CN109925289A - Desloratadine dispersible tablet - Google Patents
Desloratadine dispersible tablet Download PDFInfo
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- CN109925289A CN109925289A CN201910287897.3A CN201910287897A CN109925289A CN 109925289 A CN109925289 A CN 109925289A CN 201910287897 A CN201910287897 A CN 201910287897A CN 109925289 A CN109925289 A CN 109925289A
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- desloratadine
- solid acid
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- cornstarch
- dispersible tablet
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Abstract
The present invention provides a kind of Desloratadine dispersible tablet, add grain and additional material forms by interior, it is described in add the Desloratadine and solid acid that grain includes melting mixing, include pectin in additional material.
Description
Technical field
The invention belongs to antiallergics and pharmaceutical arts, specifically, the present invention provides a kind of Desloratadine dispersible tablet,
It adds grain and additional material forms by interior, it is described in add the Desloratadine and solid acid that grain includes melting mixing, it is additional
It include pectin in material.
Background technique
Loratadine (Loratadine), the entitled 4- of chemistry (chloro- 5,6- dihydro -11H- benzo [5, the 6]-cycloheptyl of 8- simultaneously [1,
2-b] pyridine -11- alkenyl) -1- piperidine carboxylate, molecular formula C22H23ClN2O2, molecular weight 382.89, appearance is white or close
Like the crystalline powder of white, odorless is 133-137 degrees Celsius of fusing point, almost insoluble in water, the slightly soluble in hydrochloric acid solution,
It is soluble in ethyl alcohol, methanol and acetone and other organic solvent, the active metabolite of Loratadine in vivo is Desloratadine.
Loratadine belongs to second generation histamine H 1- receptor antagonist, and the effect of selective confrontation peripheral acceptor is faced
Bed is usually used in the treatment of allergic dermatitis, allergic conjunctivitis, allergic rhinitis, pollinosis and nettle rash etc..Loratadine exists
While overcoming drowsiness effect caused by first generation antihistamine nervous centralis inhibits, there is curative effect height, rapid-action, effect
By force, the characteristics of no tolerance, no obvious adverse reaction.The Loratadine dosage form of domestic listing includes enteric coated tablet, oral cavity at present
Disintegrated tablet, syrup, suspension, capsule etc..It is especially the dissolubility in non-strongly acidic solution due to the solubility property of Loratadine
Can be bad, the Loratadine of various dosage forms is to improve dissolving out capability and its bioavilability as main purpose of design.Chlorine thunder he
Stator agent has had multiple kinds on sale on the market, and improvement direction is still to its bioavilability, especially gastric acid not
The further improvement of bioavilability in the patient of foot.
Summary of the invention
In view of the above-mentioned problems, applicant attempts Desloratadine and suitable solid acid melting mixing, for ground chlorine thunder he
Fixed dissolution/suitable the acidic environment of dissolution manufacture, and it is being aided with suitable pectin and cornstarch outside plus in material, with cooperation
Dissolved malic acid increases drug containing partial cohesive and forms the small gelatin object in part even to improve drug in alimentary canal
It is residence time, final to realize the dissolution/dissolution for improving Desloratadine and then the effect for improving its bioavilability.Utilize the original
Grain and corresponding high biology are added in reason applicants have invented a kind of Desloratadine and solid acid including melting mixing
Availability Desloratadine dispersible tablet.
On the one hand, this application provides a kind of Desloratadine dispersible tablet, grain is added and additional material forms, institute by interior
The Desloratadine and solid acid that grain includes melting mixing are added in stating.
Further, the solid acid is malic acid.
Further, Desloratadine that grain includes melting mixing is added in described and solid acid, calcium monohydrogen phosphate, corn form sediment
Powder, it is described in when adding grain preparation using purifying aqueous solvent, ground chlorine thunder in the Desloratadine and solid acid of the melting mixing
His fixed and solid acid weight ratio is 1:0.5-2.
Further, 4.55%, phosphoric acid hydrogen is accounted for by the Desloratadine and solid acid of dispersible tablet total weight melting mixing
Calcium accounts for 48.18%, cornstarch and accounts for 1.36%, Desloratadine and solid in the Desloratadine and solid acid of the melting mixing
Body acid weight ratio is 1:1.
Further, additional material includes microcrystalline cellulose, pectin, talcum powder, cornstarch, carboxyrnethyl starch sodium, tristearin
Sour magnesium.
