CN1857400A - Coated selfheal tablet and its preparing method - Google Patents
Coated selfheal tablet and its preparing method Download PDFInfo
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- CN1857400A CN1857400A CN 200610020627 CN200610020627A CN1857400A CN 1857400 A CN1857400 A CN 1857400A CN 200610020627 CN200610020627 CN 200610020627 CN 200610020627 A CN200610020627 A CN 200610020627A CN 1857400 A CN1857400 A CN 1857400A
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Abstract
The coated selfheal tablet and its preparation process belong to the field of botanical medicine technology. The preparation process of the coated selfheal tablet includes the following steps: thrice decocting selfheal, filtering to obtain filtrate, concentrating filtrate to form extractum, drying, crushing, pelletizing after adding starch slurry, tabletting, and coating. The coated selfheal tablet has the advantages of raised medicine stability, convenient taking, accurate dosage, etc.
Description
(1) technical field: coated selfheal tablet and preparation method thereof belongs to a kind of medicinal plants and preparation method.
(2) background technology: the Spica Prunellae bitter in the mouth is cold in nature, returns liver, gallbladder meridian, has clearing away liver-fire, the merit of Disperse hepatic depression.Spica Prunellae cream is national basic medical insurance medication, and is very extensive in clinical practice, swells and ache in treatment headache, dizzy, scrofula, goiter, acute mastitis, thyromegaly, tuberculous lymphadenitis, cyclomastopathy determined curative effect.But the shortcoming that it exists is: 1, the easy moldy metamorphism of unguentum, quality instability; 2, the unguentum dose is inaccurate, and has the bitterness of medicine discomfort, takes inconvenience, 3, transportation, store also inconvenient.
(3) summary of the invention:
The problem to be solved in the present invention provides a kind of steady quality reliable at above deficiency exactly, and dose is accurate, the prunella spike of taking convenience.Its technical scheme is as follows:
It is to get Spica Prunellae to decoct with water, and filtrate is condensed into thick paste, tablet forming after granulating, the bag film-coat and coated selfheal tablet.
Its preparation method comprises the following steps:
1) the water concentration contracts: get Spica Prunellae and decoct with water 2～3 times, add for the first time 8～14 times of water, for the second time or add 8～12 times of water for the third time, decocted 2 hours at every turn, filter, and merging filtrate, it is 1.21～1.25 thick paste that filtrate is concentrated into relative density;
2) pelletizing press sheet: with above-mentioned thick paste drying, pulverizing, granulate with 10% starch slurry then, granule moisture content is controlled at 5%～7%, and granule is pressed into plain sheet;
3) make film coating liquid: select for use hydroxypropyl emthylcellulose or IV polyacrylic resin as the film coating material, adding 55%～65% ethanol makes the coating material concentration reach 3%～4%, stirring makes it to dissolve fully, filter, add 0.8%～1.2% glycerol or PEG400 or propylene glycol in the filtrate, and 1.2%～2.0% red ferric oxide, stir evenly, colloid mill grinds, sieving for standby;
4) bag film-coat: first preheating coating pan to 35 ℃～45 ℃, the plain sheet that is pressed into is placed in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, start compressor pump, pressure is controlled at 0.3～0.5Mpa, uses gun spraying in the plain sheet surface of rotating, flow 0.15～0.2kg/min film coating liquid, with 60～70 ℃ of hot air dryings, continuously spraying is 2.5～3.5 hours, stops hydrojet, continue to blow 6～10 minutes with hot blast after, reuse cold wind dries up, and gets product.
The present invention compared with prior art has following beneficial effect:
1, changes unguentum into tablet, can avoid moldy metamorphism, increased medicine stability; 2, product of the present invention does not add adjuvant, and the medicine content difference is little in the tablet, and taking dose is more accurate, has enlarged the adaptation population, satisfies different patient demands; 3, by film coating, can cover the adverse drug abnormal smells from the patient, make medicine more stable; 4, tablet carries and transports than unguentum conveniently; 5, tablet adapts to the big production of modernization, and linkage is strong than unguentum.
