CN1861185A - Method for preparing coated tablets for treating cholecystitis - Google Patents
Method for preparing coated tablets for treating cholecystitis Download PDFInfo
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- CN1861185A CN1861185A CN 200610020711 CN200610020711A CN1861185A CN 1861185 A CN1861185 A CN 1861185A CN 200610020711 CN200610020711 CN 200610020711 CN 200610020711 A CN200610020711 A CN 200610020711A CN 1861185 A CN1861185 A CN 1861185A
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Abstract
A Chinese medicine in the form of coated tablet for treating cholecystitis is prepared from 7 Chinese-medicinal materials including rhubarb, ox gallstone, bupleurum root, etc and the auxiliaries chosen from lactose, cane sugar, starch, calcium carbonate and mint oil through respectively pulverizing and decocting, mixing, granulating, drying, adding ox gallstone, spraying mint oil, die pressing and coating.
Description
(1) technical field: the preparation method of the Film coated tablets of treatment cholecystitis belongs to the preparation of drug combination method.
(2) background technology: a kind of Chinese patent medicine gallbladder health coated tablet is arranged on the market, have effects such as 'Shugan Lidan ', heat-clearing and toxic substances removing, anti-inflammatory analgetic, be used for acute and chronic cholecystitis, biliary diseases such as Biliary Calculi, clinical application is extensive, has obtained better effects, does not see the untoward reaction report.But there is following shortcoming in it: 1, owing to need sugar coating, and complex procedures, production cost is higher, cause production environment to pollute easily and produce harm to the direct labor is healthy, and the coated tablet diabetics is difficult to accept, and causes its scope of application to be limited to; 2 and since this pharmaceutically dosage form single, can't satisfy the demand in clinical different patient's condition user demand and market; Problems such as 3, there is complex process in the preparation of this coated tablet, and quality is difficult to be controlled, and cost is higher.
(3) summary of the invention:
The present invention provides a kind of patient acceptant at above deficiency exactly, medicine stability is strong, can better satisfy different patient demands, make product quality more stable, quality is more controlled, further improve the preparation technology's of product the preparation method of Film coated tablets of treatment cholecystitis, its technical scheme is as follows:
1) Radix Et Rhizoma Rhei powder is broken into fine powder, the five tastes such as all the other Radix Bupleuri, Herba Taraxaci, Herba Artemisiae Scopariae, Fructus Gardeniae, Radix Curcumae decoct with water secondary, add 8～12 times of decoctings for the first time and boil 2 hours, add 8～12 times of decoctings for the second time and boil 1 hour, and collecting decoction filters filtrate for later use;
2) filtrate is concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃), add Rhubarb, or add one or more adjuvants in the lactose, sucrose, starch, calcium carbonate of thick paste weight (decocting herbs part paste-forming rate be about 15%) 8～12% again, mixing, dry, pulverize, make granule, drying;
3) in dried granules, add Calculus Bovis, spray into Oleum menthae, mixing, compacting is wrapped film-coat, promptly in flakes.
Compared with prior art the present invention has following beneficial effect:
1. the present invention's Film coated tablets drug effect for the treatment of cholecystitis has kept the good curative effect such as 'Shugan Lidan ', heat-clearing and toxic substances removing, anti-inflammatory analgetic of gallbladder health coated tablet, and is practical.
2. treat in the Film coated tablets tablet moulding process (tabletting) of cholecystitis in development the present invention, show because of in this Film coated tablets component that through various experiments a large amount of Rhubarbs is arranged, therefore in the tablet molding, can not add any adjuvant, particularly do not need to add a large amount of Icing Sugar and make adjuvant, can avoid the tablet moldy metamorphism, increase medicine stability, enlarge the adaptation population, satisfy different patient demands, do not influence the hygroscopicity and the tabletting quality of medicated powder fully.Be the hygroscopicity of improving extractum when having changed the conventional tablet molding, the technology (as starch, calcium bicarbonate) that must add adjuvant in the tabletting, and then simplify process route, further improve technology, the quality standard of product, make the quality of product more controlled, this Film coated tablets cost is reduced.
