Hydrochloric acid melphalan injection liquid and preparation method thereof

A technology of melphalan hydrochloride and injection, which is applied in the direction of medical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of poor long-term storage stability, time-consuming freeze-dried powder injection, and high cost. increase and other problems, to overcome the poor stability, reduce the cost of medication, and overcome the effects of energy consumption

Inactive Publication Date: 2010-10-13
上海丽思化工科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is well known in the art that freeze-dried powder is not an absolutely anhydrous environment, and still contains a certain amount of water. In Example 11 of this patent application, it is also pointed out that the water content of freeze-dried powder is 0.39-0.67%, and the drug is always in a wet state. , poor long-term storage stability
In addition, the preparation of freeze-dried powder takes a long time and consumes a lot of energy, resulting in a substantial increase in cost

Method used

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  • Hydrochloric acid melphalan injection liquid and preparation method thereof
  • Hydrochloric acid melphalan injection liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 Melphalan Hydrochloride Injection

[0028] Weigh 4 grams of anhydrous sodium sulfate into 200 ml of absolute ethanol, stir and dehydrate for 15 minutes, filter to obtain dehydrated absolute ethanol; weigh 1.0 g of melphalan hydrochloride, add it to 95 ml of dehydrated absolute ethanol, and Heat and stir at 25°C to dissolve, then dilute to 100 ml with dehydrated absolute ethanol; adjust the pH value to 4.5 with citric acid; add 0.5 g of activated carbon for needles, and absorb at 45°C for 30 minutes; filter with a microporous membrane, Subpackage, seal, and sterilize with high-pressure steam at 121°C for 15 minutes to obtain melphalan hydrochloride injection.

Embodiment 2

[0029] Embodiment 2 melphalan hydrochloride injection

[0030] Weigh 30 grams of anhydrous sodium sulfate into 200 ml of propylene glycol, stir and dehydrate for 10 minutes, filter to obtain dehydrated propylene glycol; weigh 2.5 grams of melphalan hydrochloride, put it into 90 ml of dehydrated propylene glycol, heat and stir at 80°C to dissolve , and then use dehydrated propylene glycol to make the volume to 100 ml; adjust the pH value to 6.3 with hydrochloric acid; add 2 grams of activated carbon for needles, and absorb for 20 minutes at 60°C; Sterilize for 15 minutes to obtain melphalan hydrochloride injection.

Embodiment 3

[0031] Embodiment 3 melphalan hydrochloride injection

[0032] Weigh 20 grams of anhydrous calcium chloride into 200 ml of polyethylene glycol 400, stir and dehydrate for 60 minutes, and filter to obtain dehydrated polyethylene glycol 400; weigh 0.5 grams of melphalan hydrochloride into 95 ml of dehydrated polyethylene glycol 400 In ethylene glycol 400, heat and stir at 70°C to dissolve, then dilute to 100 ml with dehydrated polyethylene glycol 400; adjust the pH value to 3.5 with lactic acid; add 1.2 g of activated carbon for needles, and absorb at 80°C for 15 minutes ; filter with a microporous membrane, subpackage, seal, and sterilize with high-pressure steam at 115° C. for 30 minutes to obtain melphalan hydrochloride injection.

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PUM

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Abstract

The invention relates to the technical field of medicine preparations. The hydrochloric acid melphalan is very unstable in water, and a large amount of medicine degrades after several hours to generate impurities causing toxic or side effect, so the hydrochloric acid melphalan is not suitable for being prepared into medicine water solution to be stored for a long time. The invention provides stable hydrochloric acid melphalan injection liquid, which consists of hydrochloric acid melphalan, injection-use solvents and pH value regulating agents, wherein the injection-use solvents are anhydrous solvents obtained through dewatering treatment. The hydrochloric acid melphalan injection liquid of the invention has the advantages of stable preparation, low cost, autoclaving capability and small toxic or side effect.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a melphalan hydrochloride injection and a preparation method thereof. Background technique [0002] Melphalan, common name: L-phenylalanine mustard, melphalan, milphalan, melphalan, L-sarcolysin, Ekelan; English name: Melphalan, L-Sarcolysine, Alkeran, L-PAM, CB3025 ;Chemical name: L-3{p-[bis(2-chloroethyl)amino]phenyl}alanine; Molecular formula: C 13 h 18 o 2 N 2 C 12 . Melphalan is insoluble in water and has poor stability. In order to improve its stability and water solubility, it is salted with hydrochloric acid to prepare melphalan hydrochloride. Melphalan hydrochloride is white to light yellow powder, slightly soluble in water, easily soluble in organic solvents such as absolute ethanol, unstable to light, heat and humidity. [0003] Melphalan hydrochloride is the left-handed form of phenylalanine nitrogen mustard. It is an alkylating agent and i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/198A61K47/10A61K47/16A61K47/34A61P35/00
Inventor 侯丽红高保安
Owner 上海丽思化工科技有限公司
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