CN1281233C - Orally disintegrating tablet of 'Shuanghuanglian' and its preparation - Google Patents
Orally disintegrating tablet of 'Shuanghuanglian' and its preparation Download PDFInfo
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Abstract
The present invention discloses a double coptis root orally disintegrating tablet and a preparation method thereof. The present invention is characterized in that the orally disintegrating tablet is prepared from effective components extracted from the traditional Chinese medicine of honeysuckles, scutellaria, forsythia and pharmaceutical adjuvant; a composite disintegrating agent containing erythritol is also used; erythritol and chitin or low-substituted hydroxypropyl cellulose or sodium carboxymethyl starch or crosslinked sodium carboxymethyl starch or non-soluble crosslinked polyvinyl pyrrolidone are combined with raw materials in a certain proportion to prepare a composite disintegrating agent. Since erythritol has the effect of corrigents, the dosage of pharmaceutical adjuvant of the preparation of the present invention is reduced; pharmacological experiments show that the double coptis root orally disintegrating tablet of the present invention has the characteristics of quick disintegration, rapid effect and excellent pharmacological action.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of SHUANGHUANLIAN oral cavity disintegration tablet and preparation method thereof.
Background technology
Oral cavity disintegration tablet is a kind of new pharmaceutical preparation, and it can absorb through hypoglossis mucous membrane, directly enters blood, has avoided first pass effect effectively, so taking dose is little, and safety is good, and effect rapidly.Though be oral formulations, can reach the effect of ejection preparation.Therefore just progressively become the focus that pharmaceutical manufacturer and research and development field are paid close attention to.This dosage form mainly is to select suitable fast disintegrant, by the existing certain rigidity of its tablet of making, certain sedimentation is arranged again.Can not need the water assisting deglutition when taking, can rapid disintegrate become fine grained in the oral cavity, only several swallowing acts can be finished drug administration process.Its more common solid orally ingestible absorbs fast, bioavailability height, and taking convenience.
The preparation oral cavity disintegration tablet will be considered the problem of following critical aspects: 1, the advantage of oral cavity disintegration tablet just is rapid disintegrate, and it is fast to discharge medicine, reaches rapid-action effect, seeks suitable disintegrants, to guarantee oral cavity disintegration tablet disintegrate rapidly in the oral cavity; 2, seek relatively inexpensive pharmaceutic adjuvant, to reduce production cost; 3, only need the just disintegrate fully of water of minute quantity owing to disintegrating tablet, therefore must consider stability, prolongation shelf life and the shelf-life of humidity environment oral cavity disintegration tablet higher relatively in the process of storage, significant to medical manufacturing enterprise.
Disintegrating agent is commonly used in the oral cavity disintegration tablet adjuvant have low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa), crospolyvinylpyrrolidone (PVPP), crosslinked carboxymethylstach sodium (CCMS-Na) etc. [He Jianchang, etc.New oral solid quick releasing formulation-oral cavity quick disintegrating slice.The pharmacy practice magazine, 2000,18 (3): 151].These adjuvants are all water insoluble, but a common characteristic is all arranged, and have hygroscopicity [pharmaceutical preparation portion of Shanghai Institute of Pharmaceutical Industry, Pharmaceutical National Engineering Research Center exactly.Pharmaceutic adjuvant application technology (second edition), Chinese Medicine science and technology publishing house, 2002,73～75].In the higher environment of humidity, oral cavity disintegration tablet is the moisture absorption especially easily, and cracked trend is arranged.So relatively harsher to environment requirement in production, storage and transportation with the oral cavity disintegration tablet that these adjuvants are made, must adopt special packing, seal cover, desiccant bag etc., all can produce considerable influence to production cost.And above-mentioned disintegrating agent all is synthetic through chemical process, and price is higher, for the more relatively oral cavity disintegration tablet of adjuvant content, can cause production cost to increase, and and then can increase patient's financial burden.Therefore, seek disintegrating agent functional, that price is suitable, make that the disintegration time of oral cavity disintegration tablet is shorter, price is more cheap, stability better becomes one of key problem in technology of exploitation oral cavity disintegration tablet.
Application number is 99802175 patent application bibliographical information, and during as disintegrating agent, the hardness of making oral cavity disintegration tablet is identical with disintegration time at the erythritol that uses separately equivalent or low-substituted hydroxypropyl cellulose (L-HPC).The erythritol sweet taste is pure, after eating nice and cool mouthfeel characteristic is arranged, and also can make correctives and use, and reduces the weight of oral cavity disintegration tablet.Erythritol can not influence normal carbohydrate metabolism, is fit to diabetes patient; And be sweet taste material low in calories, be suitable for obese patients, simultaneously caries prevention is also had positive role.
