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Dengyin naotong pharmaceutical composition and preparation method thereof, preparation and application thereof

A lamp-yin-nao-tong and composition technology, which is applied in the field of medicine, can solve the problems of inability to guarantee product quality and safety, inability to quickly and fully exert the efficacy of drugs, and inability to make chemical components, so as to reduce pathological changes and behavioral disorders, Fast-acting and powerful effects

Active Publication Date: 2016-02-03
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The above-mentioned prior art has the following disadvantages: 1. scutellarin, ginkgolide B, ginsenoside Rg1, and ginsenoside Rb1 are used alone, which cannot effectively combat ischemic cerebrovascular diseases with multiple mechanisms and multiple targets, so the curative effect is not good. Good; ②The purity of the drug ingredients is not high, and it cannot be made into a preparation with a clear chemical composition, especially an injection with a clear chemical composition and high purity, and the product quality and safety cannot be guaranteed; ③Although there are compound prescriptions containing the above ingredients Preparations, but for oral administration, and the oral bioavailability of scutellarin, ginkgolide B, ginsenoside Rg1, and ginsenoside Rb1 is very low, and the drug effect cannot be fully exerted quickly

Method used

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  • Dengyin naotong pharmaceutical composition and preparation method thereof, preparation and application thereof
  • Dengyin naotong pharmaceutical composition and preparation method thereof, preparation and application thereof
  • Dengyin naotong pharmaceutical composition and preparation method thereof, preparation and application thereof

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preparation example Construction

[0035] The preparation method of the Dengyinnaotong pharmaceutical composition of the present invention includes the steps of pretreatment, preparation and posttreatment, specifically including:

[0036] A. Pre-processing:

[0037] 1) Add a co-solvent with a mass volume ratio of 1:10~100 to the ginkgolide B in the formula ratio to dissolve to obtain a solution a;

[0038] 2) Dissolve the ginkgolide B weight ratio of ginkgolide B in the solubilizer with a weight ratio of 1:30~200 into water with a mass volume ratio of the solubilizer of 1:2~5 to obtain solution b;

[0039] 3) Add solution a dropwise to solution b, and stir at 20-80°C for 1-6 hours until no co-solvent remains to obtain solution c;

[0040] 4) Dissolve the scutellarin molar ratio of 1:0.95~1.05 in the base with alkali mass volume ratio of 1:50~500 to dissolve the solution d, then add the scutellarin in the formula ratio In solution d, adjust the pH value to 6.5~7.2 to obtain solution e;

[0041] B. Preparation...

Embodiment 1

[0061] Example 1—Preparation of freeze-dried powder injection of Dengyinnaotong pharmaceutical composition of the present invention

[0062] Prescription composition:

[0063] Scutellarin 23g

[0064] Ginkgolide B6g

[0065] Ginsenoside Rg126g

[0066] Ginsenoside Rb145g

[0067] Hydroxypropyl Beta Cyclodextrin 480g

[0068] Meglumine 10g

[0069] Water for injection 2000ml appropriate amount (finally removed)

[0070] Preparation method: Dissolve the prescription amount of ginkgolide B with 20 times (mass / volume ratio, mg / ml) acetone, and slowly add the solution to 30% (mass / volume ratio, mg / ml) prescription amount of hydroxyl Propyl β-cyclodextrin aqueous solution, and stirred at 60°C for 6 hours until no co-solvent remained. Dissolve the prescribed amount of scutellarin with the prescribed amount of meglumine plus an appropriate amount of aqueous solution until the pH of the solution is 6.8 for use. Mix the scutellarin solution with the ginkgolide solution, then wei...

Embodiment 2

[0071] Example 2—Preparation of freeze-dried powder injection of Dengyinnaotong pharmaceutical composition of the present invention

[0072] Prescription composition:

[0073] Scutellarin 10g

[0074] Ginkgolide B5g

[0075] Ginsenoside Rg155g

[0076] Ginsenoside Rb130g

[0077] Hydroxypropyl Beta Cyclodextrin 420g

[0078] Meglumine 4g

[0079] Cysteine ​​Hydrochloride 1g

[0080] Water for injection 2000ml appropriate amount (finally removed)

[0081] Preparation method: dissolve the prescribed amount of ginkgolide B with 20 times (mass / volume ratio, mg / ml) ethyl acetate, and slowly add the solution to 30% (mass / volume ratio, mg / ml) of the prescribed amount Hydroxypropyl β-cyclodextrin aqueous solution, and stirred at 40°C for 6 hours until no co-solvent remained. Dissolve the prescribed amount of scutellarin with the prescribed amount of meglumine plus an appropriate amount of aqueous solution until the pH of the solution is 7.2 for use. Mix the scutellarin soluti...

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Abstract

The invention discloses a Dengyin naotong pharmaceutical composition and a preparation method thereof, a preparation and an application thereof. The Dengyin naotong pharmaceutical composition is composed of 2-60 parts of scutellarin, 1-20 parts of ginkgolide B, 5-80 parts of ginsenoside Rg1, and 5-80 parts of ginsenoside Rb1 in parts by mass. The preparation method comprises the steps of pretreatment, preparation and post-treatment. The preparation is a freeze-drying powder injection prepared by adding a pharmaceutically acceptable auxiliary material in the Dengyin naotong pharmaceutical composition. The invention also provides the application of the Dengyin naotong pharmaceutical composition in preparation of medicines for preventing / treating ischemic cardio cerebrovascular disease. The Dengyin naotong pharmaceutical composition has strong drug effect and can effectively mitigate pathology change, cognition and behavior obstacle of ischemic cerebrovascular disease; security is good, the adverse reaction due to an impure compound cannot be generated when the Dengyin naotong pharmaceutical composition is used in a prescribed dosage scope; quality controllability is good, batch-to-batch difference of the traditional Chinese medicine injections can be effectively avoided; stability is good, and the Dengyin naotong pharmaceutical composition can be used for preparing the preparations comprising an injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a Dengyinnaotong pharmaceutical composition and a preparation method, preparation and application thereof. Background technique [0002] Ischemic cerebrovascular disease is one of the most important diseases causing death and disability in modern society. In China, due to the gene of hyperhomocysteinemia, it has become a high incidence area of ​​ischemic cerebrovascular disease. Ischemic cerebrovascular disease is a series of diseases such as abnormal biochemical metabolism, loss of physiological functions, and softening of morphological changes in cases caused by ischemia in the corresponding area of ​​the brain tissue caused by brain blood supply disorders, and brain tissue damage caused by hypoxia. A disease with multi-level and multi-faceted damage to brain tissue. Among them, cerebral infarction caused by cerebral ischemia, vascular dementia, and cerebral repe...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K9/19A61P9/10A61K31/704A61K31/365
Inventor 张伟李之恒尚建华刘一丹杨旭娟
Owner KPC PHARM INC
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