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
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- 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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- chondroitin sulfate
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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 |
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| 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 |
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| Country | Link |
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| 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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| WD01 | Invention patent application deemed withdrawn after publication |