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Formula of catalpol-puerarin injection and powder and preparation method

A technology for injection and powder injection, which is applied to medical preparations containing active ingredients, pharmaceutical formulations, powder delivery, etc., can solve the problems of large toxic and side effects, difficult to achieve satisfactory results, single therapeutic target, etc., and achieves low toxicity, Easy to transport, good reconstitution effect

Inactive Publication Date: 2011-02-09
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the therapeutic targets of these drugs are single, and the side effects are relatively large, so it is difficult to achieve satisfactory results.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: the preparation of Zi Ge injection

[0016] Prescription:

[0017] Catalpol 25g

[0018] Puerarin 25g

[0019] Sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin 100g

[0020] Sodium chloride 9g

[0021] Add water for injection to 1000ml

[0022] Preparation process: Dissolve prescription amount of sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin and isotonic regulator with appropriate amount of water for injection. Add the prescribed amount of puerarin and catalpol, shake at room temperature or sonicate to dissolve completely, add water for injection to the required volume, filter, dispense into 2.0ml ampoules, and sterilize at 100°C for 30 minutes.

Embodiment 2

[0023] Embodiment 2: the preparation (freeze-drying method) of Zi Ge powder needle

[0024] Prescription:

[0025] Catalpol 25g

[0026] Puerarin 25g

[0027] Sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin 100g

[0028] Sodium chloride 9g

[0029] Add water for injection to 1000ml

[0030] Preparation process: Dissolve prescription amount of sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin and isotonic regulator with appropriate amount of water for injection. Add the prescribed amount of puerarin and catalpol, shake at room temperature or sonicate to completely dissolve them, add water for injection to the required volume, filter through a G6 vertical melting funnel, and divide into 10ml vials, each with 2ml filtrate. Cool to -75°C, pre-freeze for 6 hours, sublimate under reduced pressure at -45°C for 16 hours, press the plug, and tie the cover.

Embodiment 3

[0031] Embodiment 3: the preparation (spray-drying method) of Pueraria japonica powder needle

[0032] Prescription:

[0033] Catalpol 25g

[0034] Puerarin 25g

[0035] Sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin 100g

[0036] Sodium chloride 9g

[0037] Add water for injection to 1000ml

[0038] Preparation process: Dissolve prescription amount of sulfobutyl ether-β-cyclodextrin and / or hydroxypropyl-β-cyclodextrin and isotonic regulator with appropriate amount of water for injection. Add the prescribed amount of puerarin and catalpol, shake at room temperature or sonicate to dissolve them completely, add water for injection to the required volume, filter through G6 vertical melting funnel, and spray dry (spray drying conditions: inlet temperature 170°C; outlet The temperature is 70-80°C; the air pressure is 0.8kg), and the obtained powder is subpackaged under sterile conditions.

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PUM

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Abstract

The invention relates to a formula of injection and powder prepared from catalpol and puerarin and a preparation method thereof. The formula is characterized by containing 0.05 to 30 grams of catalpol, 0.05 to 30 grams of puerarin, 1 to 100 grams of sulfobutyl ether-beta-cyclodextrin and / or hydroxypropyl-beta-cyclodextrin and 0 to 30 grams of isoosmotic adjusting agent. One or mixture of sodium chloride, glucose, cane sugar, sorbitol, mannitol, dextran and xylitol can be used as the isoosmotic adjusting agent. The invention aims to provide a Chinese medicinal effective ingredient compound injection preparation for treating cerebral ischemic diseases. The preparation can permeate the blood brain barrier, relieve the cerebral ischemic injury, improve ischemic and hypoxic tolerance of brain tissues, promote neogenesis and maturity of cerebral capillaries, protect neurovascular units, promote neuron axon and dendrite growth, enhance synaptic reconstruction, improve cerebral ischemic posterior nerve behaviors, improve the neural function score and promote affected limb motion function recovery.

Description

technical field [0001] The invention relates to the fields of traditional Chinese medicine pharmacology and traditional Chinese medicine preparations. Specifically, it relates to the prescription and preparation method of an injection and a powder injection of catalpol, an effective component of rehmannia glutinosa and puerarin, an effective component of kudzu root, and can be used clinically to treat cerebral ischemic brain diseases. Background technique [0002] Cerebrovascular disease is one of the three major causes of death that seriously endanger human health. In my country, more people die from cerebrovascular disease than heart disease and cancer, ranking first among the three major causes of death. It has the characteristics of high morbidity, disability and mortality. It is a common disease that threatens the health of human beings, especially middle-aged and elderly people. frequently-occurring disease. Among them, ischemic cerebrovascular disease accounts for 60...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/40A61K9/19A61K31/7048A61K9/08A61K31/352A61P9/10A61K9/14
Inventor 徐晓玉祝慧凤何瑶何正光李万玉陈怡马强刘家兰原欢欢
Owner SOUTHWEST UNIV
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