CN102871978A - Levosulpiride tablets and preparation method thereof - Google Patents
Levosulpiride tablets and preparation method thereof Download PDFInfo
- Publication number
- CN102871978A CN102871978A CN2012104030609A CN201210403060A CN102871978A CN 102871978 A CN102871978 A CN 102871978A CN 2012104030609 A CN2012104030609 A CN 2012104030609A CN 201210403060 A CN201210403060 A CN 201210403060A CN 102871978 A CN102871978 A CN 102871978A
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- CN
- China
- Prior art keywords
- levosulpiride
- magnesium stearate
- microcrystalline cellulose
- polyvinylpolypyrrolidone
- sheet
- 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.)
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Links
- BGRJTUBHPOOWDU-NSHDSACASA-N (S)-(-)-sulpiride Chemical compound CCN1CCC[C@H]1CNC(=O)C1=CC(S(N)(=O)=O)=CC=C1OC BGRJTUBHPOOWDU-NSHDSACASA-N 0.000 title claims abstract description 59
- 229960004145 levosulpiride Drugs 0.000 title claims abstract description 55
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 24
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 12
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 11
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 11
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 11
- 201000006549 dyspepsia Diseases 0.000 claims description 7
- 239000003814 drug Substances 0.000 claims description 5
- 230000008673 vomiting Effects 0.000 claims description 4
- 206010019196 Head injury Diseases 0.000 claims description 3
- 206010019233 Headaches Diseases 0.000 claims description 3
- 208000008469 Peptic Ulcer Diseases 0.000 claims description 3
- 208000028017 Psychotic disease Diseases 0.000 claims description 3
- 208000030886 Traumatic Brain injury Diseases 0.000 claims description 3
- 208000002173 dizziness Diseases 0.000 claims description 3
- 231100000869 headache Toxicity 0.000 claims description 3
- 208000011906 peptic ulcer disease Diseases 0.000 claims description 3
- 210000004916 vomit Anatomy 0.000 claims description 3
- 239000006185 dispersion Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 abstract description 6
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 238000004132 cross linking Methods 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 229940069328 povidone Drugs 0.000 abstract 1
- 239000012535 impurity Substances 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 239000000047 product Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 238000004128 high performance liquid chromatography Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 229960004940 sulpiride Drugs 0.000 description 4
- 230000001186 cumulative effect Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 238000005286 illumination Methods 0.000 description 3
- 238000002386 leaching Methods 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 230000001133 acceleration Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- MNWSGMTUGXNYHJ-UHFFFAOYSA-N 2-methoxybenzamide Chemical compound COC1=CC=CC=C1C(N)=O MNWSGMTUGXNYHJ-UHFFFAOYSA-N 0.000 description 1
- 108091005482 5-HT4 receptors Proteins 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 206010008479 Chest Pain Diseases 0.000 description 1
- 101150049660 DRD2 gene Proteins 0.000 description 1
- 208000020401 Depressive disease Diseases 0.000 description 1
- 206010053155 Epigastric discomfort Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 230000008485 antagonism Effects 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000013872 defecation Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- FGXWKSZFVQUSTL-UHFFFAOYSA-N domperidone Chemical compound C12=CC=CC=C2NC(=O)N1CCCN(CC1)CCC1N1C2=CC=C(Cl)C=C2NC1=O FGXWKSZFVQUSTL-UHFFFAOYSA-N 0.000 description 1
- 229960001253 domperidone Drugs 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 206010016766 flatulence Diseases 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000030136 gastric emptying Effects 0.000 description 1
- 230000030135 gastric motility Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 208000024798 heartburn Diseases 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 201000003102 mental depression Diseases 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229950002366 nafoxidine Drugs 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides levosulpiride tablets and a preparation method thereof. The levosulpiride tablets comprise levosulpiride, microcrystalline cellulose, crosslinking povidone and magnesium stearate, and have the advantages of simple prescription, high production efficiency, energy saving and cost saving; and the prepared tablets have the characteristics of quick disintegration and dissolution as well as good stability.
Description
Technical field
The present invention relates to pharmaceutical field, be specifically related to a kind of oral solid formulation.
