CN103191069A - Rapid disintegration tabella and chill-pressing method thereof - Google Patents
Rapid disintegration tabella and chill-pressing method thereof Download PDFInfo
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Abstract
The invention provides a rapid disintegration tabella and a chill-pressing method thereof, and relates to the field of pharmaceutical preparations and preparation methods. The rapid disintegration tabella provided by the invention is characterized in that ice-shaped particles containing a drug and a necessary auxiliary material as well as an additionally precool drug and an auxiliary material are uniformly mixed and pressed to be in piece shape, and then the freeze drying is carried out so as to prepare the rapid disintegration tabella, and the problems that the tabella can not rapidly disintegrate and the tabella prepared through a method in which the freeze drying is carried out after model pouring is small in rigidity when the common particles are subjected to normal temperature piece pressing. The method provided by the invention has the advantage that the production efficiency is high, and the method is suitable for industry manufacture.
Description
Technical field:
The present invention relates to pharmaceutical preparation and preparation method field, particularly, the present invention relates to a kind of ice shape granule that under low temperature environment, will contain medicine and necessary adjuvant, add medicine and the adjuvant of pre-freeze, after mixing, the compacting in flakes, the method for the rapid disintegration tablet of lyophilization preparation.
Background technology:
Quickly disintegrated tablet has polytype, has developed the rapid disintegration tablet of polytypes such as being used for oral, gynecological external use, preparation solution and purposes.Wherein, be the most frequently used with oral cavity and oral fast disintegrating preparations.Oral cavity disintegration tablet (Orally Disintegrating Tablets), be called for short oral cavity disintegration tablet, be a kind of can be in the oral cavity tablet of disintegrate or dissolving rapidly, dissolution time is that the several seconds was to tens of seconds usually, generally be no more than 1 minute, the United States pharmacopoeia specifications disintegration time is no more than 30s; And dispersible tablet both can be oral, in the quick disintegrate of gastric, also can disintegrate fast in suitable quantity of water, form solution, for oral.
The character that oral cavity disintegration tablet speed collapses depends on that can moisture infiltrate in the tablet configurations rapidly, thereby causes the rapid disintegrate of tablet.Therefore, the fundamental method of preparation oral cavity disintegration tablet is the space maximization that makes in the tablet, and adopts suitable disintegrants to be beneficial to capillarity to produce, use the highly-water-soluble adjuvant simultaneously.In the preparation process of oral cavity disintegration tablet, domestic and international existing patented technology can be divided into non-freeze-drying and freeze-drying, and non-freeze-drying comprises particle fusion method, distillation drilling method, 3D impact system, assembles extrusion molding, spray drying method, die methods, direct compression process etc.In the non-lyophilization facture, use direct compression process comparatively generally.Direct compression process earlier with lactose, mannitol etc. as filler or framework material, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium, crospolyvinylpyrrolidone etc. are as disintegrating agent, other adds a small amount of effervescent, disintegrating agent, correctives and lubricant, forms with less pressure direct compression.Though this method process equipment is simple, with short production cycle; but the products obtained therefrom porosity is low; disintegration time is longer relatively in the oral cavity; in addition; because this method mainly uses disintegrating agent to make preparation disintegrate rapidly in the oral cavity; but most disintegrating agent can not be dissolved in the water fast, therefore adopts the oral cavity disintegration tablet of this method preparation usually can grittyly to feel after the disintegrate in the oral cavity.
Outside last method, after CN200710128994.5 adopts melting heat extruding, gradient cooling, wave by rotary that granulator is granulated, direct compression process prepares oral cavity disintegration tablet.Its concrete technological process is: medicine is added in the water-solubility carrier material of fusion; stir; make medicine-carrier molten mixture; under negative pressure state, get the melting mixing material with the melting heat extruder; under gradient cooling situation, use the compressed air material extrusion; granulate by sieve plate with the rotary granulator that waves; freezing behind the cooling curing rapidly; dry; pulverize; sieve; make medicine-carrier solid dispersion; get solid dispersion and filler; disintegrating agent; correctives; the abundant mixing of fluidizer adds lubricant, mixing; tabletting is made oral cavity disintegration tablet.(＜1min) oral cavity disintegration tablet, processing step is many, complicated, and the hot melt extrusion molding is granulated and is not suitable for heat sensitive medicine though this method can obtain meeting disintegration.
