Drop pills of oleanolic acid, and preparation method

A technology for oleanolic acid and dropping pills, applied in the field of medicine, can solve the problems of low degree of pure naturalness, low dissolution rate and dissolution rate, low degree of naturalness of auxiliary materials, etc. The effect of oral pH and improving oral odor

Inactive Publication Date: 2006-12-06
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Oleanolic acid tablets and capsules are currently sold in the market. Because oleanolic acid is insoluble in water and has strong hydrophobicity, the dissolution rate and dissolution rate of oleanolic acid tablets or capsules are low, poor absorption, and low bioavailability. The proportion of excipients is large, it is inconvenient for patients to take it, and the compliance is poor, which affects the therapeutic effect of oleanolic acid
Application number: 03157672.9, application date: 2003.9.6, applicant: Nanchang Hongyi Technology Co., Ltd., invention name: oleanolic acid dripping pills and its preparation method; application number: 03112181.0, application date: 2003.04.21, application ( Patent right) Person: Shandong Provincial Academy of Traditional Chinese Medicine, name of invention: a drug for treating acute and chronic hepatitis and its preparation process. The above two patent documents provide a kind of chronic persistent hepatitis, chronic active hepatitis, primary liver The drop pill medicine of diseases such as cirrhosis, liver poisoning also provides preparation method, and this drop pill medicine uses polyethylene glycol and other auxiliary materials to make drop pill with oleanolic acid fine powder; Although this drop pill overcomes the defect of present tablet, The dissolution rate is accelerated, but the drop pill has the defect that the natural degree of the excipients used is not high
[0004] Current drop pill preparations generally face the following problems: 1. The pure natural degree of drop pill auxiliary materials is not high: at present, most of the drop pill base auxiliary materials are chemical synthetic products, and the natural degree is relatively low. The search for new alternative base auxiliary materials, especially the natural degree The search for high-alternative matrix excipients and the determination of its preparation process are very difficult things, because the preparation conditions required for common and possible natural matrix excipient substitutes are very harsh, and the temperature of the excipients and the drop-pill dripping conditions are all The key to affecting the preparation and molding of dropping pills
If the melting temperature of the excipient is too high, the viscosity will be low and the plasticity will be poor. If the melting temperature of the excipient is too low, although the plasticity is strong, the dropping pills have disadvantages such as easy sticking and deformation. The accessories are very hard work
2. Problems encountered in the export of dripping pills: With the development of the economy, the market is becoming more and more internationalized, and China is also trying to adapt to this trend. Currently, Chinese medicine dripping pills, which are used as health food, have been successfully exported to many countries, but There are also many problems at present, because different countries have different approvals for the excipients selected for the prep

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0050] Example 1

[0051] (a) Take 6.0 g of oleanolic acid fine powder, 18.3 g of xylitol, and 6.7 g of starch for use;

[0052] (b) Take xylitol and starch and mix them evenly, add the above-mentioned oleanolic acid powder and mix thoroughly, heat and melt the mixture at 64°C, stir evenly, stirring time is 10-30 minutes, keep warm, drip at 64°C, The dropper has a diameter of 1.2 to 2.5 mm, and it is dripped into methyl silicone oil at 0°C to make 1000 droplets. The droplets are drained and the coolant is wiped off to get it.

Example Embodiment

[0053] Example 2

[0054] (a) Take 20g of oleanolic acid fine powder, 76.9g of lactitol, and 23.1g of starch for use;

[0055] (b) Take lactitol and starch and mix evenly, add the above-mentioned oleanolic acid fine powder and mix thoroughly, heat and melt the mixture at 64℃, stir evenly, stirring time is 10-30 minutes, keep warm, drip and drip at 64℃ The diameter of the tube is 1.2 ~ 2.5 mm, and it is dripped into methyl silicone oil at 0°C to make 3000 drops of pills. Drain the drops of pills and wipe off the coolant to get it.

Example Embodiment

[0056] Example 3

[0057] (a) Take 40g of oleanolic acid fine powder, 71.4g of xylitol and 28.6g of gum arabic for use;

[0058] (b) Take xylitol and gum arabic and mix well, add the above-mentioned oleanolic acid powder and mix thoroughly, heat and melt the mixture at 64℃, stir evenly, stirring time is 10-30 minutes, keep warm, drip at 64℃ , The dropper has a diameter of 1.2 ~ 2.5 mm, drop it into the methyl silicone oil at 0°C to make 4000 drop pills, drain the drop pills and wipe off the coolant to get it.

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PUM

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Abstract

A dripping pill of oleanolic acid for treating chronic metastatic hepatitis features high natural level and safety and low toxic by-effect. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a medicine for treating chronic persistent hepatitis prepared from traditional Chinese medicines. Background technique [0002] Oleanolic acid (oleanolic acid) is a pentacyclic triterpenoid compound, which mostly exists in plants in the form of free or glycosides, and its distribution is wide. There are 126 kinds of plants containing oleanolic acid. Oleanolic acid can significantly reduce the serum alanine aminotransferase of animals with experimental liver damage, reduce the degeneration and necrosis of liver cells, the inflammatory response and fibrosis of liver tissue, promote the regeneration of liver cells, and accelerate the repair of necrotic tissue . For the treatment of viral persistent chronic hepatitis, it can significantly improve symptoms, signs and liver function. In addition, it has the effect of correcting protein metabolism disorders. It...

Claims

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Application Information

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IPC IPC(8): A61K31/56A61K31/704A61K9/20A61P1/16A61P31/14
Inventor 李永强郑永锋
Owner TIANJIN TASLY PHARMA CO LTD
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