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Carboprost tromethamine injection and preparation method thereof

A technology of carboprost tromethamine and injection, which is applied in the field of medicine, can solve the problems of poor storage stability of carboprost tromethamine injection, achieve strong metal ion complexing ability and reduce impurities The effect of producing and inhibiting the growth of bacteria

Active Publication Date: 2020-12-11
CHANGZHOU NO 4 PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The object of the present invention is to overcome the deficiencies in the prior art, provide a kind of carboprost tromethamine injection and its preparation method that quality stability improves significantly, in order to solve the problem of long-term storage of carboprost tromethamine injection The problem of poor stability can effectively inhibit the formation of carboprost trometamol impurities, so as to reduce the adverse reactions of drugs and improve the safety of medication

Method used

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  • Carboprost tromethamine injection and preparation method thereof
  • Carboprost tromethamine injection and preparation method thereof
  • Carboprost tromethamine injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0046] The ingredients listed in Table 1 were used to prepare carboprost tromethamine injection (250 μg / 1.0 ml / bottle, 1000 bottles).

[0047] Table 1:

[0048] Element 1000 bottles of formula effect Carboprost tromethamine (calculated as carboprost) 0.25g active ingredient Trehalose 3g stabilizer proline 1g stabilizer Disodium EDTA 0.05g antioxidant sodium benzoate 0.05g antioxidant Sodium thiosulfate 0.05g antioxidant Sodium diethyldithiocarbamate 0.2g complexing agent Disodium hydrogen citrate and trisodium citrate buffer 1000ml solvent

[0049] Preparation Process:

[0050] (1)CO 2 Preparation of saturated water for injection: injecting CO into the water for injection 2 to saturation while controlling the CO 2 The temperature of saturated water for injection is below 40°C, CO 2 The pH of saturated water for injection is 5.0-6.5;

[0051] (2) Preparation of pH buffer solution: Weigh 13g of...

Embodiment 2

[0056] The ingredients listed in Table 2 were used to prepare carboprost tromethamine injection (250 μg / 1.0 ml / bottle, 1000 bottles).

[0057] Table 2:

[0058] Element 1000 bottles of formula effect Carboprost tromethamine (calculated as carboprost) 0.25g active ingredient Trehalose 5g stabilizer proline 2g stabilizer Disodium EDTA 0.1g antioxidant sodium benzoate 0.1g antioxidant Sodium thiosulfate 0.1g antioxidant Sodium diethyldithiocarbamate 0.3g complexing agent Disodium hydrogen citrate and trisodium citrate buffer 1000ml solvent

[0059] Preparation process: prepare with reference to the preparation method of Example 1.

Embodiment 3

[0061] The ingredients listed in Table 3 were used to prepare carboprost trometamol injection (250 μg / 1.0 ml / bottle, 1000 bottles).

[0062] table 3:

[0063] Element 1000 bottles of formula effect Carboprost tromethamine (calculated as carboprost) 0.25g active ingredient Trehalose 6g stabilizer proline 3g stabilizer Disodium EDTA 0.2g antioxidant sodium benzoate 0.2g antioxidant Sodium thiosulfate 0.2g antioxidant Sodium diethyldithiocarbamate 0.5g complexing agent Disodium hydrogen citrate and trisodium citrate buffer 1000ml solvent

[0064] Preparation process: prepare with reference to the preparation method of Example 1.

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PUM

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Abstract

The invention relates to a carboprost tromethamine injection and a preparation method thereof. The injection contains carboprost tromethamine, a stabilizer, an antioxidant, a complexing agent and a buffer solution. The injection is characterized in that the stabilizer is trehalose and proline, the antioxidant is disodium EDTA, sodium benzoate and sodium thiosulfate, the complexing agent is sodiumdiethyldithiocarbamate, and the buffer solution is disodium hydrogen citrate and trisodium citrate buffer solution. Meanwhile, the invention discloses a corresponding preparation method. Compared withthe prior art, the preparation method has the advantages that the stability of the carboprost tromethamine is remarkably improved, particularly, two main impurities including a chiral isomer and a 5,6-trans isomer on 15-site carbon can be remarkably reduced, the product quality is improved, the toxic and side effects are reduced, and the preparation method is simple, low in cost and suitable forindustrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a carboprost trometamol injection and a preparation method thereof. Background technique [0002] Carboprost tromethamine [0003] Chemical name: 2-amino-2(hydroxymethyl)propane-1,3-diol (5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E ,3S)-3-Hydroxy-3-methyl-1-octene]cyclopentyl]-5-heptanoic acid methyl ester [0004] CAS:58551-69-2 [0005] Molecular formula: C 21 h 36 o 5 ·C 4 h 11 NO 3 [0006] Molecular weight: 489.64 [0007] Structural formula: [0008] [0009] The role of carboprost trometamol is mainly suitable for miscarriage and refractory postpartum uterine hemorrhage during the 13th to 20th week of pregnancy. It is more effective in the treatment of postpartum hemorrhage caused by uterine retardation that is ineffective by conventional treatment methods. [0010] There are generally two kinds of impurities in carboprost trometamol, one impurity...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/26A61K47/18A61K47/20A61K31/5575A61P7/04A61P15/00
CPCA61K9/08A61K9/0019A61K47/26A61K47/183A61K47/20A61K31/5575A61P7/04A61P15/00
Inventor 王菊香周达孙永强严益民屠永锐曹月华祁琪冯晓晖
Owner CHANGZHOU NO 4 PHARMA FACTORY
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