In the conventional non-freeze-drying, commonly the wet granule compression tablet legal system is equipped with oral cavity disintegration tablet, its must through step mainly contain preparation wet granular, dry granulate, tabletting.Japan military field drugmaker proposes a kind of oral cavity disintegration tablet preparation method.US 5720974 and US5501861 at first prepare the wet granular that water content is 0.3%-10%, molded and shaped to wet granular after, carry out drying.This method is with the step of conventional wet granular, drying, compacting, and adjusting becomes wet granular processed, molded and shaped, back dry step, has certain novelty.But wet granular is mobile poor, and in pressing process easy sticking, so be applied in certain difficulty is arranged in the large-scale production.
The Technology that freeze-drying prepares fast disintegrating preparations mainly comprises normal freeze-drying method (Zydis method), low-temperature solvent lyophilization (Quicksolv method), wet granular molded tablet lyophilization, four types of granule-low temperature compacting-lyophilization (high solid content low temperature compacting lyophilization) are frozen in solid content soft material-cryogenic refrigeration processed at high proportion.
The Zydis technology of Xie Le company research and development is oral cavity disintegration tablet production technologies the earliest, this method adopt mould annotate solution more cryodesiccated method prepare a kind of technology of oral cavity disintegration tablet.According to US5457895, US5631023 and US5976577 description, in aqueous solution, quantitatively packing is injected in the mould with medicine dissolution in Zydis method elder generation, and lyophilization again gets product behind the employing extra package.The gained tablet can disintegrate rapidly in the oral cavity.But because of the restriction of concrete drug solubility, drug loading is subjected to certain limitation; This dosage form is poor stability under hot and humid condition; In addition, also there is the depanning poor performance in Zydis method gained oral cavity disintegration tablet, easily causes problems such as fragment.
Cryodesiccated second method is the Quicksolv technology, and US5648093 has described and adopted lyophilization as the process of removing solid shape moisture.Concrete steps are for adopting the mode of heated and stirred to be dissolved in the pure water in active component, gelatin, pectin, mannitol, aminoacid, inject 0.5 ~ 1ml mould respectively, adopt freezing 1 hour of dry ice or place quick freezing in the freezing passage of cold air, goods are put into-15 ℃ capacity methanol or straight alcohol or acetone, this moment ice will be dissolved in above organic solvent, after put into vacuum chamber and remove remaining organic reagent.Adopt above method gained finished product easily to form network structure, disintegrate is rapid.The characteristics of this method maximum are to adopt the solid water-soluble solution of shape to replace the lyophilization sublimed method, though can access disintegrate tablet rapidly, but this method is wasted a large amount of organic reagents, and the organic solvent residual problem has improved production and quality control cost equally, organic solvent also can dissolve most drug, the limited by practical of this method.
Freeze-drying the third main mode as described in the house journal of above-mentioned military field, with low amounts of water moistening granule, obtain carrying out lyophilization behind the tablet with mechanography.US5720974 and US5501861 have described a kind of method for preparing dissolving tablet, comprise active component, saccharide and less and the water of capacity, forming with the above-mentioned saccharide particle surface of water-wet only is the wet granular of 0.3%-10% water content, adopt mechanography to handle to form tablet, the method by vacuum drying, lyophilization or oven dry makes tablet.Except aforesaid drawbacks, freeze-drying is used a kind of means of supplementing out economy that only are as the conventional drying method in this patent, and and 0.3%-10% stay the special applications that high porosity is beneficial to disintegrate after can't embodying the distillation of freeze-drying to solid shape solvent than low water content.
The pluses and minuses of comprehensive above-mentioned various patent Technologies, apply for a patent (number of patent application: 201310093519.4) proposed a kind of low temperature compacting lyophilization of solid content at high proportion that contains before the inventor, a kind of employing conventional method has been described with medicine, adjuvant and after suitably solvent makes soft material and gets wet granular, wet particle is frozen into the ice granule below the material freezing point, the ice granule is behind granulate, direct compression at low temperatures, a kind of quickly disintegrated agent method of making through lyophilization.Its major advantage is in conjunction with direct compression and freezing dry process, makes the gained finished tablet both possess the hardness of direct compression process, possesses freeze-drying gained high voidage again, and its ice granule is good in the cryogenic conditions current downflow, is applicable to commercial production.A kind of preparation method of pastille multilayer tablet has been advocated by Univ Maryland-Coll Park USA.The typical process flow of US 8110223 after the lyophilization, is carried out tabletting at first preparing wet granular.Its process characteristic is wet granular is adopted lyophilization, gets loose particles and carries out tabletting again.
Can be with the lyophilizing sheet (as shown in table 2) of applying for before the big inventor of dose that high solid content low temperature compacting lyophilization has obtained to have character such as good disintegration, tablet hardness.For obtaining to have the more lyophilizing sheet of high porosity after the lyophilizing, can strengthen the solvent content in the prescription, and need guarantee that it has qualified tablet hardness simultaneously, and character such as the identical scope of application, drug loading, thus the inventor has explored low solid content low temperature compacting lyophilization.
Table 1. adopts freeze drying process to prepare the technological process contrast of quickly disintegrating tablet
The effect contrast of table 2. prepared in various methods quickly disintegrating tablet
Summary of the invention:
An object of the present invention is to provide a kind of oral cavity disintegration tablet, technical problem to be solved by this invention realizes by the following technical solutions.
A kind of oral cavity quickly disintegrating tablet is characterized in that: this oral cavity disintegration tablet comprises the framework material of 5-45wt% based on the gross weight of label; The binding agent of 1-10wt%; The disintegrating agent of 1-10wt%; The solvent of 20-70wt%; The acceptable accessories of 1-20wt%; The medicine of 0-50wt%.
The preferred content ratio of the framework material that comprises in the described oral cavity disintegration tablet, binding agent, disintegrating agent, solvent, acceptable accessories and medicine is: framework material 10-40wt%, binding agent 3-8wt%, disintegrating agent 3-8wt%, solvent 25-65wt%, acceptable accessories 6-15wt%, medicine 0-40wt%.
Described framework material is ethylmethylcellulose, ethyl cellulose, chitin, chitose, methylcellulose, sesbania gum, tara gum, Ficus elastica, carbomer, Furcellaran, tragacanth, arabic gum, Resina persicae, maltose alcohol, carrageenin, tamarind gum, Nulomoline, fructose, POLY-karaya, poloxamer, alginic acid, sodium alginate, starch, pregelatinized Starch, modified starch, gelatin, dextran, mannitol, xylitol, sorbitol, maltose Chi ?alcohol, microcrystalline Cellulose, polymerization sugar coupling sugar, glucose, lactose, sucrose, dextrin, in cyclodextrin and the starch etc. one or more are preferably mannitol, gelatin, cyclodextrin.
Described binding agent is one or more in day hot glue family macromolecule polymer such as starch, pregelatinized Starch, dextrin, cyclodextrin, maltodextrin, sucrose, arabic gum or gelatin, hydrophilic cellulose base polymer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, alginic acid and alginate, xanthan gum, hydroxypropyl cellulose and the hydroxypropyl emthylcellulose etc., is preferably polyvinylpyrrolidone, gelatin, cyclodextrin.
Described disintegrating agent comprises one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low substituted hydroxy-propyl methylcellulose, cross-linking sodium carboxymethyl cellulose, pregelatinized Starch and the soybean polysaccharide etc., is preferably low substituted hydroxy-propyl methylcellulose (L-HPC), carboxymethyl starch sodium (CMS-Na).
Described acceptable accessories comprises one or more in fluidizer, filler, correctives, the adsorbent, and wherein said fluidizer comprises one or more in micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate, magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, Stepanol MG and the Pulvis Talci etc.; Described filler is selected from one or more in microcrystalline Cellulose, starch, pregelatinized Starch, dextrin, cyclodextrin, mannitol and the calcium carbonate; Described correctives comprises one or more in aspartame, sucrose, saccharin sodium, stevioside, neotame, cyclamate, citric acid, tartaric acid, malic acid ethyl maltol, essence and the cocoa powder etc.; Described adsorbent is that carboxymethyl starch is received, micropowder silica gel, light magnesium oxide, cross linked polyvinyl pyrrolidone or aluminium hydroxide desiccant gel, is scattered in carrier in the tablet as liquid drug.
Described solvent comprises water or the tert-butyl alcohol for low molecule solvent.
Another object of the present invention provides the low temperature drawing method of a kind of oral cavity quickly disintegrating tablet, the basic line of this method is that the solid content with low ratio dissolve in the water equal solvent or dispersions-ice making-granule processed-low temperature compacting-lyophilizing, that is: hang down solid content ice making low temperature and suppress lyophilization.
Technical problem to be solved by this invention realizes by the following technical solutions.
The low temperature drawing method of a kind of oral cavity quickly disintegrating tablet is characterized in that: the step that this method comprises is:
1) press prescription drug and adjuvant, add the solvent of recipe quantity, stir, dissolve settled solution;
2) in low temperature environment, be refrigerated to solution solid-state;
3) solid solution is pulverized, must be contained the ice pellets of medicine and adjuvant, ice pellets is crossed regulation order number sieve net, can get minimum ice granule;
4) add sieve and the pre-freeze processing medicine and adjuvant and ice granule mixing;
5) with tablet machine that the material compacting of mix homogeneously is in blocks;
6) the gained tablet is put into the freezer dryer inner drying, gets disintegrating tablet.
Above-mentioned steps 2-5 all carries out below the material freezing point.
The invention has the beneficial effects as follows:
Specific operation process of the present invention makes solvent become solid shape adjuvant for (freezing point following) at low temperatures, and the tabletting process is identical with common tabletting process, and tablet forming technique is simple, efficiently.The solid shape solvent content height of the high relatively solid content low temperature of the present invention tabletting freeze-drying, low, the lyophilizing sheet porosity height of solid content, disintegrate is rapider behind the chance water.And this law is explored skeleton agent and binding agent reasonable volume simultaneously, has overcome the defective of low content solid content, high porosity product friability difference, and it has good hardness.This method all is suitable for water solublity and water-insoluble medicine in addition, and the drug loading scope is wide, directly pack behind the finished product and get final product, avoided oral cavity disintegration tablet depanning poor performance in the common die lyophilization, caused the problem of fragment, the large usage quantity of water has also effectively reduced Material Cost in the prescription.
The specific embodiment:
The present invention is described further below in conjunction with embodiment, but be not any limitation of the invention.
Embodiment one:
The compressed cores prescription:
Preparation process:
1) takes by weighing gelatin, mannitol, PVP K30 by prescription; The deionized water that adds recipe quantity then; Stirring, the ultrasonic settled solution that gets;
2) settled solution being put into refrigerator-freezer is frozen into solid-state;
3) with pulverizer with solid solution pulverize ice pellets, ice pellets is crossed 50 eye mesh screens;
4) take by weighing microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, the carboxymethyl starch that pre-freeze crosses by prescription and receive (crossing 100 eye mesh screens) mix homogeneously, then with the ice pellets mix homogeneously;
5) with tablet machine ice pellets is pressed into 500;
6) the gained tablet gets oral cavity disintegration tablet with putting into the freezer dryer inner drying.
Concrete lyophilization parameter and process are: send into freezer dryer, be cooled to-40 ℃ and following rapidly, guarantee that the gained tablet freezes reality under the low temperature compacting, be incubated 1 hour, open vacuum pump, keep vacuum pressure at 1-20pa, with 1 ~ 5 ℃ heating rate per hour, slowly be warmed up to-25 ℃, be incubated 12 hours, with 1-5 ℃ heating rate per hour, slowly be warmed up to-5 ℃ again, be incubated 8 hours, first drying stage finishes, and the back slowly is warmed up to 25 ℃ with 1-5 ℃ heating rate per hour, be incubated 8 hours, finishing and packing behind the outlet.
With reference to " American Pharmacopeia ", " Japanese Pharmacopoeia " with " Chinese pharmacopoeia is to the Quality Control requirement of oral cavity disintegration tablet, suppresses the key parameter of lyophilizing oral cavity disintegration tablet at low temperature, formulates following detection method.
Disintegration time: device mainly is made up of stripping rotor, stirring paddle, disintegrate basket (screen cloth 30 orders), add the distilled water of 37 ℃ of 900 mL in stripping rotor, the disintegrate basket is fixed on the stripping wall of cup, the water surface surpasses changes basket bottom surface 1 cm, mixing speed is adjusted to 100 rpm, oral cavity disintegration tablet drops in the disintegrate basket, and record be the oral cavity disintegration tablet disintegration time from dropping into tablet till the basic noresidue to the screen cloth during this period of time, to require square meeting the requirements in 30s its disintegration.
Friability: adopt and to drop the friability that method is measured oral cavity disintegration tablet in the air, be about to tablet from the height of 0.3 m, be free fall type successively monolithic throw three times, drop down onto on the smooth glass plate, measure the oral cavity disintegration tablet mass loss then, calculate friability (%).
Through check, be 16.2 s the disintegration of gained quickly disintegrating tablet, and friability is 0.4%.
Embodiment two:
The compressed cores prescription:
Preparation process:
1) takes by weighing gelatin, mannitol, PVP K30 by prescription; The deionized water that adds recipe quantity then; Stirring, the ultrasonic settled solution that gets;
2) settled solution being put into refrigerator-freezer is frozen into solid-state;
3) with pulverizer with solid solution pulverize ice pellets, ice pellets is crossed 70 eye mesh screens;
4) with tablet machine ice pellets is pressed into 500;
5) the gained tablet gets oral cavity disintegration tablet with putting into the freezer dryer inner drying.
Freezing dry process, lyophilization parameter, disintegration and friability detect as described in the embodiment one.
Through check, be 35.6 s the disintegration of gained quickly disintegrating tablet, and friability is 0.9%.
Embodiment three:
The compressed cores prescription:
Preparation process:
1) takes by weighing gelatin, mannitol by prescription; The deionized water that adds recipe quantity then; Stirring, the ultrasonic settled solution that gets;
2) settled solution being put into refrigerator-freezer is frozen into solid-state;
3) with pulverizer with solid solution pulverize ice pellets, ice pellets is crossed 60 eye mesh screens;
4) take by weighing the 30 POVIDONE K 30 BP/USP 30(that pre-freeze crosses by prescription and cross 100 eye mesh screens), then with the ice pellets mix homogeneously;
5) with tablet machine ice pellets is pressed into 500;
6) the gained tablet gets oral cavity disintegration tablet with putting into the freezer dryer inner drying.
Freezing dry process, lyophilization parameter, disintegration and friability detect as described in the embodiment one.
Through check, be 36.0 s the disintegration of gained quickly disintegrating tablet, and friability is 0%.
Embodiment four:
The compressed cores prescription:
Preparation process:
1) takes by weighing mannitol, 30 POVIDONE K 30 BP/USP 30 by prescription; The deionized water that adds recipe quantity then; Stirring, the ultrasonic settled solution that gets;
2) settled solution being put into refrigerator-freezer is frozen into solid-state;
3) with pulverizer with solid solution pulverize ice pellets, ice pellets is crossed 45 eye mesh screens;
4) take by weighing the low-substituted hydroxypropyl cellulose (crossing 100 eye mesh screens) that pre-freeze is crossed by prescription, then with the ice pellets mix homogeneously;
5) with tablet machine ice pellets is pressed into 500;
6) the gained tablet gets oral cavity disintegration tablet with putting into the freezer dryer inner drying.
Freezing dry process, lyophilization parameter, disintegration and friability detect as described in the embodiment one.
Through check, be 15.0 s the disintegration of gained quickly disintegrating tablet, and friability is 0%.
Embodiment five:
The compressed cores prescription:
Preparation process:
1) takes by weighing gelatin, mannitol, PVP K30 by prescription; The deionized water that adds recipe quantity then; Stirring, the ultrasonic settled solution that gets;
2) settled solution being put into refrigerator-freezer is frozen into solid-state;
3) with pulverizer with solid solution pulverize ice pellets, ice pellets is crossed 60 eye mesh screens;
4) take by weighing by prescription that microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, the carboxymethyl starch that pre-freeze crosses received, melatonin (crossing 100 eye mesh screens) mix homogeneously, then with the ice pellets mix homogeneously;
5) with tablet machine ice pellets is pressed into 500;
6) the gained tablet gets oral cavity disintegration tablet with putting into the freezer dryer inner drying.
Freezing dry process, lyophilization parameter, disintegration and friability detect as described in the embodiment one.
Through check, be 15.6 s the disintegration of gained quickly disintegrating tablet, and friability is 0%.
More than show and described ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and the description only is preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.
Claims (9)
1. oral cavity quickly disintegrating tablet, it is characterized in that: this oral cavity disintegration tablet comprises the framework material of 5-45wt% based on the gross weight of label; The binding agent of 1-10wt%; The disintegrating agent of 1-10wt%; The solvent of 20-70wt%; The acceptable accessories of 1-20wt%; The medicine of 0-50wt%.