Chitin is the relatively low natural pharmaceutic adjuvant of a kind of price, and it has another name called chitin, chitin, is-kind of biological polysaccharide polymer material, extensively is present in the carapace in the unicellular lower eukaryote.This material can be degraded by lyase, has excellent biological compatibility, avirulence, chemical property quite stable.
The SHUANGHUANLIAN oral cavity disintegration tablet is made up of Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae, derives from SHUANGHUANGLIAN ZHUSHEYE, but SHUANGHUANGLIAN ZHUSHEYE is in clinical practice, found a lot of untoward reaction (time precious traditional Chinese medical science traditional Chinese medicines, 1998, the nine volume third phases, 283 pages), caused a lot of miseries to the patient; SHUANGHUANGLIAN KELI (Pharmacopoeia of the People's Republic of China 2000 version one one 420 pages) in preparation process to Flos Lonicerae, Fructus Forsythiae takes decocting to boil, the extracting method of ethanol precipitation, effective ingredient of honeysuckle chlorogenic acid chemical constitution instability, this method makes the chlorogenic acid content in the Flos Lonicerae reduce (CHINA JOURNAL OF CHINESE MATERIA MEDICA in the heating process of water extraction, 1994 19 9 phases of volume, the 545-547 page or leaf), therefore the extraction of Flos Lonicerae should adopt the warm macerating method to extract, and has the haemolysis composition in the Fructus Forsythiae, therefore in the precipitate with ethanol process, should adopt alkaline ethanol to precipitate to remove haemolysis composition (Chinese patent medicine in the Fructus Forsythiae, the fifth phase in 1997, the 46-47 page or leaf); The patent of SHUANGHUANLIAN oral cavity disintegration tablet is not found in patent retrieval.
Summary of the invention
For these reasons, in the selection course that disintegrating agent uses in oral cavity disintegration tablet, we discover that erythritol and disintegrating agent commonly used at present mix by a certain percentage, form a kind of compound disintegrating agent and have more performance, the oral cavity disintegration tablet made from it compares with the simple oral cavity disintegration tablet that uses erythritol or disintegrating agent commonly used at present to make, the disintegration time of oral cavity disintegration tablet was shortened, and because erythritol does not have hygroscopicity, the stability of the feasible oral cavity disintegration tablet of making significantly improves.In the compound disintegrating agent, erythritol is in the amount ranges of 30%-70%, and along with the increase of content, the disintegration time of oral cavity disintegration tablet shortens, and stability strengthens.
We find that in experiment chitin disintegrating agent effect with commonly used at present aspect the disintegrate effect is suitable, even are better than disintegrating agent commonly used.
We have studied compound disintegrating agent in experiment, select the mixture of use erythritol and chitin, disintegrating agent commonly used, are based on many-sided consideration.When making disintegrating agent with single erythritol, though erythritol does not have hygroscopicity, the tablet stability of making is good, and the swelling degree after the single erythritol suction is less, influences the disintegrating property of oral cavity disintegration tablet, and disintegration time is prolonged.Add a certain amount of disintegrating agent commonly used, utilize rapid expansible character after their moisture absorptions, neither influence the stability of oral cavity disintegration tablet, also kept the characteristic of its rapid disintegrate, reached reasonable effect.
The present invention adopts acidic ethanol warm macerating method to extract Flos Lonicerae, obtains honeysuckle effective part with the Amberlyst process purification; Adopt the sedimentary method of water extraction alkali alcohol to extract Fructus Forsythiae, the Amberlyst process purification obtains forsythia fruit effective part; Adopt water extraction method, the macroporous adsorbent resin linear gradient elution method obtains the effective site of Radix Scutellariae; With the effective site that obtains and filler, the mix lubricant on disintegrating agent of the present invention and the pharmaceutics, be prepared into the SHUANGHUANLIAN oral cavity disintegration tablet, pharmacological evaluation shows that it is convenient that SHUANGHUANLIAN oral cavity disintegration tablet of the present invention has storage, good stability, onset is rapid, the better characteristics of pharmacological action.
The present invention is achieved through the following technical solutions.