3. make medicine not influenced by dampness, air and light with film coating, improve medicine stability.Film coating and sugar-coat ratio, with short production cycle, consumption is few, sheet heavily increase little, clothing layer mechanical strength is good, little to medicine disintegrate influence.By the technical parameter that adopts in the film coating procedure of the present invention, make product qualified rate reach 92.3%, this also helps to reduce cost.Film coating also makes product quality more stable, also further improves technology, the quality standard of product, makes the quality of product more controlled.
4. in the preparation tablets extraction process, through test of many times, selecting extractum recovery rate and two of jasminoidin content is evaluation index, amount of water etc. has been proposed following optimum parameters: ' adding 10 times of decoctings for the first time boiled 2 hours, for the second time adding 10 times of decoctings boiled 1 hour ', through extractum recovery rate and jasminoidin content measurement comprehensive grading 98.91%, it is reasonable, feasible and stable drawing amount of water thus; For preventing that effective ingredient is subjected to heat damage for a long time, in conjunction with the commercial production condition, adopt triple effect concentrating under reduced pressure equipment to concentrate, spissated condition is: temperature is 75 ℃, vacuum is 0.08～0.1Mpa.This extraction process also is rationally and optimizes production cost and energy resource consumption thus.
5. through test, when with wet method medicated powder being granulated, selecting concentration of alcohol is 80%, and viscosity is suitable, easily granulates.When tabletting, it is better to select pellet moisture to be controlled at 2%-5%, and granule plasticity is big, and the plain tablet quality that is pressed into is better.
6. the Film coated tablets three batch samples trial-production data with the treatment cholecystitis of the present invention preparation see Table one, and sample survey the results are shown in Table two, and the result shows by table one table two, and preparation technology of the present invention is reasonable, feasible.The Film coated tablets and the existing gallbladder health tablet quality standard of the inventive method preparation relatively see Table three, Film coated tablets of the present invention has as can be seen improved the controlling index of jasminoidin than the quality standard of gallbladder health sheet on the proper mass standard base, make the quality of this product more controlled.
(4) drawing explanation:
Accompanying drawing is a process chart of the present invention.
(5) specific embodiment:
Embodiment one:
Take by weighing crude drug by following weight:
Radix Bupleuri 180g, Herba Taraxaci 360g, Radix Et Rhizoma Rhei 150g, Herba Artemisiae Scopariae 380g, Calculus Bovis 40g, Fructus Gardeniae 290g Radix Curcumae 180g, Oleum menthae 2g
Its preparation method may further comprise the steps:
1) Radix Et Rhizoma Rhei powder is broken into 100 order fine powders, the five tastes such as all the other Radix Bupleuri, Herba Taraxaci, Herba Artemisiae Scopariae, Fructus Gardeniae, Radix Curcumae decoct with water secondary, add 10 times of decoctings for the first time and boil 2 hours, for the second time adding 10 times of decoctings boiled 1 hour, collecting decoction filters filtrate for later use with 200 order filter clothes;
2) be 75 ℃ with filtrate in temperature, vacuum is to be concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃) under the condition of 0.08～0.1Mpa, adds Rhubarb, mixing, drying is pulverized, the ethanol of selection 80% is made granule, drying, and pellet moisture is controlled at 2%～5%;
3) in dried granules, add Calculus Bovis, spray into Oleum menthae, mixing, compacting is in blocks, and this embodiment does not add other adjuvant;
The technology of bag film-coat may further comprise the steps:
1) preparation coating solution: get concentration and be 60% alcoholic solution and put in the agitator tank, start agitator, treat that whole liquid level forms whirlpool after, add the commercially available Ka Lekang Opadry coating powder (stomach dissolution type) of amount of alcohol 15% with even velocity, continue to stir 45 minutes, standby;
2) preheating coating pan to 35～45 ℃, (no fine powder, fragment, the sheet stamen is bright and clean, hardness 〉=3.5kg/mm with satisfactory plain sheet
2Disintegration time≤20min) place in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, starts compressor pump, pressure is controlled at 0.1～0.2Mpa, use gun spraying in the plain sheet surface of rotating the coating solution for preparing, flow-control is between 0.12～0.15kg/min, and coating pan rotating speed 20～25r/min is with 70～80 ℃ of hot air dryings, spraying is about 30 minutes continuously, to plain sheet surface all be wrapped and surface color even, stop hydrojet, continue to blow 8 minutes with hot blast after, reuse cold wind dries up, promptly.