Background technology
Relation between socio-psychological factors and gastrointestinal tract nervous system is very close, and stress can make gastric emptying change, and regulates the sensation of importing into of internal organs, causes functional dyspepsia (Functional dyspepsia, FD).Along with the quickening of modern society's rhythm of life and the aggravation of competition, people are subject to from surrounding pressure as more as family, work and society, and functional dyspepsia has become commonly encountered diseases, frequently-occurring disease clinically.The sickness rate of FD is about 20%-40%, in the digestion special outpatient clinic, accounts for 60%-70%.FD patient has more state and the Mental Depression obstacle of anxiety than Healthy People, show as clinically the epigastric discomfort that continues or repeatedly show effect, with glutted, abdominal part flatulence after the meal, heating installation, early full, anorexia, feel sick, the symptoms such as vomiting, heartburn, regurgitation, retrosternal pain, abnormal defecation, without part or whole body organic disease.
Levosulpiride (levosulpiride) is the levo-enantiomer of sulpiride; i.e. (S)-(-)-5-aminosulfonyl-N-[(1-ethyl-2-nafoxidine base) methyl]-the 2-methoxy benzamide; but also called after (S)-(-)-N-[methyl-(1-ethyl-2-pyrrolidinyl)]-2-methoxyl group-5-(amino-sulfonyl)-Benzoylamide, be a kind of novel gastric motility new drug.Levosulpiride mainly plays a role by exciting 5-HT4 receptor and antagonism d2 dopamine receptor, main as anti-functional dyspepsia medicine clinically, also can be used as the medicine of psychosis, obstinate vomit, peptic ulcer, craniocerebral injury dizziness and headache.With motilium, compare, the activity of levosulpiride is high, and untoward reaction is low.
At present, at commercially available levosulpiride sheet (LEVOPRAID
?, Abbott) basis on, optimize prescription and preparation technology, enhance productivity, energy savings and production cost, be to need the technical staff to put forth effort the technical problem solved.
Summary of the invention
On the one hand, the invention provides a kind of levosulpiride sheet, meter by weight is comprised of the component of following content:
Wherein, the preferred 25-50 of levosulpiride, the preferred 80-120 of microcrystalline Cellulose, the preferred 10-30 of polyvinylpolypyrrolidone, the preferred 0.5-2 of magnesium stearate.
Preferably, the invention provides following 5 kinds of levosulpiride sheets:
| The levosulpiride sheet | 1 | 2 | 3 | 4 | 5 |
| Levosulpiride | 25?g | 5?g | 100?g | 50?g | 75?g |
| Microcrystalline Cellulose | 80?g | 50?g | 150?g | 120?g | 100?g |
| Polyvinylpolypyrrolidone | 10?g | 30?g | 50?g | 5?g | 20?g |
| Magnesium stearate | 0.5?g | 0.3?g | 5?g | 1.5?g | 2?g |
| Make | 1000 | 1000 | 1000 | 1000 | 1000 |
On the other hand, the invention still further relates to the preparation method of described levosulpiride sheet: levosulpiride, microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate are mixed to tabletting.
Again on the one hand, the invention still further relates to the purposes of described levosulpiride sheet in the medicine of the anti-functional dyspepsia of preparation, psychosis, obstinate vomit, peptic ulcer, craniocerebral injury dizziness and headache.
Beneficial effect of the present invention is: 1) prescription is simple, only contains three kinds of adjuvants; 2) preparation technology is simple, can adopt direct mixed pressuring plate to get final product, and has save the steps such as wet granulation, drying, granulate, enhances productivity approximately 1 times, and has saved cost and the energy; 3) impurity content is low, better quality, and drug safety is higher, is better than commercially available product; 4) stripping is rapid, is better than commercially available product; 5) good stability, under high humidity (RH92.5%, 10 days), high temperature (60 ℃, 10 days) and illumination (4500Lx, 10 days) condition, impurity content low (<0.10%), and under the acceleration environment of 40 ℃ of high temperature, relative humidity RH75%, keep stable in 6 months, be better than commercially available product.
The dosage of levosulpiride sheet of the present invention need to be determined according to clinician's judgement, and for example, daily dose can be 75mg～200mg.
The specific embodiment
The specific embodiment only, for further explaining and describing the present invention, should not be interpreted as any limitation of the invention.
Embodiment 1～5 levosulpiride sheet
The prescription of levosulpiride sheet sees the following form:
Preparation technology: by the raw material blending of recipe quantity, tabletting, obtain.
