CN1994468A - Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof - Google Patents
Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof Download PDFInfo
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Abstract
The invention relates to a particles used to shade bad taste of drug, wherein it is formed by corn element with active component and continuous polymer dress; the corn element is formed by active component and acrylic resin at 1:0.5-1:20 mass ratio; the dress is soluble gel slurry; and the drug is soluble in acid solution with bad taste. And the production comprises that: dissolving drug and soluble base material into solvent; using atomizing drier or rotation evaporator to obtain dry particles; then graining them at neutral condition via gel material; forming dress that separates drug and taste bud on the surface of particles; preparing oral agent via general method. The invention can avoid releasing bad taste in mouth but release drug in stomach.
Description
Technical field
But the present invention relates to a kind of unfavorable taste-masking drug granule chewable formulation and preparation technology thereof, but the chewable formulation and the preparation technology thereof of the good water solubility of more specifically saying so, the bad medicine of tart mouthfeel belong to field of pharmaceutical preparations.
Background technology
The basic demand of pharmaceutical preparation is safe, effective, quality controllable, and in addition, pharmaceutical preparation can improve the bad smell and the sense of taste of medicine, improves the take medicine toleration and the compliance of sufferer, thereby effective ingredient is played one's part to the full.From week, most medicine exists the bad abnormal smells from the patient and the sense of taste, and therefore, particularly child and old people's administration produce huge harmful effect.Consider the compliance that improves child old man's medication and take characteristics, a lot of drug developments become the dosage form that suitable child old man takes, as granule, dispersible tablet, powder, oral cavity disintegration tablet and chewable tablet etc.Because the mode of taking of these dosage forms is for the work that improves the adverse drug mouthfeel has caused bigger challenge.
In the industrial method that is used for flavoring of preparation coating arranged, add correctives, cyclodextrin inclusion compound, host material and drug spray drying and granulating etc.These methods are in the industrial extensive utilization of preparation.But,, exist unsurmountable shortcoming at medicine of the present invention and described preparation thereof.
Adding correctives is the modal method of improving the adverse drug mouthfeel, and correctives is divided into: sweeting agent, taste bud paralyzant, mucilage and aromatic etc.Main principle is to regulate the stimulation that medicine produces taste bud by other taste components, thereby covers the bad mouthfeel of medicine.Sweeting agent can be covered a small amount of bitter sense; The taste bud paralyzant plays the astriction of the sense of taste, thereby promotes the threshold value to bad mouthfeel; Mucilage by blocking medicine the oral cavity release reach the effect that hides bad mouthfeel.(50 times of sucrose sweetness) arrives sucralose (600 times of sucrose sweetness) and neotame (7000 times of sucrose sweetness) again from sucrose to the glucide, and the sugariness of sweeting agent constantly rises.Sweet taste can be covered the hardship sense of little bitter medicine thing to a certain extent; but for medicine of the present invention; even the granule or the chewable tablet that use the high dose sweeting agent and prepare in conjunction with mucilage, taste bud paralyzant and aromatic; find through adult volunteer taste test, think that mouthfeel acceptable ratio is generally less than 20%.For child's sufferer, can infer that the ratio of tolerance should be lower than this numerical value.Result of the test also shows: at first, the diffusion velocity of the medicine of ease of solubility in saliva is exceedingly fast, before working, correctives just begins to transmit sense of taste signal to brain, even therefore adopt a large amount of correctivess the bitter problem in earlier sweet back also can occur with the acceptor interaction of taste bud; The second, only use the aftertaste residence time of correctives medicine longer; The 3rd, correctives the consumption excessive safety issue that causes easily, the particularly additive that some consumption upper limits are lower can not surpass the state food additive and use sanitary standard.In sum, the method for interpolation flavoring is very limited for the effect of being played of covering of adverse drug mouthfeel of the present invention.