The proof of product practicality of the present invention:
The chemistry aspect: Shenyang Pharmaceutical University, and summarizes its main biological activity the chemical constituent of the Spica Prunellae summary of classifying according to the structure type of chemical compound.Spica Prunellae contains the various active chemical constituent as a result, mainly contains chemical compounds such as triterpenes, steroidal class, flavonoid, Coumarins, and it has blood pressure lowering, antibiotic, antiviral and biological activitys such as antiinflammatory and antitumor.Meng Zhengmu etc. separate from the labiate Spica Prunellae and have identified 6 monomeric compounds: oleanolic acid (I), β-Amyrin (I) etc.; Wang Zhuju, Zhao Yuying etc. separate the Spica Prunellae chemical constituent with modern various chromatographic processes, identify structure with spectroscopic technique.Result: from the dry fruit ear of Spica Prunellae, get 6 chemical compounds; through wave spectrum (IR, UV, FABMS; 1Dand2D NMR) parsing is accredited as 3 β respectively; 16 α, 24 trihydroxy olives, 12 alkene, 28 sour 3O (6 ' bytyry) β-D glycopyranoside (I), ursolic acid (II); 2 α; 3 alpha-dihydroxy-Usu 12 alkene-28 acid (III), Quercetin (IV), Quercetin-3-O-β-D-galactoside (v) and the caffeic acetate (vi).
The pharmacodynamic study documents and materials:
Effect to cardiovascular system: this product water-leach liquor, alcohol-water leachate and 30% alcohol leaching liquid have hypotensive effect to anesthetized animal.
Antibiotic, antivirus action: in vitro tests, decoct all has inhibitory action in various degree to dysentery bacterium, vibrio cholera, Bacillus typhi, escherichia coli, Bacillus proteus, staphylococcus and Bacillus tuberculosis.
Anti-inflammatory and analgesic effect: use Oleum Tiglii, carrageenin, Ovum Gallus domesticus album and cotton balls cause rat and mice inflammatory model respectively, lumbar injection acetic acid is made models such as mice pain, observe the anti-inflammatory and analgesic effect of Spica Prunellae, the result: Spica Prunellae oral liquid can significantly alleviate the mouse knoting oil ear swelling as a result, obviously reduce the capillary permeability increase of acetic acid abdominal cavity and can suppress rat chondrus ocellatus Holmes property, Ovum Gallus domesticus album foot swelling and granulation hyperplasia, the pain that Dichlorodiphenyl Acetate causes also has analgesic effect preferably, and glucocorticoid is synthetic in its antiinflammatory action mechanism and the adrenal cortex, excretory reinforcement is relevant.
Antihypertensive function: Wang Haibo etc. are observed Spica Prunellae to the protection of anesthetized rat acute myocardial infarction and the effect of bringing high blood pressure down by Spica Prunellae general glycoside (pvs); the result shows: pvs can reduce the rat acute myocardial infarct size; reduce Infant Mortality; reduce the occurrence scope of arrhythmia, pvs begins that from 2.5mg/kg rat is had significant hypotensive effect.
Anti-adenocarcinoma of stomach cytosis: Wang Kun etc. studies show that by the influence of Spica Prunellae to the SGC-7901 cell: the Spica Prunellae injection of 5% concentration can obviously suppress the growth of SGC-7901 cell and induce its apoptosis.
Hypoglycemic activity: observe the influence research of Spica Prunellae extract to laboratory animal blood glucose by making epinephrine and alloxan zoic model with hyperglycemia, the Spica Prunellae extract antagonism is because epinephrine and alloxan cause the mouse blood sugar rising.
