CN1857256A - Coated norcantharidin tablet and its preparing method - Google Patents
Coated norcantharidin tablet and its preparing method Download PDFInfo
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- CN1857256A CN1857256A CN 200610043211 CN200610043211A CN1857256A CN 1857256 A CN1857256 A CN 1857256A CN 200610043211 CN200610043211 CN 200610043211 CN 200610043211 A CN200610043211 A CN 200610043211A CN 1857256 A CN1857256 A CN 1857256A
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Abstract
The coated norcantharidin tablet has one norcantharidin tablet of 0.5-0.8 cm diameter and one surface coating of 0.3-1.0 mm thickness. It is prepared through preparing norcantharidin tablet and forming moisture-proof coating. The coated norcantharidin tablet has high moisture-proof property, high stability, high medicine leaching rate, high bioavailability and high clinical treating effect. It is used in treating liver cancer, esophageal cancer, leucopenia, hepatitis, etc. and may be also used as pre-operational medicine or in combined chemotherapy.
Description
Technical field
The present invention relates to a kind of Film coated tablets and preparation method thereof, relate in particular to Film coated tablets of a kind of norcantharidin sheet and preparation method thereof.
Background technology
The norcantharidin sheet is applicable to that hepatocarcinoma, the esophageal carcinoma, harmonization of the stomach carcinoma of gastric cardia etc. reach low leukocyte counts disease, hepatitis, liver cirrhosis, hepatitis b virus carrier, also can be used as premedicate or be used for combined chemotherapy, removed use restriction simultaneously diabetics.
Commercially available norcantharidin sheet is coated tablet mostly.Though coated tablet is beneficial to patient and takes, mouthfeel is better, and the parcel sugar-coat makes embryo sheet weight increase, and expends more material, and rate of drying is slow in the manufacturing process simultaneously, and medicine heated time lengthening can have influence on the quality of medicine; Coated tablet easily goes mouldy in addition, easily softening, easily moisture absorption disintegrate; The coated tablet irregular colour is even simultaneously, causes sign unclear easily; Moreover coated tablet is produced length consuming time, and production cost is than higher.
In recent years, the tablet film-coat has become the medicament developing direction, is used for the attention that pharmaceutical production obtains the world of medicine, and the application for a patent for invention relevant with film-coat increases gradually, but up to now, does not also have the patent application of coated norcantharidin tablet.
Summary of the invention
At the deficiencies in the prior art, the purpose of this invention is to provide a kind of Film coated tablets of norcantharidin sheet, to increase the kind of this medicine.Another object of the present invention provides the preparation method of this coated norcantharidin tablet.
Coated norcantharidin tablet of the present invention, it is characterized in that: described coated norcantharidin tablet is the sheet base with the plain sheet of the oblate norcantharidin of diameter 0.5～0.8cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.3～1.0mm.
Wherein: described coated norcantharidin tablet is the sheet base with the plain sheet of the oblate norcantharidin of diameter 0.5～0.6cm preferably, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.5～0.7mm.
In above-mentioned coated norcantharidin tablet, the component and the weight proportion thereof of the plain sheet of described norcantharidin are: norcantharidin 1～40, starch 10～100, sucrose 10～100, mass percent is 10% gelatinized corn starch 10～100, magnesium stearate 0.1～10, Pulvis Talci 0.1～10.
Wherein: the component of the plain sheet of above-mentioned norcantharidin and weight proportion thereof preferably: norcantharidin 20～30, starch 30～70, sucrose 30～70, mass percent is 10% gelatinized corn starch 30～70, magnesium stearate 1～4, Pulvis Talci 1～5.
In above-mentioned coated norcantharidin tablet, used coating material is preferably special damp-proof Opadry.
The preparation method of coated norcantharidin tablet of the present invention comprises plain sheet preparation process and bag film-coat process.
