CN102440973B - Diphenhydramine citrate orally disintegrating tablet and preparation method thereof - Google Patents
Diphenhydramine citrate orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN102440973B CN102440973B CN 201110432644 CN201110432644A CN102440973B CN 102440973 B CN102440973 B CN 102440973B CN 201110432644 CN201110432644 CN 201110432644 CN 201110432644 A CN201110432644 A CN 201110432644A CN 102440973 B CN102440973 B CN 102440973B
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Abstract
The invention discloses a diphenhydramine citrate orally disintegrating tablet, the prescription is composed by the following components in mass percent: 19% of diphenhydramine citrate, 45 swung dash 58% of filler, 15 swung dash 25% of disintegrating agent, 4 swung dash 8% of effervescent disintegrant, 0.5 swung dash 1% of lubricant, 1 swung dash 3% glidant, 1 swung dash 2% of sweetner, 0.2swung dash 0.6% aromatic and 0 swung dash 0.5% of surfactant, wherein the filler uses mannitol, or mannitol and lactose or erythritol, the disintegrating agent uses any one of polyplasdone, crosslinking sodium carboxy methyl cellulose and low substitution hydroxyl propyl cellulose together with microcrystalline cellulose, the effervescent disintegrant comprises citric acid and sodium bicarbonate which have the mass ratio of 1 swung dash 2/1, the lubricant is magnesium stearate, the glidant is aerosil or talcum powder, the sweetner is aspartame or stevia rebaudianum, the aromatic is the pharmaceutically acceptable essence, and the surfactant is lauryl sodium sulfate; and the invention further discloses a preparation method of the orally disintegrating tablet, which is simple to operate, the cost is low, the obtained product is in accordance with the quality requirement of the orally disintegrating tablet, and has attractive appearance, good taste and stable quality.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of oral cavity disintegration tablet, also relate to the preparation method of this oral cavity disintegration tablet.
Background technology
Diphenhydramine is the H1 receptor antagonist, can eliminate various allergic symptoms to the effect of antihistamine to blood vessel, gastrointestinal tract and bronchial smooth muscle, but can not antfhistamine gastric secretion effect short of money; Stronger central nerve inhibition effect is arranged, produce calm, hypnotic effect; Cholinolytic effect is arranged, can alleviate bronchospasm; Also have local anesthesia effect and town to tell effect.Be usually used in clinically skin, mucous membrane irritability disease such as pollinosis, urticaria, allergic dermatitis, pollinosis, angioedema and skin pruritus etc., also the vomiting that radiotherapy, operation, medicine and motion sickness cause be can suppress, also can parkinson disease and drug-induced extrapyramidal symptoms be controlled in conjunction with other medicines.At present, the diphenhydramine folk prescription of domestic listing and compound preparation are all take diphhydramine hydrochloride as active component, and dosage form mainly contains conventional tablet, syrup etc.But because the oral rear major part of diphenhydramine is transformed by liver metabolism, first pass effect is obvious, in body circulation precontract by metabolism 50%, therefore, be necessary to develop the Benahist that a kind of first pass effect is little, bioavailability is high, store simultaneously, carry, taking convenience, patient's compliance is good.
Summary of the invention
In view of this, one of purpose of the present invention is to provide a kind of Benahist, and first pass effect is little, and bioavailability is high, stores, carries, taking convenience, and patient's compliance is good.
For achieving the above object, the invention provides following technical scheme:
The diphenhydramine citrate oral cavity disintegration tablet is write out a prescription composed of the following components by mass percentage: diphenhydramine citrate 19%, filler 45 ~ 58%, disintegrating agent 15 ~ 25%, gas-producing disintegrant 4 ~ 8%, lubricant 0.5 ~ 1%, fluidizer 1 ~ 3%, sweeting agent 1 ~ 2%, aromatic 0.2 ~ 0.6% and surfactant 0 ~ 0.5%; Described filler is that mannitol or mannitol and lactose or erythritol share; Described disintegrating agent is that any and the microcrystalline Cellulose in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and low-substituted hydroxypropyl cellulose share; Described gas-producing disintegrant is that mass ratio is citric acid and the sodium bicarbonate of 1 ~ 2:1; Described lubricant is magnesium stearate; Described fluidizer is micropowder silica gel or Pulvis Talci; Described sweeting agent is aspartame or steviosin; Described aromatic is pharmaceutically acceptable essence; Described surfactant is sodium lauryl sulphate.