The method of coating can be divided into powder coating, granule coating, micropill coating and slice, thin piece coating according to the particle diameter difference of coating composition, and the different equipment that coating adopted is also inequality.The principle of coating is to form the isolated film of one deck at the particle surface that is wrapped up, and stops the stripping of medicine in the oral cavity, thereby reaches the effect that hides bad mouthfeel.For the child, dysphagia, so conventional tablet need break into two with one's hands or grind and take, thus bad mouthfeel causes child's medication poor compliance.In addition, because the child is in taking the process of tablet, owing to not the understanding of medicining mode, might chew earlier again and swallow, coatings is destroyed, and medicine discharges in the oral cavity, but therefore the exploitation chewable formulation has very big necessity.After the coated tablet of coating and Film coated tablets were chewed in the oral cavity, the coatings of medicine was chewed destruction, and medicine discharges in oral environment and causes bad mouthfeel, thereby the slice, thin piece behind the coating can not be chewed in the oral cavity.The characteristics of the characteristics of micropill and granule coating and slice, thin piece coating are also similar, use fluid bed to form a skim at micropill or particulate surface, and micropill or particulate diameter are between a few tenths of a mm is to several millimeters.As application number is that 00114205 Chinese patent discloses and uses enteric solubility or gastric solubility material to carry out the method for coating for the drug particles of mouthfeel difference, thereby improves bitterness and the bad smell of covering medicine.Granule and micropill coating have improved the swallowing property of preparation, and the patient who helps dysphagia uses.Become masticable preparation such as chewable tablet if but medicine need be developed, can chew granule etc., coating membrane still inevitably is damaged in the process that chew in the oral cavity, and the medicine of bad mouthfeel can discharge.Need tolerating in the oral cavity again of mouthfeel extreme difference chewed and do not discharged medicine, and micropill and granule coating can not be dealt with problems.The packaging technique of powder coating for growing up in recent years.Different with above-mentioned tablet coating and micropill, granule coating is that the particle diameter of powder is very little, generally below 80 orders.In the oral cavity, do not have grittiness, be difficult for being destroyed yet, thereby become the popular flavoring technology of developing various quick releasing formulations by teeth chewing.This method just reported in " Chinese Journal of Pharmaceuticals " 199728 (9) " formulation parameters of a powder coating " literary composition.But because the character of powder surface is irregular, powder coating can't be even at the parcel thickness at each position on surface, as long as the grain thickness of particle surface part is thinner, just allows drug release come out easily; And powder coating efficient side is low, is not that all medicines can wrap up one deck clothing film, for the medicine of mouthfeel extreme difference of the present invention, as long as a spot of medicine does not superscribe the mouthfeel that will make whole preparation and can't accept; In addition, the realization degree of the suitability for industrialized production of powder coating and granule coating is poor, the technological parameter complexity, yield is low, as " formulation parameters of powder coating " literary composition " powder coating is a very complicated process; relate to the optimized choice problem of technological parameter and prescribed parameters, and different coating parameters often produces significantly influence to the quality of the pharmaceutical preparations ".Hence one can see that, and but powder coating comprises bad mouthfeel medicine for preparation claims chewable formulation can not reach the ideal effect of expection.
The cyclodextrin bag is a kind of common method to modify taste, and principle is host molecule and enclosed molecule when carrying out clathration, and chemical reaction does not take place each other, does not have the effect of chemical bonds such as ionic bond, covalent bond or coordinate bond, and clathration mainly is a kind of physical process.The clathrate formation condition depends primarily on the stereochemical structure of host molecule and enclosed molecule and both polarity.The stability of clathrate depends on the gravitational power of Fan Desa of two kinds of molecule departments.As dispersion force, gravitation, hydrogen bond, electric charge migration force etc. between dipole, single sometimes active force works, and majority is the synergism of several active forces.Cyclodextrin has circulus. and application number is that 9310659 Chinese patent uses cyclodextrin inclusion compound to hide the bad mouthfeel of Oleum Bulbus Allii.Application number be 90106682 Chinese patent to adopt beta-schardinger dextrin-be carrier, make it under optimum process condition, to form host and guest's molecule numerator iodine one cydiodine of enclose mutually with iodine, the reduction mucosa has strong impulse and stink, is used for the application of oral disease.But, adopt cyclodextrin to wrap up medicine of the present invention and found that for taste of medicine and can not play effective covering effect.By structural analysis, cyclodextrin molecular structure " rim of a cup " part is hydrophilic hydroxyl, " cup " inside is the hydrophobic part structure, and drug molecule of the present invention belongs to hydrophilic drugs, adopt the combination rate of cyclodextrin inclusion compound lower, thereby most drug molecule is still in aqueous solution, and bitterness is very serious.Result of the test and theoretical proof cyclodextrin are very limited for the effect of covering of described adverse drug mouthfeel.
Using host material to carry out spray-drying process or rotary evaporation drying, is a kind of method to modify taste commonly used.Its method is that raw material and adjuvant prepare uniform solution or suspension, by spray drying or rotary evaporation drying and granulating, forms the structure that medicine and host material are inlayed.The material that uses from the consideration of flavoring angle and drug bioavailability is No. 4, gastric solubility material such as acrylic resin.This is that if be the enteric solubility material, the time in the oral cavity causes the dissolving of enteric solubility material and the release of medicine easily than length because the environment in oral cavity is approaching neutral.And for the water ease of solubility and present tart bad mouthfeel medicine, adopt this method to have following problem: at first, medicine is soluble in water and host material is insoluble in water, therefore, medicine can't with the abundant combination of substrate, some medicine is behind spray drying or rotary evaporation, still accumulate in particulate surface, therefore, though mouthfeel makes moderate progress than mouthfeel before the spray-drying process, still still have strong bitter sense; The second, act between the gastric solubility material of tart medicine and alkalescence, the time of granule in the oral cavity is long slightly, and after the host material cup acidic drug dissolving of gastric solubility, medicine discharges in the oral cavity, and bitterness is obvious.Therefore, there is obvious defects in this method.
Summary of the invention
First technical problem that the present invention will solve is the deficiency that overcomes above preparation technology, and a kind of taste masked particle of bad mouthfeel medicine is provided.
Second technical problem that the present invention will solve provides a kind of chewable formulation of bad mouthfeel medicine.
The 3rd technical problem that the present invention will solve provides a kind of preparation technology of chewable formulation of bad mouthfeel medicine.