Function of promoting blood circulation to disperse blood clots: Chen Wenmei, He Jiyuan are by the stasis syndrome model of QI stagnated by cold, observe Herba Ephedrae, Spica Prunellae, Os Sepiae decocting liquid respectively to PT, the ELT of rat model and the influence of hemorheological property, as a result Herba Ephedrae, Spica Prunellae obviously the lengthening model rat PT, shorten ELT (P＜0.01, P＜0.05), Spica Prunellae has the improvement effect to the hemorheology part index number.
The safety documents and materials: Medicines Inst., Hangzhou City shows the acute toxicity test in mice of Spica Prunellae extract: this product safety range is big.Cmax 10g/kg once irritates the stomach mice, observes none death in 7 days; Rat subacute test gastric infusion 45 days and drug withdrawal were observed result and matched group no significant difference in 10 days; Canis familiaris L. administration 90 days and drug withdrawal were observed administration group as a result and matched group no significant difference in 10 days.
The clinical literature data:
The resisting hyperplasia of mammary glands effect: Shaoxing, Zhejiang Province city women and children hospital is by observing Spica Prunellae oral liquid treatment cyclomastopathy 100 examples, and the result shows: treatment group effective percentage 100%, matched group effective percentage 95% (P＜0 05).The prompting Spica Prunellae oral liquid is to the cyclomastopathy determined curative effect; Huang Ruyuan cooperates Danzhi Xiaoyao San treatment acute mastitis with Spica Prunellae, and is evident in efficacy after 3 days; Guo Shaowei etc. treat cyclomastopathy, prostatic hyperplasia with Spica Prunellae.Pain relief after 3 doses as a result, lump disappears after 9 doses.
Liver heat removing and eyesight improving, hypotensive effect: Huang Ruyuan is dizzy with the Spica Prunellae treatment, dry astringent eye, xerosis conjunctivitis, determined curative effect as a result; The pool celebrating is good treats hypertension, icterohepatitis, pulmonary tuberculosis, exudative pleurisy with Spica Prunellae, has certain curative effect.
Curative effect and safety:
Spica Prunellae cream and Spica Prunellae oral liquid in clinical practice for many years, two kinds are not seen the report of any toxicity aspect all to include national basic medical insurance Class B medicine catalogue in.The Spica Prunellae capsule is the new drug kind, has gone on the market and has promoted the use of.They show that prunella spike is the extensively approval of industry institute in aspect curative effects such as treatment hepatitis B, hypertension, dizziness headache, scrofula, goiter, acute mastitis swell and ache certainly aspect safety and curative effect.
Realize purpose of the present invention, below some is very important:
Learn according to long-term practice that 1, the decocting for Chinese herbal medicine extraction effect is subjected to the influence of factors such as amount of water, extraction time, extraction time.The present invention is an evaluation index with total flavones, dried cream rate, investigates different amount of water to decocting the influence of extraction effect, and the optimised process of learning amount of water is for adding 12 times of water for the first time, and second and third time respectively adds 10 times of water.
2, the granule that makes tablet machine tabletting influences the pellet moisture that has of tablet quality, and the granule plasticity of the suitable moisture of water content is big, and the hardness of the tablet that is pressed into is better, and granule is too wet, and sticking then easily takes place.Pellet moisture is controlled in 5%～7% better.
2, because this product is full extractum sheet, the easy moisture absorption is for improving plain tablet quality, so adopt coating.Film coating compare with sugar-coat have with short production cycle, consumption is few, sheet heavily increase little, clothing layer mechanical strength is good, to advantages such as medicine disintegrate influence are little, so the employing film coating.The test and the formed product of the present invention of technical parameters such as the selecting for use of film-coat material, plasticizer, coloring agent, consumption, concentration and flow, pressure, baking temperature count for much.
(4) drawing explanation:
Accompanying drawing is a process chart of the present invention.