The preferred sugar alcohols of filler of the present invention such as mannitol, erythritol etc. and lactose, their equal no hygroscopicities, soluble in water, and self be with sweet taste, made tablet surface is bright and clean attractive in appearance.Heat absorption when dissolving due to sugar alcohols, refrigerant sense is arranged when dissolving in the oral cavity, and the sugariness of lactose is not as sugar alcohols, and heat release during dissolving, when dissolving in the oral cavity without refrigerant sense, therefore more preferably sugar alcohols of filler of the present invention as mannitol is mixed as filler with erythritol as filler or with mannitol separately, perhaps makes up as filler with the sugar alcohols of larger proportion and than the lactose of small scale.
Orally-disintegrating tablet is not need water, meet the saliva tablet of disintegrate and dissolving rapidly, and therefore, the selection of disintegrating agent is extremely important.Any in the preferred polyvinylpolypyrrolidone of disintegrating agent of the present invention, cross-linking sodium carboxymethyl cellulose and low-substituted hydroxypropyl cellulose and microcrystalline Cellulose share.Microcrystalline Cellulose is water insoluble, have good mobility and compressibility, have filling, disintegrate, lubricated multiple action concurrently, during with the strong polyvinylpolypyrrolidone of swelling behavior, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose use in conjunction, can improve the porosity of tablet, strengthen capillarity, make tablet disintegrate fast in a small amount of water.Investigate and find, the disintegrate best results that microcrystalline Cellulose and polyvinylpolypyrrolidone share.Gas-producing disintegrant is comprised of acid constituents and alkaline constituents, both meets water and can produce carbon dioxide and reach disintegration, also has in addition certain taste masking effect.In order to make the disintegrate better effects if of diphenhydramine citrate oral cavity disintegration tablet, the present invention share gas-producing disintegrant and aforementioned disintegrating agent, the acid constituents preferably citric acid of gas-producing disintegrant wherein, the preferred sodium bicarbonate of alkaline constituents.Diphenhydramine citrate is slightly soluble in water, and its hole is difficult for being penetrated by water, adds appropriate surfactant to help to increase the wettability of tablet, makes moisture borrow the capillarity rapid permeability to play disintegration to the sheet heart.But surfactant was selected not at that time, also may affect the disintegrate of tablet.Also can be with surfactant and disintegrating agent, gas-producing disintegrant use in conjunction in the present invention prescription, disintegration rate is faster, disintegrate is more even thereby make.Through investigation, surfactant preferably sodium dodecyl sulfate of the present invention, it not only is conducive to the disintegrate of tablet, and good lubrication is also arranged.
Oral cavity disintegration tablet is disintegrate and dissolving rapidly in the oral cavity, so mouthfeel is one of main investigation factor of this dosage form.Diphenhydramine citrate has certain bitterness and zest, adds appropriate sweeting agent and aromatic can cover its poor taste in prescription, improves mouthfeel, improves patient's drug compliance.Through investigation, the preferred aspartame of sweeting agent of the present invention or steviosin.Aspartame is the artificial synthesis edulcorant, unlikely dental caries, and heat is low, is applicable to diabetes, obesity patient; Steviosin is natural sweetener, does not produce heat, has refrigerant sweet taste and sweet taste lasting.The preferred medicinal essence of aromatic is as Fructus Citri Limoniae essence, apple essence, flavoring orange essence, strawberry essence, Mint Essence etc.