For achieving the above object, the present invention is by the following technical solutions:
A kind of unfavorable taste-masking drug granule is made of the continuous polymer coating of the nuclear core that comprises active component with the nuclear core, and its center core is made up of by 1: 0.5～1: 20 weight ratio active component and gastric solubleness acrylic resin, and coating material is the agent of water solublity rubber cement.
Bad mouthfeel medicine among the present invention is meant: (1) medicine mouthfeel is poor, has intensive especially bitterness, fiber crops flavor or other sense of taste that are difficult to accept.(2) medicine shows acid, can comprise acid or strong acid weak base salt.(3) water solublity of medicine is better, and certain dissolubility is arranged in water.
The nuclear core of taste masked particle can contain one or more in the various active component, and suitable active component includes but not limited to the medicine that following mouthfeel is bad: the husky fourth ammonia of berberine, acetaminophen, phenylpropanolamine HC1, pseudoephedrine hydrochloride, phenylephrine hydrochloride, hydrochloric acid Pandryl, dextromethorphan hydrobromide, chlorphenamine maleate, hydrochloric acid bromine hexylamine, ambroxol hydrochloride and sulphuric acid alcohol.
This particulate nuclear core contains pure crystallization active component, or active component and selectivity are present in the mixture of component known in the art such as binding agent, excipient etc.Can form the nuclear core with multiple known method of granulating.Preferably prepare by spray drying or rotary evaporation granulation.
The bad medicine of mouthfeel must reach effective specification in adopting the prepared sample of the present invention.Specification is different and different along with prescription.For example, the berberine granule of child's use just has the 50mg specification different with 25mg.
Gastric solubleness acrylic resin used in the present invention is No. 4, acrylic resin, and bad medicine and its compatibility of mouthfeel is good among the present invention, does not react and influences stability of drug.
The gastric solubleness acrylic resin in gastric juice, dissolve and in water undissolved characteristics guarantee that spray-dired granule can not dissolve and drug release is come out in the oral cavity.According to the weight of bitterness, the consumption of acrylic resin is an amount of to be reduced or increases.
The thickness of continuous polymer coating is generally micron 10 micron 2000 on the nuclear core, and preferred 100 microns 500 microns, this polymer coating accounts for 0.5%～600 of taste masked particle weight, and preferred 1%～30%.
Mucilage medicine used in the present invention can dissolve in water, and the aqueous solution of the medicine of low concentration presents stronger viscosity.Mucilage forms a skim in the mode of granulating in spray drying or the particulate surface of rotary evaporation process gained, meets imbibition behind the water and forms the layer of gel layer.
Invention includes but not limited to the mucilage that following mouthfeel is bad: one or more in sesbania gum, his that glue, Ficus elastica, carbomer, Furcellaran, tragacanth, Resina persicae, sodium alginate, xanthan gum, gelatin, carbopol and the guaiac gum.The preparation of mucilage solution can make water and ethanol as solvent, keeps 10＞pH＞5.5 of whole mucilage solution, i.e. neutrality or alkalescence.
The concentration of mucilage is 0.01%～30%, difference according to the glue class, adopt the concentration of different proportion, the concentration range of mucilage preferred 0.1%～10%, if mucilage concentration is crossed low a large amount of mucilage that needs, a large amount of liquid handling are difficult on commercial production, and excessive concentration then causes evaporation rate of solvent slower, reduce production efficiency.
The particle diameter of taste masked particle is preferably between the 60-120 order, and too thick granule is mixing or the real layering easily of tabletting; It is unfavorable that too thin granule hides for taste of medicine.
A kind of chewable formulation of bad mouthfeel medicine, by above-mentioned unfavorable taste-masking drug granule add the pharmaceutics acceptable auxiliary routinely preparation process make.
But the bad mouthfeel medicine of preparation chewable formulation is the medicine that has aromatic rings and have hydrophilic group, can form the amino of hydrogen bond, carboxyl or hydroxyl etc.These medicines are selected from but are not limited to analgesic, anticoagulant medicine, emetic, antihistaminic, pine flesh medicine, vasodilator, anti-arrhythmic, diarrhea, antihypertensive, antimicrobial drug, anesthetics, tracheaectasy medicine, antibiotic medicine, tranquilizer, spiritual quasi drugs, antineoplastic agent, Bendectin, anticonvulsant, hypoglycemia medicine, diuretic, spasmolytic, uterotonic, appetrol, antifungal agent and antiviral agents.It also can be the combination of above these medicines.
The pharmaceutically acceptable adjuvant that can be used for preparing the chewable formulation of bad mouthfeel medicine has filler (to be selected from lactose, sucrose, sorbitol, xylitol, glucose, calcium hydrogen phosphate, calcium phosphate, mannitol, fructose, starch, pregelatinized Starch, the combination of one or more of dextrin and sodium starch phosphate etc.), correctives (aspartame, saccharin sodium, acetyl relaxes and puts potassium, sodium glutamate, sodium chloride, Herba Menthae, refrigerant alcohol, sodium carbonate, sodium citrate, ethyl maltol, one or more combination such as stevioside), lubricant (magnesium stearate, Pulvis Talci, silicon dioxide, glyceryl monostearate, PEG, sodium lauryl sulphate, the combination of one or more of sodium stearyl fumarate etc.), essence (flavoring orange essence, grape essence, Fructus Citri Limoniae essence, flavoring pineapple essence, orange flavor, apple essence, the combination of one or more of plum flavour) etc.