(5) specific embodiment:
Take by weighing Spica Prunellae 3750g
1) the water concentration contracts: get Spica Prunellae and decoct with water 3 times, add 12 times of water for the first time, second and third time respectively adds 10 times of water, decocts 2 hours at every turn, filter, and merging filtrate, filtrate is concentrated into the thick paste that relative density is 1.21～1.25 (80～85 ℃);
2) pelletizing press sheet: with above-mentioned thick paste drying, pulverizing, granulate with 10% starch slurry then, granule moisture content is controlled at 5%, and granule is pressed into 1000 plain sheets;
3) make film coating liquid: select for use hydroxypropyl emthylcellulose as the film coating material, adding 60% ethanol makes the coating material concentration reach 3%, stirring makes it to dissolve fully, filter, add 1% glycerol in the filtrate as plasticizer, and 1.5% red ferric oxide stirs evenly as toner emphatically, colloid mill grinds, and it is standby to cross 100 mesh sieves;
4) bag film-coat: first preheating coating pan to 40 ℃, the plain sheet that is pressed into is placed in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, start compressor pump, pressure is controlled at 0.4Mpa, uses gun spraying in the plain sheet surface of rotating, flow 0.15～0.2kg/min film coating liquid, with 60～70 ℃ of hot air dryings, sprayed continuously 3 hours, to unilateral complete bright and clean, color and luster is even, stops hydrojet, continue to blow 8 minutes with hot blast after, reuse cold wind dries up, and gets product.
The film coating material also can be selected the IV polyacrylic resin for use when preparing product of the present invention, and plasticizer also can be selected PEG400 or propylene glycol for use.
Product function of the present invention cures mainly: relieve inflammation or internal heat, make eye bright, eliminating stagnation, detumescence.Be used for headache, dizzy, scrofula, goiter, acute mastitis swells and ache; Thyromegaly, tuberculous lymphadenitis, cyclomastopathy.Specification is the 0.51g/ sheet.Usage and dosage: oral, one time 6 (the crude drug amount is 22.5g), 2 times on the one.
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 54%).
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 | 20030901 | 20030902 | 20030903 |
| Inventory (kg) | 37.50 | 37.50 | 37.50 |
| Clear paste heavy (kg) | 13.0 | 11.5 | 12.6 |
| Granule heavy (kg) | 5.23 | 5.12 | 5.14 |
| Deserved number (sheet) | 10000 | 10000 | 10000 |
| The real sheet number (sheet) that gets | 9220 | 9340 | 9170 |
| Product yield (%) | 92.2 | 93.4 | 91.7 |
| The total flavones rate of transform (%) | 64 | 61 | 66 |
Table two sample survey result
| Lot number | 20030901 | 20030902 | 20030903 |
| Character | This product is a Film coated tablets, removes to show sepia behind the film-coat; Bitter and puckery flavor | This product is a Film coated tablets, removes to show sepia behind the film-coat; Bitter and puckery flavor | This product is a Film coated tablets, removes to show sepia behind the film-coat; Bitter and puckery flavor |
| Granularity | Qualified | Qualified | Qualified |
| Weight differential (%) | Up to specification | Up to specification | Up to specification |
| Tablet weight variation (%) | Up to specification | Up to specification | Up to specification |
| Microbial limit | Qualified | Qualified | Qualified |
| Dissolve scattered time limit (min) | 48 | 46 | 45 |
| General flavone content (mg/ sheet) | 65.81 | 60.21 | 70.79 |
Three batches of pilot-scale experiment show that gained preparation technology is reasonable, feasible.
Claims (6)
1, a kind of coated selfheal tablet is characterized in that it is to get Spica Prunellae to decoct with water, and filtrate is condensed into thick paste, tablet forming after granulating, the bag film-coat and coated selfheal tablet.