In the situation that in prescription, the adjuvant composition is determined, the present invention has done further screening and optimization to the weight proportion of adjuvant component in prescription.The weight proportion scope that screens as previously mentioned.The diphenhydramine citrate oral cavity disintegration tablet that makes in the said ratio scope is met saliva disintegrate and dissolving rapidly, and steady quality, and mouthfeel is better.Research is also found, when microcrystalline Cellulose and polyvinylpolypyrrolidone share as disintegrating agent, 1) along with the increase of polyvinylpolypyrrolidone consumption, the disintegration time of tablet reduces gradually, but the consumption when it in prescription greater than 10% after, disintegration time substantially no longer changes, and therefore, in prescription, the consumption of polyvinylpolypyrrolidone is preferably 5% ~ 10%; 2) along with the increase of microcrystalline Cellulose consumption, the disintegration time of tablet reduces gradually, but the water-insoluble due to microcrystalline Cellulose, consumption when it in prescription greater than 15% after, grittiness is obvious, and piles up at lingual surface and cause the thickness sense, and patient's compliance reduces, therefore, in prescription, the consumption of microcrystalline Cellulose is preferably 10% ~ 15%.In addition, in the situation that polyvinylpolypyrrolidone and microcrystalline Cellulose consumption in fixed prescription, without gas-producing disintegrant or gas-producing disintegrant consumption hour, easily pile up and the sense of generation thickness at lingual surface after disintegration of tablet, increase along with the gas-producing disintegrant consumption, the disintegration time of tablet reduces gradually, but when the gas-producing disintegrant consumption is excessive, tablet foam in disintegrating procedue the sense and tart flavour excessively strong, and the acid constituents citric acid hygroscopicity of gas-producing disintegrant is strong, the excessive storage that is unfavorable for tablet of consumption, therefore, in prescription, the consumption of gas-producing disintegrant is preferably 4 ~ 8%.
As a kind of preferred technical scheme, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 40%, erythritol 16.5%, microcrystalline Cellulose 10%, polyvinylpolypyrrolidone 5%, citric acid 3%, sodium bicarbonate 2%, magnesium stearate 0.5%, micropowder silica gel 2.5%, aspartame 1% and flavoring orange essence 0.5%.
As a kind of preferred technical scheme, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 35%, erythritol 16.7%, microcrystalline Cellulose 10%, polyvinylpolypyrrolidone 8%, citric acid 4%, sodium bicarbonate 2.5%, magnesium stearate 0.5%, Pulvis Talci 2.5%, aspartame 1.5% and Fructus Citri Limoniae essence 0.3%.
As a kind of technical scheme of the best, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 46%, microcrystalline Cellulose 15%, polyvinylpolypyrrolidone 8%, citric acid 4%, sodium bicarbonate 2%, magnesium stearate 1%, Pulvis Talci 2.5%, steviosin 1.5%, Fructus Citri Limoniae essence 0.5% and sodium lauryl sulphate 0.5%.
Two of purpose of the present invention is to provide the preparation method of described Benahist, and technique is simple, and cost is low, and constant product quality is fit to large-scale industrialization production.
For achieving the above object, the invention provides following technical scheme:
The preparation method of diphenhydramine citrate oral cavity disintegration tablet both can adopt direct powder compression, also can adopt the wet granule compression tablet method.
Described direct powder compression is all components in prescription to be ground into respectively the fine powder of 100 mesh sieves, take diphenhydramine citrate, filler, disintegrating agent, gas-producing disintegrant, fluidizer, sweeting agent, aromatic and the surfactant of recipe quantity, mix homogeneously, add again lubricant, mix homogeneously, tabletting namely gets the diphenhydramine citrate oral cavity disintegration tablet.
described wet granule compression tablet method is all components in prescription to be ground into respectively the fine powder of 100 mesh sieves, take diphenhydramine citrate and the sweeting agent of recipe quantity, mix homogeneously, the filler that adds again recipe quantity, the disintegrating agent of all or part of recipe quantity or do not add disintegrating agent, mix homogeneously, with alcoholic solution or be dissolved with the alcoholic solution soft material processed of surfactant, cross the sieve series wet granular, dry, granulate sieves, add again the disintegrating agent that remains recipe quantity and the gas-producing disintegrant of recipe quantity, aromatic and fluidizer, mix homogeneously, the lubricant that adds at last recipe quantity, mix homogeneously, tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet.