The step of the plain sheet preparation process of norcantharidin is: (1) crushing screening: the principal agent norcantharidin is crossed 100 orders, and sucrose is pulverized the back and is crossed 100 orders, and starch is crossed 100 mesh sieves, magnesium stearate is crossed 40 mesh sieves; (2) granulate: take by weighing each component respectively with described weight proportion, earlier with sucrose and starch with the norcantharidin mix homogeneously after, add mass percent again and be 10% water-soluble gelatinized corn starch; Mix under 20 ℃～40 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～50 ℃), and oven dry total time is 2 hours, granulate.(4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, measure content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate norcantharidin of diameter 0.5～0.8cm.
The step of the plain sheet bag of norcantharidin film-coat process is: (1) joins slurry: coating material is placed join the slurry filling, restrain coating material with 1: 14～15 milliliters volume, and the adding percent by volume is 70% ethanol, stirs, and is standby; (2) preheating: the plain sheet of the oblate norcantharidin of diameter 0.5～0.8cm of suppressing is placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 18--25 rev/min, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38-42 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 3.5-4.5 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.3～1.0mm on the plain sheet of norcantharidin surface, the conventional method drying promptly makes the coated norcantharidin tablet product.
In the preparation method of above-mentioned coated norcantharidin tablet: the plain sheet 12.0g coating material of per 1000 norcantharidin; Described coating material is that 70% ethanol is joined slurry with the percent by volume of 170ml.
In the preparation method of above-mentioned coated norcantharidin tablet: the footpath speed of described coating pan is preferably 20-23 rev/min.
Wherein: the footpath speed of described coating pan most preferably is 22 rev/mins.
In the preparation method of above-mentioned coated norcantharidin tablet: the atomizing pressure of described coating material is preferably the 3.8-4.2 handkerchief.
Wherein, the atomizing pressure of described coating material most preferably is 4.0 handkerchiefs.
The drug effect of coated norcantharidin tablet of the present invention and original norcantharidin coated tablet are basic identical, but coated norcantharidin tablet of the present invention is compared with existing coated tablet, have the following advantages: 1, the embryo sheet is little, uses adjuvant few, thereby has reduced cost; 2, can reduce the tablet fragmentation, improve productive rate, shorten the production cycle greatly; 3, rate of drying is fast, and the medicine reduction that is influenced by heat helps improving drug quality; 4, improved the mode of appearance of tablet; 5, humidity resistance is good, has increased stability of drug; 6, increased the dissolution rate of tablet, made the rapid disintegrate of medicine, rapid-action, improve bioavailability and clinical efficacy.
Coated norcantharidin tablet of the present invention is applicable to that hepatocarcinoma, the esophageal carcinoma, harmonization of the stomach carcinoma of gastric cardia etc. reach low leukocyte counts disease, hepatitis, liver cirrhosis, hepatitis b virus carrier, also can be used as premedicate or be used for combined chemotherapy, removed use restriction simultaneously diabetics.
Coated norcantharidin tablet preparation method of the present invention is simple, and processing ease is easy to grasp, and equipment investment is low, and is with short production cycle, and prepared tablet principal agent stable in properties helps improving drug quality, guarantees the drug effect of tablet.
The specific embodiment
With embodiment coated norcantharidin tablet of the present invention is described further below:
Embodiment 1:
The preparation of the plain sheet of oblate norcantharidin of diameter 0.5～0.6cm: (1) crushing screening: the principal agent norcantharidin is crossed 100 orders, and sucrose is pulverized the back and is crossed 100 orders, and starch is crossed 100 mesh sieves, magnesium stearate is crossed 40 mesh sieves; (2) granulate: in described weight proportion, be unit, take by weighing following each component respectively with the gram: norcantharidin 30 grams, starch 60 grams, sucrose 50 grams, mass percent is 10% gelatinized corn starch, 70 grams, magnesium stearate 2 grams, Pulvis Talci 3 grams; Earlier with sucrose and starch with the norcantharidin mix homogeneously after, add mass percent again and be 10% water-soluble gelatinized corn starch; Mix under 30 ℃～33 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～50 ℃), and oven dry total time is 2 hours, granulate; (4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, measure content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate norcantharidin of diameter 0.5～0.6cm.
Take by weighing coating material Opadry 120.00g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 70% ethanol 1700ml, stirs, and is standby; (2) preheating: plain 10000 of the sheets of the oblate norcantharidin of diameter 0.5～0.6cm of suppressing are placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 22 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 40-42 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 4.0 handkerchiefs at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.6～0.7mm on the plain sheet of norcantharidin surface, the conventional method drying promptly makes the coated norcantharidin tablet product.
Embodiment 2:
The preparation of the plain sheet of oblate norcantharidin of diameter 0.6～0.7cm: (1) crushing screening: the principal agent norcantharidin is crossed 100 orders, and sucrose is pulverized the back and is crossed 100 orders, and starch is crossed 100 mesh sieves, magnesium stearate is crossed 40 mesh sieves; (2) granulate: in described weight proportion, be unit, take by weighing following each component respectively with the gram: norcantharidin 25 grams, starch 30 grams, sucrose 30 grams, mass percent is 10% gelatinized corn starch, 45 grams, magnesium stearate 0.8 gram, Pulvis Talci 1.2 grams; Earlier with sucrose and starch with the norcantharidin mix homogeneously after, add mass percent again and be 10% water-soluble gelatinized corn starch; Mix under 28 ℃～30 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～50 ℃), and oven dry total time is 2 hours, granulate; (4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, measure content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate norcantharidin of diameter 0.6～0.7cm.
Take by weighing coating material Opadry 12.00g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 70% ethanol 170ml, stirs, and is standby; (2) preheating: plain 1000 of the sheets of the oblate norcantharidin of diameter 0.6～0.7cm of suppressing are placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 20 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38-40 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 3.7 handkerchiefs at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.5～0.6mm on the plain sheet of norcantharidin surface, the conventional method drying promptly makes the coated norcantharidin tablet product.
Embodiment 3:
The preparation of the plain sheet of oblate norcantharidin of diameter 0.7～0.8cm: (1) crushing screening: the principal agent norcantharidin is crossed 100 orders, and sucrose is pulverized the back and is crossed 100 orders, and starch is crossed 100 mesh sieves, magnesium stearate is crossed 40 mesh sieves; (2) granulate: in described weight proportion, be unit, take by weighing following each component respectively with the gram: norcantharidin 40 grams, starch 80 grams, sucrose 80 grams, mass percent is 10% gelatinized corn starch, 100 grams, magnesium stearate 8 grams, Pulvis Talci 10 grams; Earlier with sucrose and starch with the norcantharidin mix homogeneously after, add mass percent again and be 10% water-soluble gelatinized corn starch; Mix under 37 ℃～40 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～50 ℃), and oven dry total time is 2 hours, granulate; (4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, measure content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate norcantharidin of diameter 0.7～0.8cm.
Take by weighing coating material Opadry 120.00g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 70% ethanol 1800ml, stirs, and is standby; (2) preheating: with the diameter that suppresses) plain 10000 of the sheets of the oblate norcantharidin of .7～0.8cm place in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 25 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 40-41 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 4.5 handkerchiefs at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.8～0.9mm on the plain sheet of norcantharidin surface, the conventional method drying promptly makes the coated norcantharidin tablet product.
Claims (10)
1, a kind of coated norcantharidin tablet is characterized in that: described coated norcantharidin tablet is the sheet base with the plain sheet of the oblate norcantharidin of diameter 0.5～0.8cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.3～1.0mm.
2, coated norcantharidin tablet as claimed in claim 1, it is characterized in that: described coated norcantharidin tablet is the sheet base with the plain sheet of the oblate norcantharidin of diameter 0.5～0.6cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.5～0.7mm.
3, coated norcantharidin tablet as claimed in claim 1 or 2, it is characterized in that: the component and the weight proportion thereof of the plain sheet of described norcantharidin are: norcantharidin 1～40, starch 10～100, sucrose 10～100, mass percent is 10% gelatinized corn starch 10～100, magnesium stearate 0.1～10, Pulvis Talci 0.1～10; Described coating material is the damp-proof Opadry.
4, coated norcantharidin tablet as claimed in claim 3, it is characterized in that: the component and the weight proportion thereof of the plain sheet of described norcantharidin are: norcantharidin 20～30, starch 30～70, sucrose 30～70, mass percent is 10% gelatinized corn starch 30～70, magnesium stearate 1～4, Pulvis Talci 1～5.
5, the preparation method of claim 1 or 2 described coated norcantharidin tablets, it is characterized in that: the step of bag film-coat process is that (1) joins slurry: coating material is placed join the slurry filling, restrain coating material with 1: 14～15 milliliters volume, the adding percent by volume is 70% ethanol, stir, standby; (2) preheating: the plain sheet of the oblate norcantharidin of diameter 0.5～0.8cm of suppressing is placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 18--25 rev/min, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38-42 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 3.5-4.5 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.3～1.0mm on the plain sheet of norcantharidin surface, the conventional method drying promptly makes the coated norcantharidin tablet product.
6, as the preparation method of claims 5 described coated norcantharidin tablets, it is characterized in that: the plain sheet 12.0g coating material of per 1000 norcantharidin; Described coating material is that 70% ethanol is joined slurry with the percent by volume of 170ml.
7, as the preparation method of claims 5 described coated norcantharidin tablets, it is characterized in that: the footpath speed of described coating pan is 20--23 rev/min.
8, as the preparation method of claims 7 described coated norcantharidin tablets, it is characterized in that: the footpath speed of described coating pan is 22 rev/mins.
9, as the preparation method of claims 5 described coated norcantharidin tablets, it is characterized in that: the atomizing pressure of described coating material is the 3.8-4.2 handkerchief.
10, as the preparation method of claims 9 described coated norcantharidin tablets, it is characterized in that: the atomizing pressure of described coating material is 4.0 handkerchiefs.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100432119A CN100386077C (en) | 2006-03-14 | 2006-03-14 | Coated norcantharidin tablet and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100432119A CN100386077C (en) | 2006-03-14 | 2006-03-14 | Coated norcantharidin tablet and its preparing method |
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| Publication Number | Publication Date |
|---|---|
| CN1857256A true CN1857256A (en) | 2006-11-08 |
| CN100386077C CN100386077C (en) | 2008-05-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2006100432119A Expired - Fee Related CN100386077C (en) | 2006-03-14 | 2006-03-14 | Coated norcantharidin tablet and its preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991550B (en) * | 2009-08-21 | 2012-07-18 | 华北制药集团制剂有限公司 | Norcantharidin tablet and preparation method thereof |
| CN103432001A (en) * | 2013-08-23 | 2013-12-11 | 九芝堂股份有限公司 | Hyperostosis-resisting film-coated tablet and method for manufacturing same |
| CN105168198A (en) * | 2015-10-12 | 2015-12-23 | 华北制药股份有限公司 | Application of norcantharidin in preparation of drug for treating gastric cancer precancerous diseases |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1418622A (en) * | 2002-12-19 | 2003-05-21 | 王登之 | Demethyl catharidine lipid for treating malignant tumour, and its prepn. method |
| CN1557299A (en) * | 2004-02-10 | 2004-12-29 | 肖广常 | Injectio Natarii Norcantharidatis infusion and its preparation method |
| CN2894699Y (en) * | 2006-03-14 | 2007-05-02 | 山东山大康诺制药有限公司 | Film-coated tablet of norcantharidin |
-
2006
- 2006-03-14 CN CNB2006100432119A patent/CN100386077C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991550B (en) * | 2009-08-21 | 2012-07-18 | 华北制药集团制剂有限公司 | Norcantharidin tablet and preparation method thereof |
| CN103432001A (en) * | 2013-08-23 | 2013-12-11 | 九芝堂股份有限公司 | Hyperostosis-resisting film-coated tablet and method for manufacturing same |
| CN105168198A (en) * | 2015-10-12 | 2015-12-23 | 华北制药股份有限公司 | Application of norcantharidin in preparation of drug for treating gastric cancer precancerous diseases |
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| Publication number | Publication date |
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| CN100386077C (en) | 2008-05-07 |
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Granted publication date: 20080507 Termination date: 20100314 |