CN1593432A - Alendronate sodium powder for injection - Google Patents
Alendronate sodium powder for injection Download PDFInfo
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- CN1593432A CN1593432A CN 200410024386 CN200410024386A CN1593432A CN 1593432 A CN1593432 A CN 1593432A CN 200410024386 CN200410024386 CN 200410024386 CN 200410024386 A CN200410024386 A CN 200410024386A CN 1593432 A CN1593432 A CN 1593432A
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- injection
- alendronic acid
- acid sodium
- alendronate sodium
- sodium
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Abstract
Disclosed is an Alendronate sodium powder for injection which comprises the components of (by weight percentage), Alendronate sodium 0.125-100%, excipient 0-99.875%. The Alendronate sodium powder for injection can be used for treating high calcium blood disease caused by tumor or women's osteoporosis.
Description
(1) technical field
The present invention relates to injection alendronic Acid sodium injection, belong to medical technical field.
(2) background technology
Hypercalcemia is a kind of metabolism complication of malignant tumor, when calcium level significantly raises, can threaten patient's life.The reason that produces hypercalcemia is a lot, and malignant tumor is to cause one of modal reason of hypercalcemia, and morbidity is 5%～20%, is common in the patient that malignant tumor companion bone shifts, and breast carcinoma and non-small cell carcinoma account for 45%.The concurrent hypercalcemia of tumor, and clinical no bone transferrer claims the humoral hypercalcemia syndrome, accounts for 15%～20%.Wherein be common in squamous cell lung carcinoma and large cell carcinoma, renal cell carcinoma, hepatocarcinoma and cancer of biliary duct etc.In the hematological system tumor good especially in multiple myeloma (about 60%).Molten bone also takes place and changes and hypercalcemia in malignant lymphoma and T chronic myeloid leukemia sometimes.Osteoporosis is defined as the bone amount that changes with micro structure and reduces, and the sclerotin susceptibility raises.Occur more early the women, also progress is faster, particularly faster because of the decrease in estrogen bone loss after the menopause, makes the postmenopausal women be easy to fracture.The treatment postmenopausal osteoporosis has several different methods, and tradition except the bone density that increases the patient, also can be used to improve the symptom behind the postmenopausal women with estrin treatment.Because of dangerous and some other side effect of considering breast carcinoma make a lot of women be unwilling to use estrogen.The bis phosphoric acid salt is the medicine as controversies in hormone replacement in the elderly, plays an important role in the postclimacteric osteoporosis of treatment.Alendronate sodium is a kind of amino Diphosphonate, and is the same with other Diphosphonates, is a kind of synthetic pyrophosphate, is used for treating hypercalcemia and treatment osteoporosis in postmenopausal women due to the malignant tumor clinically.The preparation Alendronate sodium sheet of present domestic listing, the dosage form of external listing is sheet, injection.Because Alendronate sodium is molten in the water part omitted, dissolves in hot water, and is insoluble in ethanol or acetone, easily molten in sodium hydroxide test solution, so the alendronic Acid sodium injection is stored unstable.
(3) summary of the invention
The present invention is directed to and remedy the deficiencies in the prior art, a kind of injection alendronic Acid sodium injection is provided.
The present invention is an injection alendronic Acid sodium injection, it is characterized in that, comprises following component, all is weight percentage: Alendronate sodium 0.125%～100%, excipient are 0～99.875%.
Above-mentioned excipient is selected from one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, the sucrose.Molecular weight gets final product by this area normal ranges.
Above-mentioned injection alendronic Acid sodium injection can be a kind of in sterilized powder, the aseptic freeze-dried product.
Compared with prior art, excellent results of the present invention is as follows:
1) this product has been selected injectable powder, and moisture is less than 4.0, thereby has improved stability of drug, has guaranteed the quality of medicine, has prolonged the storage period of medicine.
2) injection alendronic Acid sodium injection has and meets the quick-dissolving characteristics of water, can be as required when clinical use and glucose injection, sodium chloride injection compatibility, and for clinical use provides convenience.
