CN1762367A - Ursodeoxycholic acid pills formula and its preparation method - Google Patents
Ursodeoxycholic acid pills formula and its preparation method Download PDFInfo
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- CN1762367A CN1762367A CN 200410155375 CN200410155375A CN1762367A CN 1762367 A CN1762367 A CN 1762367A CN 200410155375 CN200410155375 CN 200410155375 CN 200410155375 A CN200410155375 A CN 200410155375A CN 1762367 A CN1762367 A CN 1762367A
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- China
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- acid
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- preparation
- ursodeoxycholic acid
- pills
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 title claims abstract description 32
- 229960001661 ursodiol Drugs 0.000 title claims abstract description 32
- 239000006187 pill Substances 0.000 title claims abstract description 20
- RUDATBOHQWOJDD-UHFFFAOYSA-N (3beta,5beta,7alpha)-3,7-Dihydroxycholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)CC2 RUDATBOHQWOJDD-UHFFFAOYSA-N 0.000 title claims abstract description 13
- 238000002360 preparation method Methods 0.000 title claims description 11
- 238000000034 method Methods 0.000 claims abstract description 7
- 239000003814 drug Substances 0.000 claims description 14
- 239000000758 substrate Substances 0.000 claims description 14
- 239000002826 coolant Substances 0.000 claims description 10
- 229940079593 drug Drugs 0.000 claims description 6
- 230000000694 effects Effects 0.000 claims description 5
- 230000001804 emulsifying effect Effects 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 239000002253 acid Substances 0.000 claims description 3
- 239000012530 fluid Substances 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 claims description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 2
- 239000001828 Gelatine Substances 0.000 claims description 2
- 241000238631 Hexapoda Species 0.000 claims description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 2
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- 229950009789 cetomacrogol 1000 Drugs 0.000 claims description 2
- 229940008099 dimethicone Drugs 0.000 claims description 2
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 claims description 2
- 235000011187 glycerol Nutrition 0.000 claims description 2
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229940057995 liquid paraffin Drugs 0.000 claims description 2
- 229960003511 macrogol Drugs 0.000 claims description 2
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 2
- 229960000502 poloxamer Drugs 0.000 claims description 2
- 229920001983 poloxamer Polymers 0.000 claims description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 2
- 229940093430 polyethylene glycol 1500 Drugs 0.000 claims description 2
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 2
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 239000001993 wax Substances 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- 238000010008 shearing Methods 0.000 claims 1
- 239000008280 blood Substances 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 abstract description 4
- 208000006454 hepatitis Diseases 0.000 abstract description 4
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 abstract description 3
- 206010008909 Chronic Hepatitis Diseases 0.000 abstract description 2
- 230000001154 acute effect Effects 0.000 abstract description 2
- 208000019425 cirrhosis of liver Diseases 0.000 abstract description 2
- 201000005577 familial hyperlipidemia Diseases 0.000 abstract description 2
- 206010016654 Fibrosis Diseases 0.000 abstract 1
- 230000002279 cholagogic effect Effects 0.000 abstract 1
- 230000007882 cirrhosis Effects 0.000 abstract 1
- 239000000470 constituent Substances 0.000 abstract 1
- 208000001130 gallstones Diseases 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 description 8
- 239000007962 solid dispersion Substances 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 238000001035 drying Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- IIEJGTQVBJHMDL-UHFFFAOYSA-N 2-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]-5-[2-oxo-2-[3-(sulfamoylamino)pyrrolidin-1-yl]ethyl]-1,3,4-oxadiazole Chemical compound C1CN(CC1NS(=O)(=O)N)C(=O)CC2=NN=C(O2)C3=CN=C(N=C3)NC4CC5=CC=CC=C5C4 IIEJGTQVBJHMDL-UHFFFAOYSA-N 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 201000001883 cholelithiasis Diseases 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 210000000232 gallbladder Anatomy 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 238000007500 overflow downdraw method Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention provides a cholagogic Ursodeoxycholic acid drop pill for lowering blood fat and blood sugar, treating cholestrin, gall stone, hyperlipemia, acute and chronic hepatitis, cirrhosis, and its preparing process. The drop pill is prepared from Ursodeoxycholic acid as the main constituent, and right amount of base by a predetermined proportion through combined processes.
Description
Technical field
The present invention relates to a kind of strong liver of function of gallbladder promoting that has, blood fat reducing, blood sugar lowering, anti-frightened effect, be used for the dissolution therapy of cholesterol, cholelithiasis, and be applicable to hyperlipemia, acute and chronic hepatitis, the prescription of the pharmaceutical preparation of liver cirrhosis and manufacture method specifically are the dropping pill formulation and the technology manufacture method thereof of main component with the ursodesoxycholic acid.
Background technology
Ursodesoxycholic acid, 3 α, 7 beta-dihydroxies-5 β-cholestane-24 acid, molecular formula: C
24H
40O
4, ursodesoxycholic acid is one of active ingredient of Fel Ursi, modern pharmacological research shows that cardiovascular disease is also had good therapeutical effect.Drop pill is a kind of pill that utilizes the solid dispersion technology system of dripping to form, and utilizes water-solubility carrier to improve the dissolubility and the dissolution rate of medicine, improves the infiltration rate and the absorbtivity of medicine, thereby improves bioavailability, improves the curative effect of medicine.