One. process recipes
(1) crude drug of the present invention is:
Flos Lonicerae: Radix Scutellariae: Fructus Forsythiae=1: 1: 2;
(2) extracting honeysuckle, with 6-8 doubly, the alcoholic solution of 40%-50%, transferring pH value with hydrochloric acid is 4-6, keeping temperature is 40 ℃-50 ℃, soaked 3-5 hour, filter, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 40%-50% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is the extractum of 1.20-1.30 when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 80%-85%, left standstill 12-24 hour, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.05-1.10 when filtrate was concentrated into 80 ℃, last macroporous adsorptive resins, with 6-8 times of column volume washing, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site;
(4) get Fructus Forsythiae, boil 2-4 time, each 1.5 hours with 8-12 times of decocting, merge decocting liquid, filter, relative density is the clear paste of 1.20-1.25 when being concentrated into 70 ℃, when being chilled to 40 ℃, stir down and slowly add ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide, to transfer pH value be 8-10, left standstill 12 hours, filter, obtain supernatant, residue adds 75% ethanol, stir evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last macroporous adsorptive resins, with 6-8 times of column volume washing, eluent discards earlier, reuse 8-12 times column volume, concentration is that the ethanol of 60%-80% carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part;
(5) honeysuckle effective part 5-12 weight portion, Radix Scutellariae effective site 18-45 weight portion, forsythia fruit effective part 12-30 weight portion mix with disintegrating agent 64-80 weight portion of the present invention, add filler 142-177 weight portion, granulation, add lubricant 7-8 weight portion, tabletting obtains the SHUANGHUANLIAN disintegrating tablet.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, its ratio is 3-7: 7-3, and promptly the weight percentage of erythritol in compound disintegrating agent is 30%-70%.
A kind of for in the microcrystalline Cellulose, nano micro crystal cellulose of pharmaceutic adjuvant filler.
Lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG.
It is nonpolar or the low pole macroporous adsorbent resin that Radix Scutellariae, Fructus Forsythiae extract the described macroporous adsorbent resin of purification.
Two. the disintegrating agent performance is investigated experiment
Experimental raw: erythritol, chitin, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, insoluble crospolyvinylpyrrolidone, buy by market.
Experimental technique:
(1) solubility experiment: the saturated aqueous solution at 37 ℃ of preparation samples, utilize membrane filter to filter, obtain filtrate, the filtrate of predetermined of accurately weighing is utilized the freeze-drying drying, thereby is obtained the content of water, calculate water-soluble on the water content basis that obtains thus again, the results are shown in Table 1.
(2) viscosity experiment: the saturated aqueous solutions at 37 ℃ of different disintegrating agents of preparation, utilize membrane filter to filter, obtain filtrate, utilize viscometer to obtain filtrate 37 ℃ viscosity, the results are shown in Table 1.
(3) measurement of wettability: precision takes by weighing above-mentioned disintegrating agent, dry weighs fully, is put into 1 week under 25 ℃ and 75% the damp condition, takes by weighing weight, and calculating wettability (%) sees Table 1.
(4) volume increases percent: the volume of moisture absorption fore-and-aft survey disintegrating agent, calculate the percent (%) of the volume increase of disintegrating agent, and see Table 1.
Table 1 disintegrating agent performance is investigated relatively
| Disintegrating agent | Dissolubility (37 ℃) W/V | Viscosity (37 ℃) mpa.s | Wettability % | Volume increases percent % |
| The insoluble crospolyvinylpyrrolidone of erythritol chitin low-substituted hydroxypropyl methylcellulose carboxymethyl starch sodium crosslinked carboxymethyl fecula sodium | 45 - - - - - | 3.5 - - - - - | 0.03 11.29 14.09 21.07 22.18 22.64 | 0.02 16.57 20.36 22.89 28.14 27.62 |
Conclusion: the characteristics of investigating experiment and oral cavity disintegration tablet by above-mentioned performance, we can analyze, erythritol has very big advantage as disintegrating agent in wettability, but because its moisture pick-up properties is very little, volume increase degree is also very little, therefore, in disintegrating procedue volumetric expansion slow, can not reach the requirement of the rapid disintegrate of oral cavity disintegration tablet; Erythritol is again good correctives simultaneously, not only can be used as disintegrating agent but also can be used as correctives if choose suitable weight, can significantly reduce consumption, the operation in the formulation preparation process and the cost of preparation of pharmaceutic adjuvant; Other disintegrating agent hygroscopicity are too big, cause oral cavity disintegration tablet very poor aspect stable; By analyzing, erythritol is carried out mixing of proper proportion with other disintegrating agent, the compound disintegrating agent as oral cavity disintegration tablet has good advantages.
Three. the selection of compound disintegrating agent
Experimental raw: choose crosslinked carboxymethyl fecula sodium and carry out different proportion with erythritol and mix, mixed proportion is respectively erythritol: crosslinked carboxymethyl fecula sodium=1: 9 or 2: 8 or 3: 7 or 4: 6 or 5: 5 or 6: 4 or 7: 3 or 8: 2 or 9: 1, totally 9 groups, be respectively experimental group 1-9, with experimental group 1-9 and same filler (in microcrystalline Cellulose, the nano micro crystal cellulose a kind of) and lubricant (in magnesium stearate, Pulvis Talci, the Stepanol MG a kind of), carry out tabletting; Change above-mentioned disintegrating agent into chitin,, be experimental group 10, carry out tabletting with same filler, mix lubricant with weight; Change above-mentioned disintegrating agent into weight crosslinked carboxymethyl fecula sodium, with same filler, mix lubricant, experimental group 11 carries out tabletting.
