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Ropivacaine hydrochloride in use for injection and preparation technique

A technology for ropivacaine hydrochloride and its preparation process, which is applied in the field of ropivacaine hydrochloride for injection and its preparation, achieving the effects of good stability, ensuring product quality, and saving a lot of energy

Inactive Publication Date: 2005-08-31
黄健鹏 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the existence of optical isomers in the structure of ropivacaine, the key to the quality control of its products is the control of its enantiomer purity content. Injections are not conducive to product performance due to the transformation of their enantiomers in the state of aqueous solution. stable factor

Method used

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Embodiment Construction

[0009] This ropivacaine hydrochloride powder injection or freeze-dried powder injection contains ropivacaine hydrochloride and pharmacologically acceptable support substances; the support substances are any one or any combination of mannitol, lactose, glucose, and dextran Mixed use. The ratio of the ropivacaine hydrochloride to the supporting substance is 1:0.5-5.

[0010] The latest aseptic low-temperature vacuum spray drying method preparation process: under sterile and clean conditions, add ropivacaine hydrochloride and pharmacologically acceptable support substances to an appropriate amount of water for injection, heat and stir to dissolve them completely, add an appropriate amount of activated carbon for decolorization, crude Filtration of charcoal, microporous membrane filtration and sterilization to obtain sterile and pyrogen-free clarified medicinal liquid; use vacuum continuous spray dryer to dry, control the temperature in the tank at 30-50°C, and the vacuum degree a...

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Abstract

A freeze-dried powder injection of ropivacaine hydrochloride is prepared from ropivacaine hydrochloride and the pharmacologically suporting materials including material, lactose, glucose and dextran. Its preparing process features use of low-temp aseptic vacuum spray drying for shortening time.

Description

(1) Technical field [0001] The invention relates to ropivacaine hydrochloride for injection and a preparation process thereof, belonging to the technical field of anesthesia and analgesic drugs. (2) Background technology [0002] Ropivacaine is a new long-acting amide local anesthetic, suitable for surgical anesthesia, epidural anesthesia, postoperative analgesia and 72-hour local area anesthesia during childbirth. The product was first developed into Ropivacaine Hydrochloride Injection by Astra Company of Sweden in 1994, and was approved by FDA in 1995 for marketing in the United States. Due to the existence of optical isomers in the structure of ropivacaine, the key to the quality control of its products is the control of its enantiomer purity content. Injections are not conducive to product performance due to the transformation of their enantiomers in the state of aqueous solution. stable factor. (3) Contents of the invention [0003] Aiming at the aforementioned fact...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/19A61K31/445A61P23/02
Inventor 黄健鹏刘贤英
Owner 黄健鹏
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