The injection alendronic Acid sodium injection that is made by said method all complies with relevant regulations in the check of items such as content, aseptic, pH, has no side effect.This product can be used for intravenous drip, is used for the treatment of hypercalcemia and treatment osteoporosis in postmenopausal women due to the malignant tumor.
(4) specific embodiment
Embodiment 1 injection alendronic Acid sodium injection, component is as follows, all is weight percentage:
Alendronate sodium 4.762%
Mannitol 95.238%
Preparation method is as follows:
Get alendronic Acid sodium raw materials 10g, add water for injection 1.5L, stirring and dissolving, with mannitol 200g stirring and dissolving, adjust pH to 5.6 is added water for injection to 2L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is carried out packing by every 2ml, promptly obtains the aseptic freeze-dried product of Alendronate sodium through lyophilization.
Embodiment 2 injection alendronic Acid sodium injections, component is as follows, all is weight percentage:
Alendronate sodium 100%
Preparation method is as follows:
Get alendronic Acid sodium raw materials 20g, add water for injection 0.5L, stirring and dissolving, adjust pH to 6, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is carried out packing by every 3ml, promptly obtains the aseptic freeze-dried product of Alendronate sodium through lyophilization.
Embodiment 3 injection alendronic Acid sodium injections, component is as follows, all is weight percentage:
Alendronate sodium 16.667%
Lactose 83.333%
Preparation method is as follows:
Get alendronic Acid sodium raw materials 40g, add water for injection 3.0L, stirring and dissolving adds lactose 200g stirring and dissolving, and adjust pH to 6.2 is added water for injection to 4L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is at the spray-dried Alendronate sodium sterilized powder that promptly gets.Undertaken aseptic subpackagedly then by every 40mg, promptly get injection Alendronate sodium powder pin.
Embodiment 4 injection alendronic Acid sodium injections, component is as follows, all is weight percentage:
Alendronate sodium 44.444%
Sorbitol 55.556%
Preparation method is with 3.
Embodiment 5 injection alendronic Acid sodium injections, component is as follows, all is weight percentage:
Alendronate sodium 1.64%
Glucose 98.36%
Get alendronic Acid sodium raw materials 2.5g, add water for injection 0.8L, stirring and dissolving adds sorbitol 150g stirring and dissolving, and adjust pH to 5.8 is added water for injection to 1L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate promptly gets the Alendronate sodium sterilized powder through vacuum drying.Undertaken aseptic subpackagedly then by every 2.5mg, promptly get injection Alendronate sodium powder pin.
Embodiment 6 injection alendronic Acid sodium injections, component is as follows, all is weight percentage:
Alendronate sodium 0.50%
Glucose 99.50%
Preparation method is with 5.
Claims (3)
1, the present invention is an injection alendronic Acid sodium injection, comprises following component, all is weight percentage: Alendronate sodium 0.125%～100%, excipient are 0～99.875%.
2, injection alendronic Acid sodium injection as claimed in claim 1 is characterized in that, described excipient is one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, the sucrose.
3, injection alendronic Acid sodium injection as claimed in claim 1 is characterized in that, described injection alendronic Acid sodium injection can be a kind of in sterilized powder, the aseptic freeze-dried product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410024386 CN1593432A (en) | 2004-06-25 | 2004-06-25 | Alendronate sodium powder for injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410024386 CN1593432A (en) | 2004-06-25 | 2004-06-25 | Alendronate sodium powder for injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1593432A true CN1593432A (en) | 2005-03-16 |
Family
ID=34663471
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410024386 Pending CN1593432A (en) | 2004-06-25 | 2004-06-25 | Alendronate sodium powder for injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1593432A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111557902A (en) * | 2020-07-03 | 2020-08-21 | 中国人民解放军总医院 | Preparation method and application of alendronate sodium-loaded injectable polyethylene glycol hydrogel |
-
2004
- 2004-06-25 CN CN 200410024386 patent/CN1593432A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111557902A (en) * | 2020-07-03 | 2020-08-21 | 中国人民解放军总医院 | Preparation method and application of alendronate sodium-loaded injectable polyethylene glycol hydrogel |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |