Compositions comprising euphorbia prostrata and process of preparation thereof

A composition and a technique for dried spurge, applied in the field of compositions containing creeping spurge and its preparation, to achieve the effect of low long-term effectiveness

Inactive Publication Date: 2011-05-04
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Oral pharmaceutical compositions containing about 0.1% to about 99% by weight of Euphorbia creeping dry extract and pharmaceutically acceptable excipients have not been disclosed in the prior art, wherein the dry Euphorbia creeping extract or drug or active agent having an effective mean particle size of no more than about 500 microns, wherein the composition is preferably within the first 15 minutes when tested according to the dissolution method described herein using a physiological pH range of about 2 to about 7.5 and optionally using a surfactant Provides a release of not less than about 50% of the dry Euphorbia creeper extract or drug or active agent, and provides a release of not less than about 80% of the dry Euphorbia creeper extract after an entire dissolution study of about 60 minutes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0030] In an embodiment of the present invention, there is provided a preparation method of an oral pharmaceutical composition for treating anorectal or colon diseases such as hemorrhoids, dehiscence, chapped, fistula, abscess, inflammatory bowel disease, etc., said pharmaceutical composition Comprising Euphorbia creeping extract and pharmaceutically acceptable excipients as described herein, the preparation method comprises the following steps:

[0031] i) drying the extract to produce the desired pharmaceutically acceptable extract,

[0032] ii) mixing the dry extract obtained from step (i) with a pharmaceutically acceptable excipient,

[0033] iii) formulating the mixture obtained from step (ii) into a suitable dosage form.

[0034] Dissolution Study Methods

[0035] The dissolution research method (I) of the present invention has the following parameters:

[0036] Dissolution medium: 0.5% w / v sodium lauryl sulfate in distilled water

[0037] Dissolution medium volume: ...

Embodiment 1

[0054] Sample No. Composition mg / tablet

[0055] 1. Creeping Euphorbia Dried Extract 100

[0056] (The effective average particle size does not exceed 500 microns)

[0057] 2. Mannitol 348.85

[0058] 3. Microcrystalline cellulose 41

[0059] 4. Pregelatinized starch 5.5

[0060] 5. Pure water (appropriate amount) is lost during processing

[0061] 6. Croscarmellose Sodium 10

[0062] 7. Glyceryl Dibehenate 3

[0063] 8. Anhydrous colloidal silica 3

[0064] 9. Magnesium stearate 1.65

[0065] 10. Crospovidone 37

[0066] Basic Coating

[0067] 11. Opadry II 13.75

[0068] 12. Pure water (appropriate amount) lost during processing

[0069] program:

[0070] i) Sieve Euphorbia creeping dry extract, microcrystalline cellulose and mannitol through a 30# mesh sieve, and mix together.

[0071] ii) Pregelatinized starch was dispersed in pure water by continuous stirring to prepare a binder solution.

[0072] iii) The binder solution of step (ii) is mixed with the mater...

Embodiment 2

[0079] Sample No. Composition mg / tablet

[0080] 1. Creeping Euphorbia Dried Extract 100

[0081] (The effective average particle size does not exceed 500 microns)

[0082] 2. Lactose 340

[0083] 3. Microcrystalline cellulose 45

[0084] 4. Polyvinylpyrrolidone 5

[0085] 5. Pure water (appropriate amount) is lost during processing

[0086] 6. Sodium starch glycolate 10

[0087] 7. Magnesium stearate 3.5

[0088] 8. Anhydrous colloidal silica 3

[0089] 9. Stearic acid 1.5

[0090] 10. Crospovidone 35

[0091] Basic Coating

[0092] 11. Opadry II 13.75

[0093] 12. Pure water (appropriate amount) is lost during processing

[0094] film coating

[0095] 13. Opadry AMB 19.73

[0096] 14. Pure water (appropriate amount) lost during processing

[0097] program:

[0098] i) Sieve Euphorbia creeping dry extract, lactose and microcrystalline cellulose through a 30# mesh sieve and mix together.

[0099] ii) A binder solution was prepared by dispersing polyvinylpyrroli...

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Abstract

Oral pharmaceutical compositions comprising dry extract of Euphorbia prostrata from about 0.1% to about 99% by weight wherein the effective average particle size of the dry extract of Euphorbia prostrata is not more than about 500 microns with pharmaceutically acceptable excipient(s) and process(s) for the preparation of such compositions useful for the treatment of anorectal disease and colonic diseases such as hemorrhoids, fissures, cracks, fistulas, abscesses, inflammatory bowel disease and the like are provided. Further, the pharmaceutical compositions of the present invention provides for the administration of a therapeutically and / or prophylactically effective amount of the Euphorbia prostrata wherein the compositions possess properties to control inflammation, prevent capillary bleeding and fragility in mammalians, particularly human beings. Preferably the compositions of the present invention are in the form of tablets, minitablets, powders, capsules, pellets, granules, beads, compacts and the like. The present invention also provides prophylactic and / or therapeutic methods of using such compositions for the treatment of anorectal diseases including hemorrhoids and colonic diseases.

Description

field of invention [0001] The present invention relates to oral pharmaceutical compositions comprising from about 0.1% to about 99% by weight of dry extract of Euphorbia prostrata and pharmaceutically acceptable excipients, wherein the effective mean particle size of the dry extract of Euphorbia prostrata is not more than about 500 microns, and also relates to methods for the preparation of such compositions useful in the treatment of anorectal and colonic diseases, such as hemorrhoids, fissures, fissures, fistulas, abscesses, inflammatory bowel diseases, and the like. Furthermore, the pharmaceutical composition of the present invention provides for administration a therapeutically and / or prophylactically effective amount of Euphorbia creeper, wherein said composition has the property of controlling inflammation, preventing capillary hemorrhage and fragility in mammals, especially humans . In addition, the composition preferably provides not less than about 50% creep in the f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/47A61K9/00A61P17/00
CPCA61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K9/284A61K9/2886A61K9/4858A61K9/4866A61K36/47A61P1/00A61P1/04A61P17/00A61P29/00
Inventor 拉杰什·贾殷苏克吉特·辛格希尔帕·波哈辛
Owner PANACEA BIOTEC
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