CN1202816C - Glimepiride dripping pills - Google Patents
Glimepiride dripping pills Download PDFInfo
- Publication number
- CN1202816C CN1202816C CN 02110064 CN02110064A CN1202816C CN 1202816 C CN1202816 C CN 1202816C CN 02110064 CN02110064 CN 02110064 CN 02110064 A CN02110064 A CN 02110064A CN 1202816 C CN1202816 C CN 1202816C
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- CN
- China
- Prior art keywords
- glimepiride
- polyethylene glycol
- present
- poloxamer
- dripping pills
- Prior art date
- 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 - Lifetime
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Abstract
The present invention relates to a glimepiride dripping pill which is characterized in that the glimepiride dripping pill contains glimepiride, polyethylene glycol 4000 or polyethylene glycol 1500 used as water solubility auxiliary material, and poloxamer. The present invention contains the following ingredients according to the weight percentage: 2 to 7 wt% of glimepiride, 0 to 98 wt% of polyethylene glycol 4000 or polyethylene glycol 1500 used as water solubility auxiliary material, and 0 to 50 wt% of poloxamer. The dose of the present invention can be conveniently adjusted, and the present invention is especially suitable for the individuation administration scheme in the pathogenesis initial stage and the maintenance treatment stage in the long-term medication process for people who have diabetes. The present invention has the advantages of simple preparation equipment and stable quality of products.
Description
The present invention relates to a kind of glimepiride dripping pills, belong to the Western medicine preparation technical field.
Glimepiride is a kind of new oral hypoglycemic medicine.Glimepiride is applicable to all unmanageable non-insulin-dependent diabetes mellitus of alimentary abstinence and physical training, still is applicable to single line treatment and the unique sulfonylureas that uses with insulin combination simultaneously.Common dosage forms is conventional tablet and the capsule of 1mg, 2mg, 3mg and 4mg clinically at present.This medicine (1) curative effect is strong, dosage is low; (2) drug treatment is long, and individual variation is big, and patient's dosage needs the 0.5-8mg various dose respectively in treatment and maintenance stage.Clinically, (1) occurs hypoglycemia when patient's blood sugar level is not high for after preventing to take medicine, and informal dress is with the dosage of 0.5mg; (2) when glimepiride and other medicines drug combination, the informal dress dosage of 0.5mg; (3) by when taking other medicines and change glimepiride into, take the dosage of 0.5mg at first.But, the specification listing of 0.5mg dosage is not arranged at present as yet, and other dosage form is difficult to make the specification of 0.5mg.
The objective of the invention is at the problems referred to above, provide a kind of and can be used for oral drop pill easily, dosage is 0.5mg and 1mg.It can be according to the treatment needs, and the minimum dose of use acquisition blood glucose Satisfactory Control (general, the patient that diabetes are well controlled, every day, dosage was 0.5-4mg, a few patients dosage every day is greater than 6mg).
Technical characterstic of the present invention is: having selected for use water-soluble solid to disperse rerum natura pharmaceutic adjuvant Polyethylene Glycol and poloxamer is carrier, medicine is dispersed in to drip in Polyethylene Glycol and the poloxamer makes ball.Glimepiride is the medicine of slightly solubility, and poloxamer plays the solubilizing agent effect in prescription, can improve the dissolubility of medicine.
Glimepiride dripping pills of the present invention is achieved in that its composition comprises glimepiride, water soluble adjuvant Macrogol 4000, polyethylene glycol 1500 and poloxamer, the percentage by weight of each composition is glimepiride 2-7, water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500≤98 and poloxamer≤50, wherein the content of water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500 and poloxamer is all non-vanishing.
The preparation of glimepiride dripping pills agent of the present invention is with glimepiride crude drug and used adjuvant Polyethylene Glycol and poloxamer mixing, is heated to 75 ℃ and stirs, dissolves, splashes into curing in the liquid paraffin, filtration, drying, packing promptly.
This drop pill advantage is that (1) volume is little, taking convenience; (2) adjust dosage conveniently, especially be fit to period of disease and the individual administration scheme of keeping treatment in the diabetics long-term prescription process, avoided of the damage of the long-term excessive use of sulfonylureas simultaneously kidney.This product maximal dose is 8mg, and for producer, the drop pill of 0.5mg or 1mg can be applicable to all patients substantially, and the workshop of drop pill do not have dust, helps labor protection; Equipment is simple, and is easy to operate, and production process is few, and the cycle is short, the automaticity height.And working condition is easy to control, and the ball method of double differences is different little, and content is more accurate.