In above-mentioned wet granule compression tablet method, 1) because diphenhydramine citrate has certain bitterness and zest, the present invention when the design technology route preferably with the first mix homogeneously of diphenhydramine citrate and sweeting agent, thereby better cover the poor taste of diphenhydramine citrate, improve mouthfeel; 2) method that adds of disintegrating agent has three kinds: addition 1.: the disintegrating agent of whole recipe quantities is added before wet granular processed, thereby make disintegrating agent be present in granule interior; 2. outer addition: the disintegrating agent of whole recipe quantities is added after granulate, thereby make disintegrating agent be present in outside granule and between each granule; 3. inside and outside addition: disintegrating agent is divided into two parts, aly adds by interior addition, another part adds by outer addition.When same amount, adopt above-mentioned three kinds of oral cavity disintegration tablets that disintegrating agent adds method to make, its disintegration rate is outer addition＞inside and outside addition＞interior addition, dissolution rate is inside and outside addition＞interior addition＞outer addition, the preferred inside and outside addition of the present invention.3) meet waterishlogging for fear of acid, the alkaline constituents of gas-producing disintegrant in wet-granulation process and give birth to reaction, the present invention preferably adds gas-producing disintegrant after granulation.4) when wet granulation, preferably the alcoholic solution take volume fraction as 50% is as wetting agent soft material processed in the present invention, and when containing surfactant in prescription, the present invention preferably is dissolved in surfactant in wetting agent and adds.
As a kind of preferred technical scheme, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 40%, erythritol 16.5%, microcrystalline Cellulose 10%, polyvinylpolypyrrolidone 5%, citric acid 3%, sodium bicarbonate 2%, magnesium stearate 0.5%, micropowder silica gel 2.5%, aspartame 1% and flavoring orange essence 0.5%; Its preparation method is direct powder compression.
As a kind of preferred technical scheme, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 35%, erythritol 16.7%, microcrystalline Cellulose 10%, polyvinylpolypyrrolidone 8%, citric acid 4%, sodium bicarbonate 2.5%, magnesium stearate 0.5%, Pulvis Talci 2.5%, aspartame 1.5% and Fructus Citri Limoniae essence 0.3%; Its preparation method is wet granule compression tablet.
As a kind of technical scheme of the best, the prescription of described diphenhydramine citrate oral cavity disintegration tablet is composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 46%, microcrystalline Cellulose 15%, polyvinylpolypyrrolidone 8%, citric acid 4%, sodium bicarbonate 2%, magnesium stearate 1%, Pulvis Talci 2.5%, steviosin 1.5%, Fructus Citri Limoniae essence 0.5% and sodium lauryl sulphate 0.5%; Its preparation method is wet granule compression tablet.
beneficial effect of the present invention is: the present invention take diphenhydramine citrate as active fraction preparation oral cavity disintegration tablet, select pharmaceutically acceptable adjuvant and adjuvant component and proportioning thereof screened and optimized, Formulation is reasonable, simultaneously, the present invention also designs and optimizes the preparation method of diphenhydramine citrate oral cavity disintegration tablet, easy and simple to handle, technology maturation, manufacturer does not need to acquire extra special installation can realize large-scale industrialization production, with low cost, products obtained therefrom is stable and controllable for quality, reach the prescription of oral cavity disintegration tablet, appearance looks elegant, mouthfeel is good, hardness is suitable, meet disintegrate fast in saliva 30 seconds in the oral cavity, in the time of 5 minutes, drug dissolution reaches more than 85%, direct oral cavity and esophageal mucosa membrane injury absorb, first pass effect is little, bioavailability is high, store, carry, taking convenience, be suitable for the child, the old man, stupor, be unable to leave the bed, disabilities etc. have the patient of dysphagia and the patient who is difficult for obtaining drinking water.
The specific embodiment
In order to make the purpose, technical solutions and advantages of the present invention clearer, the below is described in detail the preferred embodiments of the present invention.
Embodiment 1
Prescription:
Preparation method:
Each component in prescription was ground into respectively the fine powder of 100 mesh sieves, get the diphenhydramine citrate of recipe quantity and all adjuvants except magnesium stearate, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely gets the diphenhydramine citrate oral cavity disintegration tablet, and every contains diphenhydramine citrate 19mg.
Embodiment 2
Prescription:
Preparation method:
each component in prescription was ground into respectively the fine powder of 100 mesh sieves, get diphenhydramine citrate and the steviosin of recipe quantity, mix homogeneously, the mannitol that adds again recipe quantity, lactose, microcrystalline Cellulose and polyvinylpolypyrrolidone, mix homogeneously, be that 50% alcoholic solution is wetting agent soft material processed with volume fraction, 30 mesh sieves are granulated, 50 ~ 55 ℃ of aeration-dryings, 30 mesh sieve granulate, citric acid with recipe quantity, sodium bicarbonate, flavoring orange essence and micropowder silica gel join in dried granule, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet, every contains diphenhydramine citrate 19mg.