But a kind of preparation technology of bad mouthfeel medicine chewable formulation: No. 4, medicine and the acrylic resin weight ratio by 1: 0.5～1: 20 is dissolved in the pharmaceutically acceptable solvent, the preferred alcohol aqueous solution, carry out spray drying with the spray drying instrument, regulate rotating speed and baking temperature, the solution that makes medicine and acrylic resin is with spray drying method or rotary evaporation method solvent evaporated, collecting granules; The mucilage (neutral solution) of preparation 0.01%～30%; Mucilage is added in the granule, mix, 40-60 degree centigrade of oven dry in the baking oven, according to the characteristics of prepared dosage form, can adopt different screen cloth granulate, the gained granule prepares different dosage form traditionally, comprise granule and chewable tablet, can chew and do not have bad mouthfeel.
Selected solvent can dissolve the gastric solubleness acrylic resin and to the small part medicine, help medicine and be uniformly dispersed in substrate.Selected solvent pharmaceutically is being an acceptable, usually can select alcoholic acid aqueous solution or aqueous acetone solution or acetone ethanol solution, be no more than the upper limit of national regulation if can guarantee residual solvent, other can dissolve the acrylic acid solution of gastric solubility also can select for use.
Spray-dired gained grain diameter is preferably between the 60-120 order, and reason is same as above.
In theory, can not hinder the stripping of medicine after the granule use rubber cement granulation to the spray drying preparation completely, and according to the ratio of weightening finish not high (as weightening finish＜10%), it is destroyed that one deck glue-line that forms outside the granule of spray drying preparation can not stop granule chewing in the process.But we unexpectedly find, use mucilage that the granule of medicine of the present invention and No. 4 spray dryinges of acrylic resin or rotary evaporation acquisition is granulated, after the drying, be prepared into granule and use prepared granule or the chewable tablet of this granule according to traditional method, in the oral cavity, chew and keep long-time back and do not have bitter sense.And, all can play better action to comprising berberine, acetyl aminophenol, phenylpropanolamine HC1, pseudoephedrine hydrochloride, phenylephrine hydrochloride, hydrochloric acid Pandryl, dextromethorphan hydrobromide, chlorphenamine maleate, Bisolvon, ambroxol hydrochloride, one or more employing the method for the husky fourth ammonia alcohol of sulphuric acid through a series of test.The result of the test proof all is suitable for the bad medicine of acidity mouthfeel soluble in water.
Advantage of the present invention is: (1) has avoided coating membrane destructive problem in the process of chewing.
(2) covered the problem that the flavoring technology of adding correctives can not be covered adverse drug mouthfeel of the present invention.
(3) avoided cyclodextrin to the not high problem of medicine enclose efficient of the present invention.
(4) solved in the spray drying method gained granule the acid bad medicine dissolution nuclear core substrate of mouthfeel soluble in water and the problem that causes the adverse drug mouthfeel to discharge.
(5) successfully having solved the acid anti-rate of the existing pair of the masticable oral formulations of the bad medicine of mouthfeel soluble in water of current techniques preparation should high problem.
(6) but formulation and technology suitability for industrialized production of the present invention has avoided adopting the equipment or the technology of undue sky high cost.
Below in conjunction with the drawings and specific embodiments the present invention being described in detail, is not limitation of the invention, all any this areas of doing according to the disclosure of invention be equal to replacement, all belong to protection scope of the present invention.
Description of drawings
But Fig. 1 is preparation technology's flow chart of bad mouthfeel medicine chewable formulation
The specific embodiment
With No. 4 375g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 1300g, be mixed with the alcoholic solution of acrylic resin, berberine 25g (Hainan Pharmaceutical Factory Co., Ltd.) is dispersed in the water of 320g, get the suspension of berberine, with two kinds of solution mix homogeneously, be heated to 50 degrees centigrade, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 800g of 1% xanthan gum (Shandong gold foxtail millet biological product company limited), add the 5g sucralose dissolve mucilage, it is even to pour spray drying 400g gained granule into the mucilage dispersed with stirring, and 55 degrees centigrade of oven dry detect moisture, sieve after qualified the granule of xanthan gum parcel, add filleies such as sucrose, sweeting agents such as sucralose add water and granulate, sieve, promptly get and to chew the berberine granule.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: to stop diarrhoea is standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine in continuous two days oral three times of every day, can chew each two bags of berberine groups of grains (by berberine hydrochloride 50mg).
The each a slice of Berberine Tablet group, specification 50mg.
