CN1470245A - Low-molecular-weight chondroitin sulfate injecta and its preparation method - Google Patents
Low-molecular-weight chondroitin sulfate injecta and its preparation method Download PDFInfo
- Publication number
- CN1470245A CN1470245A CNA031143741A CN03114374A CN1470245A CN 1470245 A CN1470245 A CN 1470245A CN A031143741 A CNA031143741 A CN A031143741A CN 03114374 A CN03114374 A CN 03114374A CN 1470245 A CN1470245 A CN 1470245A
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- CN
- China
- Prior art keywords
- injection
- chondroitin sulfate
- molecular weight
- low
- milliliters
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- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 title claims abstract description 59
- 229920001287 Chondroitin sulfate Polymers 0.000 title claims abstract description 59
- 229940059329 chondroitin sulfate Drugs 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title claims description 9
- 238000002347 injection Methods 0.000 claims abstract description 50
- 239000007924 injection Substances 0.000 claims abstract description 50
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 21
- 229940079593 drug Drugs 0.000 claims abstract description 17
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 12
- 239000011780 sodium chloride Substances 0.000 claims abstract description 12
- 239000008103 glucose Substances 0.000 claims abstract description 10
- 239000000203 mixture Substances 0.000 claims abstract description 5
- 230000002265 prevention Effects 0.000 claims abstract 2
- 239000003795 chemical substances by application Substances 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 13
- KXKPYJOVDUMHGS-OSRGNVMNSA-N chondroitin sulfate Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](OS(O)(=O)=O)[C@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](C(O)=O)O1 KXKPYJOVDUMHGS-OSRGNVMNSA-N 0.000 claims description 9
- 159000000000 sodium salts Chemical class 0.000 claims description 6
- 159000000007 calcium salts Chemical class 0.000 claims description 5
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 5
- 210000000845 cartilage Anatomy 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 241001465754 Metazoa Species 0.000 claims description 3
- 239000000284 extract Substances 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 1
- 239000008223 sterile water Substances 0.000 claims 1
- 229940090044 injection Drugs 0.000 abstract description 33
- 230000000694 effects Effects 0.000 abstract description 3
- 201000001320 Atherosclerosis Diseases 0.000 abstract description 2
- 206010061218 Inflammation Diseases 0.000 abstract description 2
- 208000025747 Rheumatic disease Diseases 0.000 abstract description 2
- 229940093181 glucose injection Drugs 0.000 abstract description 2
- 230000004054 inflammatory process Effects 0.000 abstract description 2
- 230000000552 rheumatic effect Effects 0.000 abstract description 2
- 238000000034 method Methods 0.000 abstract 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 4
- 150000008064 anhydrides Chemical class 0.000 description 4
- 229910052799 carbon Inorganic materials 0.000 description 4
- 238000005261 decarburization Methods 0.000 description 4
- 238000010438 heat treatment Methods 0.000 description 4
- 238000009413 insulation Methods 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 239000008215 water for injection Substances 0.000 description 4
- 241000283690 Bos taurus Species 0.000 description 2
- 241000251730 Chondrichthyes Species 0.000 description 2
- 208000031226 Hyperlipidaemia Diseases 0.000 description 2
- 241001494479 Pecora Species 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 241000282898 Sus scrofa Species 0.000 description 2
- 206010049040 Weight fluctuation Diseases 0.000 description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010003210 Arteriosclerosis Diseases 0.000 description 1
- 229920002683 Glycosaminoglycan Polymers 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000000489 anti-atherogenic effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229940004830 chondroitin sulfate a sodium Drugs 0.000 description 1
- 230000007012 clinical effect Effects 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- 230000000055 hyoplipidemic effect Effects 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 208000004296 neuralgia Diseases 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 230000036284 oxygen consumption Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- FGCSIJPPCNCQJB-FAOVPRGRSA-M sodium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal;chloride Chemical compound [Na+].[Cl-].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O FGCSIJPPCNCQJB-FAOVPRGRSA-M 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
- 150000003751 zinc Chemical class 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
Abstract
The invention is a low-molecular weight chondroitin-sulfate injection drug composition and the preparing method. The drug composition comprises the low-molecular weight chondroitin sulfate for injection, the molecular weight range 2000-8000 Daltons, and the injection glucose and/or injection NaCl. According to the preparing method of medicinal injection, the produced large-capacity low-molecular weight chondroitin-sulfate glucose injection, low-molecular weight chondroitin-sulfate NaCl injection, low-molecular weight chondroitin-sulfate glucose-NaCl injection and small-capacity low-molecular weight chondroitin-sulfate injection have very good curative effect on the prevention and cure of atherosclerosis, rheumatic inflammation, and so on.
