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Rifampicin freeze-dried powder needle for injection and production method thereof

A technology for freeze-dried powder injection and production method, applied in the field of medicine, can solve the problems of uncontrolled alkali addition speed, high overall energy consumption, potential safety hazards, etc., and achieve the effects of being beneficial to stability, high freeze-drying efficiency, and ensuring safety.

Active Publication Date: 2022-01-11
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since rifampicin is almost insoluble in water, its solubility will increase significantly under alkaline conditions, but it is easily oxidized into corresponding quinone derivatives. This patent does not control the speed of adding alkali, and uses activated carbon to control endotoxin. At present, Activated carbon is not recommended to be used in injections, and there is a risk of introducing other safety hazards; it is sublimated and dried at -15°C, the temperature is low, the cycle is long, and the overall energy consumption is high

Method used

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  • Rifampicin freeze-dried powder needle for injection and production method thereof
  • Rifampicin freeze-dried powder needle for injection and production method thereof
  • Rifampicin freeze-dried powder needle for injection and production method thereof

Examples

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Effect test

Embodiment 1

[0050] A rifampicin freeze-dried powder for injection, made of sodium formaldehyde sulfoxylate, rifampicin, sodium hydroxide and water for injection at a temperature of 10°C, sterilizing and filtering, filling and freeze-drying After that, the finished product is obtained, wherein, in the preparation process of the medicinal liquid, its pH value is adjusted to 8.4 with a pH regulator, and every 1000 parts of the medicinal liquid contains the following components by weight: the active raw material rifampicin 120 parts, 2 parts of sodium formaldehyde sulfoxylate, 4.3 parts of sodium hydroxide.

[0051] The detailed preparation process is as follows:

[0052] (1) Add a total of 80% of water for injection at 10°C in the liquid preparation tank, start stirring, and under the condition of maintaining the temperature at 10°C, add 2 parts of sodium formaldehyde sulfoxylate per 1000 parts of the liquid medicine, dissolve After complete, slowly add 120 parts of rifampicin, stir to disp...

Embodiment 2

[0065] A rifampicin freeze-dried powder for injection, made of sodium formaldehyde sulfoxylate, rifampicin, sodium hydroxide and water for injection at a temperature of 20°C, sterilizing and filtering, filling and freeze-drying After that, the finished product is obtained, wherein, in the preparation process of the medicinal liquid, its pH value is adjusted to 8.4 with a pH regulator, and every 1000 parts of the medicinal liquid contains the following components by weight: the active raw material rifampicin 120 parts, 2 parts of sodium formaldehyde sulfoxylate, 4.3 parts of sodium hydroxide.

[0066] The detailed preparation process is as follows:

[0067] (1) Add a total of 80% of water for injection at 20°C in the liquid preparation tank, start stirring, and under the condition of maintaining the temperature at 20°C, add 2 parts of sodium formaldehyde sulfoxylate per 1000 parts of the liquid medicine, dissolve After complete, slowly add 120 parts of rifampicin, stir to disp...

Embodiment 3

[0080] A rifampicin freeze-dried powder for injection, made of sodium formaldehyde sulfoxylate, rifampicin, sodium hydroxide and water for injection at a temperature of 10°C, sterilizing and filtering, filling and freeze-drying After that, the finished product is obtained, wherein, in the preparation process of the medicinal liquid, its pH value is adjusted to 8.6 with a pH regulator, and every 1000 parts of the medicinal liquid contains the following components by weight: the active raw material rifampicin 120 parts, 2 parts of sodium formaldehyde sulfoxylate, 5.0 parts of sodium hydroxide.

[0081] The detailed preparation process is as follows:

[0082] (1) Add a total of 80% of water for injection at 10°C in the liquid preparation tank, start stirring, and under the condition of maintaining the temperature at 10°C, add 2 parts of sodium formaldehyde sulfoxylate per 1000 parts of the liquid medicine, dissolve After complete, slowly add 120 parts of rifampicin, stir to disp...

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Abstract

The invention relates to a rifampicin freeze-dried powder needle for injection and a preparation method thereof. The preparation method comprises the following steps of adding antioxidant sodium formaldehyde sulfoxylate into water for injection at 5 DEG C-25 DEG C; adding raw material medicine rifampicin after complete dissolution; then controlling the feeding speed of pH regulator sodium hydroxide to maintain the pH value of an obtained mixed solution to be 8.0-8.6; preparing a liquid medicine; performing degerming, filtering and filling; and performing freeze-drying to obtain a finished product. According to the method, no excipient is adopted, the dosage of auxiliary materials is reduced, and in a liquid preparation process, the adding sequence of the raw materials and the auxiliary materials is strictly controlled, the adding amount and the adding speed of the pH regulator are precisely controlled, and the pH value of the liquid medicine is closely monitored, such that the solubility of the raw material medicine is improved; and by adopting of the freeze-drying process, the freeze-drying efficiency is high, and in a specific freeze-drying process, the temperature rising speed and the vacuum degree are strictly controlled, such that it is guaranteed that the liquid medicine is uniformly frozen, the impurity content in the liquid medicine is reduced, the moisture content of the freeze-dried product is low, and the stability of the product is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a rifampicin freeze-dried powder for injection and a production method thereof. Background technique [0002] Rifampicin is a semi-synthetic antibiotic obtained from rifamycin B. It belongs to the macrocyclic lactam antibiotics and can inhibit bacterial DNA transcription and synthesis of RNA. It is clinically used to treat tuberculosis or other tuberculosis. Rifampicin for injection is used as a substitute for oral rifampin preparations when oral treatment cannot be tolerated, and is used in combination with other anti-tuberculosis drugs to treat various types of tuberculosis, including newly diagnosed, advanced, chronic and drug-resistant cases . Rifampicin for injection was launched in the United States in 1989 under the trade name . [0003] Chinese patent CN103976959A provides a rifampicin freeze-dried powder injection and its preparation process. Sodium thio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/495A61K47/02A61K47/20A61P11/00A61P31/06
CPCA61K31/495A61K9/19A61K9/0019A61K47/20A61K47/02A61P31/06A61P11/00Y02A50/30
Inventor 石文晶张佳王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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