Table 1 curative effect situation
| Can chew berberine groups of grains (50 example) | Berberine Tablet group (50 example) | |
| Diarrhoea | 50 | 50 |
| Cure | 40 | 38 |
| Take a turn for the better | 5 | 8 |
| No change | 5 | 4 |
| Effective percentage | 90％ | 92％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 2 untoward reaction table
| Can chew berberine groups of grains (50 example) | Berberine Tablet group (50 example) | |
| Vomiting is felt sick | 0 | 50 |
| Feel all right | 48 | 0 |
| Basic acceptance | 2 | 0 |
| The side reaction rate | 0％ | 100％ |
Conclusion 2: Berberine Tablet and can chew the berberine granule and take the untoward reaction rate in the mode of chewing significance difference (p＜0.01) is arranged
Embodiment 2
With No. 4 15g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 100g, be mixed with the alcoholic solution of acrylic resin, dextromethorphan hydrobromide 15g (Shanghai Xinya Pharmaceutical Industry Co. Ltd.) is dispersed in the water of 20g, get the solution of dextromethorphan hydrobromide, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 100g of 10% arabic gum (profit source, Shandong Industrial Co., Ltd.), add the 2g sucralose dissolve mucilage, it is even to pour spray drying 20g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of arabic gum parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose add water and granulate, and sieve, granulate, weigh, add 1% magnesium stearate of particle weight, tabletting promptly gets dextromethorphan chewable tablets.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: with the cough-relieving is standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of dextromethorphan chewable tablets group (by dextromethorphan hydrobromide 15mg), each a slice of chewable tablet of common process preparation, specification 15mg, every day 3 times in continuous two days.
Table 3 curative effect situation
| Common process chewable tablet (50 example) | Technology chewable tablet group of the present invention (50 example) | |
| Cough | 50 | 50 |
| Cure | 35 | 37 |
| Take a turn for the better | 8 | 8 |
| No change | 7 | 4 |
| Effective percentage | 86％ | 90％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 4 untoward reaction table
| Common process chewable tablet (50 example) | Technology chewable tablet group of the present invention (50 example) | |
| Vomiting is felt sick | 0 | 40 |
| Feel all right | 49 | 0 |
| |
1 | 10 |
| The side reaction rate | 0％ | 80％ |
Conclusion 2: the chewable tablet of the right romilar chewable tablet of the hydrobromic acid of common process preparation and the present invention's preparation is taken the untoward reaction rate in the mode of chewing significance difference (p＜0.01).
Embodiment 3
With No. 4 750g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 3000g, be mixed with the alcoholic solution of acrylic resin, acetaminophen 150g (Shanghai Xinya Pharmaceutical Industry Co. Ltd.) is dispersed in the water of 600g, get the solution of acetaminophen, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 500g of 10% arabic gum (profit source, Shandong Industrial Co., Ltd.), add the 20g sucralose dissolve mucilage, it is even to pour spray drying 500g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of arabic gum parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose add water and granulate, and sieve, granulate, weigh, add 1% magnesium stearate of particle weight, tabletting promptly gets acetaminophen mastication tablet.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: to bring down a fever is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of acetaminophen mastication tablet group (by acetaminophen 150mg), each a slice of chewable tablet of common process preparation, specification 150mg, every day 3 times in continuous two days.
Table 5 curative effect situation
| Can chew acetaminophen mastication tablet group (50 example) | Paracetamol tablets group (50 example) | |
| Heating | 50 | 50 |
| Cure | 35 | 38 |
| Take a turn for the better | 9 | 8 |
| No change | 8 | 4 |
| Effective percentage | 88％ | 92％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 6 untoward reaction table
| Can chew acetaminophen mastication tablet group (50 example) | Paracetamol tablets group (50 example) | |
| Vomiting is felt sick | 0 | 40 |
| Feel all right | 48 | 0 |
| Basic acceptance | 2 | 10 |
| The side reaction rate | 0％ | 80％ |
Conclusion 2: paracetamol tablets and can chew acetaminophen particles and take the untoward reaction rate in the mode of chewing significance difference (p＜0.01) is arranged
Embodiment 4
With No. 4 240g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 80g, be mixed with the alcoholic solution of acrylic resin, salbutamol sulfate 24g (Jiangsu Pharmaceutical Group Plc of inferior nation makes branch company) is dispersed in the water of 25g, get the solution of salbutamol sulfate, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 50g of 2% tragacanth (profit source, Shandong Industrial Co., Ltd.), add the 1g sucralose dissolve mucilage, it is even to pour spray drying 50g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of tragacanth parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose add water and granulate, and sieve, granulate, weigh, add 1% magnesium stearate of particle weight, tabletting promptly gets the salbutamol sulfate chewable tablet.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: with Zhichuan is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of salbutamol sulfate chewable tablet group (by salbutamol sulfate 2.4mg), each a slice of chewable tablet of common process preparation, specification 2.4mg, every day 3 times in continuous two days.
