Dropping pills containing lorazepam and method for preparing the same

A technology for lorazepam and dripping pills, applied in the field of medicine, can solve the problems of low degree of pure naturalness, low degree of naturalness, and low degree of pureness of excipients of dripping pills, so as to reduce the irritating smell of drugs, improve oral pH, Highly natural effect

Inactive Publication Date: 2008-06-11
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Lorazepam tablets take a long time to disintegrate, have poor absorption, low bioavailability, and a large proportion of excipients. Children, the elderly, bedridden patients, and patients with dysphagia are inconvenient to take and have poor compliance, which affects the therapeutic effect of lorazepam. to play
Application number: 200310121924.9, application date: 2003.12.8, applicant: Nanchang Hongyi Technology Co., Ltd., invention name: "Lorazepam drop pills and its preparation method" The patent literature provides a drop pill preparation and its preparation Method, although this drop pill medicine overcomes above defective, has accelerated stripping speed, but this drop pill exists the defect that the natural degree of used adjuvant is not high
[0004] 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 preparation is a kind of high-efficiency, quick-acting new Chinese medicine preparation, which overcomes the shortcomings and deficiencies of the previous Chinese medicine preparations, but the current drop pill preparations generally face the following problems: 1. The natural degree of drop pill auxiliary materials is not high: at present, the drop pill matrix Most of the excipients are chemical synthetic products with a low degree of naturalness. It is very difficult to find new alternative matrix excipients, especially the search for alternative matrix excipients with a high degree of naturalness and the determination of their preparation process, because currently common and possible The preparation conditions required for the substitutes of natural matrix excipients are very harsh, and the temperature of excipients and the droplet dripping conditions are the key factors affecting the preparation of droplet 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 excipie

Method used

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  • Dropping pills containing lorazepam and method for preparing the same
  • Dropping pills containing lorazepam and method for preparing the same
  • Dropping pills containing lorazepam and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] (a) get lorazepam 6.0g, xylitol 18.3g, starch 6.7g for subsequent use;

[0052] (b) Mix xylitol and starch evenly, add the above-mentioned lorazepam and mix thoroughly, heat and melt the mixture at 66°C, stir evenly, and stir for 15 minutes, keep warm, drip at a temperature of 66°C, and the caliber of the dropper is 1.2 to 2.5 mm, drop into methyl silicone oil at 5°C to make 1000 drop pills, drain the drop pills and wipe off the cooling liquid.

Embodiment 2

[0054] (a) Take 20g of lorazepam, 76.9g of lactitol, and 23.1g of starch for subsequent use;

[0055] (b) Take lactitol and starch and mix evenly, add the above-mentioned lorazepam and mix thoroughly, heat and melt the mixture at 66°C, stir evenly, stir for 15 minutes, keep warm, drip at 66°C, the diameter of the dropper is 1.2 ~2.5 mm, drop into methyl silicone oil at 5°C to make 3000 drop pills, drain the drop pills and wipe off the cooling liquid, and you get it.

Embodiment 3

[0057] (a) get lorazepam 40g, xylitol 71.4g, gum arabic 28.6g for subsequent use;

[0058] (b) Mix xylitol and gum arabic evenly, add the above-mentioned lorazepam and mix well, heat and melt the mixture at 66°C, stir evenly, keep stirring for 15 minutes, keep warm, drip at 66°C, dropper caliber 1.2 to 2.5 mm in diameter, drop into methyl silicone oil at 5°C to make 4,000 drop pills, drain the drop pills and wipe off the cooling liquid to obtain the product.

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Abstract

The invention provides a dripping pill which contains lorazepam and a process for preparation. The invention is a medicament which has the function of anti anxiety disorder, insomnia, and epilepsy. 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 drop pill containing lorazepam and a preparation method thereof. The dropping pill is a medicine for anxiolytic, insomnia and epilepsy. Background technique [0002] Lorazepam is a benzodiazepine, its effect is similar to that of diazepam, but its anti-anxiety effect is stronger than that of diazepam, and its sleep-inducing effect is obvious. Oral absorption is good and rapid. The binding rate with plasma protein is about 85%. Metabolized by the liver, the metabolites are biologically inactive. t 1 / 2 About 10-18 hours. 1-4 hours after oral administration, the plasma concentration reaches the peak; 2-3 days later, the steady-state plasma concentration is reached. Clinically used for anxiety, insomnia and epilepsy. [0003] Lorazepam tablets take a long time to disintegrate, have poor absorption, low bioavailability, and a large proportion of excipients. Children, the elderly, bedr...

Claims

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Application Information

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IPC IPC(8): A61K31/5513A61K9/20A61K47/26A61K47/36A61K47/38A61K47/40A61P25/08A61P25/20A61P25/22A61J3/06
Inventor 李永强郑永锋
Owner TIANJIN TASLY PHARMA CO LTD
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