Embodiment two:
Take by weighing crude drug by following weight:
Radix Bupleuri 180g, Herba Taraxaci 360g, Radix Et Rhizoma Rhei 150g, Herba Artemisiae Scopariae 380g, Calculus Bovis 40g, Fructus Gardeniae 290g Radix Curcumae 180g, Oleum menthae 2g, calcium carbonate 20.8g
Its preparation method may further comprise the steps:
1) Radix Et Rhizoma Rhei powder is broken into 100 order fine powders, the five tastes such as all the other Radix Bupleuri, Herba Taraxaci, Herba Artemisiae Scopariae, Fructus Gardeniae, Radix Curcumae decoct with water secondary, add 10 times of decoctings for the first time and boil 2 hours, for the second time adding 10 times of decoctings boiled 1 hour, collecting decoction filters filtrate for later use with 200 order filter clothes;
2) be 75 ℃ with filtrate in temperature, vacuum is to be concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃) under the condition of 0.08～0.1Mpa, adds Rhubarb and calcium carbonate, mixing, drying is pulverized, the ethanol of selection 80% is made granule, drying, and pellet moisture is controlled at 2%～5%.Here the paste-forming rate of decocting herbs parts is about 15%, the 1390g medical material, receive thick paste 208g, so add the calcium carbonate of thick paste weight 10%, i.e. 20.8g calcium carbonate;
3) in dried granules, add Calculus Bovis, spray into Oleum menthae, mixing, compacting is in flakes;
The technology of bag film-coat may further comprise the steps:
1) preparation coating solution: get concentration and be 60% alcoholic solution and put in the agitator tank, start agitator, treat that whole liquid level forms whirlpool after, add the commercially available Opadry coating powder (stomach dissolution type) of amount of alcohol 10% with even velocity, continue to stir 45 minutes, standby;
2) preheating coating pan to 35～45 ℃, (no fine powder, fragment, the sheet stamen is bright and clean, hardness 〉=3.5kg/mm with satisfactory plain sheet
2Disintegration time≤20min) place in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, starts compressor pump, pressure is controlled at 0.1～0.2Mpa, use gun spraying in the plain sheet surface of rotating the coating solution for preparing, flow-control is between 0.12～0.15kg/min, and coating pan rotating speed 20～25r/min is with 70～80 ℃ of hot air dryings, spraying is about 30 minutes continuously, to plain sheet surface all be wrapped and surface color even, stop hydrojet, continue to blow 8 minutes with hot blast after, reuse cold wind dries up, promptly.
Embodiment three:
Take by weighing crude drug by following weight:
Radix Bupleuri 180g, Herba Taraxaci 360g, Radix Et Rhizoma Rhei 150g, Herba Artemisiae Scopariae 380g, Calculus Bovis 40g, Fructus Gardeniae 290g Radix Curcumae 180g, Oleum menthae 2g, lactose 17g
Its preparation method may further comprise the steps:
1) Radix Et Rhizoma Rhei powder is broken into 100 order fine powders, the five tastes such as all the other Radix Bupleuri, Herba Taraxaci, Herba Artemisiae Scopariae, Fructus Gardeniae, Radix Curcumae decoct with water secondary, add 10 times of decoctings for the first time and boil 2 hours, for the second time adding 10 times of decoctings boiled 1 hour, collecting decoction filters filtrate for later use with 200 order filter clothes;
2) be 75 ℃ with filtrate in temperature, vacuum is to be concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃) under the condition of 0.08～0.1Mpa, adds Rhubarb and lactose, mixing, drying is pulverized, the ethanol of selection 80% is made granule, drying, and pellet moisture is controlled at 2%～5%;
3) in dried granules, add Calculus Bovis, spray into Oleum menthae, mixing, compacting is in flakes;
The technology of bag film-coat may further comprise the steps:
1) preparation coating solution: get concentration and be 60% alcoholic solution and put in the agitator tank, start agitator, treat that whole liquid level forms whirlpool after, add the commercially available Opadry coating powder (stomach dissolution type) of amount of alcohol 20% with even velocity, continue to stir 45 minutes, standby;
2) preheating coating pan to 35～45 ℃, (no fine powder, fragment, the sheet stamen is bright and clean, hardness 〉=3.5kg/mm with satisfactory plain sheet
2Disintegration time≤20min) place in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, starts compressor pump, pressure is controlled at 0.1～0.2Mpa, use gun spraying in the plain sheet surface of rotating the coating solution for preparing, flow-control is between 0.12～0.15kg/min, and coating pan rotating speed 20～25r/min is with 70～80 ℃ of hot air dryings, spraying is about 30 minutes continuously, to plain sheet surface all be wrapped and surface color even, stop hydrojet, continue to blow 8 minutes with hot blast after, reuse cold wind dries up, promptly.