Description
[technical field]
The present invention relates to a kind of injecting medicine-feeding form of low-molecular weight chondroitin sulfate.
[background technology]
The present invention is drug regimen of a kind of low-molecular weight chondroitin sulfate injection and preparation method thereof.
Chondroitin sulfate is that a kind of waste material with aquatic products such as animal cartilage tissues such as pig, cattle, sheep and shark cartilage is a raw material, the macromole acid mucopolysaccharide series products that utilizes biochemical extraction process technology to make.Its sodium salt, potassium salt, calcium salt, zinc salt etc. are widely used in medicines and health protection product, food, cosmetics, feed for pet etc.As hypolipidemic, clinical practice chondroitin sulfate sheet treatment hyperlipidemia, the effect that the chondroitin sulfate A sodium injection has blood fat reducing and anti-atherogenic speckle to form, and anticoagulant is arranged and reduce the effect of body oxygen consumption, be used for the treatment of atheromatosis, angina pectoris, hyperlipidemia etc.
Medicinal chondroitin sulfate is mainly the mixture of chondroitin sulfate A, two kinds of configurations of chondroitin sulfate C, has different physiological roles, play an important role keeping on tissue and the immune function, be used to prevent and treat neuropathic pains such as coronary heart disease, treatment migraine, improve senile function of joint degeneration etc.
Existing commercial sulfuric acid chrondroitin medicine mainly contains: medicines such as oral dosage form (tablet, capsule), injection, eye drop.The crude drug that all medicines adopt is the water-soluble poly zoarium of bigger chondroitin sulfate A of molecular weight fluctuation range and chondroitin sulfate C, or the sodium salt of chondroitin sulfate A, chondroitin sulfate C.
At present the chondroitin sulfate medicine is not still recorded by the national drug standards (" Chinese pharmacopoeia), and existing drug standard--ministry standard does not have clear and definite requirement to its molecular weight ranges.
Generally, production technology and technology according to the medicinal chondroitin sulfate raw material of national drug administrative service division official approval, the molecular weight of resulting chondroitin sulfate pharmaceutical injection raw material is 5,000～50, between 000 dalton, the mean molecule quantity of chondroitin sulfate A is 50,000 dalton, the mean molecule quantity of chondroitin sulfate C is 25,000 dalton.Medicines such as existing Chondroitine Sulfate A injection are still got by the bigger chondroitin sulfate crude drug preparation of molecular weight fluctuation range.
Yet, the pharmacologically active and the molecular weight of chondroitin sulfate have confidential relation, U.S. Pat P3,405,120 have proved that molecular weight is 5,300-3, during 500 dalton, the pharmacologically active of chondroitin sulfate is the strongest, has better therapeutic to preventing and treating atherosclerosis, rheumatic inflammation and wound healing etc.
The low-molecular weight chondroitin sulfate injection should have than common molecular weight chondroitin sulfate essence injecta better clinical effect.At present, the injection medicine listing that has low-molecular weight chondroitin sulfate to make is not seen by China.
[summary of the invention]
The invention provides drug regimen of a kind of low-molecular weight chondroitin sulfate injection and preparation method thereof.But this pharmaceutical composition mainly by injection, molecular weight ranges is 2,000-8,000 daltonian low-molecular weight chondroitin sulfate, glucose for injection, sodium chloride for injection is formed.