Embodiment 3
Prescription:
Preparation method:
each component in prescription was ground into respectively the fine powder of 100 mesh sieves, get diphenhydramine citrate and the aspartame of recipe quantity, mix homogeneously, the mannitol and the erythritol that add again recipe quantity, and the microcrystalline Cellulose of 1/2nd recipe quantities and polyvinylpolypyrrolidone, mix homogeneously, be that 50% alcoholic solution is wetting agent soft material processed with volume fraction, 30 mesh sieves are granulated, 50 ~ 55 ℃ of aeration-dryings, 30 mesh sieve granulate, with the microcrystalline Cellulose of residue recipe quantity and the citric acid of polyvinylpolypyrrolidone and recipe quantity, sodium bicarbonate, Fructus Citri Limoniae essence and Pulvis Talci join in dried granule, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet, every contains diphenhydramine citrate 19mg.
Embodiment 4
Prescription:
Preparation method:
each component in prescription was ground into respectively the fine powder of 100 mesh sieves, get diphenhydramine citrate and the aspartame of recipe quantity, mix homogeneously, the mannitol that adds again recipe quantity, mix homogeneously, be that 30% alcoholic solution is wetting agent soft material processed with volume fraction, 30 mesh sieves are granulated, 50 ~ 55 ℃ of aeration-dryings, 30 mesh sieve granulate, again with the microcrystalline Cellulose of recipe quantity, polyvinylpolypyrrolidone, citric acid, sodium bicarbonate, Mint Essence and micropowder silica gel join in dried granule, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet, every contains diphenhydramine citrate 19mg.
Embodiment 5
Prescription:
Preparation method:
each component in prescription was ground into respectively the fine powder of 100 mesh sieves, be that 50% dissolve with ethanol solution is made solution with the sodium lauryl sulphate volume fraction of recipe quantity, get diphenhydramine citrate and the steviosin of recipe quantity, mix homogeneously, the mannitol that adds again recipe quantity, and the microcrystalline Cellulose of 1/2nd recipe quantities and polyvinylpolypyrrolidone, mix homogeneously, be wetting agent soft material processed with the alcoholic solution that is dissolved with sodium lauryl sulphate, 30 mesh sieves are granulated, 50 ~ 55 ℃ of aeration-dryings, 30 mesh sieve granulate, with the microcrystalline Cellulose of residue recipe quantity and the citric acid of polyvinylpolypyrrolidone and recipe quantity, sodium bicarbonate, Mint Essence and Pulvis Talci join in dried granule, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet, every contains diphenhydramine citrate 19mg.
The quality examination of the diphenhydramine citrate oral cavity disintegration tablet that embodiment 1 ~ 5 makes the results are shown in following table.Wherein hardness test adopts YPD-200C matrix agent hardness tester (Shanghai Huanghai Sea medicine inspection Instr Ltd.), detects altogether 10, averages.78X-6A matrix agent four-function instrument (Shanghai Huanghai Sea medicine inspection Instr Ltd.) is adopted in the friability inspection, checks by 2010 editions two appendix XG tablet friability inspection techniques of Chinese Pharmacopoeia, calculates tablet less loss weight.The disintegration time inspection comprises disintegration time inspection in external disintegration time inspection and body.Requirement with reference to " formulation characteristic of oral cavity disintegration tablet and the quality control meeting summary " of in JIUYUE, 2003 issue of State Food and Drug Administration's drug evaluation center, static disintegrate method is adopted in external disintegration time inspection, get 1 of oral cavity disintegration tablet, put in the 5mL beaker that fills 37 ± 0.5 ℃ of distilled water of 2mL, the range estimation disintegration of tablet (filters liquid in beaker till having no label with 25 eye mesh screens, substantially noresidue on screen cloth), recording the required time of said process is external disintegration time, detect altogether 10, average; In body, the disintegration time inspection is the first water cleaning oral cavitys of 6 healthy volunteers, gets at random 1 of oral cavity disintegration tablet and is placed in lingual surface, not water, do not chew yet, allow tongue suitably to move up and down, recording tablet complete required time of disintegrate in the oral cavity is disintegration time in body, averages.dissolution determination adopts 2010 editions two appendix XC dissolution method the second methods of Chinese Pharmacopoeia, dissolution medium is 900mL 0.1mol/L hydrochloric acid solution, rotating speed is 100r/min, respectively 1, 2, 5, 10, 20, 30, the 45min 5mL that takes a sample, through centrifugal, after filtration treatment, concentration according to 2010 editions two appendix VD high effective liquid chromatography for measuring diphenhydramine citrates of Chinese Pharmacopoeia, calculate dissolution, chromatographic condition is as follows: chromatographic column is Sepax-C18 post (4.6 * 250mm, 5 μ m), mobile phase is that (volume ratio is 50:50:0.5 to acetonitrile-water-triethylamine, with phosphorus acid for adjusting pH to 7.5), the detection wavelength is 213nm, column temperature is 30 ℃, flow velocity is 1.0mL/min.
