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Monoglucoside injection of cycloastragenol and preparation method and application of injection

A technology of monoglucoside and cycloastragenol, which is applied in the field of pharmaceutical preparations, can solve the problems of unsatisfactory pharmacology and toxicology, inability to administer medicines, and difficulty in achieving injection administration, so as to reduce vascular irritation and potential toxicity, and facilitate clinical use The effect of using

Inactive Publication Date: 2012-09-05
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the water injection is clinically administered by intravenous infusion, it needs to be diluted with water for injection, sodium chloride or glucose infusion before administration. Limitation, when it is diluted with an appropriate solvent for clinical use, the solution will be cloudy and unable to be administered, and it is difficult to meet the requirements of injection administration;
[0006] (2) In the examples 63-69 of this patent, the concentration of the monoglucoside of cycloastragenol is all less than 2mg / ml, which cannot meet the requirements of pharmacological and toxicological evaluation. In the examples 70-73, although the concentration of cycloastragenol The concentration of monoglucoside has reached 2mg / ml, but when diluted with water for injection, sodium chloride injection or glucose injection, it must be diluted more than 10 times to ensure the stability of the diluted drug solution

Method used

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  • Monoglucoside injection of cycloastragenol and preparation method and application of injection
  • Monoglucoside injection of cycloastragenol and preparation method and application of injection
  • Monoglucoside injection of cycloastragenol and preparation method and application of injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: The monoglucoside injection of the cycloastragenol of 2.0mg / ml without solubilizing agent Prescription Screening

[0043] When the monoglucoside concentration of table 1 cycloastragenol is 2.0mg / ml, the non-aqueous solvent ratio screening table without solubilizer

[0044]

[0045] A 2.0 mg / ml cycloastragenol monoglucoside solution was prepared according to the ratio of non-aqueous solvents in Table 1, and the physical stability under refrigeration was tested. The results show that when ethanol and PEG400 are selected as the non-aqueous solvent at the same time, the physical stability of the liquid medicine under refrigerated conditions can be guaranteed only when the amount of ethanol and PEG 400 are also 25%. During the solvent, the physical stability of the medicinal solution under refrigerated conditions can be guaranteed only when the ethanol consumption is 20%, and the propylene glycol consumption is also 20%.

Embodiment 2

[0046] Embodiment 2: Treatment of monoglucoside injection of cycloastragenol containing 2.0 mg / ml of solubilizing agent party screening

[0047] When the monoglucoside concentration of table 2 cycloastragenol is 2.0mg / ml, the non-aqueous solvent containing solubilizing agent and the ratio screening table of solubilizing agent

[0048]

[0049] According to the ratio of non-aqueous solvent and solubilizer in Table 2, a 2.0 mg / ml cycloastragenol monoglucoside solution was prepared, and the physical stability test under refrigerated conditions was carried out. The results show that when ethanol and Tween80 are selected, the amount of ethanol is 5%, the amount of Tween80 is 1.5%, or the amount of ethanol is 10%, and the amount of Tween80 is 1.0%, which can ensure the physical stability of the liquid medicine under refrigerated conditions; When propylene glycol and Tween80 are used, the consumption of propylene glycol is 10%, and the consumption of Tween80 is 1.5%, or the co...

Embodiment 3

[0051] Embodiment 3: the monoglucoside injection of the cycloastragenol of 5.0mg / ml without solubilizing agent Prescription Screening

[0052] When the monoglucoside concentration of table 3 cycloastragenol is 5.0mg / ml, the non-aqueous solvent ratio screening table without solubilizer

[0053]

[0054] According to the ratio of non-aqueous solvents in Table 3, a 5.0 mg / ml cycloastragenol monoglucoside solution was prepared, and the physical stability test under refrigerated conditions was carried out. The results show that when the amount of ethanol is 25%, and the amount of propylene glycol is also 25%, the physical stability of the medicinal solution under refrigerated conditions can be guaranteed.

[0055] Prepare a 5.0 mg / ml cycloastragenol monoglucoside solution according to the ratio of 25% ethanol and 25% propylene glycol. When diluted with 5% glucose injection, when the dilution factor is below 5 times, crystals will precipitate within 10 minutes ; When the dil...

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Abstract

The invention provides monoglucoside injection of cycloastragenol and a preparation method and application of the injection. The injection consists of monoglucoside of the cycloastragenol, non-aqueous solvent, solubilizer and water for injection. According to the injection, the solubilizer and the non-aqueous solvent are utilized to perform combined solubilization on the single glucoside of the cycloastragenol; and compared with the single solubilization of the non-aqueous solvent, the combined solubilization can be used for reducing the dosage of the non-aqueous solvent, relieving the stimulus of the non-aqueous solvent on a patient, and effectively avoiding the medicine precipitation in a medicine diluting process.

Description

technical field [0001] The invention relates to a monoglucoside injection preparation of cycloastragenol, in particular to a monoglucoside injection of cycloastragenol, its preparation method and application, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] The monoglucoside of cycloastragenol, the chemical name is cycloastragenol-6-O-β-D-glucopyranoside monohydrate, which is separated by macroporous adsorption resin after the astragaloside IV liquid is hydrolyzed by hydrolase 1. The product obtained by purification has obvious characteristics of treating cardiovascular diseases. [0003] At present, only one invention patent discloses the pharmaceutical composition of monoglucoside aqueous injection of cycloastragenol (application number: CN200810004380.0), and the patent name of the invention is "Monoglucoside of cycloastragenol, its preparation method, and drug combination Substances and Applications”, the article mentions ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/704A61K47/34A61K47/44A61P9/04
Inventor 王杏林尹东东赵专友田义红韩英梅司端运
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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