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Dezocine freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and dezocine, which is applied in the field of pharmaceuticals, can solve the problems of increased burden on preparation quality control and clinical use risks, and achieve the effect of reducing additional risks and avoiding potential safety hazards

Inactive Publication Date: 2014-12-24
NANJING YOKO PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The addition of these excipients and the increase of related substances will increase the burden on the quality control of preparations and bring risks to clinical use

Method used

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  • Dezocine freeze-dried powder injection and preparation method thereof
  • Dezocine freeze-dried powder injection and preparation method thereof
  • Dezocine freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prepare 1000 tubes of 2 mL dezocine for injection. The prescription is: 5 g of dezocine, 0.5 g of edetate disodium, 15.0 g of sodium chloride, 10.0 g of hydrochloric acid, sodium carbonate to adjust the pH value to 3.0-6.0, and add water for injection to 2000 mL .

[0037] The preparation method is as follows: 1) After mixing water for injection and hydrochloric acid, adding prescribed amount of dezocine to make it dissolve. 2) Add other excipients to dissolve according to the prescription, adjust the appropriate pH value to 3.0-6.0 with sodium carbonate, add charcoal for adsorption, filter to remove charcoal and sterilize. 3) Under aseptic operation, subpackage and freeze-dry.

Embodiment 2

[0039] Prepare 1000 vials of 5 mL dezocine for injection. The prescription is: 10 g of dezocine, 480 g of glycine, 2 g of calcium sodium edetate, 60 g of lactic acid, sodium hydroxide to adjust the pH to 3.0-6.0, and water for injection to 5000 mL.

[0040] Preparation method: 1) Weigh water for injection and mix with lactic acid, add dezocine to dissolve it. 2) According to the prescription, add other excipients to dissolve, adjust the pH value to 3.0-6.0 with sodium hydroxide solution, add charcoal for adsorption, and filter to remove charcoal and bacteria. 3) Under aseptic operation, subpackage and freeze-dry.

Embodiment 3

[0042] Prepare 1000 vials of 2 mL dezocine for injection. The prescription is: 5 g of dezocine, 10 g of citric acid, sodium hydroxide, appropriate amount to adjust the pH to 3.0-6.0, 0.2 g of sodium ascorbate, 100 g of mannitol, and water for injection to 2000 mL.

[0043] Preparation method: 1) After dissolving in water for injection and citric acid, weigh the prescribed amount of dezocine to dissolve it. 2) Add other excipients to dissolve according to the prescription, adjust the pH to 3.0-6.0 with appropriate amount of sodium hydroxide, add charcoal for adsorption, filter to remove charcoal and sterilize. 3) Under aseptic operation, subpackage and freeze-dry.

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Abstract

The invention discloses dezocine freeze-dried powder injection. The dezocine freeze-dried powder injection consists of the following components by dosage: 0.5-50mg of dezocine / per injection, 1-25% of a freeze-dried excipient and 0.5-50mg of an antioxidant / per injection, wherein the pH value of the freeze-dried solution is regulated to 3.0-6.0 by use of a pH regulator. Compared with the commercially available preparation, the dezocine freeze-dried powder injection has the advantage that the auxiliary material components are not added with sodium pyrosulfite which is taken as the antioxidant, and the sulfate possibly causes fateful anaphylactic reaction and severe asthma for a susceptible person, so that certain potential safety hazards caused by the sulfate are avoided. The commercially available preparation is added with 30% of propylene glycol as an anti-freezing agent, and made into freeze-dried powder injection in which a special solvent is not needed for separation under a low temperature condition. In a preparation process of the dezocine injection, high-temperature sterilization is needed, and associated substances in the sterilization process are suddenly increased. Compared with the injection, the dezocine freeze-dried powder injection contains less associated substances without being sterilized at the high temperature; and meanwhile, the injection solids are easier to store than the liquid, so that the increase of the associated substances is less, and thus, additional risks are reduced for clinical application.

Description

technical field [0001] The invention relates to the field of pharmaceutical technology, in particular to a dezocine freeze-dried powder injection and a preparation method thereof. Background technique [0002] Pain is an unpleasant sensory experience and emotional experience, usually a special manifestation when various tissue damages occur or cause or even continue tissue damage. At present, pain has become the fifth vital sign following the four vital signs of body temperature, pulse, respiration, and blood pressure. Eliminating pain is a basic human right. Pain classification Grade I (mild): pain but tolerable, normal life, no disturbance in sleep. Grade II (moderate): the pain is obvious and unbearable, and analgesics are required to be taken, and sleep is disturbed. Grade III (severe): The pain is severe and unbearable, requiring analgesic drugs, and the sleep is severely disturbed, which may be accompanied by autonomic disturbance or passive posture. The reason why ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/135A61K47/10A61P25/04
Inventor 葛育红张岩武朋朋
Owner NANJING YOKO PHARMA GRP CO LTD
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