Production process of cisatracurium besylate for injection for storage and transportation at 25°C

A technology for cisatracurium besylate and injection is applied in the field of cisatracurium besylate for injection and its preparation and freeze-drying production process, and can solve the problems of difficult industrialization, high price, poor stability and the like , to achieve the effect of more industrialized production, stable product quality and improved yield

Active Publication Date: 2018-05-04
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is extremely difficult to purify 97% of R-R-cis-atracurium from the ten isomers of atracurium, and there are problems of easy decomposition, poor stability, refrigerated transportation, high price, and extremely difficult to industrialize

Method used

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  • Production process of cisatracurium besylate for injection for storage and transportation at 25°C
  • Production process of cisatracurium besylate for injection for storage and transportation at 25°C
  • Production process of cisatracurium besylate for injection for storage and transportation at 25°C

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0036]

[0037]

[0038] Preparation process: Put 70% of the prescribed amount of water for injection, control the water temperature at 25°C, add 10 mg of cisatracurium besylate, 50 mg of mannitol, and 50 mg of dextran-20, which are precisely weighed, stir well to dissolve them, and measure pH value, add 20% benzenesulfonic acid solution to adjust the pH value to 3.0, add water for injection to the full amount, add 0.05% activated carbon, stir well to make it uniform, sterilize and filter through 0.45μm and 0.22μm microporous membranes, and divide the solution In a controlled vial of 7m1 size, the filling volume is 3ml / bottle.

[0039] Freeze drying process:

[0040] (1) Pre-freezing: Put the filled medicine on the partition of the freeze-drying box, and the temperature of the partition is rapidly lowered to -45°C, and kept for 3 hours to completely freeze;

[0041] (2) Sublimation drying: The temperature of the partition is -45°C, the vacuum control is less than 30Pa, ...

Embodiment B

[0045]

[0046]

[0047] Preparation process: Put 75% of the prescribed amount of water for injection, control the water temperature at 35°C, add 20 mg of cisatracurium besylate, 50 mg of mannitol, and 50 mg of dextran-20, which are precisely weighed, stir well to dissolve them, and measure For the pH value, add 20% benzenesulfonic acid solution to adjust the pH value to 4.0. Add water for injection to the full amount, add 0.1% activated carbon, stir well to make it uniform, sterilize and filter through 0.45μm and 0.22μm microporous membranes, and divide the solution In a controlled vial of 7m1 size, the filling volume is 2ml / bottle.

[0048]Freeze drying process:

[0049] (1) Pre-freezing: Put the filled medicine on the partition of the freeze-drying box, and the temperature of the partition is rapidly lowered to -50°C, and kept for 4 hours to completely freeze;

[0050] (2) Sublimation drying: The temperature of the partition is -50°C, the vacuum control is less than ...

Embodiment C

[0054]

[0055]

[0056] Preparation process:

[0057] Add 73% of the prescribed amount of water for injection, control the water temperature at 32°C, add 16 mg of cisatracurium besylate, 50 mg of mannitol, and 50 mg of dextran-20 that are precisely weighed, fully stir to dissolve it, and measure the pH value. Add a solution containing 20% ​​benzenesulfonic acid, adjust the pH value to 3.0, add water for injection to the full amount, add 0.56% activated carbon, stir well to make it uniform, sterilize and filter through 0.45 μm and 0.22 μm microporous membranes, and distribute the solution In a controlled vial of 7m1 size, the filling volume is 2.4ml / bottle.

[0058] Freeze drying process:

[0059] (1) Pre-freezing: Put the filled medicine on the partition of the freeze-drying box, and the temperature of the partition is rapidly cooled to -48°C, and kept for 3.5 hours to completely freeze;

[0060] (2) Sublimation drying: The temperature of the partition is -48°C, the v...

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PUM

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Abstract

The invention relates to a kind of cisatracurium besylate for injection used for storage and transportation at 25°C and its preparation and freeze-drying production process. The specific formula of cisatracurium besylate for injection is as follows: Tracuronium 10-20mg; Dextran-20 50mg; Mannitol 50mg; Solution containing 20% ​​benzenesulfonic acid to adjust PH; Water for injection 2000-3000ml. The freeze-drying production process includes: pre-freezing, sublimation drying, re-drying, plugging and capping. The freeze-drying production process in the present invention improves the chemical stability of the medicine, can be stored, transported and used at 25°C, ensures product quality, reduces storage and transportation conditions for finished products, and improves product quality. It is of great importance in the field of medical applications. significance.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical manufacturing, and in particular relates to cisatracurium besylate for injection for storage and transportation at 25°C and its preparation and freeze-drying production process. Background technique [0002] After emphasizing the theory of "light anesthesia, deep muscle relaxation" in recent years, the market of muscle relaxants has grown rapidly. The cisatracurium besylate for injection produced by our company is a new type of powerful medium-time-acting non-depolarizing muscle relaxant. High muscle relaxation effect, individual differences in dose-effect relationship, weak amine release, no cardiovascular adverse reactions, no hemodynamic effects, non-device-dependent Hoffman metabolism, maintenance and recovery, easy to control and no accumulation, has become a clinical The drug of choice for the development of anesthesiology and emergency medicine. Table 1 is a comparison table of cis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4725A61P21/02A61P23/00
Inventor 张秋姜丽华姜允菊张耀华王坚汪晓铭陈丽李鑫华何小虎蒋鹏
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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