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Traditional chinese medicine composition, and preparation and application thereof

a technology of composition and traditional chinese medicine, applied in the field of traditional chinese medicine composition and a preparation thereof, can solve the problems of low content of active ingredients, hindered its application in the clinic, and unsuitable for long-term use of drugs,

Active Publication Date: 2017-06-08
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is a method for improving the production of drop pills and drop pill capsules. The method involves combining vibration dropping and air cooling techniques with the fluidization drying coating method. This results in higher production rates and better forming quality of the drop pills. The method also eliminates the need for residual solvent, simplifies the production process, and reduces costs. The invention is the first to apply these techniques to the formulation of drop pills and drop pill capsules.

Problems solved by technology

However, due to the stronger toxicity and side effect, these drugs are not suitable to use for long time.
Hence, this hindered its application in clinic.
Because the production processes for the tablet and capsule are outdated, the content of active ingredients is low with no quality control indices.
Due to the hepatic first pass effect, they have low bioavailability and slow absorption, and are not competent to the first aid for the patients with angina pectoris.
However, the preparation method of traditional drop pill is to melt a medicine liquid and drop it into immiscible cooling medium to give the drop pill.
This does not meet the requirement of international market that the maximum daily dose of PEG matrix should not exceed 700 mg.
Moreover, it is difficult to prepare the traditional drop pill with diameter of less than 2.5 mm, so the patients have to take a lot of hard-to-swallow pills each time, which will not satisfy the fast-paced trend of morden life, and be prone to the problems of inaccurate dose.
Thus, it is generally unacceptable by the international consumers.
Because the cooling liquid has been used for solidifying the drop pill, the neccecary step is needed in the sequent process to remove the cooling liquid, and the remaining cooling liquid may pose the problem of residual organic solvent.
Besides, drying methods for the traditional drop pill have the defects of prolonged time, slow speed, uneven drying and easily leading to evaporation of volatile oil and precipitation of Borneol that is included in the products.
Although the preparation of CSDP is known as a very mature technique in the prior art, there are still a lot of problems faced during preparation process, e.g. large amount of matrix and small drug-loading capacity.

Method used

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  • Traditional chinese medicine composition, and preparation and application thereof
  • Traditional chinese medicine composition, and preparation and application thereof
  • Traditional chinese medicine composition, and preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0091]820 g of crude medicine of Salvia Militiorrhiza was cut into the pieces of 1˜2 cm in length and 160 g of crude medicine of Panax Notoginseng ground into particles of 0.18 cm. Sodium bicarbonate accounting for 2.25 wt % of total crude medicine was weighed and charged into an extracting tank together with Salvia Militiorrhiza and Panax Notoginseng and 5 times of water was added to heat and keep boiling for 2 h and filtered. Resultant residues were extracted for 2nd time by adding with 4 times of water to heat and keep boiling for 2 h and filtered. The residues were removed. The extraction solution obtained by two extractions was concentrated to a relative density of 1.16-1.20 (80±5° C.) or a relative sugar degree of 48˜52% to give the concentrated liquid. The liquid was delivered to the alcohol precipitation tank, into which a proper amount of ethanol was poured to make final ethanol content of 65˜70% and allowed to stand still for 12 hours to precipitate completely. The superna...

example 2

[0094]75 g of Salvia Militiorrhiza and Panax Notoginseng extract obtained from Example 1 and 25 g of borneol was mixed uniformly to give the traditional Chinese medicine composition.

example 3

[0095]800.0 g of crude medicine of Salvia Militiorrhiza and 150.0 g of Panax Notoginseng were decocted with water under alkaline condition for 3 times (pH=9), 1 hour each time and filtered to give filtrate I. Resultant residue was decocted with water for 3 times, 1 hour each time and filtered to give the filtrate II. Filtrate I and filtrate II were combined and concentrated. The concentrated liquid was added with ethanol to make final ethanol content of 70% and allowed to stand still. The supernatant was filtered to recover the ethanol, which was concentrated and dried to obtain Salvia Militiorrhiza and Panax Notoginseng extract.

[0096]By aforesaid method, the Salvia Militiorrhiza and Panax Notoginseng extract was determined and the concentration of ingredients was presented as follows: the Danshensu at 40 mg / g, Salvianolic acid T at 12 mg / g, protocatechuic aldehyde at 20 mg / g, Salvianolic acid D at 7 mg / g, rosmarinic acid at 9 mg / g, Salvianolic acid B at 16 mg / g, Salvianolic acid A ...

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Abstract

A traditional Chinese medicine composition for treating cardiovascular disease, and a preparation thereof, particularly a micro drop pill preparation thereof, and a method for preparing the preparation; the method for preparing the micro drop pill preparation can be used to prepare drop pills, coated drop pills, and drop pill capsules with a high drug loading capacity.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a traditional Chinese medicine composition and a preparation thereof, more particular to a traditional Chinese medicine composition for treating cardiovascular disease and a preparation thereof, especially a micro drop pill preparation. Also, the present invention relates to a method for preparing the traditional Chinese medicine and the preparation thereof. Wherein, the method for preparing the micro drop pill preparation can be used to prepare the drop pills, coated drop pills ans drop pill capsules with high drug-loading capacity.BACKGROUND OF THE INVENTION[0002]With the improvement of living standards, worldwide population aging and younger onset population, the patients with cerebral and cardiovascular diseases are increased year by year. It has become the second large disease that does harm to human health. Angina pectoris is a clinical syndrome which is characterized in chest pain and chest discomfort, caused by myo...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/704A61K36/258A61K31/045A61K9/28A61K31/192A61K31/216A61K31/343A61K36/537A61K9/20
CPCA61K31/704A61K36/537A61K36/258A61K31/045A61K9/2009A61K9/2013A61K9/2893A61K9/2018A61K9/2031A61K31/192A61K31/216A61K31/343A61K9/2059A61K9/19A61K9/28A61K9/4866A61K2300/00A61K9/16A61K9/1664A61K9/20A61K9/2068A61K31/11A61K36/82A61P7/02A61P9/00A61P9/10
Inventor YAN, XIJUNWU, NAIFENGYAN, KAIJINGYE, ZHENGLIANGZHANG, SHUNNANZHOU, LIHONGZHANG, WENSHENGDONG, HAI'OU
Owner TIANJIN TASLY PHARMA CO LTD