The stripping comparative study of experimental example 1 levosulpiride sheet and commercially available prod
Get levosulpiride sheet and commercially available prod LEVOPRAID that embodiment 1～5 makes
?according to " two appendix XC first methods of Chinese pharmacopoeia version in 2010 are measured dissolution, the 0.1mol/L hydrochloric acid solution 1000ml of take is solvent, rotating speed is 50 turn/min, operation in accordance with the law, through certain hour, get the 0.1mol/L hydrochloric acid solution that solution 5ml(adds same volume simultaneously in stripping rotor), filter, precision measures subsequent filtrate, and according to high performance liquid chromatography, (with octadecylsilane chemically bonded silica, be filler, 0.05mol/L phosphate buffer (the pH3.5)-acetonitrile (90:10) of take is mobile phase; Flow velocity is 1ml per minute; The detection wavelength is 220nm.Number of theoretical plate is pressed the levosulpiride peak and is calculated, and should be not less than 2000.The separating degree of levosulpiride and adjacent impurity peaks is all up to specification.Get the dissolution subsequent filtrate as need testing solution; It is appropriate that precision takes the levosulpiride reference substance, adds the mobile phase dilution and make the solution that contains 25 μ g in every 1ml, product solution in contrast.Precision measures need testing solution and reference substance solution 10 μ l, and the injection liquid chromatography, record chromatogram, by external standard method, with calculated by peak area, measures the accumulation stripping percentage rate of tablet.Result is as follows:
The cumulative leaching rate % of commercially available prod sees the following form:
| Time | 3min | 5min | 10min | 15min | 30min | 45min |
| Cumulative leaching rate % | 91.2 | 97.1 | 96.9 | 97.5 | 96.3 | 96.5 |
The cumulative leaching rate % of levosulpiride sheet prepared by embodiment 1-5 sees the following form:
| Embodiment | 1 | 2 | 3 | 4 | 5 |
| 1min | 70.8 | 72.8 | 65.1 | 56.8 | 52.2 |
| 2min | 88.9 | 89.2 | 88.6 | 86.4 | 89.6 |
| 3min | 99.4 | 98.3 | 99.7 | 96.3 | 98.5 |
| 4min | 99.6 | 98.8 | 99.3 | 99.7 | 99.5 |
| 5min | 99.7 | 99.5 | 99.2 | 99.9 | 100.2 |
| 10min | 99.2 | 99.9 | 99.8 | 99.5 | 100.3 |
The stability study (25 ℃, RH75%, without packing) of experimental example 2 levosulpiride sheets under super-humid conditions
High wet test is carried out in levosulpiride sheet and commercially available prod that embodiment 1～5 is made, according to " the high performance liquid chromatography of two sulpiride determination of foreign matters of Chinese pharmacopoeia version in 2010, measure impurity and content, adopt experimental example 1 method to measure dissolution (be 5 minutes sample time), result is as follows:
The stability study (Lx4500, without packing) of experimental example 3 levosulpiride sheets under the strong illumination condition
Exposure experiments to light is carried out in levosulpiride sheet and commercially available prod that embodiment 1～5 is made, by standard, is detected, and result is as follows:
The stability study (60 ℃, without packing) of experimental example 4 levosulpiride sheets under hot conditions
Hot test is carried out in levosulpiride sheet and commercially available prod that embodiment 1～5 is made, according to " the high performance liquid chromatography of two sulpiride determination of foreign matters of Chinese pharmacopoeia version in 2010, measure impurity and content, adopt experimental example 1 method to measure dissolution (be 3 minutes sample time), result is as follows:
The stability study of experimental example 5 levosulpiride sheets under acceleration environment (40 ℃, RH75%)
The levosulpiride sheet that embodiment 1～5 is made and commercially available levosulpiride sheet carry out accelerated test, according to " the high performance liquid chromatography that two sulpiride related substances of Chinese pharmacopoeia version in 2010 check, measure impurity and content, adopt experimental example 1 method to measure dissolution (be 3 minutes sample time), result is as follows:
Experimental example 1～5 shows, compared with prior art, the present invention has the following advantages: 1) can complete stripping in 3 minutes, and stripping is rapider, and onset is faster; 2) impurity content lower (being about 0.05%), be about 1/3 of commercially available product (0.16%); 3) under high humidity, high temperature, illumination, place 10 days, and accelerated test 6 months, product stripping etc. has no significant change, and impurity is no more than 0.10%, and quality is more stable, and clinical efficacy can be better with the safety expection.