Further, the Desloratadine dispersible tablet is interior by weight adds the Desloratadine that grain includes melting mixing
With solid acid 4.55%, calcium monohydrogen phosphate 48.18%, cornstarch 1.36%, additional material include microcrystalline cellulose 36.20%,
Pectin 3.55%, talcum powder 2.73%, cornstarch 1.82%, carboxyrnethyl starch sodium 0.91%, magnesium stearate 0.70%.
On the other hand, this application provides the preparation methods of above-mentioned Desloratadine oral disnitegration tablet, including by ground chlorine thunder
His fixed and solid acid is 130-155 degrees Celsius lower melting mixing 5-15 minutes the step of.
Further, the preparation method of above-mentioned Desloratadine oral disnitegration tablet, comprising:
(1) the desired amount of various composition is weighed, Desloratadine is sieved with 100 mesh sieve, calcium monohydrogen phosphate crosses 200 meshes, talcum
Powder crosses 1250 meshes；
(2) it is heated to melting under 155 degrees Celsius after mixing Desloratadine and malic acid, molten condition 5 is maintained to divide
Clock；
(3) cornstarch of slightly more than theoretical amount is dispersed in cold water and is stirred, it is Celsius to reach 70 to aqueous temperature
Start timing when spending, persistently stir 30 minutes or more, it needs to add the moisture of loss after the completion of mashing off, is reduced to 75-80 to temperature
Spare after degree Celsius, cornstarch solid content is 8.0%；
(3) Desloratadine and malic acid of calcium monohydrogen phosphate and melting mixing are put into wet granulation pot together, is stirred
60rpm is mixed, 1500rpm is cut, operation is shut down after five minutes, and adjusting liquid feeding tank air pressure is 0.4Mpa, to corn starch liquid full of pipe
It is added in the form of whitewashing behind road, to shutting down after 8 minutes, wet granular crosses 8 × 8mm pelletizing machine whole grain for operation；
(4) it is arranged 70 degrees Celsius of inlet air temperature, 60 degrees Celsius of temperature of charge, starts when temperature of charge reaches 40 degrees Celsius
105 degrees Celsius of sample detection processing, 10 minutes losss on drying, when loss on drying≤3.0%, stop drying；
(5) by the sieve whole grain in the dry particl aperture 0.65mm, setting revolving speed is 470-530rpm；
(6) dry particl and microcrystalline cellulose, pectin, talcum powder, cornstarch and carboxyrnethyl starch sodium are pre-mixed, if
Setting revolving speed is 10rpm, is run 20 minutes, adds magnesium stearate and runs 5 minutes, shuts down discharging；
(7) tabletting.
On the other hand, this application provides a kind of drug containing particles treats nettle rash, pruritus dermatopathy, anaphylaxis in preparation
Skin disease, allergic rhinitis drug in application, the drug containing particle includes the Desloratadine and solid acid of melting mixing
8.4%, calcium monohydrogen phosphate 89.1%, cornstarch 2.5%, in the Desloratadine and solid acid of the melting mixing chlorine thunder he
Fixed and solid acid weight ratio is 1:1, and purifying aqueous solvent is used when prepared by the drug containing particle.
Desloratadine dispersible tablet/drug containing particle of the application can be used for treating various Loratadine/Desloratadines
Know/treatable disease to be found, including but not limited to nettle rash, pruritus dermatopathy, anaphylaxis dermatosis, anaphylaxis
The drug of above-mentioned disease is treated in rhinitis or preparation.
Its in the Desloratadine dispersible tablet of the application in addition to the Desloratadine of melting mixing, solid acid and pectin
His ingredient and solvent, including but not limited to microcrystalline cellulose, pectin, talcum powder, cornstarch, carboxyrnethyl starch sodium, magnesium stearate,
Calcium monohydrogen phosphate, cornstarch, purified water can select other classes according to the common sense and simple experiment of art of pharmacy technical staff
Replace like the excipient or solvent of performance, various excipient and solvent can select each producer commercial product or manufacturer from
Product processed.
In addition to oral disnitegration tablet, the drug containing particle of the application can be used for preparing other Desloratadine dosage forms, including
But be not limited to oral preparations such as dispersible tablet, enteric coatel tablets, dry suspensoid agent, suspension, syrup, external preparation for example spray, plastics,
Creme, paste, patch.
