CN100586432C - Yiganling dispersion tablet for treating liver disease and its preparation method - Google Patents
Yiganling dispersion tablet for treating liver disease and its preparation method Download PDFInfo
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- CN100586432C CN100586432C CN200510135679A CN200510135679A CN100586432C CN 100586432 C CN100586432 C CN 100586432C CN 200510135679 A CN200510135679 A CN 200510135679A CN 200510135679 A CN200510135679 A CN 200510135679A CN 100586432 C CN100586432 C CN 100586432C
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- silymarin
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- ethanol
- hydrogen phosphate
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- 238000002360 preparation method Methods 0.000 title claims description 12
- 208000019423 liver disease Diseases 0.000 title claims description 7
- 239000006185 dispersion Substances 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 41
- SEBFKMXJBCUCAI-UHFFFAOYSA-N NSC 227190 Natural products C1=C(O)C(OC)=CC(C2C(OC3=CC=C(C=C3O2)C2C(C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-UHFFFAOYSA-N 0.000 claims description 40
- SEBFKMXJBCUCAI-HKTJVKLFSA-N silibinin Chemical compound C1=C(O)C(OC)=CC([C@@H]2[C@H](OC3=CC=C(C=C3O2)[C@@H]2[C@H](C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-HKTJVKLFSA-N 0.000 claims description 40
- 229960004245 silymarin Drugs 0.000 claims description 31
- 235000017700 silymarin Nutrition 0.000 claims description 31
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 17
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 17
- 239000007919 dispersible tablet Substances 0.000 claims description 16
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 12
- SEBFKMXJBCUCAI-DBMPWETRSA-N silybin Chemical compound C1=C(O)C(OC)=CC(C2C(OC3=CC=C(C=C3O2)[C@@H]2[C@H](C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-DBMPWETRSA-N 0.000 claims description 11
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 9
- 235000014899 silybin Nutrition 0.000 claims description 9
- 239000002671 adjuvant Substances 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 8
- 239000000843 powder Substances 0.000 claims description 8
- 229950000628 silibinin Drugs 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 7
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 7
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 210000005229 liver cell Anatomy 0.000 abstract description 2
- 230000008569 process Effects 0.000 abstract description 2
- 239000000654 additive Substances 0.000 abstract 1
- 230000003908 liver function Effects 0.000 abstract 1
- 239000008187 granular material Substances 0.000 description 18
- 230000000694 effects Effects 0.000 description 12
- 239000003814 drug Substances 0.000 description 11
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 10
- 239000000463 material Substances 0.000 description 9
- 239000000080 wetting agent Substances 0.000 description 9
- 239000002994 raw material Substances 0.000 description 6
- 239000003826 tablet Substances 0.000 description 6
- 239000002552 dosage form Substances 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 238000012216 screening Methods 0.000 description 4
- 208000006454 hepatitis Diseases 0.000 description 3
- 206010008909 Chronic Hepatitis Diseases 0.000 description 2
- 206010019799 Hepatitis viral Diseases 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 210000003494 hepatocyte Anatomy 0.000 description 2
- 230000008595 infiltration Effects 0.000 description 2
- 238000001764 infiltration Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 201000001862 viral hepatitis Diseases 0.000 description 2
- 241000700721 Hepatitis B virus Species 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- FDQAOULAVFHKBX-UHFFFAOYSA-N Isosilybin A Natural products C1=C(O)C(OC)=CC(C2C(OC3=CC(=CC=C3O2)C2C(C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 FDQAOULAVFHKBX-UHFFFAOYSA-N 0.000 description 1
- 102000004020 Oxygenases Human genes 0.000 description 1
- 108090000417 Oxygenases Proteins 0.000 description 1
- VLGROHBNWZUINI-UHFFFAOYSA-N Silybin Natural products COc1cc(ccc1O)C2OC3C=C(C=CC3OC2CO)C4Oc5cc(O)cc(O)c5C(=O)C4O VLGROHBNWZUINI-UHFFFAOYSA-N 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 102000003929 Transaminases Human genes 0.000 description 1
- 108090000340 Transaminases Proteins 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 208000002672 hepatitis B Diseases 0.000 description 1
- 206010073071 hepatocellular carcinoma Diseases 0.000 description 1
- 230000002443 hepatoprotective effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 150000003254 radicals Chemical class 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 229940043175 silybin Drugs 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A dispersing tablet of Yiganling for improving liver functions, protecting liver cell and treating hepatitides is prepared from silymarinum and proper additives. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of content from Yi-Gan-Ling Dispersible Tablets that is used for the treatment of hepatopathy and preparation method thereof, belong to technical field of Chinese medicine.