2. according to the described rapid disintegration tablet of claim 1 and low temperature drawing method thereof, it is characterized in that the preferred content ratio of the framework material that comprises in the described oral cavity disintegration tablet, binding agent, disintegrating agent, solvent, acceptable accessories and medicine is: framework material 10-40wt%, binding agent 3-8wt%, disintegrating agent 3-8wt%, solvent 25-65wt%, acceptable accessories 6-15wt%, medicine 0-40wt%.
3. according to the described rapid disintegration tablet of claim 2 and low temperature drawing method thereof, it is characterized in that: described framework material is ethylmethylcellulose, ethyl cellulose, chitin, chitose, methylcellulose, sesbania gum, tara gum, Ficus elastica, carbomer, Furcellaran, tragacanth, arabic gum, Resina persicae, maltose alcohol, carrageenin, tamarind gum, Nulomoline, fructose, POLY-karaya, poloxamer, alginic acid, sodium alginate, starch, pregelatinized Starch, modified starch, gelatin, dextran, mannitol, xylitol, sorbitol, maltose Chi ?alcohol, microcrystalline Cellulose, polymerization sugar coupling sugar, glucose, lactose, sucrose, dextrin, in cyclodextrin and the starch etc. one or more.
4. according to the described rapid disintegration tablet of claim 2 and low temperature drawing method thereof, it is characterized in that: described binding agent is one or more in day hot glue family macromolecule polymer such as starch, pregelatinized Starch, dextrin, cyclodextrin, maltodextrin, sucrose, arabic gum or gelatin, hydrophilic cellulose base polymer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, alginic acid and alginate, xanthan gum, hydroxypropyl cellulose and the hydroxypropyl emthylcellulose etc.
5. according to the described rapid disintegration tablet of claim 2 and low temperature drawing method thereof, it is characterized in that: described disintegrating agent comprises one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low substituted hydroxy-propyl methylcellulose, cross-linking sodium carboxymethyl cellulose, pregelatinized Starch and the soybean polysaccharide etc.
6. according to the described rapid disintegration tablet of claim 2 and low temperature drawing method thereof, it is characterized in that: described acceptable accessories comprises fluidizer, filler, correctives, in the adsorbent one or more, wherein said fluidizer comprises micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate, magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, in Stepanol MG and the Pulvis Talci etc. one or more; Described filler is selected from one or more in microcrystalline Cellulose, starch, pregelatinized Starch, dextrin, cyclodextrin, mannitol and the calcium carbonate; Described correctives comprises one or more in aspartame, sucrose, saccharin sodium, stevioside, neotame, cyclamate, citric acid, tartaric acid, malic acid ethyl maltol, essence and the cocoa powder etc.; Described adsorbent is that carboxymethyl starch is received, micropowder silica gel, light magnesium oxide, cross linked polyvinyl pyrrolidone or aluminium hydroxide desiccant gel, is scattered in carrier in the tablet as liquid drug.
7. according to each described rapid disintegration tablet and low temperature drawing method thereof among the claim 1-6, it is characterized in that: described solvent comprises water or the tert-butyl alcohol for low molecule solvent.
8. the low temperature drawing method of the described oral cavity of claim 1 quickly disintegrating tablet, it is characterized in that: the step that this method comprises is:
1) press prescription drug and adjuvant, add the solvent of recipe quantity, stir, dissolve settled solution;
2) in low temperature environment, be refrigerated to solution solid-state;
3) solid solution is pulverized, must be contained the ice pellets of medicine and adjuvant, ice pellets is crossed regulation order number sieve net, can get minimum ice granule;
4) add sieve and the pre-freeze processing medicine and adjuvant and ice granule mixing;
5) with tablet machine that the material compacting of mix homogeneously is in blocks;
6) the gained tablet is put into the freezer dryer inner drying, gets disintegrating tablet.
9. the low temperature drawing method of oral cavity according to claim 8 quickly disintegrating tablet, it is characterized in that: step 2-5 all carries out below the material freezing point.
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| CN106619539A (en) * | 2015-11-02 | 2017-05-10 | 董玲 | Method for preparing freeze-dried excipient preparation in any shape and product of method |
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| CN107137233A (en) * | 2017-04-20 | 2017-09-08 | 扬州大学 | A kind of processing method with cocktail curative effect oral tablets |
| CN107137233B (en) * | 2017-04-20 | 2022-09-13 | 扬州大学 | Processing method of oral tablet with cocktail curative effect |
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