This product is 40 ℃ of temperature, under the condition of relative humidity 75%, and long term test six months, its content and dissolution result are as follows:
Glimepiride dripping pills accelerated test 6 months
| Time (moon) | Dissolution (%) | Content (%) |
| 0 | 91.85 | 107.60 |
| 1 | 91.49 | 105.14 |
| 2 | 92.85 | 107.49 |
| 3 | 93.78 | 107.02 |
| 6 | 93.72 | 106.55 |
Remarks: dissolution: according to dissolution determination method (two appendix XC of Chinese Pharmacopoeia version in 2000 three therapeutic methods of traditional Chinese medicine), with 0.02% tris solution 100ml is solvent, and rotating speed is that per minute 75 changes, operation in accordance with the law, sampling in 45 minutes, the mensuration wavelength is 229nm.
Assay: measure according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2000).
The system suitability test is a filler with octadecylsilane chemically bonded silica; Methanol-0.01mol ammonium dihydrogen phosphate pH=3.5 (70: 30) is a mobile phase; The detection wavelength is 229nm.Press external standard method with calculated by peak area content.
By long term test 12 months as can be known, this product is stable.
The embodiment of the invention:
Example 1:
The glimepiride dripping pills prescription
Former, every consumption of adjuvant title
Glimepiride 0.5mg
Macrogol 4000 12.5mg
Poloxamer 2.5mg
The liquid paraffin condensing agent
Operating procedure
Glimepiride, Macrogol 4000 are put in the beaker, be heated to 75 ℃, stir, be uniformly dispersed, the dropper with Φ 1mm splashes into mixed liquor in refrigerative liquid paraffin, and sedimentation was placed after 30 minutes, filtered, and dried, promptly.Every heavily about 15mg of ball contains glimepiride 0.5mg.
Claims (1)
1, a kind of glimepiride dripping pills, it is characterized in that comprising glimepiride, water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500 and poloxamer, the percentage by weight of each composition is glimepiride 2-7, water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500≤98 and poloxamer≤50, wherein the content of water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500 and poloxamer is all non-vanishing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110064 CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110064 CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1436527A CN1436527A (en) | 2003-08-20 |
| CN1202816C true CN1202816C (en) | 2005-05-25 |
Family
ID=27628156
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02110064 Expired - Lifetime CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1202816C (en) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1292737C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Oral administration dripping pill for nourishing heart to calm mind and its preparing method |
| CN1292736C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Dripping pill made from haw, chrysanthemum and Chinese wolfberry fruit and its preparing method |
| CN1292741C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and schisandra fruit dripping pill and its preparing method |
| CN1292739C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Shenerwuwei dripping pill for benefiting qi and nourishing yin and its preparing method |
| CN1292740C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and Chinese angelica root dripping pill and its preparing method |
| CN1292738C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method |
| CN1332651C (en) * | 2005-02-24 | 2007-08-22 | 北京正大绿洲医药科技有限公司 | Wuji dripping pill for treating liver and stomach diseases and its preparing method |
| CN1307980C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Lemai dripping pill for treating cardiovascular diseases and its preparing method |
| CN1307983C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Mai-an dripping pill for treating hyperlipoproteinemia and its preparing method |
| CN1307981C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Xuening dripping pill having hemostatic function and its preparing method |
| CN1307982C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Maishu dripping pill for reducing blood fat and its preparing method |
| CN1307984C (en) * | 2005-03-28 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Cervix cancer drip pill and its preparation method |
| CN104173308B (en) * | 2014-08-30 | 2017-03-22 | 山东新时代药业有限公司 | Glimepiride dropping pill |
-
2002
- 2002-02-07 CN CN 02110064 patent/CN1202816C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1436527A (en) | 2003-08-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20160519 Address after: 273400 Shandong Feixian County North Ring Road No. 1 Patentee after: Shandong Xinshidai Pharmaceutical Industry Co., Ltd. Address before: 250100 Ji'nan Industrial Road, Shandong, No. 106 Patentee before: Wang Zhigang |
|
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20050525 |