Experimental technique:
(1) hardness of mensuration tablet: utilize the tablet hardness tester to measure the hardness of tablet, the results are shown in Table 2.
(2) stability experiment: tablet is put into 12 weeks under 25 ℃ and 75% the damp condition, observes the tablet spoilage, the results are shown in Table 2.
(3) disintegrate experiment: according to the disintegration of tablet method of testing of stipulating in the Pharmacopoeia of People's Republic of China, utilize the disintegrate tester to measure, the results are shown in Table 2.
(4) disintegrate test in the oral cavity, disintegration time, grittiness, taste to three health adults have tested experimental group the results are shown in Table 2.
The selection of table 2 experimental group disintegrating agent
| Experimental group | Hardness (kg) | Spoilage (%) | Disintegration time (s) | The Orally disintegrating time (s) | Grittiness | Taste |
| 1 2 3 4 5 6 7 8 9 10 11 | 4.1 3.9 2.1 2.2 2.2 2.1 2.0 1.9 1.8 4.6 4.8 | 22.1 21.6 9.3. 8.6 8.1 8.6 9.3 9.6 10.2 33.9 36.5 | 42.1 43.6 26.3 25.2 26.1 26.9 26.8 35.9 35.6 54.1 55.6 | 51.2 52.9 32.9 28.3 26.7 27.4 27.3 38.6 39.1 62.9 62.8 | Having seldom to have much has a lot | Bad generally carefully good carefully very poor |
Change above-mentioned chitin, crosslinked carboxymethyl fecula sodium into chitosan, low-substituted hydroxypropyl methylcellulose, crosslinked carboxymethyl fecula sodium, insoluble crospolyvinylpyrrolidone, experimentize, the result of experiment conclusion and table 2 is close.
Conclusion: experimental result shows, erythritol is mixed with into the mixing disintegrating agent with other disintegrating agent, has good effect, simultaneously because erythritol has sweet taste, so can reduce or replace correctives to use, by experiment erythritol: the suitable ratio of other disintegrating agent be 3-7: 7-3.
Four. check and analysis
The check and analysis of baicalin
According to the Pharmacopoeia of the People's Republic of China (version in 2000, one one, 420 pages) [assay], carry out check and analysis, see Table 3:
Table 3 content of baicalin relatively
| The medicine group | Content of baicalin mg/g |
| SHUANGHUANGLIAN KELI (1 bag of total content) SHUANGHUANLIAN oral cavity disintegration tablet of the present invention (1 total content) | 32.8 50.6 |
Conclusion: by above-mentioned check and analysis experiment, we can determine that technology of the present invention has practical significance.
Five. the preparation disintegration time mensuration
In order to prove absolutely that the employed compound disintegrating agent of SHUANGHUANLIAN oral cavity disintegration tablet of the present invention has disintegrate characteristics rapidly than single disintegrating agent, we have carried out following experiment: disintegrating agent is selected in the design by table 4 for use, make into oral cavity disintegration tablet with effective ingredient at identical pressure lower sheeting, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir with 30 rev/mins speed, measure the disintegration of the oral cavity disintegration tablet that contains different disintegrating agents.
The disintegration time mensuration of the different disintegrating agents of table 4
| The experiment number | Disintegrating agent | Disintegration (s) | |
| Form | Consumption (g: g) | ||
| 1 2 3 4 5 6 | Chitin antierythrite: chitin low-substituted hydroxypropyl methylcellulose antierythrite: low-substituted hydroxypropyl methylcellulose sodium carboxymethyl starch antierythrite: sodium carboxymethyl starch | - (3∶7) - (4∶6) - (5∶5) | 30.2 17.5 27.6 16.8 38.3 15.2 |
| 7 8 9 10 | Crosslinked carboxymethyl fecula sodium erythritol: the insoluble crospolyvinylpyrrolidone erythritol of crosslinked carboxymethyl fecula sodium: insoluble crospolyvinylpyrrolidone | - (6∶4) - (7∶3) | 40.4 14.6 33.4 13.4 |
The result: the oral cavity disintegration tablet that uses compound disintegrating agent is in 13.4-17.5 all disintegrates and by No. 2 sieves in second; The oral cavity disintegration tablet that uses single disintegrating agent is in 27.6-40.4 all disintegrates and by No. 2 sieves in second.Illustrate that compound disintegrating agent of the present invention has disintegrate characteristics rapidly really.
Six. the disintegration experiment
Get SHUANGHUANLIAN oral cavity disintegration tablet of the present invention, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir with 30 rev/mins speed.Oral cavity disintegration tablet of the present invention whole disintegrates in 20 seconds are also sieved by No. 2.
Seven. the dissolution experiment
1. instrument and reagent: the full-automatic digestion instrument of SR-6 type (U.S. Hanson company); Distilled water (self-control); SHUANGHUANGLIAN KELI agent (Harbin Children Pharmaceutical Factory); SHUANGHUANLIAN oral cavity disintegration tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides).
2. experimental technique: second method of pressing in the dissolution method (" 2000 editions two appendix XC of Chinese pharmacopoeia) is measured.Each container fills the distilled water through degassing processing of 100ml, and heating makes water temperature remain on 37 ℃ ± 0.5 ℃, and rotating speed of agitator is 50 rev/mins.Put into 1 of SHUANGHUANLIAN oral cavity disintegration tablet of the present invention, in the time of 20 minutes, get 2ml solution, centrifugal 10 minutes (12000rpm), supernatant is as need testing solution.Measure with above-mentioned check and analysis baicalin assay method.The results are shown in Table 5.
The dissolution of two kinds of medicines of table 5 relatively
| The medicine group | (min) content of baicalin sample time (mg) | |||||||
| 0.5 | 1 | 2 | 4 | 8 | 12 | 16 | 20 | |
| SHUANGHUANGLIAN KELI agent SHUANGHUANLIAN oral cavity disintegration tablet | 59.3 26.8 | 68.6 35.8 | 76.8 42.6 | 89.1 46.7 | 106.4 50.1 | 126.8 50.5 | 134.5 50.5 | 142.0 50.5 |
Conclusion: strippings in 30 seconds of SHUANGHUANLIAN oral cavity disintegration tablet of the present invention were dissolved almost completely in the time of 50%, 8 minute.
Seven. pharmacology embodiment
The SHUANGHUANLIAN oral cavity disintegration tablet is observed the vivo bacteria corrosion action of mouse infection model
1. material
Experiment medicine: SHUANGHUANGLIAN KELI agent (Harbin Children Pharmaceutical Factory); SHUANGHUANLIAN oral cavity disintegration tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides).
Laboratory animal: Kunming mouse (60 of 8～22g) 1 Kunming mouses, before the experiment, equal one week of breeding observing of each animal.
Infection bacteria species: staphylococcus aureus all is clinical isolating pathogenic bacterium, and the proud drug research institute virus research chamber in sky, Guangzhou provides.
2. experimental technique:
(1) preparation of bacterium liquid:, in 37 ℃ of incubators, cultivate 18h with clinical isolating typical gold Staphylococcus aureus and being inoculated in the Carnis Bovis seu Bubali cream soup body culture test tube.With the bacterium liquid turbidimetry for Determination bacterial concentration of this cultivation, add 5% yeast mixture doubling dilution again and become variable concentrations.
(2) get 60 of the healthy Kunming mouses of body weight 18～22g, male and female half and half (female unpregnancy), random pair is divided into 3 groups, every group 20, SHUANGHUANLIAN oral cavity disintegration tablet group is according to the dosed administration that is equivalent to crude drug 20g/kg, SHUANGHUANGLIAN KELI agent group is according to the dosed administration that is equivalent to crude drug 20g/kg, administration 5d, and the blank group is irritated stomach and is given the isometric(al) distilled water.Every mouse peritoneal injection staphylococcus aureus 9.5 * 106CFU/ml, 0.5ml.Equal conditions is raised, and continues administration 7d.Every day, the dead mouse number respectively organized in record.The results are shown in Table 6.
The antibacterial action of staphylococcus aureus is infected in table 6 SHUANGHUANLIAN oral cavity disintegration tablet prevention administration to mouse peritoneal
| The medicine group | Number of animals (only) | Dosage (g/kg) | Mortality rate (%) | Survival rate (%) | Mean survival time (d) |
| Blank group SHUANGHUANGLIAN KELI agent SHUANGHUANLIAN oral cavity disintegration tablet | 20 20 20 | Distilled water 20 20 | 95.0 50.0 30.0 | 5.0 50.0 ** 70.0 **[ *] | 1.57±1.49 4.15±2.87 ** 5.84±2.19 **[ *] |
Annotate: compare with the blank group
*P＜0.01, compare with positive controls [
*] P＜0.05
Conclusion: show that by pharmacological evaluation oral cavity disintegration tablet of the present invention has better pharmacological action.
