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Liquid drug injection containing ropivacaine mesylate and preparation method thereof

A technology of ropivacaine mesylate and water injection, which is applied in the field of drug preparation, can solve the problems of easy change, high cost, and dextro-isomer production, and achieve convenient transportation, good stability, and isomer little effect

Inactive Publication Date: 2019-04-05
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The preparation of medicinal ropivacaine mainly uses L-ropivacaine, but in the process of production and storage, it is prone to change, resulting in D-isomer and other related impurities, and the current preparation process is relatively complicated and the cost is high

Method used

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  • Liquid drug injection containing ropivacaine mesylate and preparation method thereof
  • Liquid drug injection containing ropivacaine mesylate and preparation method thereof
  • Liquid drug injection containing ropivacaine mesylate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] prescription:

[0016]

[0017] Preparation:

[0018] (1) Add 80L of water for injection in the dispensing tank, cool down to 40°C, add 0.75kg of sodium chloride and 0.894kg of ropivacaine mesylate, and stir for 30 minutes; the ropivacaine mesylate It was stored at 0°C after being recrystallized with methanol at 5°C before being formulated into an aqueous injection. After visually observing that the raw materials are completely dissolved, add 0.03 kg of wetted activated carbon for needles, and stir and adsorb for 20 minutes. (2) Use 0.01mol / L sodium hydroxide solution to adjust the pH value to 5.5, add water for injection to the full amount, and pull the loop for 20 minutes. (3) Sampling and testing the pH value, content and endotoxin of semi-finished products. (4) After the semi-finished product is qualified, the three-in-one equipment is used to make bottles and fill them with N 2 Filling, sealing. (5) Sterilize at 121°C for 15 minutes, cool down to below 45°C...

Embodiment 2

[0020] prescription:

[0021]

[0022] Preparation:

[0023] (1) Add 80L of water for injection in the dispensing tank, cool down to 40°C, add 0.75kg of sodium chloride and 0.894kg of ropivacaine mesylate, and stir for 30 minutes; the ropivacaine mesylate It was stored at -40°C after being recrystallized with methanol at 5°C before being formulated into an aqueous injection. After visually observing that the raw materials are completely dissolved, add 0.03 kg of wetted activated carbon for needles, and stir and adsorb for 20 minutes. (2) Use 0.01mol / L sodium hydroxide solution to adjust the pH value to 5.5, add water for injection to the full amount, and pull the loop for 20 minutes. (3) Sampling and testing the pH value, content and endotoxin of semi-finished products. (4) After the semi-finished product is qualified, the three-in-one equipment is used to make bottles and fill them with N 2 Filling, sealing. (5) Sterilize at 121°C for 15 minutes, cool down to below 45...

Embodiment 3

[0025] prescription:

[0026]

[0027] Preparation:

[0028] (1) Add 80L of water for injection in the dispensing tank, cool down to 40°C, add 0.75kg of sodium chloride and 0.894kg of ropivacaine mesylate, and stir for 30 minutes; the ropivacaine mesylate It was stored at -80°C after being recrystallized with methanol at 5°C before being formulated into an aqueous injection. After visually observing that the raw materials are completely dissolved, add 0.03 kg of wetted activated carbon for needles, and stir and adsorb for 20 minutes. (2) Use 0.01mol / L sodium hydroxide solution to adjust the pH value to 5.5, add water for injection to the full amount, and pull the loop for 20 minutes. (3) Sampling and testing the pH value, content and endotoxin of semi-finished products. (4) After the semi-finished product is qualified, the three-in-one equipment is used to make bottles and fill them with N 2 Filling, sealing. (5) Sterilize at 121°C for 15 minutes, cool down to below 45...

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Abstract

The invention belongs to the technical field of drug preparation, and relates to a liquid drug injection containing ropivacaine mesylate and a preparation method thereof. The preparation method comprises the following concrete steps that 1) 80 percent of theoretical preparation quantity of water for injection is added into a drug preparation tank; a prescription dosage of sodium chloride and ropivacaine mesylate is added; stirring is performed till dissolution is complete; wetted active carbon for needles is added; the stirring is performed for adsorption; (2) a pH value is regulated to 4.5 to5.5 by a pH value regulating agent; the water for injection is supplemented to the full dose; pull circulation is performed for 10 to 20 minutes; (3) bottle preparation by three-in-one equipment, N2filling for filling, opening sealing, sterilization and package are performed. Compared with the prior art, the ropivacaine mesylate injection liquid prepared by the method has the advantages of safeand reliable effects, high stability, and few isomers. In addition, compared with glass ampule package, the polypropylene ampule package of a bottle blowing, filling and opening sealing three-in-one sterile system has the advantages that in an opening process, fragments and particulate fine powder cannot be easily generated; the transportation is convenient; the safety and reliability are realized.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and specifically relates to an aqueous injection containing ropivacaine mesylate and a preparation method thereof. Background technique [0002] Ropivacaine is an amide local anesthetic, mainly used for surgical anesthesia: epidural anesthesia (including epidural anesthesia for cesarean section); local infiltration anesthesia. Acute pain control: used for postoperative or labor analgesia, either continuous epidural infusion or intermittent medication; local infiltration anesthesia. By raising the threshold of nerve action potential, delaying the spread of nerve impulses, reducing the speed of action potential rise, and blocking the generation and conduction of nerve impulses. [0003] The pKa of ropivacaine is 8.1, and the distribution ratio is 141 (25°C n-octanol / phosphate buffer pH7.4). Plasma concentrations of ropivacaine depend on the dose, route of administration and vascular ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/445A61K47/02A61P23/02
CPCA61K9/0019A61K9/08A61K31/445A61K47/02A61P23/02
Inventor 王静张国华石井岗
Owner CISEN PHARMA
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