Technical background
Hepatitis B is one of common transmittable disease of current serious harm people ' s health, and infectiousness is strong, and treatment is difficult, and easily develops into chronic hepatitis, and wherein part can develop into liver cirrhosis and primary hepatoma.So study effective Therapeutic Method is the very important task of medical circle.The medicine that is used at present the Type B viral hepatitis treatment both at home and abroad is numerous, and the Chinese medicine Type B viral hepatitis has sure curative effect.According to document record, the history in existing more than 2,000 year.Along with the development of medical science and modern science, adopt Chinese medicine and modern medicine to combine, make curative effect bring up to new level, demonstrate the peculiar advantage of Chinese medicine hepatitis.
Yiganling tablet shows that through clinical verification for many years the treatment that this medicine is used for acute, chronic hepatitis has better curative effect.Its main component silymarin (silymarin) have significantly protect the liver, the effect of hepatoprotective, studies show that to have the free radical resisting activity recently; Lipoid peroxidization resistant; The effect of lipotropism oxygenase; Antitumor action; Effects such as blood fat reducing; Clinical research is the result show, with the silymarin be Yiganling tablet that raw material is made have suppress hepatitis B virus duplication, repair damaged hepatocyte, promote liver cell regeneration, reduce serum the transaminase, improve effect such as hepatocyte function.But because the silymarin slightly soluble in water in the silybin influences its dissolving and absorbs, exist bioavailability low simultaneously, drawback such as dosage form falls behind, and the curative effect undulatory property is big, limited in clinical use.For this reason, develop the very big concern that a kind of bioavailability height, dosage form advanced person, the sure novel dosage form of curative effect just are subjected to medicine enterprise and research and development unit.
Summary of the invention
Based on Yiganling tablet treatment hepatopathy good clinical basis and the present deficiency that exists, the object of the present invention is to provide a kind of new pharmaceutical dosage form and preparation method thereof, the said preparation dosage form is not so good at the dissolubility of silymarin, influence the drawback that its dissolving absorbs, be made into the dispersible tablet of the good reputation of Peroral solid dosage form liquid, not only increased its dissolubility in water greatly, can in cold water, form uniform suspension after the disintegrate fast, directly drunk; Also can directly swallow taking convenience; Increased surface area simultaneously, drug release is fast, can increase the infiltration rate of Herba Silybi mariani, plays quick-acting and effect efficiently.
The present invention constitutes like this:
A kind of content from Yi-Gan-Ling Dispersible Tablets preparation that is used for the treatment of hepatopathy is characterized in that, it mainly is made by silymarin and suitable adjuvant.Described silymarin must not be less than 68% in silibinin; Described adjuvant is meant disintegrating agent, filler, wetting agent.Specifically, calculate according to parts by weight, it mainly is made by silymarin (in silibinin) 50-100 part, low-substituted hydroxypropyl cellulose 30-70 part, microcrystalline Cellulose 0-20 part and an amount of calcium hydrogen phosphate.Best proportioning is: calculate according to parts by weight, it mainly is made by 77 parts of silymarin (in silibinin), 50 parts of low-substituted hydroxypropyl celluloses, 10 parts of microcrystalline Cellulose and an amount of calcium hydrogen phosphate.
A kind of preparation method that is used for the treatment of the content from Yi-Gan-Ling Dispersible Tablets of hepatopathy is: water intaking flies silibin and the pharmaceutic adjuvant pulverize separately becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulate in right amount with 40-80% ethanol, and drying, tabletting, promptly.
Specifically, this dispersible tablet is like this preparation: water intaking flies silibin and low-substituted hydroxypropyl cellulose, the microcrystalline Cellulose pulverize separately becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulate in right amount with 60% ethanol, and drying, tabletting, promptly.