Eight. preparation embodiment
Embodiment 1
(1) crude drug of the present invention is:
Flos Lonicerae is 150 grams, and Radix Scutellariae is 150 grams, and Fructus Forsythiae is 300 grams;
(2) extracting honeysuckle is with 6 times, 40% alcoholic solution, transferring pH value with hydrochloric acid is 4, keeping temperature is 40 ℃, soaks 3 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 40% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.20 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 80%, left standstill 12 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 5.0 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.05 when filtrate was concentrated into 80 ℃, last AB-8 type macroporous adsorptive resins, with 6 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 18.0 grams;
(4) get Fructus Forsythiae, boil 2 times, each 1.5 hours with 8 times of decoctings, merge decocting liquid, filter, relative density is 1.20 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 8, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last NKA type macroporous adsorptive resins, with 6 times of column volume washings, eluent discards earlier, 8 times of column volumes of reuse, concentration is that 60% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 12.0 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 80 grams of the present invention,
Disintegrating agent of the present invention is an erythritol: chitin=3: 7 or erythritol: low-substituted hydroxypropyl methylcellulose=3: 7 or erythritol: carboxymethyl starch sodium=3: 7 or erythritol: crosslinked carboxymethyl fecula sodium=3: 7 or erythritol: insoluble crospolyvinylpyrrolidone=3: 7, promptly the weight percentage of erythritol in compound disintegrating agent is 30%.
Add filler microcrystalline Cellulose 177 grams, granulate, add magnesium stearate lubricant 8 grams, tabletting obtains 1000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 2
(1) crude drug of the present invention is:
Flos Lonicerae is 150 grams, and Radix Scutellariae is 150 grams, and Fructus Forsythiae is 300 grams;
(2) extracting honeysuckle is with 8 times, 50% alcoholic solution, transferring pH value with hydrochloric acid is 6, keeping temperature is 50 ℃, soaks 5 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 50% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.30 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 85%, left standstill 24 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 12.0 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.10 when filtrate was concentrated into 80 ℃, last AB-8 type macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 45.0 grams;
(4) get Fructus Forsythiae, boil 4 times, each 1.5 hours with 12 times of decoctings, merge decocting liquid, filter, relative density is 1.25 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 10, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last D101 type macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, 12 times of column volumes of reuse, concentration is that 80% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 30.0 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 64.0 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=4: 6 or erythritol: low-substituted hydroxypropyl methylcellulose=4: 6 or erythritol: carboxymethyl starch sodium=4: 6 or erythritol: crosslinked carboxymethyl fecula sodium=4: 6 or erythritol: insoluble crospolyvinylpyrrolidone=4: 6, promptly the weight percentage of erythritol in compound disintegrating agent is 40%.
Add filler nano microcrystalline fiber 142.0 grams, granulate, add lubricant Pulvis Talci 7.0 grams, tabletting obtains 1000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 3
(1) crude drug of the present invention is:
Flos Lonicerae is 300 grams, and Radix Scutellariae is 300 grams, and Fructus Forsythiae is 600 grams;
(2) extracting honeysuckle is with 7 times, 45% alcoholic solution, transferring pH value with hydrochloric acid is 5, keeping temperature is 45 ℃, soaks 4 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 45% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.25 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 82%, left standstill 14 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 21.9 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.06 when filtrate was concentrated into 80 ℃, last D101 type macroporous adsorptive resins, with 7 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 79.8 grams;
(4) get Fructus Forsythiae, boil 3 times, each 1.5 hours with 9 times of decoctings, merge decocting liquid, filter, relative density is 1.22 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 9, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last macroporous adsorptive resins, with 7 times of column volume washings, eluent discards earlier, 9 times of column volumes of reuse, concentration is that 65% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 57.3 grams;
(6) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 132.3 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=5: 5 or erythritol: low-substituted hydroxypropyl methylcellulose=5: 5 or erythritol: carboxymethyl starch sodium=5: 5 or erythritol: crosslinked carboxymethyl fecula sodium=5: 5 or erythritol: insoluble crospolyvinylpyrrolidone=5: 5, promptly the weight percentage of erythritol in compound disintegrating agent is 50%.