The quality examination result of the diphenhydramine citrate oral cavity disintegration tablet that table embodiment 1 ~ 5 makes
Explanation is at last, and above embodiment only technical scheme of the present invention does not consist of the restriction to content of the present invention for illustrating.Although the present invention has been done comparatively detailed exemplifying by above-described embodiment, but those skilled in the art still can be according to summary of the invention part and the described technology contents of embodiment part, in the form and details it is made various changes, and do not depart from the spirit and scope of the present invention that appended claims limits.
Claims (2)
1. diphenhydramine citrate oral cavity disintegration tablet, it is characterized in that, write out a prescription composed of the following components by mass percentage: diphenhydramine citrate 19%, mannitol 46%, microcrystalline Cellulose 15%, polyvinylpolypyrrolidone 8%, citric acid 4%, sodium bicarbonate 2%, magnesium stearate 1%, Pulvis Talci 2.5%, steviosin 1.5%, Fructus Citri Limoniae essence 0.5% and sodium lauryl sulphate 0.5%.
2. the preparation method of the described diphenhydramine citrate oral cavity disintegration tablet of claim 1, it is characterized in that, each component in prescription was ground into respectively the fine powder of 100 mesh sieves, be that 50% dissolve with ethanol solution is made solution with the sodium lauryl sulphate volume fraction of recipe quantity, get diphenhydramine citrate and the steviosin of recipe quantity, mix homogeneously, the mannitol that adds again recipe quantity, and the microcrystalline Cellulose of 1/2nd recipe quantities and polyvinylpolypyrrolidone, mix homogeneously, be wetting agent soft material processed with the alcoholic solution that is dissolved with sodium lauryl sulphate, 30 mesh sieves are granulated, 50 ~ 55 ℃ of aeration-dryings, 30 mesh sieve granulate, with the microcrystalline Cellulose of residue recipe quantity and the citric acid of polyvinylpolypyrrolidone and recipe quantity, sodium bicarbonate, Fructus Citri Limoniae essence and Pulvis Talci join in dried granule, mix homogeneously, the magnesium stearate that adds again recipe quantity, mix homogeneously, controlling tablet hardness is 7 ± 2N tabletting, namely get the diphenhydramine citrate oral cavity disintegration tablet.
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| CN103989639A (en) * | 2014-04-30 | 2014-08-20 | 浙江康乐药业股份有限公司 | Diphenhydramine hydrochloride particles and preparation method thereof |
| US9855227B2 (en) * | 2015-12-18 | 2018-01-02 | The Procter & Gamble Company | Quick dissolving diphenhydramine oral dosage form |
| CN107510671A (en) * | 2016-06-16 | 2017-12-26 | 杨永新 | A kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form |
| CN114788817A (en) * | 2021-01-25 | 2022-07-26 | 南京宁丹新药技术有限公司 | Diphenhydramine pharmaceutical composition |
| CN113679687A (en) * | 2021-09-29 | 2021-11-23 | 江苏集萃新型药物制剂技术研究所有限公司 | Composite drug release composition, orally disintegrating tablet composition, orally disintegrating preparation and application thereof |
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| CN101095679A (en) * | 2007-07-28 | 2008-01-02 | 南昌弘益科技有限公司 | Granisetron hydrochloride orally disintegrating tablets |
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| CN101095679A (en) * | 2007-07-28 | 2008-01-02 | 南昌弘益科技有限公司 | Granisetron hydrochloride orally disintegrating tablets |
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