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Production method of silybin meglumine tablets

A technology of silibinin and meglumine tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of high cost investment and brittle packaging materials, etc. Achieve the effect of basic quality indicators, stable quality indicators, and accelerated detoxification ability

Active Publication Date: 2010-08-25
ZHONGXING PHARM CO LTD JIANGSU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, PVDC is used as the inner packaging material, and the cost investment is relatively large, and the packaging material is relatively brittle, so it must be kept warm before use.

Method used

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  • Production method of silybin meglumine tablets

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Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: the present invention is a kind of production method of silibinin meglumine tablet, and this method is: respectively take by weighing 48.85g of silybin meglumine, lactose 91.59g, carboxymethyl starch sodium 11.29g, dioxidized Silicon 10.10g, pregelatinized starch 38.67g, magnesium stearate 3.05g, the mass content of each crude drug is obtained by calculation: silibinin meglumine 24%, lactose 45%, sodium starch glycolate 5.55% %, silicon dioxide 5%, pregelatinized starch 19%, magnesium stearate 1.5%; then the above-mentioned silibinin meglumine, lactose, sodium starch glycolate, silicon dioxide, pregelatinized The starch is made into a soft material with ethanol with a volume content of 80%, followed by 12-mesh granulation, 60°C drying, 14-mesh granulation, adding magnesium stearate, mixing, tableting, coating, and packaging. The silybin meglumine tablet adopts polyvinyl chloride (PVC) as packaging material during wherein packaging.

[0022] Existing produ...

Embodiment 2

[0025] Embodiment 2: the present invention is a production method of silibinin meglumine tablets, the method is: respectively weigh 52.92g of silybin meglumine, 85.95g of lactose, 18.30g of sodium starch glycolate, and Silicon 18.30g, pregelatinized starch 27.00g, magnesium stearate 1.08g; through calculation, the mass content of each raw material medicine is respectively: silibinin meglumine 26%, lactose 42.2%, carboxymethyl starch sodium 9 %, silicon dioxide 9%, pregelatinized starch 13.3%, magnesium stearate 0.5%. Then the above-mentioned silibinin meglumine, lactose, sodium starch glycolate, silicon dioxide, and pregelatinized starch that were weighed above are made into a soft material with a volume content of 95% ethanol, and then successively carry out 16 mesh granulation, 80 ℃ drying, granulation at 14 meshes, adding magnesium stearate and mixing evenly, tableting, coating, and packaging to obtain the silybin meglumine tablets, wherein polyvinyl chloride (PVC) is used ...

Embodiment 3

[0026] Embodiment 3: the present invention is a kind of production method of silibinin meglumine tablet, and this method is: take by weighing 40.71g of silybin meglumine, lactose 81.42g, carboxymethyl starch sodium 20.35g, dioxide 20.35g of silicon, 38.67g of pregelatinized starch, and 2.05g of magnesium stearate; the mass content of each bulk drug is obtained by calculation: 20% of silibinin meglumine, 40% of lactose, and 10% of sodium starch glycolate %, silicon dioxide 10%, pregelatinized starch 19%, magnesium stearate 1.0%. Then the above-mentioned silibinin meglumine, lactose, sodium starch glycolate, silicon dioxide, and pregelatinized starch that were weighed above are made into a soft material with a volume content of 95% ethanol, and then successively carry out 14 mesh granulation, 50 ℃ drying, granulation at 16 mesh, adding magnesium stearate and mixing, tableting, coating, and packaging to obtain the silybin meglumine tablets, wherein polyvinyl chloride (PVC) is use...

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Abstract

The invention discloses a production method of silybin meglumine tablets, and the method comprises the following steps: weighing the following materials in percent by weight: 20-30% of silybin meglumine, 35-45%of lactose, 5-10% of sodium carboxy methyl starch, 5-10% of silicon dioxide, 13-19% of pre-gelatinized starch and 0.5-1.5% of magnesium stearate respectively; then preparing the weighed silybin meglumine, lactose, sodium carboxy methyl starch, silicon dioxide and pre-gelatinized starch into soft material by ethanol of which the concentration is 80-95%, granulating by 12-20 meshes, drying at 50-80DEG C, sizing by 14-16 meshes; and adding the magnesium stearate, mixing, tabletting, coating and packaging to obtain the silybin meglumine tablets. The method can guarantee various quality indexes of the product to be basically stable within the period of validity; by adopting polyvinyl chloride as the packaging material, the heat preservation problem before use can be solved, and the production cost can be greatly reduced.

Description

technical field [0001] The invention relates to a preparation method of medicine, in particular to a production method of silybin meglumine tablets. Background technique [0002] Silybin Meglumine Tablets, English name: Silybin Meglumine Tablets, chemical structural formula: [0003] [0004] Silybin Meglumine Tablets are used for the adjuvant treatment of acute and chronic hepatitis, initial liver cirrhosis, and toxic liver damage. At present, the main drug in the production of silybin meglumine tablets is silybin meglumine, and the excipients are lactose, sodium starch glycolate, silicon dioxide, meglumine, ethanol, and magnesium stearate. Manufactured through granulation, tablet compression, coating and packaging. The content and dissolution rate of the product decreased rapidly. The reason is that the main drug has a strong hygroscopicity, and some of the excipients have a great impact on the quality inspection of the product. The product is stored for two years. Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/357A61K47/36A61P1/16
Inventor 戴军武俊明张红梅
Owner ZHONGXING PHARM CO LTD JIANGSU
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