Add filler nano micro crystal cellulose 293.5, granulate, add lubricant Stepanol MG 15.2 grams, tabletting obtains 2000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 4
(1) crude drug of the present invention is:
Flos Lonicerae is 450 grams, and Radix Scutellariae is 450 grams, and Fructus Forsythiae is 900 grams;
(2) extracting honeysuckle is with 6 times, 50% alcoholic solution, transferring pH value with hydrochloric acid is 6, keeping temperature is 50 ℃, soaks 4 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 40% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.28 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 85%, left standstill 16 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 33.9 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.07 when filtrate was concentrated into 80 ℃, last NKA type macroporous adsorptive resins, with 6 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 103.6 grams;
(4) get Fructus Forsythiae, boil 3 times, each 1.5 hours with 12 times of decoctings, merge decocting liquid, filter, relative density is 1.22 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 8, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last D101 type macroporous adsorptive resins, with 7 times of column volume washings, eluent discards earlier, 10 times of column volumes of reuse, concentration is that 70% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 87.0 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 202.6 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=6: 4 or erythritol: low-substituted hydroxypropyl methylcellulose=6: 4 or erythritol: carboxymethyl starch sodium=6: 4 or erythritol: crosslinked carboxymethyl fecula sodium=6: 4 or erythritol: insoluble crospolyvinylpyrrolidone=6: 4, promptly the weight percentage of erythritol in compound disintegrating agent is 60%.
Add filler microcrystalline Cellulose 449.8 grams, granulate, add lubricant Pulvis Talci 23.1 grams, tabletting obtains 3000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 5
(1) crude drug of the present invention is:
Flos Lonicerae is 1500 grams, and Radix Scutellariae is 1500 grams, and Fructus Forsythiae is 3000 grams;
(2) extracting honeysuckle is with 8 times, 45% alcoholic solution, transferring pH value with hydrochloric acid is 5, keeping temperature is 45, soaks 5 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 50% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.26 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 80%, left standstill 12-24 hour, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 99.1 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.09 when filtrate was concentrated into 80 ℃, last AB-8 type macroporous adsorptive resins, with 6 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 398.1 grams;
(4) get Fructus Forsythiae, boil 2 times, each 1.5 hours with 11 times of decoctings, merge decocting liquid, filter, relative density is 1.20 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 8, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, 12 times of column volumes of reuse, concentration is that 75% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 248.3 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 676.4 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=7: 3 or erythritol: low-substituted hydroxypropyl methylcellulose=7: 3 or erythritol: carboxymethyl starch sodium=7: 3 or erythritol: crosslinked carboxymethyl fecula sodium=7: 3 or erythritol: insoluble crospolyvinylpyrrolidone=7: 3, promptly the weight percentage of erythritol in compound disintegrating agent is 70%.
Add filler microcrystalline Cellulose 1503.5 grams, granulate, add magnesium stearate lubricant 74.6 grams, tabletting obtains 10000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 6
(1) crude drug of the present invention is:
Flos Lonicerae is 3000 grams, and Radix Scutellariae is 3000 grams, and Fructus Forsythiae is 6000 grams;
(2) extracting honeysuckle is with 8 times, 40% alcoholic solution, transferring pH value with hydrochloric acid is 6, keeping temperature is 50 ℃, soaks 3 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 50% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.20 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 85%, left standstill 24 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 198.6 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.05 when filtrate was concentrated into 80 ℃, last NKA type macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 845.6 grams;
(4) get Fructus Forsythiae, boil 2 times, each 1.5 hours with 12 times of decoctings, merge decocting liquid, filter, relative density is 1.25 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 10, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last NKA type macroporous adsorptive resins, with 7 times of column volume washings, eluent discards earlier, 9 times of column volumes of reuse, concentration is that 75% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 578.3 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 1313.2 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=4: 6 or erythritol: low-substituted hydroxypropyl methylcellulose=4: 6 or erythritol: carboxymethyl starch sodium=4: 6 or erythritol: crosslinked carboxymethyl fecula sodium=4: 6 or erythritol: insoluble crospolyvinylpyrrolidone=4: 6, promptly the weight percentage of erythritol in compound disintegrating agent is 40%.
Add filler nano micro crystal cellulose 2921.3 grams, granulate, add lubricant Stepanol MG 143 grams, tabletting obtains 20000 of SHUANGHUANLIAN disintegrating tablets.
Embodiment 7
(1) crude drug of the present invention is:
Flos Lonicerae is 1500 grams, and Radix Scutellariae is 1500 grams, and Fructus Forsythiae is 3000 grams;
(2) extracting honeysuckle is with 8 times, 50% alcoholic solution, transferring pH value with hydrochloric acid is 5, keeping temperature is 50 ℃, soaks 4 hours, filters, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 45% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is 1.25 extractum when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 80%, left standstill 24 hours, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part 89.8 grams;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.09 when filtrate was concentrated into 80 ℃, last D101 type macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site 378.9 grams;
(4) get Fructus Forsythiae, boil 4 times, each 1.5 hours with 8 times of decoctings, merge decocting liquid, filter, relative density is 1.24 clear paste when being concentrated into 70 ℃, when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide accent pH value is 8, leaves standstill 12 hours, filters, obtain supernatant, residue adds 75% ethanol, stirs evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last D101 type macroporous adsorptive resins, with 8 times of column volume washings, eluent discards earlier, 10 times of column volumes of reuse, concentration is that 70% ethanol carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part 249.3 grams;
(5) extracting honeysuckle effective site, Radix Scutellariae effective site, forsythia fruit effective part mix with disintegrating agent 684.6 grams of the present invention, disintegrating agent of the present invention is an erythritol: chitin=6: 4 or erythritol: low-substituted hydroxypropyl methylcellulose=6: 4 or erythritol: carboxymethyl starch sodium=6: 4 or erythritol: crosslinked carboxymethyl fecula sodium=6: 4 or erythritol: insoluble crospolyvinylpyrrolidone=6: 4, promptly the weight percentage of erythritol in compound disintegrating agent is 60%.