Product function of the present invention cures mainly: 'Shugan Lidan ', heat-clearing and toxic substances removing, anti-inflammatory analgetic.Be used for acute and chronic cholecystitis, biliary diseases such as Biliary Calculi.Specification: every heavy 0.40g.Usage and dosage: oral, one time 4～5,3 times on the one.30 days is a course of treatment.
Product of the present invention should carry out packing in 300,000 grades of clean areas (18～25 ℃ of room temperatures, relative humidity is below 53%).
Manufacture experimently three batches of investigations by above-mentioned technology, wherein three batch datas and run-of-the-mill check result see Table one, table two.
Table one three batch samples trial-production data
| Lot number | 20050301 | 20050302 | 20050303 |
| Inventory (kg) | 15.82 | 15.82 | 15.82 |
| Medicated powder heavy (kg) | 3.98 | 4.01 | 3.97 |
| Deserved number (sheet) | 10000 | 10000 | 10000 |
| The real sheet number (sheet) that gets | 9230 | 9150 | 9140 |
| Product yield (%) | 92.3 | 91.5 | 91.4 |
Table two sample survey result
| Lot number | 20050301 | 20050302 | 20050303 |
| Character | This product is a Film coated tablets, remove film-coat after, show sepia; Gas perfume (or spice), acrid in the mouth, little hardship, puckery. | This product is a Film coated tablets, remove film-coat after, show sepia; Gas perfume (or spice), acrid in the mouth, little hardship, puckery. | This product is a Film coated tablets, remove film-coat after, show sepia; Gas perfume (or spice), acrid in the mouth, little hardship, puckery. |
| Differentiate | Up to specification | Up to specification | Up to specification |
| Weight differential (%) | Up to specification | Up to specification | Up to specification |
| Disintegration (min) | 41 | 43 | 45 |
| Microbial limit | Up to specification | Up to specification | Up to specification |
| Jasminoidin content (mg/ sheet) | 1.434 | 1.453 | 1.388 |
The comparison sheet of table three product of the present invention and the gallbladder health sheet that gone on the market:
| Compare index | This tablet | The listing tablet |
| Dose (at every turn) | Identical | Identical |
| Character | This product is a Film coated tablets, remove film-coat after, show sepia; Gas perfume (or spice), acrid in the mouth, little hardship, puckery. | This product is a coated tablet, remove the sugar-coat clothing after, show sepia; Gas perfume (or spice), acrid in the mouth, little hardship, puckery. |
| Differentiate | TLC discriminating 1, Calculus Bovis 2, jasminoidin 3, Radix Et Rhizoma Rhei | TLC discriminating 1, Calculus Bovis 2, jasminoidin 3, Radix Et Rhizoma Rhei |
| The content controlling index | HPLC measures jasminoidin | Do not have |
Claims (6)
1, a kind of preparation method for the treatment of the Film coated tablets of cholecystitis is characterized in that this method comprises the following steps:
1) standby by following weight proportion weighting raw materials:
Radix Bupleuri 180g, Herba Taraxaci 360g, Radix Et Rhizoma Rhei 150g, Herba Artemisiae Scopariae 380g, Calculus Bovis 40g, Fructus Gardeniae 290g Radix Curcumae 180g, Oleum menthae 2g;
2) Radix Et Rhizoma Rhei powder is broken into fine powder, the five tastes such as all the other Radix Bupleuri, Herba Taraxaci, Herba Artemisiae Scopariae, Fructus Gardeniae, Radix Curcumae decoct with water secondary, add 8～12 times of decoctings for the first time and boil 2 hours, add 8～12 times of decoctings for the second time and boil 1 hour, and collecting decoction filters filtrate for later use;
3) filtrate being concentrated into relative density is 1.35～1.40 thick paste, adds Rhubarb, mixing, and drying is pulverized, and makes granule, drying;
4) in dried granules, add Calculus Bovis, spray into Oleum menthae, mixing, compacting is wrapped film-coat, promptly in flakes.
