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Ropivacaine freeze-dried powder and injection preparation in use for injection and preparation method

A ropivacaine and freeze-drying technology, applied in freeze-dried delivery, anesthetic, powder delivery, etc., can solve the problems of easy freezing, inconvenient storage and transportation, poor stability of injections, etc.

Inactive Publication Date: 2005-06-15
BEIJING BOERDA BIO TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the preparation of ropivacaine has only one dosage form of injection, and the injection has poor stability, heat resistance, easy freezing, and inconvenient storage and transportation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Prescription: Ropivacaine Mesylate 84.5g

[0020] Mannitol 84.5g

[0021] Add water for injection to 2000ml

[0022] A total of 1000 pieces were made

[0023] Preparation method: Weigh the prescribed amount of mannitol, add 1900ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of ropivacaine mesylate, add gradually in portions, and stir while adding. After the addition, continue to heat (80°C) and stir for 20 minutes to completely dissolve. Control the pH of the liquid to 4.0-6.0, and add water for injection to 2000ml. Use 0.1% (w / v) activated carbon, adsorb at 50°C for 15 minutes, decarbonize and filter; the obtained filtrate is continued to be filtered with a 0.22 μm microporous membrane, and the semi-finished product inspection is carried out on the obtained clear filtrate. Fill the qualified semi-finished liquid medicine. Each bottle is filled with 2ml. Freeze dry as follows. Then seal and crimp the cap. ...

Embodiment 2

[0031] Prescription: Ropivacaine Mesylate 22.5g

[0032] Mannitol 22.5g

[0033] Add water for injection to 2000ml

[0034] A total of 1000 pieces were made

[0035] Preparation method: Weigh the prescribed amount of mannitol, add 1900ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of ropivacaine mesylate, add gradually in portions, and stir while adding. After the addition, continue to heat (80°C) and stir for 20 minutes to completely dissolve. Control the pH value of the liquid medicine to 5.0-7.0, and add water for injection to 2000ml. Use 0.1% (w / v) activated carbon, adsorb at 50°C for 15 minutes, decarbonize and filter; the obtained filtrate is continued to be filtered with a 0.22 μm microporous membrane, and the semi-finished product inspection is carried out on the obtained clear filtrate. Fill the qualified semi-finished liquid medicine. Each bottle is filled with 2ml. Freeze dry as follows. Then seal and...

Embodiment 3

[0040] Prescription: Ropivacaine Hydrochloride 75g

[0041] Mannitol 75g

[0042] Add water for injection to 2000ml

[0043] A total of 1000 pieces were made

[0044] Preparation method: Weigh the prescribed amount of mannitol, add 1900ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of ropivacaine hydrochloride, add gradually in portions, and stir while adding. After the addition, continue to heat (80°C) and stir for 20 minutes to completely dissolve. Control the pH of the liquid to 4.0-6.0, and add water for injection to 2000ml. Use 0.1% (w / v) activated carbon, adsorb at 50°C for 15 minutes, decarbonize and filter; the obtained filtrate is continued to be filtered with a 0.22 μm microporous membrane, and the semi-finished product inspection is carried out on the obtained clear filtrate. Fill the qualified semi-finished liquid medicine. Each bottle is filled with 2ml. Freeze dry as follows. Then seal and crimp th...

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PUM

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Abstract

A freeze-dried injection of ropivacaine is prepared from the ropivacaine methanesulfonate (or hydrochloride), diluent chosen from mannitol, lactose, sodium chloride, dextran, glucose, glycine, hydrolytic gelatin and povidone, isotonic regulator and pH regulator through dissolving them in the water for injection, stirring, cooling, adding the water for injection, adding activated carbon, adsorption, filtering for removing carbon, fitlering by millipore filter and freeze drying.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a ropivacaine freeze-dried powder injection and a preparation method. Background technique [0002] Ropivacaine (ropivacaine) is a new type of long-acting amide local anesthetic listed by Astra Pharmaceuticals in 1996. In December 1998, ropivacaine hydrochloride injection was imported into China. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction, so no need to add epinephrine, and it has no obvious effect on uterine placental blood flow. Low concentrations of ropivacaine can effectively block sensory nerve transmission and have little effect on motor nerves. Therefore, this drug is especially suitable for postoperative analgesia and obstetric anesthesia. Judging from the clinical application of ropivacaine in recent years at home and abroad, newborns have good tolerance to this drug, and the motor ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/445A61P23/00
Inventor 张成飞
Owner BEIJING BOERDA BIO TECH DEV
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