Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same

A technology of Shenmai injection and composition, applied in the field of medicine, can solve the problems of pH value drop of solution, easy rancidity of polysorbate 80, accelerated pH value of liquid medicine, etc. The effect of improving safety

Active Publication Date: 2009-09-02
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the traditional Chinese medicine injection itself still has the problem that the pH value of the solution drops significantly during the sterilization and storage process, and polysorbate 80 (Tween 80) is prone to rancidity, which accelerates the drop of the pH value of the liquid medicine.

Method used

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  • Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same
  • Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same
  • Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Red Ginseng 1000g

[0016] Ophiopogon japonicus 1000g

[0017] Solutol 20g

[0018] Extracts of red ginseng and Ophiopogon japonicus after extraction and refining process, adding polyethylene glycol (PEG) lauryl hydroxystearate (Solutol ) as cosolvent and water for injection to be prepared into 10000ml solution. Adjust the pH of the solution to 6.0-8.5. The above solution was filtered through a microporous membrane. Filling, sterilization, that is.

Embodiment 2

[0020] Red Ginseng 1000g

[0021] Ophiopogon japonicus 1000g

[0022] Solutol 10g

[0023] Polysorbate 80 (Tween 80) 10g

[0024] Red ginseng and Ophiopogon japonicus extract after extraction and refining process, adding polyethylene glycol (PEG) lauryl hydroxystearate (Solutol HS-15 ) and polysorbate 80 (Tween 80) as cosolvent and water for injection are prepared into 10000ml solution. Adjust the pH of the solution to 6.0-8.5. The above solution was filtered through a microporous membrane. Filling, sterilization, that is.

Embodiment 3

[0026] Red Ginseng 1000g

[0027] Ophiopogon japonicus 1000g

[0028] Solutol 20g

[0029] Red ginseng and Ophiopogon japonicus extract after extraction and refining process, adding polyethylene glycol (PEG) lauryl hydroxystearate (Solutol HS-15 ) as co-solvent and water for injection to prepare a solution. Adjust the pH value of the solution to 6.0-8.5. The above solution was filtered through a microporous membrane. Subpackaged, freeze-dried, that is.

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Abstract

The invention discloses a pharmaceutical composition for improving the safety of Shenmai injection and a method for preparing the same. The pharmaceutical composition is a pharmaceutical composition for injection and is mainly prepared from red ginseng extract, dwarf lilyturf root extract and polyethylene glycol 12-hydroxy stearic acid ester. The pharmaceutical composition adopts a latent solvent with better safety and more obvious hydrotropy to replace the latent solvent polysorbate-80 which has potential safety hazard and influences the product quality, thus the reduction of the pH value of the Shenmai injection in the processes of storing and high temperature sterilization is obviously delayed, and the stability of the pharmaceutical composition is increased; besides, the safety of the polyethylene glycol 12-hydroxy stearic acid ester is higher than that of the polysorbate-80 and the dosage thereof is lower, thus the probability and the risk of untoward reactions of the pharmaceutical composition is reduced, and the safety for clinical application is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for improving the safety of Shenmai injection and a preparation method thereof Background technique [0002] The standards of Shenmai injection are recorded in the drug standards issued by the Ministry of Health (Chinese medicine prescription preparations), and the raw materials are red ginseng and Ophiopogon japonicus, which belong to Chinese medicine injections. It has the effects of replenishing qi and solidifying, nourishing yin and promoting body fluid, and promoting pulse. It is clinically used to treat shock, coronary heart disease, viral myocarditis, chronic pulmonary heart disease, and neutropenia of Qi and Yin deficiency. It can improve the immune function of tumor patients. When used in combination with chemotherapy drugs, it has a certain synergistic effect and can reduce the toxic and side effects caused by chemotherapy drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/08A61K9/19A61K47/34A61P9/10A61P9/02A61P9/00A61P11/00A61P7/00A61K47/14A61K47/26
Inventor 郭成辉毛长兴陈开军
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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