Specific embodiment
Main agents:
Desloratadine: Hainan Puli Pharmacy stock Co., Ltd production；
Malic acid: Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.；
Microcrystalline cellulose, pectin, talcum powder, cornstarch, carboxyrnethyl starch sodium, magnesium stearate, calcium monohydrogen phosphate, corn form sediment
Powder: limited by Anhui Shanhe Medicinal Subsidiary Material Co., Ltd., Lianyun Harbour De Bang Fine Chemical Co., Ltd, Huzhou prospect medicine company
The production such as company, the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI, JRS.
The preparation of 1 Desloratadine dispersible tablet of embodiment.
Formula 1
Inside add grain: Desloratadine and malic acid 4.55% (Desloratadine and the malic acid ratio of melting mixing
1:1), calcium monohydrogen phosphate 48.18%, cornstarch 1.36%
Additional material: microcrystalline cellulose 36.20%, pectin 3.55%, talcum powder 2.73%, cornstarch 1.82%, carboxylic
First sodium starch 0.91%, magnesium stearate 0.70%.
Formula 2
Inside add grain: Desloratadine and malic acid 4.55% (Desloratadine and the malic acid ratio of melting mixing
1:1), calcium monohydrogen phosphate 48.18%, cornstarch 1.36%
Additional material: microcrystalline cellulose 39.75%, talcum powder 2.73%, cornstarch 1.82%, carboxyrnethyl starch sodium
0.91%, magnesium stearate 0.70%.
Comparative formula
Inside add grain: Desloratadine 7.45%, calcium monohydrogen phosphate 48.18%, cornstarch 1.36%
Additional material: microcrystalline cellulose 39.75%, talcum powder 4.63%, cornstarch 2.82%, carboxyrnethyl starch sodium
0.91%, magnesium stearate 0.70%.
Preparation process are as follows:
(1) the desired amount of various composition is weighed, Desloratadine is sieved with 100 mesh sieve, calcium monohydrogen phosphate crosses 200 meshes, talcum
Powder crosses 1250 meshes；
(2) it is heated to melting under 155 degrees Celsius after mixing Desloratadine and malic acid, molten condition 5 is maintained to divide
Clock (formula 1 and 2)/without melting mixing step (comparative formula)；
(3) cornstarch of slightly more than theoretical amount is dispersed in cold water and is stirred, it is Celsius to reach 70 to aqueous temperature
Start timing when spending, persistently stir 30 minutes or more, it needs to add the moisture of loss after the completion of mashing off, is reduced to 75-80 to temperature
Spare after degree Celsius, cornstarch solid content is 8.0%；
(3) Desloratadine and malic acid of calcium monohydrogen phosphate and melting mixing are put into wet granulation pot together, is stirred
60rpm is mixed, 1500rpm is cut, operation is shut down after five minutes, and adjusting liquid feeding tank air pressure is 0.4Mpa, to corn starch liquid full of pipe
It is added in the form of whitewashing behind road, to shutting down after 8 minutes, wet granular crosses 8 × 8mm pelletizing machine whole grain for operation；
(4) it is arranged 70 degrees Celsius of inlet air temperature, 60 degrees Celsius of temperature of charge, starts when temperature of charge reaches 40 degrees Celsius
105 degrees Celsius of sample detection processing, 10 minutes losss on drying, when loss on drying≤3.0%, stop drying；
(5) by the sieve whole grain in the dry particl aperture 0.65mm, setting revolving speed is 470-530rpm；
(6) dry particl and microcrystalline cellulose, pectin, talcum powder, cornstarch and carboxyrnethyl starch sodium are pre-mixed, if
Setting revolving speed is 10rpm, is run 20 minutes, adds magnesium stearate and runs 5 minutes, shuts down discharging；
(7) tabletting.
Dispersible tablet every of preparation is 5 milligrams containing Desloratadine.
Rotary pelleting machine used in preparation is produced by Guangzhou Jin Ben mechanical equipment Co., Ltd, YC-9；；Mixing machine is by normal
Rise in river dry Engineering Co., Ltd's production, SYH-1000 in state city；Wet granulator (not indicating special model) is by the auspicious nation's system in Nanjing
The production of medicine equipment Co., Ltd.
