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Folic acid composition for treating intestinal flora imbalance induced constipation and diarrhea

A technology of composition and folic acid, which is applied in the direction of medical raw materials derived from bacteria, drug combinations, medical preparations containing active ingredients, etc., and can solve problems such as bacterial imbalance

Inactive Publication Date: 2016-03-02
CINKATE PHARMA INTERMEDIATES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are a variety of microorganisms in the intestinal tract of the human body. Under normal conditions, the types and proportions of these microorganisms are balanced, but when taking antibiotics or other antifolate drugs, the flora is often imbalanced

Method used

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  • Folic acid composition for treating intestinal flora imbalance induced constipation and diarrhea
  • Folic acid composition for treating intestinal flora imbalance induced constipation and diarrhea

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0071] The preparation method of pellets or pills mainly includes two steps: drug loading and coating.

[0072] The drug loading is to directly coat the folic acid powder of the drug on the outer surface of the round core particle (also called the drug) or use different techniques to mix the drug and excipients to form a round pellet directly. The drug-loading method of the present invention mainly includes a pill core drug method and a direct pill method.

[0073] In the present invention, when the folic acid pellets are prepared by the method of bolus core drug application, the folic acid pellets include a pellet core, a drug layer, an isolation layer and a functional layer in order from the inside to the outside.

[0074] The coating method of the drug layer is as follows: the active ingredient of the drug, folic acid, the adhesive in the drug layer, and water and / or organic solvent are formulated into a drug solution, and the drug solution is sprayed on the surface of the blank p...

Embodiment 1

[0091] Preparation of pellets (pills) and capsules

[0092] Pellets prescription (10000 capsules)

[0093] (0.9-1.12mm) sucrose core 105.3g

[0094] Folic acid 9.1g

[0095] PVPS630 (Germany BASF) 1.8g

[0096] HPMC2.3g

[0097] EudragitS10011.1g

[0098] EudragitL1002.8g

[0099] Triethyl citrate 82.1g

[0100] Talc 4.3g

[0101] 186ml of water

[0102] 95% ethanol 268ml

[0103] Preparation process: add 1.8g PVPS630 and 9.1g folic acid into 75ml water to make the upper medicinal solution; add 2.3g HPMC into 111ml water to make isolation layer liquid; preparation of EudragitS100 and EudragitL100 alcohol solution: Dissolve 11.1gEudragitS100, 2.8EudragitL100 in proper amount of ethanol , 82.1g of triethyl citrate and 4.3g of talc are added to the remaining 95% ethanol, and the solution containing the plasticizer and anti-adhesive agent is poured into the Eudragit solution to make a functional layer coating solution. Put 105.3g of sucrose blank pellets with an average particle size of 0.9-1.12...

Embodiment 2

[0106] Preparation of pellets (pills) and capsules

[0107] Pellets prescription (10000 capsules)

[0108] 0.6-0.8mm starch pellet core 607.5g

[0109] Folic acid 21.8g

[0110] PVPVA64 (Germany BASF) 25.7g

[0111] HPC117.9g

[0112] Eudragit S100 (Evonik Degussa) 157.3g

[0113] Eudragit L100-55 (Evonik Degussa) 98.9g

[0114] NaOH solution (1mol / L / 4%) 32.9g

[0115] Ammonia (1mol / L / 1.7%) 115.5g

[0116] Propylene glycol 11.8g

[0117] Polyethylene glycol 138.6g

[0118] Glyceryl monostearate 98.9g

[0119] Water 4441ml

[0120] Preparation process: The preparation method of the upper liquid medicine and the isolation layer is the same as that of Example 1.

[0121] The preparation method of the functional layer is as follows: (1) Preparation of Eudragit L100-55 aqueous dispersion coating solution: Add 272 ml of water to a beaker, and sprinkle 98.9 g Eudragit L100-55 in portions under stirring. Slowly add 32.9g of sodium hydroxide solution under stirring, continue to stir for 30 minutes to obt...

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Abstract

The invention discloses a folic acid composition for treating intestinal flora imbalance induced constipation and diarrhea. The folic acid composition includes a pharmaceutically acceptable folic acid carrier. The dissolution rate of the folic acid composition at a pH value of 6.8-7 within 45-90min reaches 90% or above. The invention also discloses a preparation method of a pill, a capsule and a tablet of the folic acid composition. The folic acid composition can be optionally combined with probiotics to effectively prevent and / or treat the intestinal flora imbalance induced constipation and diarrhea.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a folic acid composition for treating constipation or diarrhea caused by intestinal flora imbalance and a preparation method thereof. Background technique [0002] Folic acid is a water-soluble B vitamin composed of pteridine, p-aminobenzoic acid and glutamic acid residues. It is a substance necessary for the growth and reproduction of body cells and helps protein metabolism. There are many kinds of microorganisms in the human intestinal tract. Under normal conditions, the types and proportions of these microorganisms are in balance. However, taking antibiotics or other antifolate drugs often leads to flora imbalance. [0003] The main symptom of dysbacteriosis is the occurrence of constipation or diarrhea. In the current treatment of constipation or diarrhea, symptomatic treatment is often applied to increase or decrease gastrointestinal motility. In a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K35/74A61P1/10A61P1/12
Inventor 肖飞刘荣军柯兴发李秋实张丽娜袁西伦
Owner CINKATE PHARMA INTERMEDIATES
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