Medication composition of containing

A technology of etoposide and its composition, which is applied in the field of etoposide freeze-dried powder injection and its preparation, and can solve the problems of increasing the dosage, increasing the frequency of taking medicine, poor solubility of etoposide, etc.

Inactive Publication Date: 2006-07-05
云南创立生物医药集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are problems in soft capsules: (1) etoposide has poor solubility and is easily degraded under the action of gastric acid; (2) due to individual differences, the bioavailability of oral dosage forms varies greatly and the availability is low , ranging from 25% to 74%, in order to prolong the effective blood drug concentration, it is necessary to increase the number of times of taking medicine or increase the dosage of medicine, which will lead to an increase of toxic and side effects; Poor, has high requirements for storage and transportation, and is greatly restricted in use
(2) The pH value of the injection is less than 4, and antibacterial ingredients are added, which is more irritating to the human body
At present, there are units to develop the enteric-coated slow (controlled) release solid dispersion preparation of etoposide, and apply for a patent (application number: 02153962.6), but still can not reach the stable effective blood drug concentration that intravenous injection can achieve, for this reason, clinical There is an urgent need for a new dosage form containing etoposide that can effectively change the above-mentioned drug deficiency

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Etoposide 40mg Citrate 5mg Macrogol 400 1200mg

[0021] Propylene Glycol 200mg Mannitol 600mg

[0022] a. Etoposide is fully dissolved with a mixed solution of polyethylene glycol 400 and propylene glycol;

[0023] b. Dissolve mannitol and citric acid with 4ml of water;

[0024] c. Mix the two solutions prepared by a and b;

[0025] d. Freeze-dry the mixture obtained in c after depyrogenation to obtain this product.

Embodiment 2

[0027] Etoposide 40mg Tartaric acid 6.5mg Macrogol 400 2100mg

[0028] Propylene Glycol 300mg Mannitol 800mg Xylitol 200mg

[0029] a. Etoposide is fully dissolved with a mixed solution of polyethylene glycol 400 and propylene glycol;

[0030] b. Mannitol, xylitol and tartaric acid are dissolved in 7ml of water;

[0031] c. Mix the two solutions prepared by a and b;

[0032] d. Freeze-dry the mixture obtained in c after depyrogenation to obtain this product.

Embodiment 3

[0034] Etoposide 40mg Malic acid 25mg Macrogol 400 1800mg

[0035] Propylene Glycol 300mg Mannitol 700mg Glycine 200mg

[0036] Aspartic Acid 100mg

[0037] a. Etoposide is fully dissolved with a mixed solution of polyethylene glycol 400 and propylene glycol;

[0038] b. Dissolve mannitol, glycine, aspartic acid and malic acid with 4ml of water;

[0039] c. Mix the two solutions prepared by a and b;

[0040] d. Freeze-dry the mixture obtained in c after depyrogenation to obtain this product.

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PUM

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Abstract

A composite medicine containing etoposide in the form of freeze-dried powder injection contains etoposide, organic acid, polyethanediol 400, propanediol and excipient. It has high stability.

Description

【Technical field】 [0001] The invention relates to a pharmaceutical composition of etoposide and a preparation method thereof, in particular to etoposide freeze-dried powder injection and a preparation method thereof. 【Background technique】 [0002] Etoposide is a cytotoxic broad-spectrum antineoplastic drug, and its pharmacokinetics has two main characteristics: (1) because etoposide is reversibly combined with topoisomerase II, and etoposide acts on cells The longer duration of the S phase and the G phase of the cycle 2 Therefore, the duration of blood drug concentration has a greater impact on drug efficacy than the peak concentration, which is a typical time-dependent drug [see: Cavalli F, Sonntag RW, Jung F, et al. VP-16-213 monotherapy for remission induction of small cell lung cancer: arandomized trial using three dosages chedules. Cancer TreatRep, 1978, 62: 473]; (2) when the plasma concentration is 1-3 mg.L -1 When , the cytotoxic effect is better, and the bone mar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/19A61P35/00
Inventor 和芳王波宇周春莺胡玉霞
Owner 云南创立生物医药集团股份有限公司
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