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Preparation method of taxol injection

A technology of paclitaxel and injection, which is applied in the field of preparation of anticancer drug injection, can solve the problems of excessive local concentration and low overall content, and achieve the effects of improving safety, solving stability and solving stability problems.

Active Publication Date: 2009-11-11
HAIKOU PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The preparation method of paclitaxel injection of the present invention removes the trace moisture in the raw material of paclitaxel, dissolves the raw material of paclitaxel first, and then prepares the solution, thereby avoiding excessive local concentration or partial overall content caused by too long time for the preparation of the solution or incomplete dissolution of the raw material. Low, solve the uniformity problem of raw material dissolution in the liquid preparation process

Method used

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  • Preparation method of taxol injection
  • Preparation method of taxol injection
  • Preparation method of taxol injection

Examples

Experimental program
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Effect test

Embodiment 1

[0025] 1. Prescription: Percentage based on the total weight of the prescription

[0026] Paclitaxel raw material 0.6%

[0027] Polyoxyethylene castor oil 55%

[0028] Absolute Ethanol 43%

[0029] Oleic Acid, Sodium Glycocholate Blend 1%

[0030] 2. Production process:

[0031] (1) Add polyoxyethylene castor oil and 4A molecular sieve with a mass ratio of 5:1 into the liquid mixing tank, stir for 30 minutes, fully mix, seal, and wait for filtration.

[0032] (2) Pass the feed solution prepared in step (1) through a 0.22 μm filter membrane for sterile pressure filtration.

[0033] (3) Accurately weigh the prescribed amount of paclitaxel (according to the national standard for paclitaxel injection WS1-(X-026)-2001Z, every 5ml of paclitaxel injection contains 30 mg of paclitaxel), and add 10 times the amount of absolute ethanol of paclitaxel according to the mass ratio Mix evenly, then add oleic acid and sodium glycocholate mixture (3:1 in mass ratio) as a stabilizer, stir ...

Embodiment 2

[0045] 1. Prescription

[0046] Paclitaxel raw material 0.6%

[0047] Polyoxyethylene Castor Oil 45%

[0048] Absolute Ethanol 50%

[0049] Citrate-sodium citrate 0.5%

[0050] 2. Production process:

[0051] (1) Add polyoxyethylene castor oil and 4A molecular sieve with a mass ratio of 5:1 into the liquid mixing tank, stir for 30 minutes, fully mix, seal, and wait for filtration.

[0052] (2) Pass the feed solution prepared in step (1) through a 0.22 μm filter membrane for sterile pressure filtration.

[0053] (3) Accurately weigh the paclitaxel of the prescribed amount (according to the national standard WS for paclitaxel injection) 1 -(X-026)-2001Z, every 5ml paclitaxel injection contains paclitaxel 30mg calculation), add dehydrated alcohol of 10 times amount of paclitaxel by mass ratio and mix evenly, then add sodium citrate, citrate mixture (mass ratio is 2:1) as a stabilizer, stir until the paclitaxel and stabilizer are completely dissolved, then add absolute ethan...

Embodiment 3

[0065] 1. Prescription

[0066] Paclitaxel raw material 0.6%

[0067] Polyoxyethylene castor oil 35%

[0068] Absolute Ethanol 60%

[0069] Sodium sulfite 4.5%

[0070] 2. Production process:

[0071] (1) Add polyoxyethylene castor oil and 4A molecular sieve with a mass ratio of 5:1 into the liquid mixing tank, stir for 30 minutes, fully mix, seal, and wait for filtration.

[0072] (2) Pass the feed solution prepared in step (1) through a 0.22 μm filter membrane for sterile pressure filtration.

[0073] (3) Accurately weigh the paclitaxel of the prescribed amount (according to the national standard WS for paclitaxel injection) 1 -(X-026)-2001Z, every 5ml paclitaxel injection contains paclitaxel 30mg calculation), add 10 times the amount of absolute ethanol of paclitaxel according to the mass ratio and mix evenly, then add sodium sulfite as a stabilizer, stir until paclitaxel and stabilizer are completely dissolved , add absolute ethanol to the prescription amount.

[00...

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Abstract

The invention provides a preparation method of taxol injection, comprising the following steps: (1) blending polyoxyethylene castor oil and molecular sieve, and filtering and degerming; (2) removing trace moisture in taxol, and filtering and degerming; (3) blending, filtering and degerming solutions obtained in step (1) and step (2),. The method avoids overlarge local concentration or low whole content caused by overlong time used for blending solutions or incomplete solution of materials, thus solving the uniformity problem of solution of materials and the stability problem of the taxol injection in the process of blending solutions.

Description

technical field [0001] The invention relates to a preparation method of anticancer drug injection, in particular to a preparation method of paclitaxel injection. Background technique [0002] Paclitaxel is a structurally complex diterpenoid with the chemical name 5β,20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytaxane-11-en-9-one-4 , 10-diacetate-2-benzoate-13-(2′R,3′S)-N-benzoyl-3-phenylisoserine ester, the molecular formula is C 47 h 51 NO 14 , the molecular weight is 853.92, and the structural formula is as follows: [0003] [0004] Paclitaxel is insoluble in water and many pharmaceutical solvents, the solubility in water is only 0.006mg.ml -1 . Paclitaxel is relatively stable in the pH range of 4-8, decomposes quickly under alkaline conditions, reacts violently in sodium methoxide solution, and is relatively stable under acidic conditions. In addition, paclitaxel can be absorbed by MnO under certain conditions 2 , Jones's reagent is oxidized, but it is extremely diffi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/337A61K47/44A61P35/00
Inventor 沙莹张志兰王俊红温平庄欣
Owner HAIKOU PHARMA FACTORY
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