2, the preparation method of coated selfheal tablet is characterized in that comprising the following steps:
1) the water concentration contracts: get Spica Prunellae and decoct with water 2～3 times, add for the first time 8～14 times of water, for the second time or add 8～12 times of water for the third time, decocted 2 hours at every turn, filter, and merging filtrate, it is 1.21～1.25 thick paste that filtrate is concentrated into relative density;
2) pelletizing press sheet: with above-mentioned thick paste drying, pulverizing, granulate with starch slurry then, granule moisture content is controlled at 5%～7%, and granule is pressed into plain sheet;
3) make film coating liquid: select for use hydroxypropyl emthylcellulose or IV polyacrylic resin as the film coating material, adding 55%～65% ethanol makes the coating material concentration reach 3%～4%, stirring makes it to dissolve fully, filter, add 0.8%～1.2% glycerol or PEG400 or propylene glycol in the filtrate, and 1.2%～2.0% red ferric oxide, stir evenly, colloid mill grinds, sieving for standby;
4) bag film-coat: first preheating coating pan to 35 ℃～45 ℃, the plain sheet that is pressed into is placed in the coating pan, start coating pan, start air draft and dust exhaust apparatus, plain sheet is heated evenly, start compressor pump, pressure is controlled at 0.3～0.5Mpa, uses gun spraying in the plain sheet surface of rotating, flow 0.15～0.2kg/min film coating liquid, with 60～70 ℃ of hot air dryings, continuously spraying is 2.5～3.5 hours, stops hydrojet, continue to blow 6～10 minutes with hot blast after, reuse cold wind dries up, and gets product.
3, according to the preparation method of the described coated selfheal tablet of claim 2, it is characterized in that decocting with water in the step 1) 3 times, add 12 times of water for the first time, second and third time respectively adds 10 times of water.
4, according to the preparation method of the described coated selfheal tablet of claim 2, it is characterized in that step 2) in the concentration of starch slurry be 10%.
5, according to the preparation method of the described coated selfheal tablet of claim 2, it is characterized in that making in the step 3) material selection hydroxypropyl emthylcellulose of film coating liquid, add 60% ethanol and make the coating material concentration reach 3%, the glycerol of adding 1.0% and 1.5% red ferric oxide in the filtrate.
6,, it is characterized in that the coating pan of bag film-coat in the step 4) is preheated to 40 ℃ earlier according to the preparation method of the described coated selfheal tablet of claim 2; Pressure is controlled at 0.4Mpa; Spraying is 3 hours continuously; Continued to blow 8 minutes with hot blast.
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| CN 200610020627 CN1857400A (en) | 2006-03-30 | 2006-03-30 | Coated selfheal tablet and its preparing method |
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| CN 200610020627 CN1857400A (en) | 2006-03-30 | 2006-03-30 | Coated selfheal tablet and its preparing method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988474A (en) * | 2012-11-16 | 2013-03-27 | 湖北诺克特药业有限公司 | Processing method for prunella vulgaris extract |
| CN104367608A (en) * | 2014-11-03 | 2015-02-25 | 成都森科制药有限公司 | Method for preparing compound pseudo-ginseng film coated tablet |
| CN104367625A (en) * | 2014-11-03 | 2015-02-25 | 成都森科制药有限公司 | Method for preparing selfheal tablet |
| EP2937094A4 (en) * | 2012-12-21 | 2016-08-31 | Tasly Pharmaceutical Group Co | Pharmaceutical composition for treating headache, and preparation method thereof |
-
2006
- 2006-03-30 CN CN 200610020627 patent/CN1857400A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988474A (en) * | 2012-11-16 | 2013-03-27 | 湖北诺克特药业有限公司 | Processing method for prunella vulgaris extract |
| EP2937094A4 (en) * | 2012-12-21 | 2016-08-31 | Tasly Pharmaceutical Group Co | Pharmaceutical composition for treating headache, and preparation method thereof |
| US9795648B2 (en) | 2012-12-21 | 2017-10-24 | Tasly Pharmaceutical Group Co., Ltd. | Pharmaceutical composition for treating headache, and preparation method thereof |
| CN104367608A (en) * | 2014-11-03 | 2015-02-25 | 成都森科制药有限公司 | Method for preparing compound pseudo-ginseng film coated tablet |
| CN104367625A (en) * | 2014-11-03 | 2015-02-25 | 成都森科制药有限公司 | Method for preparing selfheal tablet |
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