Claims (9)
1. a levosulpiride sheet, count by weight, composed as follows:
Levosulpiride 5-100,
Microcrystalline Cellulose 50-150,
Polyvinylpolypyrrolidone 5-50,
Magnesium stearate 0.3-5.
2. levosulpiride sheet according to claim 1, wherein the parts by weight of levosulpiride are 25-50, and microcrystalline Cellulose is 80-120, and polyvinylpolypyrrolidone is 10-30, and magnesium stearate is 0.5-2.
3. levosulpiride sheet according to claim 1, the prescription of every 1000 is as follows:
Levosulpiride 25 g,
Microcrystalline Cellulose 80 g,
Polyvinylpolypyrrolidone 10 g,
Magnesium stearate 0.5 g.
4. levosulpiride sheet according to claim 1, the prescription of every 1000 is as follows:
Levosulpiride 5 g,
Microcrystalline Cellulose 50 g,
Polyvinylpolypyrrolidone 30 g,
Magnesium stearate 0.3 g.
5. levosulpiride sheet according to claim 1, the prescription of every 1000 is as follows:
Levosulpiride 100 g,
Microcrystalline Cellulose 150 g,
Polyvinylpolypyrrolidone 50 g,
Magnesium stearate 5 g.
6. levosulpiride sheet according to claim 1, the prescription of every 1000 is as follows:
Levosulpiride 50 g,
Microcrystalline Cellulose 120 g,
Polyvinylpolypyrrolidone 5 g,
Magnesium stearate 1.5 g.
7. levosulpiride sheet according to claim 1, the prescription of every 1000 is as follows:
Levosulpiride 75 g,
Microcrystalline Cellulose 100 g,
Polyvinylpolypyrrolidone 20 g,
Magnesium stearate 2 g.
8. the preparation method of the arbitrary described levosulpiride sheet of claim 1-7, comprise the levosulpiride of recipe quantity, polyvinylpolypyrrolidone, microcrystalline Cellulose, magnesium stearate mixed, tabletting.
9. the purposes of the levosulpiride sheet of the arbitrary described rapid dispersion of claim 1-7 in the medicine of preparation anti-functional dyspepsia, psychosis, obstinate vomit, peptic ulcer, craniocerebral injury dizziness and headache.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210403060.9A CN102871978B (en) | 2012-10-19 | 2012-10-19 | Levosulpiride tablets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210403060.9A CN102871978B (en) | 2012-10-19 | 2012-10-19 | Levosulpiride tablets and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102871978A true CN102871978A (en) | 2013-01-16 |
| CN102871978B CN102871978B (en) | 2014-04-09 |
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|---|---|---|---|
| CN201210403060.9A Active CN102871978B (en) | 2012-10-19 | 2012-10-19 | Levosulpiride tablets and preparation method thereof |
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| Country | Link |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113332276A (en) * | 2021-06-01 | 2021-09-03 | 大桐制药（中国）有限责任公司 | Production method of sulpiride preparation |
| CN116585305A (en) * | 2023-05-12 | 2023-08-15 | 上海市肺科医院（上海市职业病防治院） | Application of levosulpiride in preparation of medicines for treating pulmonary arterial hypertension |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113332276A (en) * | 2021-06-01 | 2021-09-03 | 大桐制药（中国）有限责任公司 | Production method of sulpiride preparation |
| CN116585305A (en) * | 2023-05-12 | 2023-08-15 | 上海市肺科医院（上海市职业病防治院） | Application of levosulpiride in preparation of medicines for treating pulmonary arterial hypertension |
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| Publication number | Publication date |
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| CN102871978B (en) | 2014-04-09 |
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Owner name: HEBEI RENHE YIKANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: SHIJIAZHUANG DEVELOPMENT AREA BOXIN MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD. Effective date: 20140208 |
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Address after: Haixing road Zhaoxian County Industrial Park 051500 Hebei city of Shijiazhuang Province Patentee after: HEBEI RENHE YIKANG PHARMACEUTICAL CO., LTD. Address before: Hengshui City, Hebei province 053411 cool Zhen Wuyi County Patentee before: HEBEI RENHE YIKANG PHARMACEUTICAL CO., LTD. |
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