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A kind of preparation technology of Chuanhuning for injection

A preparation process and technology for injection, applied in the field of medicine, can solve the problems of many impurities, long production cycle, complex process, etc., and achieve the effect of safe and reliable quality, low production cost and strong operability

Active Publication Date: 2021-09-21
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chuanhuning for injection prepared by this patent also has problems such as high content of impurities and yellowish color.
[0007] Although the patents that have been applied in China can only adapt to the previous impurity content standards, the single impurity does not exceed 2%, and the total impurity does not exceed 4%, which cannot meet the national requirements for impurities in 2018. % standard
The products produced have too many impurities, and also have the disadvantages of long production cycle, many control variables, complex process, high energy consumption and high cost.

Method used

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  • A kind of preparation technology of Chuanhuning for injection
  • A kind of preparation technology of Chuanhuning for injection
  • A kind of preparation technology of Chuanhuning for injection

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preparation example Construction

[0028] The invention provides a preparation process of Chuanhuning for injection, comprising the following steps:

[0029] A) adjusting the pH of the aqueous solution of citric acid to 7.0 to 7.5 with a pH regulator to obtain a mixed solution;

[0030] B) After mixing and stirring part of the water for injection and the prescribed amount of Chuanhuning, then add sodium bicarbonate and cysteine ​​hydrochloride and heat and stir at 60-75°C, then add the mixed solution and adjust the pH to 7.0-7.5 , to obtain the precursor solution;

[0031] C) performing activated carbon adsorption, decarburization and constant volume on the precursor solution in sequence to obtain a raw material solution;

[0032] D) Freeze-drying the raw material solution to obtain Chuanhuning powder for injection.

[0033] In the present invention, firstly, the pH of citric acid is adjusted to 7.0-7.5 with an aqueous solution of a pH regulator to obtain a mixed solution. Wherein, in the present invention, ...

Embodiment 1

[0065] 1. The raw material formula (taking 200mg / bottle as an example) is shown in Table 5

[0066] Table 5 raw material formula table

[0067]

[0068]

[0069] 2. Preparation method:

[0070] ① Weigh the prescribed amount of citrate, dissolve it with an appropriate amount of water for injection, and then adjust the pH to 7.0 with 10% arginine solution to make solution 1 for later use.

[0071] ② Add 70% of the total volume of water for injection into the concentrated preparation tank, add the prescribed amount of Chuanhuning, and stir.

[0072] ③Add the prescribed amount of sodium bicarbonate and cysteine ​​hydrochloride, heat and stir, and keep the temperature at 65°C.

[0073] ④ Add solution 1 to the concentrated preparation tank, check the pH value, add 10% arginine solution, and adjust the pH value to 7.5.

[0074] ⑤ Add 0.1% (g / ml) activated carbon according to the total volume of the preparation, stir for 10 minutes, decarburize, and constant volume.

[0075]...

Embodiment 2

[0077] 1, the formula is the same as in Example 1

[0078] 2. Preparation method

[0079] ① Weigh the prescribed amount of citrate, dissolve it with an appropriate amount of water for injection, and then adjust the pH to 7.5 with 10% arginine solution to make solution 1 and set aside.

[0080] ② Add 60% of the total volume of water for injection into the concentrated preparation tank, add the prescribed amount of Chuanhuning, and stir.

[0081] ③Add the prescribed amount of sodium bicarbonate and cysteine ​​hydrochloride, heat and stir, and keep the temperature at 60°C.

[0082] ④ Add solution 1 to the concentrated preparation tank, check the pH value, add 10% arginine solution, and adjust the pH value to 7.0.

[0083] ⑤ Add 0.1% (g / ml) activated carbon according to the total volume of the preparation, stir for 20 minutes, decarburize, and constant volume.

[0084] ⑥The storage temperature of the filtrate is controlled at 10°C, and the filling is carried out within 6 hours ...

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Abstract

The invention provides a preparation process of Chuanhuning for injection, comprising the following steps: A) adjusting the pH of the aqueous solution of citric acid to 7.0-7.5 with a pH regulator to obtain a mixed solution; B) mixing part of the water for injection with the prescribed amount of Chuanhuning After stirring, add sodium bicarbonate and cysteine ​​hydrochloride and heat and stir at 60-75°C, then add the mixed solution, and adjust the pH to 7.0-7.5 with a pH regulator to obtain a precursor solution; C) The precursor solution is subjected to active carbon adsorption, decarburization and constant volume in sequence to obtain a raw material solution; D) freeze-drying the raw material solution to obtain Chuanhuning powder for injection. In the present invention, the freeze-dried powder injection of Chuanhuning prepared by controlling the temperature and pH value of water for injection, adding an appropriate amount of antioxidant, and combining the heat preservation temperature has strong operability, lower production cost, strong stability, It has outstanding features such as less impurities and more reliable quality and safety.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation process of Chuanhuning for injection. Background technique [0002] Chuanhuning for injection is a refined 14-decarboxylation-11,12-didehydrogenated product made from Andrographis paniculata (Burm.f.) Nees extract-andrographolide through esterification, dehydration and salt formation. Andrographolide-3,19-disuccinic acid half-ester monopotassium salt [monopotassi-umsaltofl4-deoxy1112dldehydroandrographode3,19disuccinate (DASK)]- made by adding pH regulator, sodium bicarbonate and other auxiliary agents and freeze-dried for intramuscular injection Sterile powder injection preparation for use. Chuanhuning for injection is an antiviral drug, the main ingredient is Chuanhuning, which is used for viral pneumonia and viral upper respiratory tract infection. This product has obvious anti-inflammatory, antipyretic, sedative and antiviral effects, and has inac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/365A61K47/02A61K47/12A61K47/18A61P25/20A61P29/00A61P31/14A61P31/16
CPCA61K9/0019A61K9/19A61K31/365A61K47/02A61K47/12A61K47/183A61P25/20A61P29/00A61P31/14A61P31/16
Inventor 刘伟强吴中华刘思川庞海河廖孝曙刘志军廖国栋黄松生寻中华葛自强薛文谋
Owner HUNAN KELUN PHARMA