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Potassium dehydroandrographolide succinate injection and preparation method

A technology for Chuanhuning and water for injection, which is applied in the field of medicine, can solve the problems of easy hydrolysis of aqueous solutions, decreased content, and deepening of product color and luster.

Active Publication Date: 2013-10-02
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is believed that there are bridge-shaped conjugated structures, α and β-unsaturated lactone bonds in the molecular structure of Chuanhuning drug, and its aqueous solution is prone to hydrolysis, resulting in darker color and lower content of the product
Common chemical stability is manifested by the increase of impurities and / or the decrease of content, such as Fu Chunmei et al. Research, Journal of Pharmaceutical Analysis, 2005, 25(2): 157) reported: "Injection stability investigation found that the peak area of ​​related substances increased significantly, and the content decreased, and the content of many commercially available products was only the labeled amount after half a year About 80%, and the increase of related substances does not match the decrease of content, indicating that the inspection of related substances did not fully reflect the decomposition products of the sample...It is recommended that the production unit improve the production process of injection or make powder injection to improve its stability

Method used

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  • Potassium dehydroandrographolide succinate injection and preparation method
  • Potassium dehydroandrographolide succinate injection and preparation method
  • Potassium dehydroandrographolide succinate injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0086] Preparation Example 1, Preparation of Injection Containing Chuanhuning

[0087] formula:

[0088] Compound of formula I

100mg,

sodium bicarbonate

15 mg,

L-cysteine

5 mg,

Hydroxypropyl-β-cyclodextrin

300mg,

Water for Injection

Appropriate amount, add to 5ml.

[0089] Preparation:

[0090] (a) Dissolving alkali metal salts, cysteine ​​or its pharmaceutically acceptable salts, and cyclodextrin in about 85% of the prescribed amount of water for injection;

[0091] (b) Add Chuanhuning to the above solution, stir to dissolve;

[0092](c) Add about 0.3% activated carbon to the solution, stir and adsorb for 30 minutes, filter and decarbonize;

[0093] (d) Add water for injection to the full amount, check the pH value of the solution, and adjust the pH value of the solution to 7.3 with an acid-base regulator if necessary; filter the medicinal solution with 0.4 μm and 0.22 μm microporous membranes, and divide t...

preparation example

[0096] Supplementary preparation example 1: In different prescriptions, except that the amount of sodium bicarbonate is changed to the consumption listed in the second row (mg row) of the following table, other elements in the prescription and the preparation process are all the same as the above-mentioned preparation example 1. Line 1 (No. line) in the table is the obtained injection sample number, the complete number of No. 01 is Eb1-01, which means supplementing No. 01 injection obtained in Preparation Example 1, and the complete number of No. 02 is Eb1-02. similar meaning.

[0097] No.

01

02

03

04

05

06

mg

5

9

12

17

20

25

[0098] Investigate the above samples of Ex1-01 and Eb1-01 to Eb1-06:

[0099] Appearance: Colorless clear liquid.

[0100] Carry out the stability test and test of high temperature treatment according to the above "A, test method example part" method, the result:

[0101] Conten...

preparation example 2

[0105] Supplementary preparation example 2: In different formulations, except that the amount of cysteine ​​is changed to the amount listed in the second row (mg row) of the following table, other elements and preparation processes in the prescription are the same as the above-mentioned preparation example 1. Line 1 (No. line) in the table is the obtained injection sample number, the complete number of No. 01 is Eb2-01, which means supplementing No. 01 injection obtained in Preparation Example 2, and the complete number of No. 02 is Eb2-02. similar meaning.

[0106] No.

01

02

03

04

05

06

mg

0

1

3

7

10

15

[0107] Investigate the above samples from Eb2-01 to Eb2-06:

[0108] Appearance: Colorless clear liquid.

[0109] Carry out the stability test and test of high temperature treatment according to the above "A, test method example part" method, the result:

[0110] Content residual percentage (%): The ...

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PUM

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Abstract

The invention relates to potassium dehydroandrographolide succinate injection and a preparation method, in particular to a pharmaceutical composition which comprises potassium dehydroandrographolide succinate, alkali metal salt and water for injection. The preparation method of the pharmaceutical composition comprises steps as follows: auxiliary materials such as the alkali metal salt and the like are dissolved in an appropriate amount of the water for injection, the potassium dehydroandrographolide succinate is added to the solution and stirred to be dissolved, about 0.1%-0.5% of activated carbon is added to the solution and stirred for absorption for 30 minutes, and filtration is performed to remove carbon; the water for injection is refilled to a full dose, a pH value of the solution is checked, and if necessary, an acidifying or alkalizing agent is used for adjusting the pH value of the solution to be in the range from 6.5 to 8.0; 0.4 mu m and 0.22 mu m millipore filtering films are used for filtering a liquid medicine, the liquid medicine is split and filled in glass bottles, then sealed and autoclaved at the temperature of 115 DEG C for 30 minutes, and the potassium dehydroandrographolide succinate injection is obtained. The prepared potassium dehydroandrographolide succinate injection has a good pharmaceutical property.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicament for treating viral pneumonia and viral upper respiratory tract infection, in particular to a Chuanhuning preparation, in particular to a stable Chuanhuning injection and the preparation of the injection method. Background technique [0002] Chuanhuning, chemical name: 14-dehydroxyl 11,12-didehydroandrographolide-3,19-disuccinic acid half ester monopotassium salt, English name: Potassium Dehydroandrograpolide Succinate; molecular formula: C28H35KO10, molecular weight: 570.68, its molecular formula Following formula I (it also can be referred to as formula I compound in the present invention): [0003] [0004] The existing clinically used Chuanhuning preparations include freeze-dried powder injections, small-volume water injections and large-volume infusions. Due to the stability of Chuanhuning, there are usually problems, so the classic powder injections are still...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/40A61K31/365A61P11/00A61P31/12
Inventor 赵东明贾红军谷娟潘旭张林董国明
Owner CHENGDU TIANTAISHAN PHARMA
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