Ginseng total saponins double-layer osmotic pump tablet and preparation method thereof

Abstract

The present invention relates to the field of medicine, in particular to total ginseng saponins double-layer osmotic pump tablet, which is prepared from the following raw materials with the following weight ratio: (1) The amount of each tablet of drug-containing layer: total ginseng saponins 75-150 mg, HPMC 5 ~10mg, CMC Na 5~10mg, sodium chloride 30~50mg, lactose 150~200mg, magnesium stearate 8~12mg, total 340mg; Sodium 30-50 mg, HPMC 50-70 mg, magnesium stearate 3-7 mg, total 145 mg; (3) Coating solution composition: 2% CA / PEG400 acetone solution, wherein the volume ratio of CA to PEG400 is 4-6 : 1; A drug release hole with a diameter of 0.54um is drilled in the middle of one side of the drug-containing layer. The drug release speed and in vivo absorption of the preparation of the invention are constant, the fluctuation of the effective blood drug concentration is small, the maintenance time is long, the frequency of taking the drug is small, the "peak and valley" phenomenon is avoided, and the safety and effectiveness are improved.

Description

[0001] This application is a divisional application of the invention patent application with the application number: 200610021969.2, the invention title: an osmotic pump controlled release preparation, its preparation method and application, and the application date is September 28, 2006. technical field [0002] The invention belongs to the field of medicine, and relates to a controlled-release preparation prepared from total ginsenosides as raw materials, in particular to a double-layer osmotic pump tablet of total ginsenosides. Background technique [0003] Oral osmotic pump preparations are made by using the principle of osmotic pressure to release drugs uniformly and at a constant rate, and are the most ideal oral controlled-release preparations so far. Its drug release rate can be several orders of magnitude higher than drug release through a diffusion-controlled release barrier (such as a matrix drug release system), and its constant release characteristics are more ob...

AI Technical Summary

Problems solved by technology

[0006] At present, the common preparations with total ginseng saponins as effective components mainly include tablets, injections, granules, capsules, oral liquids, etc., which require frequent administration and are prone to "peak and valley" phenomenon, which is inconvenient for clinical application; There are many reactions, which can cause serious side effects on the nervous system, cardiovascular system, digestive system, etc., and even death. It can also cause side effects such as allergic reactions, electrolyte disturbances, withdrawal reactions, and blurred vision.

In addition, due to the complex composition of saponins in total ginseng saponins, the indications of various saponins are different, and the release time is different, the release time of total ginseng saponins preparations is uncertain.

[0007] At present, there is no effective dosage form to overcome the defects of "peak and valley" phenomenon and many adverse reactions, which is convenient for clinical use

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