The stability of 2 Desloratadine dispersible tablet of embodiment
Hot conditions: it is placed in 60 degrees Celsius of insulating boxs；
Super-humid conditions: being placed in 25 degrees Celsius, under 90% humidity；
Intense light conditions: under the illumination condition of 5000Lx
Assay: referring to Chinese Pharmacopoeia 2010 version second, annex VD and the " bioavilability of Desloratadine
The HPLC method of research " part: 1100 high performance liquid chromatograph system of Agilent, Agilent C18 column (4.6mm × 150mm, 5 are used
μm)；Mobile phase is acetonitrile: 20 mM/ls of ammonium acetate buffers: 1% formic acid 80:20:3, flow velocity: 0.5 ml/min, column
20 degrees Celsius of temperature, Detection wavelength 247nm.
It carries out Desloratadine dissolution with reference to Chinese Pharmacopoeia (method of 2010 editions second annex XC) to test: 500 milliliters
Dissolution medium, when 5,10,15,30 minutes, takes 5 milliliters of solution (adding equivalent dissolution medium) by 50 revs/min, and filtration takes filter
Liquid HPLC detection；It is appropriate to weigh the dry Desloratadine reference substance to constant weight, adds dissolution medium to dissolve and be quantitatively diluted to and contains
The solution of 10 mcg/ml of Loratadine is as reference substance.Digestion instrument is raw for Tianjin extremely big Tian Fa development in science and technology Co., Ltd
It produces.
As a result as shown in the table:
*Appearance is off-white color tablet appearance, without obvious spot or abnormal conditions.
Experiment shows that the dispersible tablet piece of formula 1,2 and comparative formula remains to accord with after high temperature and humidity intense light conditions 15 days
The requirement that pharmacopeia impurity summation is less than or equal to 1.0% is closed, dissolving out capability is not substantially change.It is tested by further long-term preservation
With can be used for actual production after accelerated aging tests.
The high pH of 2 Desloratadine dispersible tablet of embodiment dissolves out experiment
HPLC method, dissolution measuring method and instrument are tested three times with " stability of Desloratadine dispersible tablet " part
It is averaged.
Dissolution experimental result see the table below shown:
Result of extraction in the PBS buffer solution of pH 4.5
| Sample | 5 minutes (%) | 10 minutes (%) | 20 minutes (%) | 30 minutes (%) |
| Formula 1 | 94.9 | 96.3 | 99.7 | 100.1 |
| Formula 2 | 94.7 | 95.9 | 99.5 | 100.3 |
| Comparative formula | 60.2 | 65.7 | 70.5 | 72.9 |
Result of extraction in the pure water of pH 6.7
| Sample | 5 minutes (%) | 10 minutes (%) | 20 minutes (%) | 30 minutes (%) |
| Formula 1 | 60.9 | 67.2 | 74.8 | 90.1 |
| Formula 2 | 59.3 | 65.2 | 71.0 | 86.5 |
| Comparative formula | 38.2 | 44.4 | 54.7 | 61.3 |
Above data shows that dissolving out capability is significantly better than comparative formula to formula 1 and 2 at a high ph, especially in pH 4.5
Dissolving out capability in buffer has basically reached general dissolution of the Loratadine tablet in the simulated gastric fluid of pH2 in document report
Ability (substantially all dissolution in 10 minutes), in pure water, dissolving out capability is also substantially better than comparative formula.By Desloratadine
The acidic environment created with suitable fixed acid melting mixing can significantly improve dissolution/result of extraction of Desloratadine.In addition,
When formula 1 is dissolved out and tested, visible micro gelatin/cotton-shaped clast in instrument edge, becomes apparent from pure water.
The bioavailability study of 3 Desloratadine dispersible tablet of embodiment
According to document (Xu Xiaojie etc., " the HPLC fluorescence detection and bioequivalence Journal of Sex Research of Loratadine blood concentration ",
Acta Pharmaceutica Sinica, 2004, volume 39, the 2nd phase and its citation) record and applicant researcher practice, due to
The difference of P450 enzyme system, there are great differences between individuals for Loratadine medicine dynamic characteristic and bioavilability, therefore its medicine
It is not appropriate for for the small sample amount Primary Study of dynamics and bioavilability using statistical method.Applicant is studying this Shen
Please Loratadine dosage form medicine dynamic characteristic and bioavilability compared with other similar dosage form when, use in identical aspiration
The mode compared in person.The bioequivalence of more large sample size is tested after determining formula just in the tissue.