Summary of the invention
The object of the present invention is to provide oral Ursodeoxycholic acid pills preparation that a kind of drug effect is fast, bioavailability is high and preparation method thereof, and effectively control its quality.It is molten soon diffusing that the Ursodeoxycholic acid pills that this preparation adopts solid dispersion technology and dropping pill formulation Technology to make not only has disintegrate, the dissolution height, steady quality, the pill volume is little, and both can swallow also can buccal, easy to carry and use, onset is characteristics rapidly, but also have working condition and advantage such as production equipment is simple, and production cost is low, demonstrated fully the new drug research exploitation spirit that people-oriented.
The solution of the present invention is: adopt solid dispersion technology, produce little, quick-acting, the pharmaceutical dosage form efficiently of dosage.
Drop pill is the product of solid dispersion technology, is characterized in: adopt fusion method to make medicine be scattered in the physiology inertia with molecularity and in the carrier soluble in water, form disperse system.(3～4um) is also little, thereby improved surface area greatly, and its bioavailability is much higher than the medicine of general dosage form than micronized particles for drug particle (0.001-0.1um).After entering the intestines and stomach, water-solubility carrier dissolves rapidly, because particle is little, the solid dispersion dissolution velocity is fast, can be absorbed by cell rapidly to enter blood circulation, thereby reach efficient and quick-acting effects.
For achieving the above object, the present invention by the following technical solutions: 1 weight portion ursodesoxycholic acid is added in the 2 weight portion molten matrix, and the emulsifying of high speed shear ultra micro splashes into and is condensed into ball in the coolant, removes coolant, drying, promptly.
Substrate among the present invention includes but not limited to Polyethylene Glycol 12000, polyethylene glycol 6000, Macrogol 4000, polyethylene glycol 1500, cetomacrogol 1000, Macrogol 600, PEG400, sodium stearate, glycerin gelatine, poloxamer, stearic acid, glycerol monostearate acid, insect wax etc.
Coolant among the present invention includes but not limited to dimethicone, liquid paraffin, plant wet goods.
Medicine of the present invention is made (consumption is a weight portion) by following component:
1 part of ursodesoxycholic acid
1～9 part of substrate
The ratio range of the formula optimization weight of preparation medicine of the present invention is:
1 part of ursodesoxycholic acid
1.5～3 parts of substrate
The optimum weight proportioning of medicine of the present invention is:
1 part of ursodesoxycholic acid
2 parts of substrate
Said components is made method of the present invention is:
With substrate heating, fully dissolving.
Two, ursodesoxycholic acid is joined in the substrate emulsifying of high speed shear ultra micro
Three, medicinal liquid is splashed in the coolant, rely on surface tension to be shrunk to ball naturally.
Another important feature of the present invention is the high speed shear ultra micro emulsification technology by uniqueness, and effective ingredient is organically combined, fully fusion, and therefore, " ursodesoxycholic acid sheet " curative effect of more existing old dosage form is better.
Medicine of the present invention is taked the recipe quantity of 6 kinds of different proportions, and through the dissolve scattered time limit test, its result shows than reference substance " ursodesoxycholic acid sheet " bigger advantage is arranged.
Dissolve scattered time limit: check according to inspection technique disintegration (two appendix XA of Chinese Pharmacopoeia version in 2000):
| Medicine name or numbering | Dissolve scattered time limit (min) |
| The ursodesoxycholic acid sheet | 32 |
| Example 1 | 15 |
| Example 2 | 12 |
| Example 3 | 10 |
| Example 4 | 12 |
| Example 5 | 11 |
| Example 6 | 13 |
The specific embodiment
Embodiment (1000, every 50mg):
Ursodesoxycholic acid: 1 part
Polyethylene Glycol: 2 parts
Make 1000 altogether, every heavy 50mg
Glutinous? the Tan (a state in the Zhou Dynasty) crucible:
Ursodesoxycholic acid by said components joins in the molten matrix, and the emulsifying of high speed shear ultra micro is incubated in 85 ℃ of fluid reservoirs.
With coolant cools to the 10 ℃ system of dripping, water dropper to the distance of coolant liquid level is 5cm, opens and by-pass cock, and medicinal liquid is splashed in the coolant according to certain frequency in cooling column, and messenger drug drips slowly and sinks, and relies on self tension force to be shrunk to ball gradually.After becoming ball, clean the coolant on surface, drying at room temperature or blowing and finished product.
Claims (9)
1. prescription of Ursodeoxycholic acid pills and preparation method thereof is characterized in that the weight proportion of ursodesoxycholic acid and substrate is: 1: 1～1: 9.
Wherein said ursodesoxycholic acid meets standards of pharmacopoeia.
2. Ursodeoxycholic acid pills preparation according to claim 1 is characterized in that wherein the weight proportion preferable range of ursodesoxycholic acid and substrate is: 1: 1.5～1: 3.
3. Ursodeoxycholic acid pills preparation according to claim 1 is characterized in that wherein the optimum weight proportioning of ursodesoxycholic acid and substrate is: 1: 2.
4. according to claim 1,2 or 3 described Ursodeoxycholic acid pills, it is characterized in that described medicament is a drop pill.
5. a manufacture method for preparing the described Ursodeoxycholic acid pills of claim 5 is characterized in that: choose ursodesoxycholic acid by the state-promulgated pharmacopoeia standard;
Choose substrate by national standard;
Any one is heated to 85 ℃ of fusings with substrate by claim 1-3 with above-mentioned effective ingredient; Join then in the substrate, the emulsifying of high speed shear ultra micro, fluid reservoir is incubated at 85 ℃, injects fluid reservoir, open switch, adjust pressure and vacuum equipment, splash at regular time and quantity in 5～15 ℃ the coolant, under capillary effect, be shrunk to ball naturally, clean dry after promptly.
6. the preparation method of Ursodeoxycholic acid pills according to claim 5 is characterized in that:
Wherein ursodesoxycholic acid adds dissolve with ethanol.
7. the preparation method of Ursodeoxycholic acid pills according to claim 5 is characterized in that:
Medicine is added 85 ℃ of fully substrate high speed shearing ultra micro emulsifyings of fusing of temperature.
8. substrate according to claim 5 includes but not limited to Polyethylene Glycol 12000, polyethylene glycol 6000, Macrogol 4000, polyethylene glycol 1500, cetomacrogol 1000, Macrogol 600, PEG400, sodium stearate, glycerin gelatine, poloxamer, stearic acid, glycerol monostearate acid, insect wax etc.
9. coolant according to claim 5 includes but not limited to dimethicone, liquid paraffin, plant wet goods.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155375 CN1762367A (en) | 2004-10-18 | 2004-10-18 | Ursodeoxycholic acid pills formula and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155375 CN1762367A (en) | 2004-10-18 | 2004-10-18 | Ursodeoxycholic acid pills formula and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1762367A true CN1762367A (en) | 2006-04-26 |
Family
ID=36746825
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410155375 Pending CN1762367A (en) | 2004-10-18 | 2004-10-18 | Ursodeoxycholic acid pills formula and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1762367A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106687460A (en) * | 2014-07-29 | 2017-05-17 | 深圳君圣泰生物技术有限公司 | Berberine salt, ursodeoxycholate, related compound and its preparation method and application |
| CN109200243A (en) * | 2018-09-30 | 2019-01-15 | 泓博元生命科技（深圳）有限公司 | A kind of blood-fat reducing composition, preparation and the preparation method and application thereof |
| CN109224029A (en) * | 2018-09-30 | 2019-01-18 | 泓博元生命科技（深圳）有限公司 | Blood-fat reducing composition, preparation containing NMN and the preparation method and application thereof |
| KR20190076687A (en) * | 2017-12-22 | 2019-07-02 | 연세대학교 산학협력단 | Pharmaceutical compositions for preventing or treating cholesterol gallstone comprising ursodeoxycholic acid(UDCA) and omega-3 and process for producing the same |
-
2004
- 2004-10-18 CN CN 200410155375 patent/CN1762367A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106687460A (en) * | 2014-07-29 | 2017-05-17 | 深圳君圣泰生物技术有限公司 | Berberine salt, ursodeoxycholate, related compound and its preparation method and application |
| CN106687460B (en) * | 2014-07-29 | 2019-05-17 | 深圳君圣泰生物技术有限公司 | Berberine salt, ursodeoxycholate, related compound and preparation method and application thereof |
| US10301303B2 (en) | 2014-07-29 | 2019-05-28 | Shenzhen Hightide Biopharmaceutical, Ltd. | Berberine salts, ursodeoxycholic salts and combinations, methods of preparation and application thereof |
| US10988471B2 (en) | 2014-07-29 | 2021-04-27 | Shenzhen Hightide Biopharmaceutical, Ltd. | Pharmaceutical composition comprising berberine ursodeoxycholic acid salt for the treatment of various diseases or disorders |
| US11685735B2 (en) | 2014-07-29 | 2023-06-27 | Shenzhen Hightide Biopharmaceutical, Ltd. | Pharmaceutical composition comprising berberine salts for the treatment of various diseases or disorders |
| KR20190076687A (en) * | 2017-12-22 | 2019-07-02 | 연세대학교 산학협력단 | Pharmaceutical compositions for preventing or treating cholesterol gallstone comprising ursodeoxycholic acid(UDCA) and omega-3 and process for producing the same |
| CN109200243A (en) * | 2018-09-30 | 2019-01-15 | 泓博元生命科技（深圳）有限公司 | A kind of blood-fat reducing composition, preparation and the preparation method and application thereof |
| CN109224029A (en) * | 2018-09-30 | 2019-01-18 | 泓博元生命科技（深圳）有限公司 | Blood-fat reducing composition, preparation containing NMN and the preparation method and application thereof |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
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