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Drop pills of 'Yixintong' and prepartion method

A technology of Yixin ketone and dripping pills, which is applied in the directions of pill delivery, pharmaceutical formulations, cardiovascular system diseases, etc., can solve the problems of low degree of pure naturalness, low degree of naturalness, and low degree of pureness of the auxiliary materials of dripping pills. The irritating smell of drugs, the improvement of oral pH, and the high degree of pure natural effect

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

[0008] 1. The natural degree of drop pill excipients is not high: at present, the base excipients of drop pills are mostly chemical synthetic products with a low degree of naturalness. The search for new alternative base excipients, especially the search and preparation of alternative base excipients with high natural degree The determination of the process is very difficult, because the preparation conditions required by the common and possible substitutes for natural matrix excipients are very harsh, and the temperature of the excipients and the dripping conditions of the dripping pills are the key factors that affect the preparation of the dripping 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
[0009] 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 preparation of Chinese medicine dripping pills, especially in Europe with developed industries, which have stricter regulations on food excipients and pharmaceutical excipients, and the drops exported as health food The chemically synthesized auxiliary materials (such as polyethylene glycol) selected for pill preparations are not listed in the food additive catalogs of some countries, which is very unfavorable for Chinese medicine dripping pill preparations to enter the international market, and has become a stumbling block for Chinese medicine to enter the international market. Therefore, looking for One or more new matrix excipients that can be accepted by the international market are particularly important and urgent
[0010] 3. Disadvantages of mouthfeel and speed of onset of action: Poor taste of traditional Chinese medicine and its preparations is one of its major characteristics. When people take certain medicines, they are far more afraid of the bad taste of the medicine than they are of the disease. What's more, some patients give up the treatment of traditional Chinese medicine because they can't overcome the bad taste or smell of traditional Chinese medicine or its preparations. For example, making the medicine into capsules or sugar-coated tablets can improve the taste and reduce stimulation, but the disintegration speed is prolonged. , which is not conducive to the rapid onset of the drug, and is not suitable for some diseases, especially those that require the rapid onset of the drug
[0011] 4. Difficult preparation process for industrial production of dripping pills: In the replacement process of dripping pill preparation auxiliary materials, it is very difficult to determine the preparation process for industrial production, such as the melting temperature of matrix auxiliary materials, dripping temperature, auxiliary materials and The ratio of the drug, the ratio of the caliber of the dropper, and the condensing agent are all factors that affect the drop pills. Therefore, it is time-consuming and expensive to replace the matrix and be suitable for industrial production.
[0012] In order to change the long-term situation that the base excipients of drop pills are mainly chemically synthesized excipients, and solve the problem that the base of drop pills is currently facing a low level of naturalness, it is increasingly unable to meet people's requirements for returning to nature, taking pure natural medicines with low toxicity and no side effects It can also solve some problems encountered in the export process of Chinese medicine preparations, especially dripping pill preparations, and enhance the competitiveness of the international market; the present invention has invented a toxic and side effect through a large number of experiments and research on preparation technology. Pure Chinese medicine dripping pill preparation with low cost, significant curative effect, moderate price, and suitable for industrialized large-scale production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Mix 21.25g of xylitol with 4.25g of starch, add 7.5g of total hawthorn flavonoids, mix well, heat and melt the mixture at 64°C, stir evenly, stir for 10 to 30 minutes, keep warm, drip at 64°C, The caliber of the dropper is 1.2-2.5 mm, drop into the methyl silicone oil at 0°C, and make 1000 pellets, drain the formed drop pills and wipe off the cooling liquid, and pack them after drying.

Embodiment 2

[0056] Take 6.5g of hawthorn total flavonoids, 19.6g of lactitol, and 5.9g of starch for later use;

[0057] Add the above-mentioned hawthorn total flavonoids to the mixture of lactitol and starch, mix well, heat and melt the mixture at 64°C, stir evenly, stir for 10-30 minutes, put it in the liquid storage cylinder of the dripping pill machine, keep it warm, and keep it warm at 64°C Dropping at high temperature, the inner diameter of the drop head of the liquid storage tank is 1.2 mm, the outer diameter is 4.0 mm, the drop distance is adjusted to 8 cm, and the drop rate is 30 drops / min. granules, drain the formed drop pills and wipe off the cooling liquid, pack them separately after drying, and make drop pills.

Embodiment 3

[0059] Take a mixture of 18.2g of xylitol and 7.3g of gum arabic, add 5.5g of total hawthorn flavonoids, heat and melt the mixture at 60-85°C, put it in the liquid storage cylinder of the dropping pill machine, keep it warm and drip at 60-66°C, and store the liquid The inner diameter of the barrel dripper is 1.7mm and the outer diameter is 3.0mm. Adjust the drop distance to 10cm, and drop it into the liquid paraffin condensate at a constant speed of 30 drops / min (the temperature of the upper 25cm of the condensate is 20±2°C, and the temperature of the lower 35cm is 2±1°C), collect the dripping pills, Drain, wipe off the paraffin wax on the surface of the dripping pills, let it dry naturally, and make 1000 pills.

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Abstract

A dripping pill of haw flavone for treating cardiovascular and cerebrovascular diseases 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 a new dosage form prepared from natural plant active ingredients and a preparation method thereof, in particular to a drop pill prepared from total flavonoids of hawthorn leaves and a preparation method thereof. Background technique [0002] Cardiovascular and cerebrovascular disease is a common and frequently-occurring disease. With the improvement of people's living standards and the continuous change of lifestyle, the incidence of cardiovascular and cerebrovascular diseases is also increasing. Patients with cardiovascular and cerebrovascular diseases have become It is one of the three major causes of death in my country. Over the years, traditional Chinese medicine has been clinically proven to treat cardiovascular and cerebrovascular diseases such as salvia miltiorrhiza, tribulus terrestris, hawthorn, and breviscapus. Therefore, the research on the aforementioned traditional Chinese medicine h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/736A61K9/20A61P9/00A61K127/00
Inventor 李永强郑永锋
Owner TIANJIN TASLY PHARMA CO LTD
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