2, according to the preparation method of the Film coated tablets of the described treatment cholecystitis of claim 1, it is characterized in that step 3) selects 75%～85% alcohol granulation, pellet moisture is controlled at 2%～5%.
3, according to the preparation method of the Film coated tablets of claim 1 or 2 described treatment cholecystitis, it is characterized in that the condition that step 3) concentrates thick paste is: temperature is 75 ℃, and vacuum is 0.08～0.1Mpa.
4,, it is characterized in that adding in the step 3) one or more adjuvants in the lactose, sucrose, starch, calcium carbonate of thick paste weight 8～12% according to the preparation method of the Film coated tablets of the described treatment cholecystitis of claim 1.
5, according to the preparation method of the Film coated tablets of the described treatment cholecystitis of claim 1, it is characterized in that wrapping film-coat technology and comprise the steps:
1) preparation coating solution: get concentration and be 60% alcoholic solution and put in the agitator tank, start agitator, add the Opadry coating powder of amount of alcohol 10～20%, continue to stir 40～50 minutes, standby;
2) preheating coating pan to 35～45 ℃, plain sheet is placed in the coating pan, start coating pan, start compressor pump, the coating solution for preparing is sparged the plain sheet surface of rotation, with 70～80 ℃ of hot air dryings, continuously spraying is 25～35 minutes, stops hydrojet, continue to blow 6～10 minutes with hot blast after, reuse cold wind dries up, promptly.
6, according to the preparation method of the Film coated tablets of the described treatment cholecystitis of claim 6, it is characterized in that the pressure of compressor pump is controlled at 0.1～0.2Mpa, the spray coating flow quantity is controlled between 0.12～0.15kg/min, coating pan rotating speed 20～25r/min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100207110A CN100512871C (en) | 2006-04-13 | 2006-04-13 | Method for preparing coated tablets for treating cholecystitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100207110A CN100512871C (en) | 2006-04-13 | 2006-04-13 | Method for preparing coated tablets for treating cholecystitis |
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| Publication Number | Publication Date |
|---|---|
| CN1861185A true CN1861185A (en) | 2006-11-15 |
| CN100512871C CN100512871C (en) | 2009-07-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100207110A Expired - Fee Related CN100512871C (en) | 2006-04-13 | 2006-04-13 | Method for preparing coated tablets for treating cholecystitis |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102847068A (en) * | 2012-08-31 | 2013-01-02 | 李承平 | Capillary wormwood herb tablets with function of heat clearing |
| CN103417377A (en) * | 2013-08-23 | 2013-12-04 | 九芝堂股份有限公司 | Bronchitis film-coated tablet and preparation method thereof |
-
2006
- 2006-04-13 CN CNB2006100207110A patent/CN100512871C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102847068A (en) * | 2012-08-31 | 2013-01-02 | 李承平 | Capillary wormwood herb tablets with function of heat clearing |
| CN103417377A (en) * | 2013-08-23 | 2013-12-04 | 九芝堂股份有限公司 | Bronchitis film-coated tablet and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100512871C (en) | 2009-07-15 |
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Assignee: CHENGDU SENKE PHARMACEUTICAL CO., LTD. Assignor: Shi Shenghong Contract record no.: 2010510000029 Denomination of invention: Method for preparing coated tablets for treating cholecystitis Granted publication date: 20090715 License type: Exclusive License Open date: 20061115 Record date: 20100609 |
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Assignee: CHENGDU SENKE PHARMACEUTICAL CO., LTD. Assignor: Shi Shenghong Contract record no.: 2011510000084 Denomination of invention: Method for preparing coated tablets for treating cholecystitis Granted publication date: 20090715 License type: Exclusive License Open date: 20061115 Record date: 20110617 |
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