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Temperature-sensitive controlled-release pharmaceutical composition of taxane drugs

A technology of taxanes and compositions, applied in the field of medicine, can solve the problems of patient suffering, dose-dependent immunosuppression, hypersensitivity reactions and the like

Active Publication Date: 2015-07-22
王子厚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the structure, microtubule binding ability and pharmacokinetic characteristics of different taxane drugs are different, they have similar side effects, such as dose-dependent immunosuppression, followed by neurotoxicity, mucositis, and hair loss. and gastrointestinal reactions
And because the solubility of taxane drugs in water is low, non-ionic surfactants are often used for solubilization in the injections of such drugs on the market. For example, polyoxyethylated castor oil is used for solubilization in paclitaxel injection. However, docetaxel injection uses Tween 80 to solubilize, etc., and these solvents usually cause hypersensitivity reactions and bring great pain to patients.

Method used

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  • Temperature-sensitive controlled-release pharmaceutical composition of taxane drugs
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  • Temperature-sensitive controlled-release pharmaceutical composition of taxane drugs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Embodiment 1: preparation pharmaceutical composition of the present invention

[0089] formula

[0090] paclitaxel

0.2g

Chitosan

2g

Sodium β-glycerophosphate

10g

ethanol

2.5g

Cit

1 / 100

water

Appropriate amount, add to 100g

Final solution pH

7.0

[0091] Preparation: under the conditions of preparing sterile preparations, prepare according to the following steps:

[0092] a) dissolving chitosan with an aqueous solution (0.1M acetic acid) of an acidic reagent is made into a 2.5% chitosan solution;

[0093] b) dissolving taxanes in ethanol, then slowly adding it to the above-mentioned chitosan solution, autoclaving, cooling in an ice-water bath for at least 30 minutes, and setting aside;

[0094] c) Dissolve β-glycerophosphate sodium in an appropriate amount of water for injection to make a solution with a concentration of 60%, pass through a 0.22 μm filter membrane to sterilize, coo...

Embodiment 2

[0097] Embodiment 2: preparation pharmaceutical composition of the present invention

[0098] formula:

[0099] paclitaxel

0.05g

Chitosan

3g

Sodium β-glycerophosphate

5g

ethanol

5g

Cit

0.5 / 100

water

Appropriate amount, add to 100g

Final solution pH

6.5

[0100] Preparation: Carry out with reference to the method of Example 1, use 0.1M hydrochloric acid to dissolve chitosan in step a).

[0101] The results of fluidity measurement: gelation time (t1, 37°C) = 7min, decoagulation time (t2, 20°C) = 56min.

Embodiment 3

[0102] Embodiment 3: preparation pharmaceutical composition of the present invention

[0103] formula:

[0104] paclitaxel

0.5g

Chitosan

1g

Sodium β-glycerophosphate

15g

ethanol

1g

Cit

2 / 100

water

Appropriate amount, add to 100g

Final solution pH

7.5

[0105] Preparation: Carry out with reference to the method of Example 1.

[0106] The results of fluidity measurement: gelling time (t1, 37°C) = 57min, defrosting time (t2, 20°C) = 12min.

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PUM

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Abstract

The invention relates to a temperature-sensitive controlled-release pharmaceutical composition of taxane drugs. Specifically speaking, the invention relates to the pharmaceutical composition which comprises taxane drugs, chitosan, sodium beta-glycerophosphate, ethanol and water, and further relates to a preparation method for the pharmaceutical composition. The pharmaceutical composition can be used for preparation of anticancer drugs. In particular, the anticancer drugs are applied to treatment of malignant tumors or prevention of recurrence after operation through a stereotaxical injection approach and can be cooperatively used with radiotherapy and traditional Chinese medicine.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a pharmaceutical composition for tumor / cancer treatment, in particular to a slow-release temperature-sensitive pharmaceutical composition containing taxane pharmaceutical components. The composition of the present invention can be administered by intratumoral injection, peritumoral injection and other localized injection methods for the treatment of various tumors, especially for those tumors that are highly toxic or cannot be treated with conventional chemotherapy or radiation, it can be administered after localization. Local injection in the tumor can increase the drug concentration to improve the curative effect and reduce systemic toxicity. Background technique [0002] Cancer is a disease caused by abnormalities in the mechanisms that control cell growth and proliferation. In addition to being able to proliferate indefinitely, cancer cells can locally invade surrounding no...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/06A61K31/337A61K47/36A61K47/24A61K47/12A61P35/00
Inventor 陈西敬王子厚李萃云李大魁唐伟松曲昌海冯凤仪赵娣梅丹
Owner 王子厚
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