Medicine combination including high-concentration polydatin

Abstract

The invention relates to a pharmaceutical composition containing high concentration of polydatin and process for preparation, wherein the composition comprises polydatin, meglumine and / or cyclodextrin, and other pharmaceutically acceptable auxiliary materials and carriers. The composition can be polydatin aqueous solution, or the lyophilized product prepared into aqueous solution before use. In the aqueous solution, the concentration of polydatin is not lower than 5mg / ml.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing high-concentration polydatin, in particular to a pharmaceutical composition containing a medicinal active ingredient polydatin and a cosolvent meglumine and / or cyclodextrin. Background technique [0002] Polydatin, namely 3,4’,5-trihydroxystilbene-3-β-D-glucoside (C 20 h 22 o 8 ) as a medicinal ingredient can be found in literature and patent reports. Basic pharmacology studies have shown that polydatin has pharmacological activities such as improving microcirculation, lowering blood fat, and anti-tumor. [0003] Chinese patent application CN 1709269A pointed out that: in the literature on the basic pharmacology of polydatin, in vivo test studies mostly use intravenous route to administer polydatin, and the test samples mostly use water or normal saline to prepare polydatin solution with a concentration of 2-5mg / ml, but The literature has no further explanation on the feasible preparat...

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Problems solved by technology

[0003] Chinese patent application CN 1709269A pointed out that: in the literature on the basic pharmacology of polydatin, in vivo test studies mostly use intravenous route to administer polydatin, and the test samples mostly use water or normal saline to prepare polydatin solution with a concentration of 2-5mg / ml, but The literature has no further explanation on the feasible preparation method of the solution; according to the literature calculation, the clinical effective dose of polydatin (adult) should be more than 112mg / time, and the concentration of polydatin in the clinical injection should not be low under the standard of 1-20ml conventional injection at 5.6 mg / ml; the solubility of polydatin in pure water or normal saline solution is limited, and its conventional aqueous solution is difficult to reach the drug concentration described in the literature: at room temperature, the saturation concentration of polydatin in water and normal saline is lower than 0.5 mg / ml, much lower than the above-mentioned 2~5mg / ml administration concentration

But the polydatin injection provided by this patent is a concentrated solution for injection, that is to say, the polydatin injection provided by this patent must be diluted to a certain extent with water for injection or normal saline before it can be used for injection administration. The reason is that , its injection is not suitable for direct injection because it contains a high concentration of organic solvents

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