Table 7 curative effect situation
| Salbutamol sulfate chewable tablet group (50 example) | Salbutamol sulfate sheet group (50 example) | |
| Heating | 50 | 50 |
| Cure | 35 | 33 |
| Take a turn for the better | 9 | 10 |
| No change | 6 | 4 |
| Effective percentage | 88％ | 86％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 8 untoward reaction table
| Salbutamol sulfate chewable tablet group (50 example) | Salbutamol sulfate sheet group (50 example) | |
| Vomiting is felt sick | 0 | 35 |
| Feel all right | 49 | 0 |
| |
1 | 15 |
| The side reaction rate | 0％ | 70％ |
Conclusion 2: salbutamol sulfate sheet and salbutamol sulfate chewable tablet are taken the untoward reaction rate in the mode of chewing significance difference (p＜0.01).
Embodiment 5 (chlorphenamine maleate)
With No. 4 200g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 800g, be mixed with the alcoholic solution of acrylic resin, chlorphenamine maleate 40g (the diligent pharmaceutcal corporation, Ltd in Jiangsu Province) is dispersed in the water of 200g, get the solution of chlorphenamine maleate, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 50g of 1% pectin (Sanmenxia Gorge richness reaches pectin Industrial Co., Ltd), and it is even to pour spray drying gained granule 50g into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of pectin parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose, adding water granulates, sieve, granulate is weighed, add 1% magnesium stearate of particle weight, tabletting promptly gets Chlo-Amine.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: to eliminate allergic symptom is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of Chlo-Amine group (by chlorphenamine maleate 4mg), each a slice of chewable tablet of common process preparation, specification 4mg, every day 3 times in continuous three days.
Table 9 curative effect situation
| Chlo-Amine group (50 example) | Chlorate group (50 example) | |
| Pollen hypersensitivity | 50 | 50 |
| Cure | 35 | 33 |
| Take a turn for the better | 9 | 5 |
| No change | 6 | 12 |
| Effective percentage | 88％ | 86％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 10 untoward reaction table
| Chlo-Amine group (50 example) | Chlorate group (50 example) | |
| Vomiting is felt sick | 0 | 25 |
| Feel all right | 49 | 1 |
| |
1 | 15 |
| The side reaction rate | 0％ | 50％ |
Conclusion 2: Chlorate and Chlo-Amine are taken the untoward reaction rate in the mode of chewing significance difference (p＜0.01).
Embodiment 6 (pseudoephedrine hydrochloride)
With No. 4 600g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 5000g, be mixed with the alcoholic solution of acrylic resin, pseudoephedrine hydrochloride 6000g (Chifeng Ecodipin Pharmaceutical Technology Co., Ltd) is dispersed in the water of 20000g, get the solution of pseudoephedrine hydrochloride, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 125-130 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 50g of 2% gelatin (Qinghai gelatin limited company), and it is even to pour spray drying 30g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of tragacanth parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose, adding water granulates, sieve, granulate is weighed, add 1% magnesium stearate of particle weight, tabletting promptly gets the pseudoephedrine hydrochloride chewable tablet.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: with Zhichuan is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of pseudoephedrine hydrochloride chewable tablet group (by pseudoephedrine hydrochloride 60mg), each a slice of chewable tablet of common process preparation, specification 60mg, every day 3 times in continuous two days.
Table 11 curative effect situation
| Pseudoephedrine hydrochloride chewable tablet group (50 example) | Pseudoephedrine hydrochloride sheet group (50 example) | |
| Heating | 50 | 50 |
| Cure | 40 | 38 |
| Take a turn for the better | 5 | 8 |
| No change | 5 | 4 |
| Effective percentage | 90％ | 88％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 12 untoward reaction table
| Pseudoephedrine hydrochloride chewable tablet group (50 example) | Pseudoephedrine hydrochloride sheet group (50 example) | |
| Be difficult to accept | 0 | 38 |
| Feel all right | 49 | 0 |
| |
1 | 15 |
| The side reaction rate | 0％ | 76％... |
Conclusion 2: pseudoephedrine hydrochloride sheet and pseudoephedrine hydrochloride chewable tablet are taken the untoward reaction rate in the mode of chewing significance difference (p＜0.01).
Embodiment 7 (ambroxol hydrochloride)
With No. 4 170g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 800g, be mixed with the alcoholic solution of acrylic resin, ambroxol hydrochloride 200g (Pharmaceutical Co Ltd, Changzhou Pharmaceutical Factory No.4) is dispersed in the water of 25g, get the solution of ambroxol hydrochloride, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 50g of 2% sodium alginate (ISP company), add the 1g sucralose dissolve mucilage, it is even to pour spray drying 40g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry detect moisture, sieve after qualified the granule of tragacanth parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose add water and granulate, and sieve, granulate, weigh, add 1% magnesium stearate of particle weight, tabletting promptly gets the ambroxol hydrochloride chewable tablet.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: to reduce phlegm is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of ambroxol hydrochloride chewable tablet group (by ambroxol hydrochloride 20mg), each a slice of chewable tablet of common process preparation, specification 20mg, every day 3 times in continuous two days.
