CN100387251C - Film coated tablet for bone injury and preparation process thereof - Google Patents
Film coated tablet for bone injury and preparation process thereof Download PDFInfo
- Publication number
- CN100387251C CN100387251C CNB2005100213418A CN200510021341A CN100387251C CN 100387251 C CN100387251 C CN 100387251C CN B2005100213418 A CNB2005100213418 A CN B2005100213418A CN 200510021341 A CN200510021341 A CN 200510021341A CN 100387251 C CN100387251 C CN 100387251C
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- China
- Prior art keywords
- radix
- film coated
- coated tablet
- fine powder
- musae
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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.)
- Expired - Fee Related
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 239000007941 film coated tablet Substances 0.000 title claims abstract description 18
- 206010061363 Skeletal injury Diseases 0.000 title claims description 12
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 24
- 235000003143 Panax notoginseng Nutrition 0.000 claims abstract description 17
- 241000180649 Panax notoginseng Species 0.000 claims abstract description 17
- 239000003814 drug Substances 0.000 claims abstract description 15
- 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 claims abstract description 12
- 229920002472 Starch Polymers 0.000 claims abstract description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 12
- 239000011734 sodium Substances 0.000 claims abstract description 12
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 12
- 239000008107 starch Substances 0.000 claims abstract description 12
- 235000019698 starch Nutrition 0.000 claims abstract description 12
- 239000011248 coating agent Substances 0.000 claims abstract description 7
- 238000000576 coating method Methods 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims abstract description 5
- 238000009501 film coating Methods 0.000 claims abstract description 4
- 239000000843 powder Substances 0.000 claims description 26
- 239000000758 substrate Substances 0.000 claims description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 10
- 239000006071 cream Substances 0.000 claims description 10
- 239000008187 granular material Substances 0.000 claims description 8
- 239000002671 adjuvant Substances 0.000 claims description 6
- 239000000047 product Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- 239000007779 soft material Substances 0.000 claims description 5
- 206010013786 Dry skin Diseases 0.000 claims description 3
- 230000006837 decompression Effects 0.000 claims description 3
- 238000000605 extraction Methods 0.000 claims description 3
- 239000000706 filtrate Substances 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000005507 spraying Methods 0.000 claims description 3
- 239000010409 thin film Substances 0.000 claims description 3
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 206010017076 Fracture Diseases 0.000 abstract description 3
- 208000001132 Osteoporosis Diseases 0.000 abstract description 3
- 208000014674 injury Diseases 0.000 abstract description 3
- 238000000034 method Methods 0.000 abstract description 3
- 230000001225 therapeutic effect Effects 0.000 abstract description 3
- 230000008736 traumatic injury Effects 0.000 abstract description 3
- 239000003826 tablet Substances 0.000 abstract 2
- 241000123589 Dipsacus Species 0.000 abstract 1
- 235000000139 Musa basjoo Nutrition 0.000 abstract 1
- 240000000569 Musa basjoo Species 0.000 abstract 1
- 241000208167 Oxalis Species 0.000 abstract 1
- 235000008098 Oxalis acetosella Nutrition 0.000 abstract 1
- 241001446509 Psoralea Species 0.000 abstract 1
- 235000013399 edible fruits Nutrition 0.000 abstract 1
- 239000007888 film coating Substances 0.000 abstract 1
- 208000034133 primary 1 avascular necrosis of femoral head Diseases 0.000 abstract 1
- 238000003908 quality control method Methods 0.000 abstract 1
- 208000024891 symptom Diseases 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 5
- 210000000988 bone and bone Anatomy 0.000 description 4
- 238000005728 strengthening Methods 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 210000003205 muscle Anatomy 0.000 description 3
- 208000010392 Bone Fractures Diseases 0.000 description 2
- 208000007875 Femur Head Necrosis Diseases 0.000 description 2
- XDROKJSWHURZGO-UHFFFAOYSA-N angelicin Chemical compound C1=C2OC=CC2=C2OC(=O)C=CC2=C1 XDROKJSWHURZGO-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- ZCCUUQDIBDJBTK-UHFFFAOYSA-N psoralen Chemical compound C1=C2OC(=O)C=CC2=CC2=C1OC=C2 ZCCUUQDIBDJBTK-UHFFFAOYSA-N 0.000 description 2
- VXGRJERITKFWPL-UHFFFAOYSA-N 4',5'-Dihydropsoralen Natural products C1=C2OC(=O)C=CC2=CC2=C1OCC2 VXGRJERITKFWPL-UHFFFAOYSA-N 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- MLMVLVJMKDPYBM-UHFFFAOYSA-N pseudoisopsoralene Natural products C1=C2C=COC2=C2OC(=O)C=CC2=C1 MLMVLVJMKDPYBM-UHFFFAOYSA-N 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 238000004809 thin layer chromatography Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention discloses a gu kang film coated tablet and a preparing method thereof. The gu kang film coated tablet has therapeutical effects on symptoms such as various fractures, traumatic injury, osteoporosis, avascular necrosis of the femoral head, etc. The prsent invention is characterized in that 1000 tablets are prepared from main medicine and auxiliary material according to the following prescription quantity via the steps of extracting Chinese medicine, preparing base tablets and coating film coatings, wherein the main medicine comprises 600g of basjoo root, 400g of wood sorrel, 600g of psoralea fruit, 300g of himalayan teasel root and 150g of radix notoginseng; the auxiliary material comprises 35 to 90g of starch, 5 to 15g of carboxymethylstach sodium and 1.5 to 2.5g of magnesium stearate. The present invention has the advantages of advanced processes, easy quality control, difficult moisture absorption of the prepared preparation, good dispersibility, high stability, rapid absorption, high bioavailability, easy swallow, convenient administration and portability.
