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Preparation method of ropivacaine mesylate injection packed by soda-lime glass bottle

A technology of ropivacaine mesylate and vials, which is applied in the field of medical injections, and can solve the problem of poor chemical stability and thermal stability of neutral glass, poor ability to withstand temperature changes, hand scratches of medical staff, ampoule packaging Bottles are crushed and other problems, to achieve the effect of convenient clinical application, avoid pollution, and reduce the probability of occurrence

Inactive Publication Date: 2010-03-03
陕西吉尾斯美业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A technical problem is that the current domestic injection ampoule packaging bottle is made of neutral glass, which is commonly referred to as Grade B material. The chemical stability and thermal stability of neutral glass and the ability to withstand temperature changes are relatively poor. Strong acid and strong alkaline liquids are prone to "flaking off" phenomenon, while the pH value of ropivacaine mesylate injection is 4.0-6.0, which requires the packaging bottle to be acid-resistant and not chemically react with the liquid. Some ampule packaging bottles are not suitable for use as packaging bottles for ropivacaine mesylate injection
Another technical problem is the high rate of breakage of ampoules during sealing and up to 10% of ampoules during filling
The third technical problem is that it is easy to break. Currently, the injection ampoule packaging bottles used in China often scratch the hands of medical staff during use. After the ampoule is broken, broken glass chips enter the liquid medicine, which is harmful to the health of patients. cause some damages
Additionally, ampoules are often crushed during shipping

Method used

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  • Preparation method of ropivacaine mesylate injection packed by soda-lime glass bottle
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  • Preparation method of ropivacaine mesylate injection packed by soda-lime glass bottle

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Take 100 ropivacaine mesylate injections of production vial packaging as an example and its preparation method is as follows:

[0041] 1. Ingredients

[0042] Prepare the ropivacaine mesylate injection 1000mL of vial packaging according to the following ingredients:

[0043] Ropivacaine Mesylate 8940mg

[0044] Sodium chloride 7500mg

[0045] Add water for injection to 1000mL

[0046] 2. Dosing

[0047] Take 800ml of water for injection in the JCG-150 liquid mixing tank, fill it with nitrogen, the nitrogen flow rate is 10L / min, add sodium chloride and ropivacaine mesylate, stir to dissolve it fully, and oxidize it with 0.1moL / L hydroxide Sodium solution to adjust the pH to 4.25±0.1; add 0.02% by weight of activated carbon with a concentration of g / ml to the solution, stir at 40-50°C for 15 minutes, filter and decarburize the titanium rod, and take samples to detect the pH value of the intermediate product and methanesulfonic acid For the content of ropivacaine, add...

Embodiment 2

[0065] Take 100 ropivacaine mesylate injections of production vial packaging as an example and its preparation method is as follows:

[0066] Ingredients:

[0067] Prepare the ropivacaine mesylate injection 1000mL of vial packaging according to the following ingredients:

[0068] Ropivacaine Mesylate 11920mg

[0069] Sodium chloride 7100mg

[0070] Add water for injection to 1000mL

[0071] Its preparation method is as follows:

[0072] In the process step 3 of cleaning vials and rubber stoppers, the vials are ultrasonically cleaned, rinsed with circulating water, blown with clean compressed air, rinsed with injection water, dried with clean compressed air, and then optimized with a sterilizing dryer. Sterilize with dry heat at 260°C for 25 minutes; pour the rubber stopper into the KJCS-3 rubber stopper cleaning machine, wash it with water for injection, rinse with ion, and wash it with water for injection in sequence, and sterilize it with steam at 110°C for 30 minutes, h...

Embodiment 3

[0074] Take 50 ropivacaine mesylate injections of production vial packaging as an example and its preparation method is as follows:

[0075] Ingredients:

[0076] Prepare the ropivacaine mesylate injection 1000mL of vial packaging according to the following ingredients:

[0077] Ropivacaine Mesylate 2385mg

[0078] Sodium chloride 8600mg

[0079] Add water for injection to 1000mL

[0080] Its production method is as follows:

[0081] In the process step 3 of cleaning vials and rubber stoppers, the vials are ultrasonically cleaned, rinsed with circulating water, blown with clean compressed air, rinsed with injection water, dried with clean compressed air, and then optimized with a sterilizing dryer. Sterilize by dry heat at 410°C for 10 minutes; pour the rubber stopper into the KJCS-3 rubber stopper cleaning machine, wash it with water for injection, rinse with ion, and wash it with water for injection in sequence, then sterilize it with steam at 125°C for 30 minutes, and h...

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Abstract

The invention relates to a preparation method of ropivacaine mesylate injection packed by a soda-lime glass bottle, which comprises the following processing steps of ingredient preparation, liquor preparation, soda-lime glass bottle and rubber plug cleaning, filling, capping, sterilization, lamp test, labeling, packing and finished product inspection. The injection is subject to a filtration sterilization processing step once and a flowing steam sterilization processing step once, wherein microorganisms larger than 0.22 microns in liquid medicine are removed by a filter method, microorganismssmaller than 0.22 microns are killed by flowing steam sterilization, and insoluble particles in the liquid medicine are removed during filtration sterilization simultaneously, thereby greatly reducingthe occurrence of phlebitis; and the invention is packed by the soda-lime glass bottle which has the advantages of heat resistance, acid and alkali resistance, large strength, and the like, thereby ensuring the stability of the medicine. Clinic comparison tests show that the ropivacaine mesylate injection packed by a soda-lime glass bottle has the advantages of quicker effect, long action time, reliable anesthetic effect, small toxicity to heart, separate blocking pf sensory and motor nerves, and the like, thereby being suitable for anesthesia in surgeries and postoperative analgesia.

Description

technical field [0001] The invention relates to the technical field of medical injection, in particular to a preparation method of ropivacaine mesylate injection. Background technique [0002] Ropivacaine mesylate is an amide local anesthetic, by increasing 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. Anesthesia is related to nerve fiber shaft diameter, myelination and conduction velocity. Ropivacaine mesylate injection is currently clinically mainly used for surgical anesthesia, epidural anesthesia (including cesarean section epidural anesthesia), local infiltration anesthesia; secondly for acute pain control, postoperative or Labor analgesia. Continuous epidural infusion, intermittent medication, and local infiltration anesthesia were used. [0003] In the preparation method of ropivacaine mesylate injection, the ampule bottle pac...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/445A61P23/02A61J3/00A61M5/28
Inventor 杨继安
Owner 陕西吉尾斯美业有限公司
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