Table 13 curative effect situation
| Ambroxol hydrochloride chewable tablet group (50 example) | Ambroxol hydrochloride sheet group (50 example) | |
| Reduce phlegm | 50 | 50 |
| Cure | 43 | 38 |
| Take a turn for the better | 4 | 10 |
| No change | 3 | 4 |
| Effective percentage | 94％ | 96％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 14 untoward reaction table
| Ambroxol hydrochloride chewable tablet group (50 example) | Ambroxol hydrochloride sheet group (50 example) | |
| Mouthfeel can not be accepted | 0 | 40 |
| Feel all right | 49 | 0 |
| Basic acceptance | 0 | 10 |
| The side reaction rate | 0％ | 70％ |
Conclusion 2: ambroxol hydrochloride sheet and ambroxol hydrochloride chewable tablet are taken the untoward reaction rate in the mode of chewing significance difference (p＜0.01).
Embodiment 8 (Bisolvon)
With No. 4 420g (Degussa companies of acrylic resin, Eudragit E-100) is dissolved in the dehydrated alcohol among the 1600g, be mixed with the alcoholic solution of acrylic resin, pure hydrochloric acid bromhexine 80g (Zhejiang Prov WanBang Pharmaceutical Co., Ltd) is dispersed in the water of 400g, get the solution of pure hydrochloric acid bromhexine, with two kinds of solution mix homogeneously, get solution.This solution enters spray drying instrument spray drying, and the adjusting rotating speed is 300HZ, and baking temperature is set at 115-120 degree centigrade, gets 60-120 order granule after the collection drying, sieves.Compound concentration is the aqueous solution 50g of 2% tragacanth (profit source, Shandong Industrial Co., Ltd.), and it is even to pour spray drying 50g gained granule into the mucilage dispersed with stirring, 55 degrees centigrade of oven dry, detect moisture, sieve after qualified the granule of tragacanth parcel, add filleies such as sucrose and lactose, sweeting agents such as sucralose, adding water granulates, sieve, granulate is weighed, add 1% magnesium stearate of particle weight, tabletting promptly gets pure hydrochloric acid bromhexine chewable tablet.
Packet conditions: adult men and women half and half, divide two groups every group 50 people, men and women half and half in the group.
Diagnostic criteria: with Zhichuan is treatment onset standard.
Administering mode: the mode of taking is swallowed after respectively granule and slice, thin piece being chewed in the oral cavity.
Administration time: took medicine oral three times of every day each a slice of pure hydrochloric acid bromhexine chewable tablet group (by pure hydrochloric acid bromhexine alcohol 8mg), each a slice of chewable tablet of common process preparation, specification 8mg, every day 3 times in continuous two days.
Table 15 curative effect situation
| Bisolvon chewable tablet group (50 example) | Bisolvon sheet group (50 example) | |
| Expectorant is arranged | 50 | 50 |
| Cure | 35 | 33 |
| Take a turn for the better | 9 | 10 |
| No change | 6 | 4 |
| Effective percentage | 88％ | 86％ |
1: two group of effective percentage of conclusion does not have significant difference (p＞0.01).
Table 16 untoward reaction table
| Bisolvon chewable tablet group (50 example) | Bisolvon sheet group (50 example) | |
| Vomiting is felt sick | 0 | 33 |
| Feel all right | 50 | 0 |
| Basic acceptance | 0 | 15 |
| The side reaction rate | 0％ | 66％ |
Conclusion 2:, Bisolvon sheet and Bisolvon chewable tablet are taken the untoward reaction rate in the mode of chewing that significance difference (p＜0.01) is arranged.
Claims (12)
1. unfavorable taste-masking drug granule, continuous polymer coating by nuclear core that comprises active component and nuclear core constitutes, it is characterized in that: its center core is made up of by 1: 0.5～1: 20 weight ratio active component and gastric solubleness acrylic resin, and coating material is the agent of water solublity rubber cement.
2. a kind of unfavorable taste-masking drug granule according to claim 1 is characterized in that: described active component is selected from one or more in the husky fourth ammonia of berberine, acetaminophen, phenylpropanolamine HC1, pseudoephedrine hydrochloride, phenylephrine hydrochloride, hydrochloric acid Pandryl, dextromethorphan hydrobromide, chlorphenamine maleate, hydrochloric acid bromine hexylamine, ambroxol hydrochloride and the sulphuric acid alcohol.
3. a kind of unfavorable taste-masking drug granule according to claim 1 is characterized in that: the gastric solubleness acrylic resin is No. 4, gastric solubleness acrylic resin.
4. a kind of unfavorable taste-masking drug granule according to claim 1 is characterized in that: the thickness of continuous polymer coating is generally 0.2～100 micron of micron on the described nuclear core.
5. a kind of unfavorable taste-masking drug granule according to claim 1 is characterized in that: described mucilage is selected from one or more in sesbania gum, his that glue, Ficus elastica, carbomer, Furcellaran, tragacanth, Resina persicae, sodium alginate, xanthan gum, gelatin, carbopol and the guaiac gum.
6. a kind of unfavorable taste-masking drug granule according to claim 1 is characterized in that: the particle diameter of described taste masked particle is 60～120 orders.
7. the chewable formulation of a bad mouthfeel medicine, by any one described unfavorable taste-masking drug granule in the claim 1 to 6 add pharmaceutics acceptable auxiliary routinely preparation process make.