At prior art, the dissolubility of silymarin is not so good, and ordinary preparation can not improve its deliquescent drawback well, the present invention is made into dispersible tablet, not only improved its dissolubility in water greatly, and the mode of taking is various, can in cold water, forms uniform suspension after the disintegrate fast, also directly drink and directly to swallow taking convenience; Increased surface area simultaneously, drug release is fast, can increase the infiltration rate of Herba Silybi mariani, plays quick-acting and effect efficiently.While preparation low production cost of the present invention; Advantages such as quality controllability, medicine stability, bioavailability improve greatly.
The inventor finds in development process, the kind of disintegrating agent, consumption, and the concentration of wetting agent has considerable influence to it, and for this reason, the applicant has carried out a series of experiments, to prove beneficial effect of the present invention.
Experimental example 1: technology examination
1.1 wetting agent screening
With carboxymethyl starch sodium (CMS) is that disintegrating agent, calcium hydrogen phosphate are filler, and fixing prescription screens wetting agent, the results are shown in following table.
Table: the screening of wetting agent (unit: gram)
Name of material 1 name of material, the 2 names of material prescription 3 of writing out a prescription of writing out a prescription
Silymarin 11 silymarin 11 silymarin 11
CMS 6C MS 5 CMS 4
Calcium hydrogen phosphate 3 calcium hydrogen phosphate 4 calcium hydrogen phosphate 5
80% ethanol Q.S, 60% ethanol Q.S, 40% ethanol Q.S
The about 4% granule water content about 4% of the about 4% granule water content of granule water content
Disintegrate (branch) 4 disintegrates (branch) 5 disintegrates (branch) 3.8
Hardness (KG) 2.8 hardness (KG) 3.6 hardness (KG) 4.5
The frangible outward appearance good appearance of outward appearance part partly has pit
Last table shows that 40%～80% ethanol all can satisfy the preparation requirement substantially, but each material is formed under the identical condition in prescription, and when the ethanol with 80% was wetting agent, the part granule was looser, and the tablet that is pressed into is frangible, illustrates that granule viscosity is not enough; When 40% ethanol was wetting agent, pellet hardness tablet big, that be pressed into partly had pit; 60% ethanol liquid is during as wetting agent, and granule viscosity is moderate, and the slice, thin piece hardness that is pressed into is moderate, and outward appearance is good.Therefore, 60% ethanol as wetting agent for more preferably selecting.
1.2 disintegrating agent screening
All too slow in view of the disintegration of tablet that above-mentioned 3 prescriptions are pressed into, do not reach dispersible tablet desired disintegration, possible cause is that CMS meets the sticking cause of water.Therefore change CMS into L-HPC (low-substituted hydroxypropyl cellulose), result such as following table:
Prescription screening tables of data (unit: gram)
Name of material 4 names of material, the 5 names of material prescription 6 of writing out a prescription of writing out a prescription
Silymarin 11 silymarin 11 silymarin 11
L-HPC 3 L-HPC 7 L-HPC 7
MCC 2 MCC 2 calcium hydrogen phosphate 2
Calcium hydrogen phosphate 4 60% ethanol Q.S 60% ethanol Q.S
60% ethanol Q.S
The about 4% granule water content about 4% of the about 4% granule water content of granule water content
Disintegrate (branch) 1.0 disintegrates (branch) 2.0 disintegrates (branch) 1.5
Hardness (KG) 4 hardness (KG) 4.3 hardness (KG) 3.5
The name of material 7 names of material prescription 8 of writing out a prescription
Silymarin 11 silymarin 11
L-HPC 3 L-HPC 3
Calcium hydrogen phosphate 6 MCC 6
60% ethanol Q.S, 60% ethanol Q.S
The about 4% granule water content about 4% of granule water content
Disintegrate (branch) 1.0 disintegrates (branch) 2.0
Hardness (KG) 3.8 hardness (KG) 4.4
Last table result shows: content from Yi-Gan-Ling Dispersible Tablets can be made by silymarin (in silibinin) 50-100 part, low-substituted hydroxypropyl cellulose 30-70 part, microcrystalline Cellulose 0-20 part and an amount of calcium hydrogen phosphate.
Because of the moisture silibin that flies of regulation in the silymarin raw material must not be less than 68% in silibinin, the amount of raw material silymarin should be converted by actual content when feeding intake, so be the dosage regulator with the calcium hydrogen phosphate, adds to full dose.
