Dropping pills containing berberine or berberine salt and method for preparing the same

Abstract

The invention provides an antibiotic drug, which particularly relates to a drilling pill which contains berberine and berberine salt and a process for preparation. The invention overcomes the shortcomings of the prior dripping pills that pure natural degrees of findings which are used by the prior dripping pills are not high, and chemosynthesis findings which are commonly used are not in food additives catalogs of some countries, and tastes of the dripping pills are worse. The invention is a pharmaceutical preparation whose natural degree is higher, safety is stronger, and side effect is lower.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a dripping pill containing berberine or berberine salt and a preparation method thereof. Background technique [0002] Berberine has a broad antibacterial spectrum, and has inhibitory effects on a variety of Gram-positive and Gram-negative bacteria in vitro, including hemolytic streptococcus, Staphylococcus aureus, Vibrio cholerae, meningococcus, Shigella, and typhoid bacillus , diphtheria bacilli, etc. have a strong inhibitory effect. [0003] In vitro experiments have confirmed that berberine can enhance the phagocytosis of leukocytes and liver reticuloendothelial system. Shigella, hemolytic streptococcus, and Staphylococcus aureus are prone to develop resistance to berberine. It is mainly used clinically for intestinal infections such as gastroenteritis and bacillary dysentery caused by sensitive pathogenic bacteria, and is also used for the treatment of irritable bowel syndrome. ...

AI Technical Summary

Problems solved by technology

[0004] The oral preparations of berberine or berberine salt currently on the market include tablets and capsules, but they have long disintegration time, low dissolution rate and dissolution rate, poor absorption, low bioavailability, and large proportion of excipients. Children, the elderly People, bedridden patients and patients with dysphagia are inconvenient to take and have poor compliance, which affects the therapeutic effect of berberine or berberine salt

Application number: 03159116.7, application date: 2003.9.8, applicant: Nanchang Hongyi Technology Co., Ltd., invention name: berberine or berberine salt drop pills and the patent literature of its preparation method provides a kind of drop pill preparation and Its preparation method, this drop pill medicine uses polyethylene glycol and other auxiliary materials to make drop pill with berberine or berberine salt; Although this drop pill overcomes the above defects of berberine or berberine salt tablet and capsule, makes The therapeutic effect of berberine or berberine salt can be brought into full play, but the natural degree of the adjuvant used in this drop pill is not high

[0005] With the global expansion of the market and the requirement of human beings to return to nature, the use of drugs with low toxicity and side effects, especially pure natural drugs, has become the first choice of people. The dropping pill preparation is a new type of Chinese medicine preparation with high efficiency and quick effect. The shortcomings and deficiencies of traditional Chinese medicine preparations in the past, but the current drop pill preparations generally face the following problems: 1. The drop pill auxiliary materials are not purely natural: at present, most of the drop pill base auxiliary materials are chemically synthesized, and the natural degree is low. New alternatives The search for matrix excipients, especially the search for alternative matrix excipients with a high degree of naturalness and the determination of their preparation process, is also very difficult, because the preparation conditions required for common and possible substitutes for natural matrix excipients are very harsh. And its dripping pill dripping conditions are the key to affect the preparation of 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

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

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

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.

[0006] 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

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