, the release amount of more than 5 times the sugar coated tablets. The clinical efficacy of the T50 was 1 times faster than that of the crown and the heart of the pill, and the clinical effect was obvious, and the biological parameters were superior to those of the coronary heart Su He pill. Therefore, in vitro dissolution determination can be used to select the ideal dosage form. In the treatment of acute disease, we should choose a large dosage form, which can make the medicine quickly effective. When treating chronic diseases, we can choose small dosage form, so that the drug is slow to work.
2, the preparation of prescription drugs and additives including two parts
The release and dissolution of active components in the solid formulation are related to the nature of the drug (solubility, crystal form, particle size, etc.), and the type and dosage of the additive play a major role in the disintegration of the preparation. In traditional Chinese medicine Qing Lan, radix puerariae, rutin respective flavone extract respectively with different excipients production. The results show that different additives of different flavonoids drug dissolution have significant influence. The blue piece of aluminum hydroxide with sodium carbonate, Radix Puerariae tablet Rutinum Tablets, using alumina as well. Shanghai Traditional Chinese medicine plant to carry out research showed that magnesium stearate is added for the Soviet ice dropping pills with stearic acid magnesium of Subing drop pills dissolution rate is much lower.
3, the preparation process has a great impact on the dissolution rate
In production, the process of small changes, will lead to the change of the dissolution of the formulation, the production of Compound Danshen tablets of different manufacturers can reach 93%, and the lowest is only 47%. With ginseng stems and leaves were used to 4 kinds of different preparation process of preparing tablets, in vitro release and rabbit blood drug concentration compared, organic solvent extract tablets release the fastest, blood drug concentration highest; crude drug is the worst. Release Yeh orchid extract tablet and semi extract and total flavonoids is compared. The results show that the three tablets of T50 had significant differences, which extract the slowest, total flavone tablets were the fastest.