8. the chewable formulation of a kind of bad mouthfeel medicine according to claim 7 is characterized in that: described pharmaceutics acceptable auxiliary comprises filler: be selected from one or more combination of lactose, sucrose, sorbitol, xylitol, glucose, calcium hydrogen phosphate, calcium phosphate, mannitol, fructose, starch, pregelatinized Starch, dextrin and sodium starch phosphate; Correctives: be selected from aspartame, saccharin sodium, acetyl and relax and put one or more the combination of potassium, sodium glutamate, sodium chloride, Herba Menthae, refrigerant alcohol, sodium carbonate, sodium citrate, ethyl maltol, stevioside; Lubricant: be selected from one or more combination of magnesium stearate, Pulvis Talci, silicon dioxide, glyceryl monostearate, PEG, sodium lauryl sulphate, sodium stearyl fumarate etc.; Essence: be selected from one or more combination of flavoring orange essence, grape essence, Fructus Citri Limoniae essence, flavoring pineapple essence, orange flavor, apple essence, plum flavour.
9. but the preparation technology of a bad mouthfeel medicine chewable formulation, it is characterized in that: No. 4, medicine and the acrylic resin weight ratio by 1: 0.5～1: 20 is dissolved in the solvent, carry out spray drying with the spray drying instrument, regulate rotating speed and baking temperature, the solution that makes medicine and acrylic resin is with spray drying method or rotary evaporation method solvent evaporated, collecting granules; The preparation mucilage; Mucilage is added in the granule, mix, 40-60 degree centigrade of oven dry in the baking oven according to the characteristics of prepared dosage form, can be adopted different screen cloth granulate, and the gained granule prepares different dosage form traditionally, comprises granule and chewable tablet.
10. but the preparation technology of a kind of bad mouthfeel medicine chewable formulation according to claim 9 is characterized in that: described solvent is the solvent of No. 4, acceptable solubilized acrylic resin pharmaceutically.
But 11. the preparation technology of a kind of bad mouthfeel medicine chewable formulation according to claim 9 is characterized in that: the concentration of described mucilage is 0.01%～30%
But 12. the preparation technology of a kind of bad mouthfeel medicine chewable formulation according to claim 9 is characterized in that: described spray-dired gained grain diameter is 60～120 orders.
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| CN101791297A (en) * | 2010-02-10 | 2010-08-04 | 中国药科大学 | Atorvastatin calcium oral disintegrating tablet and preparation method thereof |
| CN101810617A (en) * | 2010-04-17 | 2010-08-25 | 江西天施康中药股份有限公司 | Preparation method and quality test method of pseudoephedrine hydrochloride and dextromethorphan hydrobromide chewable tablets |
| CN102309562A (en) * | 2011-09-20 | 2012-01-11 | 江阴天江药业有限公司 | Preparation method of taste-masked suspension granules of Gegenqinlian decoction |
| CN102512377A (en) * | 2011-12-22 | 2012-06-27 | 杭州高成生物营养技术有限公司 | Tasteless quick-releasing berberine hydrochloride pellet |
| CN104490813A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Dextromethorphan hydrobromide composition chewable tablets and preparation method thereof |
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| CN101791297A (en) * | 2010-02-10 | 2010-08-04 | 中国药科大学 | Atorvastatin calcium oral disintegrating tablet and preparation method thereof |
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| CN101810617B (en) * | 2010-04-17 | 2011-08-31 | 江西天施康中药股份有限公司 | Preparation method and quality test method of pseudoephedrine hydrochloride and dextromethorphan hydrobromide chewable tablets |
| CN102309562A (en) * | 2011-09-20 | 2012-01-11 | 江阴天江药业有限公司 | Preparation method of taste-masked suspension granules of Gegenqinlian decoction |
| CN102512377A (en) * | 2011-12-22 | 2012-06-27 | 杭州高成生物营养技术有限公司 | Tasteless quick-releasing berberine hydrochloride pellet |
| CN104490813A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Dextromethorphan hydrobromide composition chewable tablets and preparation method thereof |
| CN104490807A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Ambroxol hydrochloride composition chewable tablet and preparation method thereof |
| CN104689322A (en) * | 2015-03-24 | 2015-06-10 | 北京化工大学 | Composition containing fluoxertine hydrochloride and enteric acrylic resin and preparation method thereof |
| CN105535147A (en) * | 2015-12-30 | 2016-05-04 | 广西壮族自治区花红药业股份有限公司 | Taste-improved Gegen Qinlian pills and preparation method |
| CN108273020A (en) * | 2018-03-05 | 2018-07-13 | 武汉市华本汇医药发展有限公司 | A kind of banxia xiexin decoction granule |
| CN108813167A (en) * | 2018-05-25 | 2018-11-16 | 成都大帝汉克生物科技有限公司 | A kind of composite sweetener and preparation method thereof with reduction diarrhea |
| CN109432291A (en) * | 2018-11-28 | 2019-03-08 | 哈尔滨新海德智能环境工程有限公司 | A kind of Chinese medicine chronic disease sustained release conditioning chewing granulate |
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Open date: 20070711 |