Pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, preparation process and quality control method thereof

A cardiovascular and cerebrovascular disease and composition technology, which is applied in cardiovascular system diseases, drug combinations, testing drug preparations, etc., can solve the problems of inapplicability for long-term use, low bioavailability, and clinical application limitations, and achieve strong pharmacological effects. , Overcome the large fluctuation of curative effect and stabilize the effect of medication safety

Inactive Publication Date: 2007-05-30
BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Codonopsis pilosula has the functions of invigorating the middle and replenishing qi, invigorating the spleen and benefiting the lungs. It is used for symptoms such as weak spleen and lungs, shortness of breath, palpitations, lack of appetite, loose stools, cough due to deficiency, internal heat and quenching thirst. Studies have shown that glycosides in Codonopsis pilosula are mainly The effective parts have the functions of invigorating qi and strengthening the heart, relieving myocardial ischemia, promoting blood circulation and removing blood stasis. Pharmacodynamics and modern clinical studies show that Codonopsis pilosula has good curative effect on heart disease and shock caused by qi deficiency and spleen deficiency; dipyridamole, As an anti-platelet aggregation and coronary artery dilating drug, it is widely used in the treatment of cardiovascular and cerebrovascular diseases. However, it has been found in clinical practice that Codonopsis pilosula preparations are mostly pure Chinese medicine preparations, with slow onset of action, long course of treatment, low bioavailability, and fluctuations in curative effect large; and dipyridamole has certain toxic and side effects, it is not suitable for long-term use, and its clinical application is also limited
Searched the literature and patent databases, but found no preparations that combined the effective parts of Codonopsis pilosula and dipyridamole

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1 of the present invention: dipyridamole 1g Codonopsis glycosides 50g

[0069] Take dipyridamole, add water for injection, add tartaric acid or citric acid and stir to dissolve, and set aside the liquid medicine; take total codonopsis glycosides and add water for injection, stir to dissolve, filter, and set aside the filtrate; combine the above two liquid medicines, boil Finally, add 0.5% (W / V) activated carbon, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH value of the filtrate to 5.5-7.0, boil, refrigerate (4°C) overnight, coarse filter, fine filter; add mannitol Prepare water for injection into a 120 mg / ml solution, mix with the above filtrate, filter, add water for injection to the specified amount, subpackage, freeze-dry, pre-freeze at -45°C, and pre-freeze for 10 hours; start vacuuming, and heat up to -40°C, keep it for 8h; and within 12 to 72 hours, gradually increase the temperature to 10°C with a differential gradient, kee...

Embodiment 2

[0070] Embodiment 2 of the present invention: dipyridamole 2g Codonopsis glycosides 30g

[0071] Take dipyridamole, add water for injection, add tartaric acid or citric acid and stir to dissolve, and set aside the liquid medicine; take total codonopsis glucoside and add water for injection, stir to dissolve, filter, and set aside the filtrate; combine the above two liquid medicines, adjust The pH value is 5.5-7.0, add 0.5% activated carbon for needles, boil for adsorption, remove carbon, fine filter, add water for injection to the filtrate to the specified amount, refrigerate at 4°C overnight, coarse filter, fine filter, and pack into ampoules bottle, sterilized, and packaged to obtain 15 parts of Codonopsis glucosides and 1 part of dipyridamole small-volume injection or concentrated solution for injection.

Embodiment 3

[0072] Embodiment 3 of the present invention: dipyridamole 5g Codonopsis glycosides 5g

[0073] Take dipyridamole, add water for injection, add tartaric acid to stir to dissolve, and prepare the liquid for later use; take total codonopsis glycosides, add appropriate amount of water for injection to dissolve, and prepare the liquid for later use; combine the above two liquids, and add a specified amount of glucose or chloride Sodium, after mixing and dissolving, add 0.6% activated carbon for needles according to the volume, boil, keep boiling slightly for 30 minutes, filter slightly cold, add water for injection to the filtrate to an appropriate amount, adjust the pH value to 5.5-7.0, boil, refrigerate overnight at 4 °C, crude Filtration, fine filtration, add water for injection to the full amount, subpackage, and sterilize to obtain glucose or sodium chloride intravenous infusion containing 1 part of dipyridamole and 1 part of codonopsis glycosides.

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PUM

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Abstract

The invention provides a pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, its preparing process and quality control method, wherein Dipyridamole and total glycosides of codonopsis pilosula are employed in combination to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating coronary disease, pulmonary heart disease, cerebral ischemia, nervous prostration, climacteric metancholia, The preparation of the invention has the advantages of high purity, ensured constituents, controllable quality, improved curative effect, wider range of safely, and less fluctuation of treatment effects.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, a preparation method and a quality control method thereof, and belongs to the technical field of medicines. technical background [0002] At present, about 4 million people die from cardiovascular and cerebrovascular diseases in my country every year, accounting for more than 3 / 5 of the death toll, and it has become the primary factor threatening human health. Although there are a large number of Chinese and Western medicine interviews at present, with the continuous change of disease spectrum and the arrival of aging age, the current medicine continues to show its limitations. Therefore, research and development of medicines for the treatment of cardiovascular and cerebrovascular diseases are always Become the focus and hot spot of people's attention. [0003] Codonopsis pilosula has the functions of invigorating the middle and replenishing...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/344A61K31/7048A61K31/519A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P11/00A61P25/20A61P15/12G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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