Description
Technical field
The present invention relates to a kind of bone and muscle strengthening oral Chinese patent medicine preparation and preparation method thereof, particularly a kind of have oral Film coated tablets of therapeutical effect and preparation method thereof to diseases such as miscellaneous fracture, traumatic injury, osteoporosis, ischemic necrosis of femoral head.
Background technology
The bone and muscle strengthening oral Chinese patent medicine preparation variety that uses at present clinical is various, but because the limitation of dosage form or prescription, more Chinese patent medicine only plays the auxiliary treatment effect.Film coated tablet for bone injury is the new Chinese medicine that the effective ingredient that extracts from All Pure Nature Chinese medicine is made, it has the effect of reducing swelling and alleviating pain, channels sootheing and network vessel quickening, blood circulation promoting and blood stasis dispelling, invigorating the kidney and strengthening the bones, vital energy regualting and blood circulation-promoting, and miscellaneous fracture, traumatic injury, osteoporosis, ischemic necrosis of femoral head etc. are had better curative effect.For excavating the rarity in motherland's medical science, its developmental research is become the convenient Film coated tablets preparation that uses, very positive society and economics meaning will be arranged.
Summary of the invention
One of purpose of the present invention is to provide a kind of bone and muscle strengthening oral Chinese patent medicine Film coated tablets, and the said preparation patient that is more convenient for carries and takes, and keeping and store also more convenient.
Two of purpose of the present invention is to provide the preparation method of this pharmaceutical preparation, and by the medicine that this method obtains, mass ratio is easier to control, and effective ingredient also is easy to detect.
Concrete technical scheme of the present invention is as follows:
A kind of film coated tablet for bone injury is characterized in that: it is to be mixed with 1000 after principal agent by following recipe quantity adds adjuvant again:
Principal agent:
Radix Musae 600g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g
Radix Dipsaci 300g Radix Notoginseng 150g
Adjuvant:
Starch 35～90g
Carboxymethylstach sodium 5～15g
Magnesium stearate 1.5～2.5g
Described starch is the disintegrating agent and the filler of Chinese patent medicine preparation, has capillary tube sample water absorption, between it and the medicated powder bigger peptizaiton is arranged.
Described carboxymethylstach sodium is a disintegrating agent, has the effect of the thorough disintegrate of further promotion preparation.
Described magnesium stearate is the excellent lubrication agent, can effectively improve the fineness of particulate flowability and finished product.
A kind of preparation method of film coated tablet for bone injury is characterized in that: comprise following processing step:
A, extraction Chinese medicine: measure a certain amount of Radix Musae and Radix Notoginseng by prescription earlier, pulverize 100 mesh sieves respectively after the clean dry and made fine powder, again remaining Radix Musae and Herba Oxalidis Corniculatae, Fructus Psoraleae, Radix Dipsaci are added 10 times of water gagings decoctions three times, each 1 hour, collecting decoction filters, and filtrate decompression is concentrated into the thick paste that relative density is 1.31～1.35 (60 ℃), dry below 80 ℃, it is standby that broken mistake 100 mesh sieves of dried cream powder are made fine powder;
B, preparation substrate: the dried cream fine powder that steps A is made and above-mentioned Radix Musae, Radix Notoginseng fine powder and starch, the abundant mix homogeneously of carboxymethylstach sodium, reuse ethanol is made soft material, granulates, in 40 ℃～75 ℃ dryings, carry out always mixing with magnesium stearate behind the granulate, and make substrate through tabletting;
C, pack film-coat: the substrate that step B is suppressed places in the high-efficiency coating pot, and even spraying adds thin film coating material, the heating coating that rolls, and promptly getting sheet heavily is the finished product of 0.45～0.52g.
