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Ropivacaine mesylate freeze-dried powder injection

A technology of ropivacaine mesylate and freeze-dried powder injection, which is applied in the field of western medicine preparations, can solve the problems of being unsuitable for large-scale industrial production, poor product appearance, and high cost investment, and achieve loose and uniform appearance, fast cooling rate, crystallization The effect of small particle size

Active Publication Date: 2011-05-04
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method adopts the aseptic low-temperature vacuum spray drying method, but using this method to prepare ropivacaine mesylate powder injection, the operation is complicated, the cost input is very high, and it is not suitable for industrialized large-scale production
[0005] In short, in order to ensure a good freeze-dried appearance, the prior art for preparing ropivacaine freeze-dried powder injections has added excipients, such as mannitol, to solve the problems of poor product appearance and low yield
However, excipients such as mannitol may bring safety risks during lumbar epidural injection (Clinical Safety of Mannitol, Xia Xiaoping, Journal of Adverse Drug Reactions, Issue 4, 2003), therefore, For the anesthetic ropivacaine administered as an epidural injection, if any excipients can be reduced or not added during the preparation of the powder injection, the clinical safety of the drug will be greatly increased

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of ropivacaine mesylate freeze-dried powder injection

[0024] Prescription: Ropivacaine Mesylate 89.4g

[0025] Add water for injection to 1000mL

[0026] 1000 made

[0027] Preparation: Weigh 89.4g of ropivacaine mesylate, add 80% of the prescription amount of water for injection cooled to room temperature, stir to dissolve completely, adjust the pH of the liquid to 4-7 with sodium hydroxide or phosphoric acid, add 0.5‰ of the injection Use activated carbon, stir and adsorb for 10 minutes, then decarbonize and filter, add water for injection to 1000mL, and stir evenly. Afterwards, it is filtered through a 0.22 μm sterile filter membrane in two stages of sterilization, and the filtrate is sampled to detect the content of the semi-finished product. According to the content, the specified amount of liquid medicine is filled into clean vials, half-filled with rubber stoppers, and placed in a freeze dryer for freeze-drying. The freeze-drying proce...

Embodiment 2

[0032] Example 2 Preparation of ropivacaine mesylate freeze-dried powder injection

[0033] Prescription: Ropivacaine Mesylate 47.7g

[0034] Add water for injection to 1000mL

[0035] 1000 made

[0036] Preparation: Weigh 47.7g of ropivacaine mesylate, add 80% of the prescription amount of water for injection cooled to room temperature, stir to dissolve completely, adjust the pH of the liquid to 4-7 with sodium hydroxide or phosphoric acid, add 1‰ of the injection Use activated carbon, stir and adsorb for 10 minutes, then decarbonize and filter, add water for injection to 1000mL, and stir evenly. Afterwards, it is filtered through a 0.22 μm sterile filter membrane in two stages of sterilization, and the filtrate is sampled to detect the content of the semi-finished product. According to the content, the specified amount of liquid medicine is filled into clean vials, half-filled with rubber stoppers, and placed in a freeze dryer for freeze-drying. The freeze-drying proce...

Embodiment 3

[0041]Example 3 Preparation of ropivacaine mesylate freeze-dried powder injection

[0042] Prescription: Ropivacaine Mesylate 89.4g

[0043] Add water for injection to 500mL

[0044] 1000 made

[0045] Preparation: Weigh 89.4g of ropivacaine mesylate, add 80% of the prescribed amount of water for injection cooled to room temperature, stir to dissolve completely, adjust the pH of the liquid to 4-7 with sodium hydroxide or phosphoric acid, add 1‰ of the injection Use activated carbon, stir and adsorb for 10 minutes, then decarbonize and filter, add water for injection to 500mL, and stir evenly. Afterwards, it is filtered through a 0.22 μm sterile filter membrane in two stages of sterilization, and the filtrate is sampled to detect the content of the semi-finished product. According to the content, the specified amount of liquid medicine is filled into clean vials, half-filled with rubber stoppers, and placed in a freeze dryer for freeze-drying. The freeze-drying process is ...

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Abstract

The invention relates to a ropivacaine mesylate freeze-dried powder injection which consists of ropivacaine mesylate and a PH regulator and is prepared by using the following freeze drying method: (1) a section quick-freezing stage: keeping bulked ropivacaine mesylate solution at the temperature of 0 DEG C for 10-30 minutes, and then keeping the bulked ropivacaine mesylate solution at the temperature of minus 35 DEG C-minus 45 DEG C for 1-2 hours; (2) a lyophilization stage: heating to 0 DEG C under the vacuum degree of 10-20 Pa and at the speed of 2-10 DEG C / h, and then keeping the temperature for 1-3 hours; and (3) a desorption drying stage: heating to 30 DEG C under the vacuum degree of 0-10 Pa and at the speed of 5-10 DEG C / h and keeping the temperature for 2-5 hours. The freeze-dried powder injection provided by the invention has the advantages of high yield, good re-dissolubility, more stable quality and the like.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, and in particular relates to a ropivacaine mesylate freeze-dried powder injection. Background technique [0002] Ropivacaine mesylate is a new domestic amide local anesthetic after changing the hydrochloride root of ropivacaine hydrochloride to mesylate root. It has low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction. effect, so there is no need to add epinephrine when using it. Because it only blocks pain nerves when used, does not affect motor nerves, and hardly passes through the placenta, it has the following advantages: (1) It can provide effective analgesia for parturients; (2) Ensure the normal function of motor nerves, without It affects uterine contraction and increases maternal physical strength; (3) does not affect infant breastfeeding and mother's postpartum recovery; (4) has low toxicity and improves the safety of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/445A61P23/02A61J3/02
Inventor 赵志全蒋新利
Owner 鲁南新时代生物技术有限公司
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