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Freeze-dried ropivacaine hydrochloride composition for injection and its quality control method

A kind of technology of ropivacaine hydrochloride and composition, applied in the field of medicine

Active Publication Date: 2020-02-07
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] However, there is still a need for improvement in the prior art in terms of maintaining the excellent properties of the medicament, such as its stability, and in improving the quality control methods of the medicament.

Method used

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  • Freeze-dried ropivacaine hydrochloride composition for injection and its quality control method
  • Freeze-dried ropivacaine hydrochloride composition for injection and its quality control method
  • Freeze-dried ropivacaine hydrochloride composition for injection and its quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0129] Embodiment 1: Preparation of ropivacaine hydrochloride freeze-dried powder injection

[0130] formula:

[0131] Ropivacaine hydrochloride 75mg,

[0132] Lactose 40mg,

[0133] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0134] Water for injection: add to 3ml.

[0135] Preparation method:

[0136] (a) take by weighing ropivacaine hydrochloride, lactose of prescription quantity, add prescription quantity 60% water for injection, stir and make to dissolve;

[0137] (b) Add activated carbon (0.1% by volume of the medicinal liquid) to the medicinal liquid obtained in the previous step, adjust the pH value of the solution to 3.2 with an acid-base regulator, stir for 2.0 hours at a temperature of 25° C., filter for decarbonization, and use an acid-base regulator to The regulator adjusts the pH of the solution to 5.0;

[0138] (c) Add water for injection to the full amount of the prescription, ...

Embodiment 2

[0141] Embodiment 2: Preparation of ropivacaine hydrochloride freeze-dried powder injection

[0142] formula:

[0143] Ropivacaine hydrochloride 75mg,

[0144] Lactose 45mg,

[0145] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0146] Water for injection: add to 3.75ml.

[0147] Preparation method:

[0148] (a) take by weighing ropivacaine hydrochloride, lactose of prescription quantity, add prescription quantity 65% ​​water for injection, stir and make to dissolve;

[0149] (b) Add activated carbon (0.05% by volume of the medicinal solution) to the medicinal solution obtained in the previous step, adjust the pH value of the solution to 3.0 with an acid-base regulator, stir for 2.0 hours at a temperature of 20°C, filter for decarbonization, and use an acid-base regulator to The regulator adjusts the pH of the solution to 5.5;

[0150] (c) Add water for injection to the full amount of the prescr...

Embodiment 3

[0153] Embodiment 3: Preparation of ropivacaine hydrochloride freeze-dried powder injection

[0154] formula:

[0155] Ropivacaine hydrochloride 75mg,

[0156] Lactose 35mg,

[0157] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0158] Water for injection: add to 2.5ml.

[0159] Preparation method:

[0160] (a) take by weighing ropivacaine hydrochloride, lactose of prescription quantity, add prescription quantity 55% water for injection, stir and make dissolving;

[0161] (b) Add activated carbon (0.15% by volume of the medicinal solution) to the medicinal solution obtained in the previous step, adjust the pH value of the solution to 3.5 with an acid-base regulator, stir for 2.3 hours at a temperature of 30° C., filter for decarbonization, and use an acid-base regulator to The regulator adjusts the pH4.5 of the solution;

[0162] (c) Add water for injection to the full amount of the prescription...

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Abstract

The invention relates to a freeze-drying ropivacaine hydrochloride composition for injection and a quality control method thereof. The composition is prepared from ropivacaine hydrochloride and lactose, for example, the composition is prepared from, by weight, 75 parts of ropivacaine hydrochloride and 20-60 parts of lactose. The composition is basically prepared through the following steps that ropivacaine hydrochloride and lactose are weighed according to the amount in the prescription, a proper amount of injection water is added, and stirring is carried out to dissolve the mixture; active carbon is added in the medicine liquor obtained in the last step, stirring is carried out, and filtering is carried out to remove carbon; injection water is supplemented to the full amount of the prescription, the mixture is stirred evenly, the pH value of the solution is measured, the content of active ingredients is optionally measured, and the pH is regulated with an acid-base regulator if necessary; the medicine liquor is sterilized, filtered and then poured into penicillin bottles; freeze-drying is carried out to remove moisture, plugs are pressed, and the freeze-drying ropivacaine hydrochloride composition is obtained. The freeze-drying ropivacaine hydrochloride composition has the excellent pharmaceutical properties stated in the description, and the quality control method has excellent methodological performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a local anesthetic pharmaceutical composition, in particular to a ropivacaine hydrochloride freeze-dried powder injection pharmaceutical composition with excellent properties. The invention also relates to a preparation method of the ropivacaine hydrochloride freeze-dried powder injection pharmaceutical composition. The pharmaceutical composition of ropivacaine hydrochloride freeze-dried powder for injection can be used for surgical anesthesia; epidural anesthesia, including caesarean section; acute pain control; continuous epidural infusion or intermittent single administration, such as postoperative or Pain in labor; regional block. The ropivacaine hydrochloride powder for injection prepared by the invention has excellent physical and chemical properties. The invention also relates to a method for quality control of the composition. Background technique [0002] Ropivacaine...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/445A61K47/26A61P23/02G01N30/02
CPCA61K9/0019A61K9/19A61K31/445A61K47/26G01N30/02G01N2030/027
Inventor 赵东明方专陈娟张莲莲吴国庆伍隆霞
Owner CHENGDU TIANTAISHAN PHARMA
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