The invention has the advantages that:
1, technology advanced person of the present invention, quality is easy to control, and the Film coated tablets of making is Chinese medicine advanced person's dosage form, and is with high content of technology, and patient's taking convenience can increase the crowd of being suitable for.
2, preparation of the present invention is difficult for the moisture absorption, and good stability not only is easy to swallow, and takes not only convenient but also be easy to absorb, and has the few but characteristics of curative effect and other dosage form equivalence of dose.
3, the present invention adopts high performance liquid chromatography, and the content of psoralen and isopsoralen is measured, and it is qualitative to adopt thin layer chromatography that Radix Musae, Radix Notoginseng, Fructus Psoraleae are carried out again simultaneously, thereby has fully guaranteed controllable quality.
4, preparation good dispersion of the present invention, absorb fast, bioavailability is high, therapeutic effect is good, and carries more convenient.
The specific embodiment
Embodiment 1
A kind of film coated tablet for bone injury is characterized in that: it is formulated by the principal agent of following recipe quantity and adjuvant:
Radix Musae 600g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g
Radix Dipsaci 300g Radix Notoginseng 150g
Starch 35g
Carboxymethylstach sodium 5g
Magnesium stearate 1.5g
Make 1000
A kind of preparation method of film coated tablet for bone injury is characterized in that: comprise following processing step:
A, extraction Chinese medicine: measure a certain amount of Radix Musae and Radix Notoginseng by prescription earlier, pulverize 100 mesh sieves respectively after the clean dry and made fine powder, again remaining Radix Musae and Herba Oxalidis Corniculatae, Fructus Psoraleae, Radix Dipsaci are added 10 times of water gagings decoctions three times, each 1 hour, collecting decoction filters, and filtrate decompression is concentrated into the thick paste that relative density is 1.31～1.35 (60 ℃), dry below 80 ℃, it is standby that broken mistake 100 mesh sieves of dried cream powder are made fine powder;
B, preparation substrate: the dried cream fine powder that steps A is made and above-mentioned Radix Musae, Radix Notoginseng fine powder and starch, the abundant mix homogeneously of carboxymethylstach sodium, reuse ethanol is made soft material, granulates, in 40 ℃～75 ℃ dryings, carry out always mixing with magnesium stearate behind the granulate, and make substrate through tabletting;
C, pack film-coat: the substrate that step B is suppressed places in the high-efficiency coating pot, and even spraying adds thin film coating material, and the heating coating that rolls promptly gets sheet and heavily is the finished product of 0.45g.
Embodiment 2
A kind of film coated tablet for bone injury is characterized in that: it is formulated by the principal agent of following recipe quantity and adjuvant:
Radix Musae 600g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g
Radix Dipsaci 300g Radix Notoginseng 150g
Starch 60g
Carboxymethylstach sodium 10g
Magnesium stearate 2g
Make 1000
A kind of preparation method of film coated tablet for bone injury, it is characterized in that: by above-mentioned recipe quantity, earlier Radix Musae, Radix Notoginseng are pulverized 100 mesh sieves and made fine powder, to remain again and make dried cream powder after Radix Musae and its excess-three kind principal agent decoct with water, broken mistake 100 mesh sieves of dried cream powder are made fine powder, with above-mentioned Radix Musae, Radix Notoginseng fine powder and starch, the abundant mix homogeneously of carboxymethylstach sodium, reuse ethanol is made soft material, behind granulation, drying, granulate, carry out always mixing with magnesium stearate, and make substrate through tabletting, pack film-coat, promptly get sheet and heavily be the finished product of 0.48g.
Embodiment 3
Radix Musae 600g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g
Radix Dipsaci 300g Radix Notoginseng 150g
Starch 90g
Carboxymethylstach sodium 15g
Magnesium stearate 2.5g
Make 1000
A kind of preparation method of film coated tablet for bone injury, it is characterized in that: by above-mentioned recipe quantity, earlier Radix Musae, Radix Notoginseng are pulverized 100 mesh sieves and made fine powder, to remain again and make dried cream powder after Radix Musae and its excess-three kind principal agent decoct with water, broken mistake 100 mesh sieves of dried cream powder are made fine powder, with above-mentioned Radix Musae, Radix Notoginseng fine powder and starch, the abundant mix homogeneously of carboxymethylstach sodium, reuse ethanol is made soft material, behind granulation, drying, granulate, carry out always mixing with magnesium stearate, and make substrate through tabletting, pack film-coat, promptly get sheet and heavily be the finished product of 0.52g.