Add filler microcrystalline Cellulose 1521.8 grams, granulate, add lubricant Pulvis Talci 75.6 grams, tabletting obtains 10000 of SHUANGHUANLIAN disintegrating tablets.
Claims (2)
1. SHUANGHUANLIAN oral cavity disintegration tablet, it is characterized in that it is by extracting through acid 40%-50% ethanol warm macerating, the ethanol elution of D101 type macroporous adsorbent resin 40%-50% obtains honeysuckle effective part 5-12 weight portion, water extraction, macroporous adsorbent resin 10%, 30%, 50% different concentration ethanol gradient elution obtains Radix Scutellariae effective site 18-45 weight portion, water extraction, the alkaline ethanol precipitation, the forsythia fruit effective part 12-30 weight portion that macroporous adsorbent resin 60%-80% ethanol elution obtains, compound disintegrating agent 64-80 weight portion, filler 142-177 weight portion, lubricant 7-8 weight portion is prepared from, compound disintegrating agent is by erythritol and chitin, the low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, a kind of composition in the insoluble crospolyvinylpyrrolidone, the weight percentage of compound disintegrating agent mesoerythrit are 30%-70%.
2. the preparation method of a kind of SHUANGHUANLIAN oral cavity disintegration tablet according to claim 1 is characterized by:
(1) crude drug is: Flos Lonicerae: Radix Scutellariae: Fructus Forsythiae=1: 1: 2;
(2) extracting honeysuckle, with 6-8 doubly, the alcoholic solution of 40%-50%, transferring pH value with hydrochloric acid is 4-6, keeping temperature is 40 ℃-50 ℃, soaked 3-5 hour, filter, merge soak, reclaim ethanol to most, the vacuum concentration drying, complete with water dissolution, filter D101 type macroporous adsorptive resins on the filtrate, elder generation's water flushing post is to clarification, the ethanol elution of reuse 40%-50% is eluted to and carries out fluoroscopic examination and do not have blue-fluorescence, collects eluent, relative density is the extractum of 1.20-1.30 when being evaporated to 50 ℃, add 95% ethanol to containing alcohol amount 80%-85%, left standstill 12-24 hour, filter, get supernatant, reclaim ethanol to most, the vacuum concentration drying obtains honeysuckle effective part;
(3) get Radix Scutellariae, section, water decocts 3 times, 2 hours for the first time, second and third time each 1 hour merged decocting liquid, filter, relative density was 1.05-1.10 when filtrate was concentrated into 80 ℃, last macroporous adsorptive resins, with 6-8 times of column volume washing, eluent discards earlier, and the ethanol of reuse 10%, 30%, 50% carries out gradient elution, merge eluent, reclaim ethanol to most, the vacuum concentration drying obtains Radix Scutellariae effective site;
(4) get Fructus Forsythiae, boil 2-4 time, each 1.5 hours with 8-12 times of decocting, merge decocting liquid, filter, relative density is the clear paste of 1.20-1.25 when being concentrated into 70 ℃, when being chilled to 40 ℃, stir down and slowly add ethanol, make to contain the alcohol amount and reach 75%, adding sodium hydroxide, to transfer pH value be 8-10, left standstill 12 hours, filter, obtain supernatant, residue adds 75% ethanol, stir evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to most, last macroporous adsorptive resins, with 6-8 times of column volume washing, eluent discards earlier, reuse 8-12 times column volume, concentration is that the ethanol of 60%-80% carries out eluting, eluent reclaims ethanol to most, and the vacuum concentration drying obtains forsythia fruit effective part;
(5) extracting honeysuckle effective site 5-12 weight portion, Radix Scutellariae effective site 18-45 weight portion, forsythia fruit effective part 12-30 weight portion and the compound recipe disintegrating agent 64-80 weight portion that contains erythritol mix, add filler 142-177 weight portion, granulate, add lubricant 7-8 weight portion, tabletting obtains the SHUANGHUANLIAN disintegrating tablet.
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