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Composition for treating autonomic nerve disorder, preparation and uses thereof

A composition and drug technology, applied in the direction of drug combination, steroids, nervous system diseases, etc., can solve the problems of poor water solubility, etc., and achieve the effect of low cost, high purity of raw materials, and reduced irritation

Active Publication Date: 2010-09-01
BEIJING CENTURY BIOCOM PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Refined and purified cycloartenyl ferulic acid ester composition (the sum of the percentages of cycloartenyl ferulic acid ester and 24-methylene cycloartenyl ferulic acid ester is more than 90%) , can be further made into water-soluble injection and freeze-dried powder preparation for intravenous injection, which solves the problem of poor water solubility of the product

Method used

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  • Composition for treating autonomic nerve disorder, preparation and uses thereof
  • Composition for treating autonomic nerve disorder, preparation and uses thereof
  • Composition for treating autonomic nerve disorder, preparation and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. Take 1kg of commercially available oryzanol raw material (purity is 70-75%"), use 5 times the amount of ethyl acetate and absolute ethanol mixed solution with a ratio of 20:1, reflux to dissolve, filter, stand still, precipitate crystals and filter, Drying. The dried crystals (purity is about 84-88%) are reconstituted with 8 times the amount of ethyl acetate, filtered, left to stand, crystals are precipitated, filtered, and dried. The above recrystallization steps are repeated 3-5 times.

[0043] 2. Combine and recover the mother liquor filtered out after recrystallization in step 1 until the volume is 2 times that of the contained solute, let stand, precipitate crystals, filter, and dry.

[0044] 3. The crystallization (purity is about 85-87%) in step 2 is refluxed and dissolved with 8 times the amount of ethyl acetate, filtered, allowed to stand, crystals are precipitated, filtered, and dried. Repeat the above recrystallization step 3-5 times.

[0045] 4. Combine ...

Embodiment 2

[0050] 1. Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol-acetonitrile (40:60) is used as mobile phase; flow rate is 1.5ml / min; detection wavelength is 327nm; sensitivity is 0.005 AUFS. The number of theoretical plates should not be less than 2000 according to the calculation.

[0051] 2. Preparation of the test solution: Accurately weigh 10 mg of the commercially available oryzanol raw material and 10 mg of the raw material of the present invention, put it in a 10 ml measuring bottle, add water to dissolve and constant volume, and shake well to obtain the test solution.

[0052] 3. Determination: Accurately draw 10 μl of the test solution, inject it into a liquid chromatograph, record the chromatogram, and check the percentage content of each component by the area normalization method.

[0053] 4. Measurement results

[0054] Table 2 Measurement results

[0055]

[0056] Illustrate tha...

Embodiment 3

[0058] prescription

[0059] 1000 bottles of freeze-dried powder of the present invention for injection (containing 20 mg / bottle of the present invention):

[0060] Raw material 20g of the present invention

[0061] Macrogol 400 250g

[0062] Tween 80 250g

[0063] 10% Mannitol 6000g

[0064] Add water for injection to 5000ml

[0065] A total of 1000 tubes were freeze-dried

[0066] In the prescription, the raw material of the present invention is used as the main agent, Tween 80 is used as a solubilizing agent, polyethylene glycol 400 is used as a cosolvent, mannitol is used as a proppant, and water for injection is used as a freeze-drying solvent.

[0067] Preparation process

[0068] Weigh the raw material of the present invention, Tween-80, PEG-400, mannitol and 80% of the prescribed amount of water for injection, stir to make the raw material of the present invention dissolve until the solution is clear, stir at room temperature for 20 minutes, and filter with a 0.4...

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Abstract

The invention discloses a composition taking cycloartenyl ferulate and 24-methylene cycloartenyl ferulate as active ingredients, a preparation of the composition used as a medicine, and an application of the preparation. The total content of the cycloartenyl ferulate and the 24-methylene cycloartenyl ferulate is over 90 percent of the total active ingredients by weight percentage. As the medicine, the composition can be injection and frozen-dried powder injection and also can be an oral solid preparation, a medicine composition used for treating autonomic imbalance, climacteric syndrome, primary dysmenorrheal and premenstrual tension, periodic psychosis, vascular headache, head trauma syndrome, gastrointestinal imbalance and hyperlipemia, etc.

Description

technical field [0001] The invention relates to a medicine for treating autonomic nervous disorder, climacteric syndrome, primary dysmenorrhea, premenstrual tension disorder, periodic psychosis, vascular headache, head trauma syndrome, gastrointestinal nervous disorder and hyperlipidemia. Composition, preparation containing the pharmaceutical composition, preparation process and use thereof. Background technique [0002] With the gradual acceleration of the pace of life and work in modern society, the sub-health status of modern urbanites is not optimistic. According to statistics, patients with autonomic disorders, menopausal syndrome, primary dysmenorrhea, premenstrual tension, etc., due to autonomic dysfunction, lead to an imbalance between sympathetic and parasympathetic nerves, and the incidence of non-organic diseases is increasing year by year. trend. [0003] Autonomic disorders are usually caused by mental trauma, long-term tension and fatigue, which lead to weake...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/575A61K9/08A61P25/00
CPCA61K9/0019A61K31/575A61K31/215A61K9/19C07J75/00A61P3/06A61P15/12A61P25/00A61P25/18A61P43/00
Inventor 郝守祝
Owner BEIJING CENTURY BIOCOM PHARMA TECH
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