Claims (2)
1. film coated tablet for bone injury is characterized in that: it is to be mixed with 1000 after principal agent by following recipe quantity adds adjuvant again:
Principal agent:
Radix Musae 600g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g
Radix Dipsaci 300g Radix Notoginseng 150g
Adjuvant:
Starch 35～90g
Carboxymethylstach sodium 5～15g
Magnesium stearate 1.5～2.5g.
2. the preparation method of film coated tablet for bone injury as claimed in claim 1 is characterized in that: comprise following processing step:
A, extraction Chinese medicine: measure a certain amount of Radix Musae and Radix Notoginseng by prescription earlier, pulverize 100 mesh sieves respectively after the clean dry and made fine powder, again remaining Radix Musae and Herba Oxalidis Corniculatae, Fructus Psoraleae, Radix Dipsaci are added 10 times of water gagings decoctions three times, each 1 hour, collecting decoction filters, and filtrate decompression is concentrated into relative density and is determined as 1.31～1.35 thick paste in the time of 60 ℃, dry below 80 ℃, it is standby that broken mistake 100 mesh sieves of dried cream powder are made fine powder;
B, preparation substrate: the dried cream fine powder that steps A is made and above-mentioned Radix Musae, Radix Notoginseng fine powder and starch, the abundant mix homogeneously of carboxymethylstach sodium, reuse ethanol is made soft material, granulates, in 40 ℃～75 ℃ dryings, carry out always mixing with magnesium stearate behind the granulate, and make substrate through tabletting;
C, pack film-coat: the substrate that step B is suppressed places in the high-efficiency coating pot, and even spraying adds thin film coating material, the heating coating that rolls, and promptly getting sheet heavily is the finished product of 0.45～0.52g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100213418A CN100387251C (en) | 2005-07-28 | 2005-07-28 | Film coated tablet for bone injury and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100213418A CN100387251C (en) | 2005-07-28 | 2005-07-28 | Film coated tablet for bone injury and preparation process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1736410A CN1736410A (en) | 2006-02-22 |
| CN100387251C true CN100387251C (en) | 2008-05-14 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100213418A Expired - Fee Related CN100387251C (en) | 2005-07-28 | 2005-07-28 | Film coated tablet for bone injury and preparation process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100387251C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103454374B (en) * | 2013-08-29 | 2015-03-25 | 贵州维康药业有限公司 | Detection method of bone rehabilitation medicine |
-
2005
- 2005-07-28 CN CNB2005100213418A patent/CN100387251C/en not_active Expired - Fee Related
Non-Patent Citations (2)
| Title |
|---|
| 《国家中成药标准汇编》（中成药地方标准上升国家标准部分）. 国家药品监督管理局编，312－313页. 2002 |
| 《国家中成药标准汇编》（中成药地方标准上升国家标准部分）. 国家药品监督管理局编，312－313页. 2002 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1736410A (en) | 2006-02-22 |
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| Date | Code | Title | Description |
|---|---|---|---|
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: SICHUAN LIANCHENG XUNKANG MEDICINE CO., LTD. Free format text: FORMER OWNER: YUE SHUNJIANG Effective date: 20150820 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20150820 Address after: 610000 Sichuan City, Chengdu Province, Qingyang Road, No. 229, No. 6, building 1, No. 5 Patentee after: Sichuan is unified into fast health medicine limited company Address before: 610041, 10 building, 5 garden, Rainbow Garden, Nanpu West Road, Chengdu, Sichuan, Wuhou District 3, China Patentee before: Yue Shunjiang |
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| TR01 | Transfer of patent right |
Effective date of registration: 20190702 Address after: 620000 No. 6 Xiangzhang Road, Meishan Economic Development Zone, Meishan City, Sichuan Province Patentee after: Sichuan Senke Pharmaceutical Co. Ltd. Address before: 610000 No. 1, 5th Floor, Building 229 Jingye Road, Qingyang District, Chengdu City, Sichuan Province Patentee before: Sichuan is unified into fast health medicine limited company |
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Granted publication date: 20080514 Termination date: 20200728 |
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| CF01 | Termination of patent right due to non-payment of annual fee |