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Vinorelbine soft capsule and method for preparation and application thereof

A technology of vinorelbine and vinorelbine tartrate, which is applied in the field of capsule preparations and can solve problems such as complex prescriptions

Active Publication Date: 2008-03-05
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] But the prescription of this composition is relatively complicated, and there are still unsatisfactory places that need further improvement, such as the stability of the active ingredient, the negative promotion effect of the auxiliary material on the adverse reaction after taking the drug, etc.

Method used

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  • Vinorelbine soft capsule and method for preparation and application thereof
  • Vinorelbine soft capsule and method for preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The prescription screening of embodiment 1 soft capsule

[0018] Preparation: According to the following prescriptions A-C, take the prescription amount of each auxiliary material in a clean container, add the prescribed amount of vinorelbine tartrate raw materials while stirring, stir to dissolve, and become a clear liquid. Then on the soft capsule machine, the liquid is encapsulated in the soft capsule material composed of gelatin and pressed into pellets, and dried.

[0019] The preparation composition of table 1 vinorelbine soft capsule

[0020]

[0021] See Table 2 for the results of the stability investigation test of formulations A-C.

[0022] Table 2 Dissolution Data and Related Substances of Vinorelbine Soft Capsules

[0023] A

B

C

When the preparation is complete

Vinorelbine was completely dissolved,

Slightly sticky.

Vinorelbine was completely dissolved,

Slightly sticky.

Vinorelbine was completely...

Embodiment 2

[0026] Embodiment 2 soft capsule liquid filling composition prescription (according to 1000 grains):

[0027] Vinorelbine Tartrate 27.7g

[0028] Ethanol 70g

[0029] Macrogol 400 707.3g

Embodiment 3

[0030] Embodiment 3 soft capsule liquid filling composition prescription (according to 1000 grains):

[0031] Vinorelbine Tartrate 41.5g

[0032] Ethanol 65g

[0033] Macrogol 400 707.5g

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Abstract

The present invention relates to a prescription-improved navelbine soft capsule, its preparation method and application. It is characterized by that said soft capsule composition contains navelbine or navelbine tartrate, ethyl alcohol and polyethylene glycol, and in said soft capsule the water and glycerine are not contained.

Description

technical field [0001] The invention relates to a capsule preparation, in particular to a soft capsule containing vinorelbine, in particular to a soft capsule of vinorelbine tartrate. Background technique [0002] Vinorelbine belongs to the vinblastine class of antineoplastic drugs that inhibit cell division. It directly acts on the dynamic balance of tubulin / microtubules, inhibits the polymerization of tubulin, and disintegrates microtubules during division. Only at high concentrations Affects axonal microtubules, has a lower effect on tubulin helicalization than vincristine, and causes cell death in interphase or anaphase by blocking mitosis of cells in G2 and M phases. Clinically, it is mainly used for the treatment of non-small cell lung cancer and metastatic breast cancer. [0003] The main form of drug currently used clinically is the intravenous route. After intravenous administration, the pharmacokinetics presents a three-compartment model, the average half-life of...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/475A61K47/34A61K47/10A61P35/00
Inventor 钟慧娟
Owner JIANGSU HANSOH PHARMA CO LTD
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