The principal agent low-molecular weight chondroitin sulfate of indication of the present invention, from animal cartilage tissues such as pig, cattle, sheep, shark, extract, meet injection raw material medicinal standard, mean molecule quantity is lower than 10,000 daltonian chondroitin sulfate includes but not limited to low-molecular weight chondroitin sulfate A and sodium salt thereof, potassium salt, calcium salt; Low-molecular weight chondroitin sulfate C and sodium salt thereof, potassium salt, calcium salt; The mixture of low-molecular weight chondroitin sulfate A and salt and low-molecular weight chondroitin sulfate C and salt.
Low-molecular weight chondroitin sulfate injection of the present invention comprises following specification: 1 milliliter, 2 milliliters, 5 milliliters, 10 milliliters, 50 milliliters, 100 milliliters, 250 milliliters, 500 milliliters, 1000 milliliters.
The preferred concentration of low-molecular weight chondroitin sulfate injection principal agent of the present invention (in percentage by weight g/100ml) scope is 0.04-4.0%, and perhaps every (bottle) preferred drug content scope is 10-1000mg.
Preferred concentration of glucose (in percentage by weight g/100ml) scope is 5-10% in the low-molecular weight chondroitin sulfate injection of the present invention, generally adds glucose when preparation high capacity (100ml or more than) injection.
Preferred sodium chloride concentration (in percentage by weight g/100ml) scope is 0.45-0.9% in the low-molecular weight chondroitin sulfate injection of the present invention.Generally when preparation high capacity (100ml or more than) injection, add sodium chloride.
[the specific embodiment 1
The following examples are provided,, but do not limit the present invention in any way so that be described in detail scope of the present invention in all fields.
Embodiment 1
The present embodiment prescription is as follows:
Per 1,000 consumption of per 1 consumption
Low-molecular weight chondroitin sulfate (by anhydride) 80mg 80g
Water for injection adds to 2ml 2L
The principal agent low-molecular weight chondroitin sulfate is fed intake by 105% of recipe quantity, be dissolved in water, add water to volume, mixing, 60-70 ℃ of heating also is incubated; Add 0.1% injection active carbon, 60-70 ℃ adds insulation about 20 minutes, and Sha Xin filters decarburization; Fill; Seal; 115 ℃ of pressure sterilizings 30 minutes; Quality examination promptly gets the low-molecular weight chondroitin sulfate injection of 2ml.
Embodiment 2
The present embodiment prescription is as follows:
Per 1, the 000 bottle of consumption of per 1 bottle of consumption
Low-molecular weight chondroitin sulfate (by anhydride) 100mg 100g
Sodium chloride 0.9g 900g
Water for injection adds to 100ml 100L
The principal agent low-molecular weight chondroitin sulfate is fed intake by 105% of recipe quantity, be dissolved in water, add the sodium chloride dissolving, add water to volume, mixing, 60-70 ℃ of heating also is incubated; Add 0.1% injection active carbon, 60-70 ℃ adds insulation about 20 minutes, and Sha Xin filters decarburization; Fill; Seal; 120 ℃ of pressure sterilizings 30 minutes; Quality examination promptly gets the low-molecular weight chondroitin sulfate injection of 100ml.
Embodiment 3
The present embodiment prescription is as follows:
Per 1, the 000 bottle of consumption of per 1 bottle of consumption
Low-molecular weight chondroitin sulfate (by anhydride) 200mg 100g
Glucose 5.0g 500g
Water for injection adds to 250ml 250L
The principal agent low-molecular weight chondroitin sulfate is fed intake by 105% of recipe quantity, be dissolved in water, add the glucose dissolving, add water to volume, mixing, 60-70 ℃ of heating also is incubated; Add 0.1% injection active carbon, 60-70 ℃ adds insulation about 20 minutes, and Sha Xin filters decarburization; Fill; Seal; 120 ℃ of pressure sterilizings 30 minutes; Quality examination, the low-molecular weight chondroitin sulfate glucose injection agent that promptly gets 250ml.
Embodiment 4
The present embodiment prescription is as follows:
Per 1, the 000 bottle of consumption of per 1 bottle of consumption
Low-molecular weight chondroitin sulfate (by anhydride) 200mg 100g
Sodium chloride 4.5g 450g
Glucose 5.0g 500g
Water for injection adds to 500ml 500L
The principal agent low-molecular weight chondroitin sulfate is fed intake by 105% of recipe quantity, be dissolved in water, add sodium chloride, glucose dissolving, add water to volume, mixing, 60-70 ℃ of heating also is incubated; Add 0.1% injection active carbon, 60-70 ℃ adds insulation about 20 minutes, and Sha Xin filters decarburization; Fill; Seal; 120 ℃ of pressure sterilizings 30 minutes; Quality examination promptly gets the low-molecular weight chondroitin sulfate glucose sodium chloride injection of 500ml.