Concrete embodiment
Part is a unit of weight, as ton, kilogram, gram.
Embodiment 1: 77 parts of silymarin *, 50 parts of low-substituted hydroxypropyl celluloses, 10 parts of microcrystalline Cellulose, calcium hydrogen phosphate are an amount of
The adjuvant pulverize separately that water intaking flies in silibin * and the prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulates in right amount with 60% ethanol, and drying, compacting promptly gets dispersible tablet of the present invention in flakes.
Embodiment 2: 50 parts of silymarin *, 30 parts of low-substituted hydroxypropyl celluloses, calcium hydrogen phosphate are an amount of
The adjuvant pulverize separately that water intaking flies in silibin * and the prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulates in right amount with 70% ethanol, and drying, compacting promptly gets dispersible tablet of the present invention in flakes.
Embodiment 3: 100 parts of silymarin *, 70 parts of low-substituted hydroxypropyl celluloses, 20 parts of microcrystalline Cellulose, calcium hydrogen phosphate are an amount of
The adjuvant pulverize separately that water intaking flies in silibin * and the prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulates in right amount with 40% ethanol, and drying, compacting promptly gets dispersible tablet of the present invention in flakes.
Embodiment 4: 60 parts of silymarin *, 50 parts of low-substituted hydroxypropyl celluloses, 5 parts of microcrystalline Cellulose, calcium hydrogen phosphate are an amount of
The adjuvant pulverize separately that water intaking flies in silibin * and the prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulates in right amount with 50% ethanol, and drying, compacting promptly gets dispersible tablet of the present invention in flakes.
Embodiment 5: 85 parts of silymarin *, 30 parts of low-substituted hydroxypropyl celluloses, 1 part of microcrystalline Cellulose, calcium hydrogen phosphate are an amount of
The adjuvant pulverize separately that water intaking flies in silibin * and the prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, granulates in right amount with 80% ethanol, and drying, compacting promptly gets dispersible tablet of the present invention in flakes.
Annotate: * refer to this amount in the silymarin raw material moisture fly silibin in the actual content of silibinin (because of stipulating in the silymarin raw material that the moisture silibin that flies is in silibinin, must not be less than 68%, so the amount of raw material silymarin should be converted by actual content when feeding intake).
Claims (1)
1, a kind of content from Yi-Gan-Ling Dispersible Tablets that is used for the treatment of hepatopathy, it is characterized in that calculate by weight, it mainly is made in right amount by 77 parts of silymarin, 50 parts of low-substituted hydroxypropyl celluloses, 10 parts of microcrystalline Cellulose, calcium hydrogen phosphate, wherein, silymarin weight is in silibinin; Its preparation method is: the adjuvant pulverize separately during water intaking flies silibin and writes out a prescription becomes fine powder, with the method mix homogeneously that equivalent increases progressively, uses 60% alcohol granulation, drying, and compacting promptly gets content from Yi-Gan-Ling Dispersible Tablets in flakes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200510135679A CN100586432C (en) | 2005-12-31 | 2005-12-31 | Yiganling dispersion tablet for treating liver disease and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200510135679A CN100586432C (en) | 2005-12-31 | 2005-12-31 | Yiganling dispersion tablet for treating liver disease and its preparation method |
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| Publication Number | Publication Date |
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| CN100586432C true CN100586432C (en) | 2010-02-03 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101856396B (en) * | 2009-04-07 | 2012-07-25 | 北京天科仁祥医药科技有限公司 | Dispersible tablet for treating hepatitis B and preparation method thereof |
| CN106511757A (en) * | 2016-11-10 | 2017-03-22 | 苏州慧宁堂生物科技有限公司 | Silymarin worm grass lozenge and preparing method |
-
2005
- 2005-12-31 CN CN200510135679A patent/CN100586432C/en active Active
Non-Patent Citations (4)
| Title |
|---|
| 分散片中的崩解剂. 王玉玲.食品与药品，第7卷第3A期. 2005 |
| 分散片中的崩解剂. 王玉玲.食品与药品，第7卷第3A期. 2005 * |
| 药物新剂型. 朱盛山，108-113，化学工业出版社. 2003 |
| 药物新剂型. 朱盛山，108-113，化学工业出版社. 2003 * |
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