CN2894699Y - Film-coated tablet of norcantharidin - Google Patents

Film-coated tablet of norcantharidin Download PDF

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Publication number
CN2894699Y
CN2894699Y CN 200620081778 CN200620081778U CN2894699Y CN 2894699 Y CN2894699 Y CN 2894699Y CN 200620081778 CN200620081778 CN 200620081778 CN 200620081778 U CN200620081778 U CN 200620081778U CN 2894699 Y CN2894699 Y CN 2894699Y
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CN
China
Prior art keywords
tablet
norcantharidin
film
coated
coating
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 - Fee Related
Application number
CN 200620081778
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Chinese (zh)
Inventor
冯军涛
刘建峰
赵桂森
李思林
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANDONG SHANDA KANGNUO PHARMACEUTICAL CO Ltd
Original Assignee
SHANDONG SHANDA KANGNUO PHARMACEUTICAL CO Ltd
Priority date (The priority date 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 date listed.)
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Priority to CN 200620081778 priority Critical patent/CN2894699Y/en
Application granted granted Critical
Publication of CN2894699Y publication Critical patent/CN2894699Y/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

The utility model discloses a norcantharidin film-coated tablet which is characterized in that an oblate norcantharidin film-coated tablet with a diameter of 0.5-0.8cm is designed as a film base, and the surface of the film is sprayed and coated with the coating material with a thickness of 0.3-1.0mm. The coating material belongs to moisture proof OPADRY. The preparation of the norcantharidin film-coated tablet consists of a preparative course of the tablet and a coating course of the film. The film coating tablet of the utility model has the advantages of smaller embryo tablet, few auxiliary materials and low costs, and meanwhile, the finished film coating tablet has a good performance of moisture proof, strong stability, thereby increasing the dissolution rate of the tablet and then improving the bioavailability and the clinical effectiveness. The norcantharidin film-coated tablet of the utility model applies to the diseases such as liver cancer, esophageal cancer, gastric cancer, cardiac cancer and so on as well as leukocyte hypofunction, hepatitis, liver cirrhosis and carriers of hepatitis virus B. The tablet could also be used as a pre-operation medicine or being used in the combined chemotherapy; meanwhile relieves the operating restrictions upon the diabetic patients.

Description

A kind of coated norcantharidin tablet
Technical field
This utility model relates to a kind of Film coated tablets, relates in particular to a kind of Film coated tablets of norcantharidin sheet.
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 patent application relevant with film-coat increases gradually, but up to now, does not also have the patent application of coated norcantharidin tablet.
The utility model content
At the deficiencies in the prior art, the purpose of this utility model provides a kind of Film coated tablets of norcantharidin sheet, to increase the kind of this medicine.
Coated norcantharidin tablet described in the utility model, 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 described in the utility model 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 utility model and original norcantharidin coated tablet are basic identical, but coated norcantharidin tablet of the present utility model 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 utility model 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 utility model 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.
Description of drawings
Fig. 1 coated norcantharidin tablet stereo display of the present utility model tangent plane ideograph
Wherein: 1 shows coating material film-coat layer, and 2 show the plain sheet of oblate norcantharidin.
The specific embodiment
With embodiment coated norcantharidin tablet of the present utility model 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 oblate coated norcantharidin tablet product (see figure 1) of diameter 0.5~0.6cm.
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: plain 10000 of the sheets of the oblate norcantharidin of diameter 0.7~0.8cm of suppressing are placed 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 (2)

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.
CN 200620081778 2006-03-14 2006-03-14 Film-coated tablet of norcantharidin Expired - Fee Related CN2894699Y (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200620081778 CN2894699Y (en) 2006-03-14 2006-03-14 Film-coated tablet of norcantharidin

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200620081778 CN2894699Y (en) 2006-03-14 2006-03-14 Film-coated tablet of norcantharidin

Publications (1)

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CN2894699Y true CN2894699Y (en) 2007-05-02

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Country Status (1)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100386077C (en) * 2006-03-14 2008-05-07 山东山大康诺制药有限公司 Coated norcantharidin tablet and its preparing method
CN102119913A (en) * 2011-02-14 2011-07-13 江中药业股份有限公司 Method for coating film on large-size planar double-round table angle-ground Chinese medicinal tablet

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100386077C (en) * 2006-03-14 2008-05-07 山东山大康诺制药有限公司 Coated norcantharidin tablet and its preparing method
CN102119913A (en) * 2011-02-14 2011-07-13 江中药业股份有限公司 Method for coating film on large-size planar double-round table angle-ground Chinese medicinal tablet
CN102119913B (en) * 2011-02-14 2014-05-28 江中药业股份有限公司 Method for coating film on large-size planar double-round table angle-ground Chinese medicinal tablet

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C14 Grant of patent or utility model
GR01 Patent grant
C17 Cessation of patent right
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20070502

Termination date: 20100314