Claims (10)
1. the injecting medicine-feeding form of a low-molecular weight chondroitin sulfate is characterized in that being is the sterile water solution of principal agent with the low-molecular weight chondroitin sulfate.
2. injection according to claim 1 is characterized in that the mean molecule quantity of principal agent low-molecular weight chondroitin sulfate is lower than 10,000 dalton.
3. injection according to claim 1, the molecular weight ranges that it is characterized in that the principal agent low-molecular weight chondroitin sulfate is 8,000-2,000 dalton.
4. injection according to claim 1, it is characterized in that the principal agent low-molecular weight chondroitin sulfate is meant the chondroitin sulfate injection crude drug that extracts, meet medicinal standard from animal cartilage, include but not limited to chondroitin sulfate A and sodium salt thereof, potassium salt, calcium salt; Chondroitin sulfate C and sodium salt thereof, potassium salt, calcium salt; The mixture of chondroitin sulfate A and salt and chondroitin sulfate C and salt.
5. injection according to claim 1, it is characterized in that the principal agent low-molecular weight chondroitin sulfate can be separately or with other drug and pharmaceutics on the adjuvant that is fit to, according to the preparation method of injection, be prepared into different pharmaceutical concentration, different size, can supply clinical practice in the medicine of difference prevention with therapeutic use, different injection systems.
6. injection according to claim 1 is characterized in that concentration (in the percentage by weight g/100ml) scope of principal agent low-molecular weight chondroitin sulfate in injection is 0.04-4.0%.
7. injection according to claim 1 is characterized in that the principal agent low-molecular weight chondroitin sulfate can be with other drug but be not limited to glucose and/or sodium chloride and adjuvant, the injection of making according to the preparation method of injection.
8. injection according to claim 1 is characterized in that the specification of this injection includes but not limited to that loading amount is 1 milliliter, 2 milliliters, 5 milliliters, 10 milliliters, 50 milliliters, 100 milliliters, 250 milliliters, 500 milliliters, 1000 milliliters a injection.
9. injection according to claim 7 is characterized in that concentration (in the percentage by weight g/100ml) scope of glucose is 5-10%.
10. injection according to claim 7 is characterized in that concentration (in the percentage by weight g/100ml) scope of sodium chloride is 0.45-0.9%.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031143741A CN1470245A (en) | 2003-05-07 | 2003-05-07 | Low-molecular-weight chondroitin sulfate injecta and its preparation method |
| CN 200310119302 CN1262277C (en) | 2003-05-07 | 2003-12-03 | Injection of low molecular weight chondroitin sulfate and its prepn. method |
| CN 200410036753 CN1562072A (en) | 2003-05-07 | 2004-04-29 | Powder injection of medium and/or low molecular weight chondroitin sulfate |
| CNB2004100388210A CN1296052C (en) | 2003-05-07 | 2004-04-30 | Non-injection preparation containing medium and/or low molecular weight chondroitin sulfate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031143741A CN1470245A (en) | 2003-05-07 | 2003-05-07 | Low-molecular-weight chondroitin sulfate injecta and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1470245A true CN1470245A (en) | 2004-01-28 |
Family
ID=34152554
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031143741A Pending CN1470245A (en) | 2003-05-07 | 2003-05-07 | Low-molecular-weight chondroitin sulfate injecta and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1470245A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100446775C (en) * | 2006-03-17 | 2008-12-31 | 南京长澳医药科技有限公司 | Chonsurid for venous injection administration and its preparing method |
-
2003
- 2003-05-07 CN CNA031143741A patent/CN1470245A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100446775C (en) * | 2006-03-17 | 2008-12-31 | 南京长澳医药科技有限公司 | Chonsurid for venous injection administration and its preparing method |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |