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Compound salvianic acid injection for treating cerebral vascular thrombosis diseases and preparation process thereof

The technology of a plain injection and compound danshen is applied in the field of compound danshensu injection, which can solve the problems such as difficulty in dissolving paeonol

Inactive Publication Date: 2012-03-21
FOURTH MILITARY MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention uses 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) to clathrate paeonol in the prescription, solving the problem that paeonol is difficult to dissolve in water for injection

Method used

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  • Compound salvianic acid injection for treating cerebral vascular thrombosis diseases and preparation process thereof
  • Compound salvianic acid injection for treating cerebral vascular thrombosis diseases and preparation process thereof

Examples

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preparation example Construction

[0018] 4. The preparation method of compound danshensu injection

[0019] (1) In parts by weight, take 1 part of paeonol and dissolve it with 20 parts of absolute ethanol; take another 6 parts of hydroxypropyl-β-cyclodextrin, add water for injection in a water bath at 50°C to make a saturated solution; Slowly add paeonol absolute ethanol solution dropwise to hydroxypropyl-β-cyclodextrin at a rate of 3 drops / min, keep stirring at the temperature of the water bath until the absolute ethanol evaporates, sonicate for 1 hour, and refrigerate at 4°C Overnight, filter, and dry the filter residue at 40°C to obtain paeonol-hydroxypropyl-β-cyclodextrin inclusion compound; measure the encapsulation efficiency and the content of paeonol in the inclusion compound.

[0020] (2) Weigh danshensu, paeonol inclusion compound and excipients according to the weight indicated on the prescription, mix them, dissolve them with water for injection, filter, adjust the pH of the filtrate to 6.8-7.2, st...

example 1

[0026] [Prescription] Danshensu 100g Paeonol 1g Mannitol 60g

[0027] [Preparation process] (1) Take 1g of paeonol and dissolve it in 20mL of absolute ethanol; take another 6g of hydroxypropyl-β-cyclodextrin and add water for injection in a water bath at 50°C to make a saturated solution; Slowly add absolute ethanol solution to hydroxypropyl-β-cyclodextrin at a rate of 3 drops / min, keep stirring at the temperature of the water bath until the absolute ethanol evaporates, sonicate for 1 hour, refrigerate overnight at 4°C, and filter , and the filter residue was dried at 40°C to obtain paeonol-hydroxypropyl-β-cyclodextrin inclusion compound.

[0028] (2) Weigh danshensu, paeonol inclusion compound and excipients according to the weight indicated on the prescription, mix them, dissolve them with water for injection, filter, adjust the pH of the filtrate to 6.8-7.2, sterilize, filter, and use aseptic injection Dilute it with water to the designed total volume, divide it into brown...

example 2

[0030] [Prescription] Danshensu 100g Paeonol 5g Mannitol 70g

[0031] [Preparation process] (1) Take 5g of paeonol and dissolve it in 100mL of absolute ethanol; take another 30g of hydroxypropyl-β-cyclodextrin, add water for injection in a water bath at 50°C to make a saturated solution; Slowly add absolute ethanol solution to hydroxypropyl-β-cyclodextrin at a rate of 3 drops / min, keep stirring at the temperature of the water bath until the absolute ethanol evaporates, sonicate for 1 hour, refrigerate overnight at 4°C, and filter , The filter residue was dried at 40°C to obtain paeonol-hydroxypropyl-β-cyclodextrin inclusion compound.

[0032] (2) Weigh danshensu, paeonol inclusion compound and excipients according to the weight indicated on the prescription, mix them, dissolve them with water for injection, filter, adjust the pH of the filtrate to 6.8-7.2, sterilize, filter, and use aseptic injection Dilute it with water to the designed total volume, divide it into brown contro...

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Abstract

The invention aims to provide a compound salvianic acid injection which uses salvianic acid and paeonol as main components with high efficiency, advanced dosage form and stable preparation, as well as a preparation process thereof, and belongs to the field of biological pharmacy. The method comprises the following steps: extracting salvianic acid from salvia, and extracting paeonol from peony bark and enamelling with 2-hydroxypropyl-beta-cyclodextrin to prepare paeonol- hydroxypropyl-beta-cyclodextrin clathrate compound; weighting and mixing the salvianic acid, the paeonol clathrate compound and an excipient according to marked weights in the prescription, dissolving with injection water, filtering, and regulating the pH of the filtrate to be between 6.8 and 7.2; sterilizing and filtering, and diluting with aseptic injection water to the total designing solution; and packaging in a brown glass tube vial, and lyophilizing. The injection has the effects of activating blood circulation to remove stasis, and dredging collaterals and relieving pain, and is suitable for patients with cerebral vascular thrombosis diseases, such as coronary heart disease, angina pectoris, cerebral thrombosis, cerebral infarction and the like. The injection for adults is used for intramuscular injection or intravenous drip, and is dosed 1 to 5 vials one time, 1 to 2 times per day or as professionally prescribed.

Description

Technical field [0001] The present invention adopts high-purity danshensu and paeonol extracted from salvia miltiorrhiza and moutan cortex respectively as raw materials, and prepares compound danshensu injection for treating vascular embolism diseases according to the pharmaceutical method, and its technology belongs to pharmaceutical pharmacy and clinical application field. Background technique [0002] Heart and cerebrovascular embolism diseases such as coronary heart disease, angina pectoris, cerebral thrombosis, and cerebral infarction (also known as stroke) are common clinical diseases and frequently-occurring diseases. For example, cerebral infarction is a sudden-onset cerebral blood or cerebrovascular circulation disorder disease. The main clinical manifestations are sudden fainting, unconsciousness or sudden crooked mouth and eyes, hemiplegia, tongue slurring, and mental retardation. Stroke is divided into ischemic stroke and hemorrhagic stroke. Acute ischemic strok...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K31/12A61K9/19A61K47/40A61P29/00A61P9/10A61P7/02
Inventor 李骅王四旺谢艳华杨倩曹蔚张邦乐毕琳琳
Owner FOURTH MILITARY MEDICAL UNIVERSITY
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