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Preparation method of stable dezocine injection

A technology of xin injection and dezocine, which is applied in the field of pharmaceutical preparations and can solve problems such as the difference in production amount

Inactive Publication Date: 2017-06-23
TIANJIN TAIPU PHARMA SCI & TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, propylene glycol is used as a stabilizer. During the high-temperature sterilization process, we found that there is also a new impurity B formed behind the main peak. There are differences in the amount of impurity B produced by different manufacturers of propylene glycol.

Method used

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  • Preparation method of stable dezocine injection
  • Preparation method of stable dezocine injection
  • Preparation method of stable dezocine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Prescription (1000 sticks)

[0042] Dezocine 5g

[0043] Lactic acid 7.3g

[0044] Add water for injection to 1000ml

[0045] pH 4.0

[0046] Preparation method: Add lactic acid to water for injection (temperature 50°C) with 70% of the prescription amount, saturate with nitrogen, and stir evenly. Add API and stir until completely dissolved. Adjust pH to 4.0 with 1mol / L sodium hydroxide solution, add water for injection to 1000ml; add 0.05% medicinal charcoal, supplement nitrogen, stir for 15 minutes, keep the temperature at 50 °C for about 30 minutes, and sterilize by coarse filtration Filtration, the obtained liquid is potted (with nitrogen gas, 1ml / piece), melted and sealed, and the finished product is obtained. After potting, the sample is put into a sterilization cabinet. Light inspection, labeling and packaging to get the finished product.

Embodiment 2

[0048] Prescription (1000 sticks)

[0049] Dezocine 5g

[0050] Lactic acid 2.5g

[0051] Add water for injection to 1000ml

[0052] pH 4.0

[0053] Preparation method: Add lactic acid to water for injection (temperature 40°C) with 70% of the prescription amount, saturate with nitrogen, and stir evenly. Add API and stir until completely dissolved. Adjust pH to 4.0 with 1mol / L sodium hydroxide solution, add water for injection to 1000ml; add 0.2% medicinal charcoal, supplement nitrogen, stir for 15 minutes, keep the temperature at 35~50°C for about 30 minutes, pass through coarse filtration, After sterilization and filtration, the obtained liquid is potted (with nitrogen gas, 1ml / piece), melted and sealed, and the finished product is obtained. After potting, the sample is put into a sterilization cabinet. Light inspection, labeling and packaging to get the finished product.

Embodiment 3

[0055] Prescription (1000 sticks)

[0056] Dezocine 5g

[0057] Lactic acid 25g

[0058] Add water for injection to 1000ml

[0059] pH 4.0

[0060]Preparation method: Add lactic acid to 70% water for injection (temperature 45°C) of the prescription, saturate with nitrogen, and stir evenly. Add raw material drug and stir until completely dissolved. Use 1mol / L sodium hydroxide solution to adjust the pH to 4.0, add water for injection to 1000ml; add 0.05% medicinal charcoal, supplement nitrogen, stir for 15 minutes, keep the temperature at 45°C for about 30 minutes, and then pass coarse filtration to sterilize After filtering, the obtained medicinal solution is potted (nitrogen gas, 1ml / bottle), melted and sealed, and finally the finished product is obtained. After the potting is completed, the sample is put into a sterilizing cabinet, and the sterilization condition is: 121°C for 15 minutes. Light inspection, labeling and packaging to get the finished product.

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Abstract

The invention provides a preparation method of dezocine injection. The preparation method comprises the following steps: selecting water for injection as the solvent, adding with lactic acid, carrying out stirring for dissolving, and carrying out heating till the temperature is 35-50 DEG C; adding with the medicine, namely, dezocine, and carrying out stirring for clarification; adjusting the pH by adopting sodium hydroxide; and enabling the obtained solution to pass through carbon, carrying out filling, and carrying out high-temperature sterilization, thus obtaining the dezocine injection. For the dezocine injection prepared by adopting the method provided by the invention, the related substance of the medicine is not increased during the preparation process of the injection, meanwhile, three auxiliary materials, namely, sodium pyrosulfite, propylene glycol and sodium chloride are correspondingly reduced, and thus the stability of the injection is further enhanced; moreover, the variety of the used auxiliary materials is reduced, so that the risks generated due to the side effects of clinical medication are reduced, and the preparation method is suitable for the large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, relates to the preparation of dezocine injections, and more particularly relates to a preparation method of stable dezocine injections. Background technique [0002] Dezocine is a powerful opioid analgesic, a κ receptor agonist and a μ receptor antagonist. It has the characteristics of strong analgesic effect, small addiction, and rapid absorption by subcutaneous and intramuscular injection. It is now widely used in the treatment of postoperative pain, visceral and cancer pain. [0003] The drug was originally developed by Wyeth Laboratories INc., and applied for the preparation patent of this variety in 1985 (British patent GB2165149); it was listed in China in 2008. The research and development unit is Tianjin Pharmaceutical Research Institute, and the production unit is Yangzijiang Pharmaceutical Group Co., Ltd. [0004] The specifications of dezocine injections listed in...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/135A61K47/12A61P25/04
CPCA61K9/08A61K9/0019A61K31/135A61K47/12
Inventor 周世旺代奕韩建萍许莉莉张克星赵健
Owner TIANJIN TAIPU PHARMA SCI & TECH DEV
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