Subject
3 trial volunteers (male 2, age 26,28 years old, weight 69.9kg, 76.1kg of collection；Female 1, the age 27
Year, weight 62.1kg).Subject confirms the heart, liver, normal pulmonary function through routine physical examination, and main related blood biochemical indexes are normal, nothing
Major disease or medical history.Other drugs were not used in tested first 1 month, tested period ensures without using any drug and health care
Product, and no smoking and drinking.
Experimental program
After subject's fasting 12 hours, the Desloratadine dispersion of the formula 1 of the application is taken between early 7:00-8:00
Piece 2 (effective component 10mg).Administration before and administration after 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,
24,36 hours forearm vein blood 3mL are placed in anticoagulant blood-collecting pipe, and 3000 turns of 15 minutes separated plasmas of centrifugation are stored in subzero 20 and take the photograph
In family name's degree refrigerator, as analysis sample.
After last time takes blood, subject passes through drug removing phase on the 10th, again after fasting 12 hours, early 7:00-8:
The formula 2 (1) of the application and 2 (effective components of Desloratadine dispersible tablet of comparative formula (2) are taken between 00
10mg).Administration before and administration after 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36 hour forearm
Venous blood 3mL is placed in anticoagulant blood-collecting pipe, and 3000 turns of 15 minutes separated plasmas of centrifugation are stored in subzero 20 degrees Celsius of refrigerators, is made
To analyze sample.
As subject during drug removing phase illness or use drug, then terminate the experiment of the subject, no longer adopt
Its result (being originally 4 subjects, wherein having one because heavy cold does not complete experiment, data are not included in scheme).
Sample treatment
It is drawn in 0.5 milliliter of addition test tube of blood plasma when analysis, the Clozapine inner mark solution 20 that 1.25 mcg/mls are added is micro-
It rises, is uniformly mixed.3 milliliters of ether are added, are uniformly mixed, are centrifuged 5000 turns 10 minutes, takes in ether layer vacuum oven and dries extremely
It is dry, 0.2 milliliter of mobile phase dissolved residue is added, is uniformly mixed, 4000 turns of centrifugation 15 minutes, take 50 microlitres of supernatant for then
Liquid matter join analysis.
Liquid matter connection analysis blood concentration and data processing
Use 1100 high performance liquid chromatograph system of Agilent, Agilent LC/MSD Trap XCT mass spectrograph.
Chromatographic column: Agilent C18 column (4.6mm × 150mm, 5 μm)；Mobile phase is acetonitrile: 20 mM/ls of ammonium acetates are slow
Fliud flushing: 1% formic acid 80:20:3, flow velocity: 0.5 ml/min, 20 degrees Celsius of column temperature ().
Mass spectrum: ESI ion source, Mass Spectrometry Conditions: positively ionized (Clozapine 327 → 270, Desloratadine 311 → 259),
4000 kilovolts of capillary voltage, 30 pounds/square inch of atomization gas pressure, dry 350 degrees Celsius of temperature degree, 8 liters of dry gas stream amount/
Minute.
The blood concentration of acquisition carries out two chamber models fittings using PKS program and calculates pharmacokinetic parameter, and AUC makes
It is calculated with trapezoidal method.
Experimental result
PRELIMINARY RESULTS shows that the bioavilability of the application formula 1 is substantially better than comparative formula (AUC numerical value is close to 2 times),
In the case where dissolving out capability is similar, also it is apparently higher than formula 2 (AUC numerical value is close to 1.3 times).It is observed in conjunction with dissolving out in experiment
The phenomenon that, this should be dissolved malic acid and pectin and cornstarch has an effect and increases drug containing partial cohesive even formation office
Portion small gelatin object improves residence time of the drug in alimentary canal, most ends and improves the biological utilisation of Desloratadine
Degree.
Claims (9)
1. a kind of Desloratadine dispersible tablet, add grain and additional material forms by interior, it is described in add grain include that melting is mixed
The Desloratadine and solid acid of conjunction.
2. Desloratadine dispersible tablet according to claim 1, wherein the solid acid is malic acid.
3. the Desloratadine dispersible tablet of any one of claims 1 or 2, wherein adding the ground chlorine that grain includes melting mixing in described
Lei Tading and solid acid, calcium monohydrogen phosphate, cornstarch, interior add use purifying aqueous solvent when prepared by grain, the melting mixes
Desloratadine and solid acid weight ratio are 1:0.5-2 in the Desloratadine and solid acid of conjunction.
4. Desloratadine dispersible tablet according to claim 3, wherein by dispersible tablet total weight melting mixing ground chlorine thunder he
Fixed and solid acid, which accounts for 4.55%, calcium monohydrogen phosphate and accounts for 48.18%, cornstarch, accounts for 1.36%, the Desloratadine of the melting mixing with
Desloratadine and solid acid weight ratio are 1:1 in solid acid.
5. any one of -4 Desloratadine dispersible tablet according to claim 1, wherein additional material includes microcrystalline cellulose, fruit
Glue, talcum powder, cornstarch, carboxyrnethyl starch sodium, magnesium stearate.
6. Desloratadine dispersible tablet according to claim 5, the Desloratadine dispersible tablet is interior by weight to add grain packet
The Desloratadine and solid acid 4.55%, calcium monohydrogen phosphate 48.18%, cornstarch 1.36%, additional material for including melting mixing include
Microcrystalline cellulose 36.20%, pectin 3.55%, talcum powder 2.73%, cornstarch 1.82%, carboxyrnethyl starch sodium 0.91%, magnesium stearate
0.70%。
7. any one of -6 Desloratadine disperses piece preparation method according to claim 1, including by Desloratadine and solid
Acid is 130-155 degrees Celsius lower melting mixing 5-15 minutes the step of.
8. preparation method according to claim 7, comprising:
(1) the desired amount of various composition is weighed, Desloratadine is sieved with 100 mesh sieve, calcium monohydrogen phosphate crosses 200 meshes, talcum powder mistake
1250 meshes；
(2) it is heated to melting under 155 degrees Celsius after mixing Desloratadine and malic acid, maintain molten condition 5 minutes；
(3) cornstarch of slightly more than theoretical amount is dispersed in cold water and is stirred, when aqueous temperature reaches 70 degrees Celsius
Start timing, persistently stir 30 minutes or more, it needs to add the moisture of loss after the completion of mashing off, it is Celsius to be reduced to 75-80 to temperature
Spare after degree, cornstarch solid content is 8.0%；
(3) Desloratadine and malic acid of calcium monohydrogen phosphate and melting mixing are put into wet granulation pot together, is stirred
60rpm cuts 1500rpm, and operation is shut down after five minutes, and adjusting liquid feeding tank air pressure is 0.4Mpa, is full of pipeline to corn starch liquid
It is added in the form of whitewashing afterwards, to shutting down after 8 minutes, wet granular crosses 8 × 8mm pelletizing machine whole grain for operation；
(4) it is arranged 70 degrees Celsius of inlet air temperature, 60 degrees Celsius of temperature of charge, starts to sample when temperature of charge reaches 40 degrees Celsius
Detect 105 degrees Celsius of processing, 10 minutes losss on drying, when loss on drying≤3.0% stops drying；
(5) by the sieve whole grain in the dry particl aperture 0.65mm, setting revolving speed is 470-530rpm；
(6) dry particl and microcrystalline cellulose, pectin, talcum powder, cornstarch and carboxyrnethyl starch sodium are pre-mixed, setting turns
Speed is 10rpm, is run 20 minutes, adds magnesium stearate and runs 5 minutes, shuts down discharging；
(7) tabletting.
9. the drug that a kind of drug containing particle treats nettle rash, pruritus dermatopathy, anaphylaxis dermatosis, allergic rhinitis in preparation
In application, the drug containing particle includes the Desloratadine and solid acid 8.4%, calcium monohydrogen phosphate 89.1%, corn of melting mixing
Starch 2.5%, Desloratadine and solid acid weight ratio are 1:1 in the Desloratadine and solid acid of the melting mixing, described
Purifying aqueous solvent is used when prepared by drug containing particle.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113230235A (en) * | 2021-04-15 | 2021-08-10 | 海南普利制药股份有限公司 | Compound sustained-release capsule containing desloratadine and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113230235A (en) * | 2021-04-15 | 2021-08-10 | 海南普利制药股份有限公司 | Compound sustained-release capsule containing desloratadine and preparation method thereof |
| CN113230235B (en) * | 2021-04-15 | 2022-11-11 | 海南普利制药股份有限公司 | Compound sustained-release capsule containing desloratadine and preparation method thereof |
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