CN1634059A - Pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleates gel formulation and its preparing process - Google Patents

Pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleates gel formulation and its preparing process Download PDF

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Publication number
CN1634059A
CN1634059A CN 200410040848 CN200410040848A CN1634059A CN 1634059 A CN1634059 A CN 1634059A CN 200410040848 CN200410040848 CN 200410040848 CN 200410040848 A CN200410040848 A CN 200410040848A CN 1634059 A CN1634059 A CN 1634059A
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pseudoephedrine hydrochloride
dextromethorphan hydrobromide
preparation
gel
beta
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于文勇
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Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
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Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
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Abstract

The invention relates to a pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleates gel formulation and its preparing process, which is prepared from chlorpheniramine maleate, d-pesudoephedrine hydrochloride, Dextromethorphan Hydrobromide, and right amount of base material. The preparation is in the form of gel type oral form, children are willing to take the preparation, the preparation has good effects for controlling children's virus infection of upper respiratory tract and treating children's common cold.

Description

Pseudoephedrine hydrochloride gel preparation and preparation method thereof
Technical field: the present invention is a kind of pseudoephedrine hydrochloride gel preparation and preparation method thereof, belongs to the technical field of medicine.
Technical background: flu also claims acute upper respiratory tract infection, is commonly encountered diseases and the frequently-occurring disease that influences human health.Cold virus has nearly 200 kinds, and children's is because health defensive enginery immaturity also, and a little less than the resistance against diseases, so that all must catch 6-7 time every year, Kai Fa children coryza medicine kind increases gradually in recent years, and dosage form is different; As: disclosed number of patent application is " 02110056 " in the Chinese patent communique, patent application, number of patent application that name is called " Rationed fenmameimin drops " are called the patent application of " U.S.A pounces on pseudo-numb dry suspension and processing technology " for " 00136032 ", name; They all are to be used for active drug that infantile common cold is prevented and treated; But antihistamine composition acetaminophen has all been used in two parts of applications, is with the most use, the most general anti-flu composition, and still long-term or large dose oral administration can cause hepatic injury, needs prudent when the child uses.And the product that has gone on the market: pseudoephedrine hydrochloride solution, the secretions drying and the thickness that make lower respiratory tract have been adopted, reduce the chlorphenamine maleate of sneeze and secretion Rhinorrhea, selectivity shrinks the pseudoephedrine hydrochloride of upper respiratory tract blood capillary, the dextromethorphan hydrobromide of maincenter antitussive effect, though product has good antipyretic-antalgic, antitussive, alleviate the congested curative effect of nasal mucosa, but be dosage form kind at the children characteristics, infant uses existing product that certain difficulty is arranged, displeased acceptance, particularly for some little infants, the head of a family takes to advise and feeds, the method that pressure is fed causes the child to dislike easily; The patent application that name is called " Rationed fenmameimin drops " has in fact solved the inaccurate practical problem of the amount of feeding; Utilize it can determine to drip the amount of feeding, but still can not change the situation that the child is unwilling to accept; In the real life, child patient quantity is huge, and is poor to the ability to accept of general formulation, and the outward appearance of medicine, mouthfeel directly influence the application and the curative effect of medicine; Infantile common cold is a kind of commonly encountered diseases that has a strong impact on child health, the dosage form of selecting suitable prescription control children's upper respiratory tract viral infection and being suitable for child administration is setting about a little of research and development children coryza medicine, in view of the develop rapidly of medical science and these situations that deepen continuously that cold virus is studied, need exploitation effective medicine preparation that a kind of market prospect is wide, the child takes like a shot, the treatment of infantile common cold is reached a new high, thereby infantile common cold patient's quality of life is further improved.
Summary of the invention: the objective of the invention is to: a kind of pseudoephedrine hydrochloride gel preparation and preparation method thereof is provided; The present invention is directed to prior art, we are made fruit jelly or the soft sweet type gel that liked by the child, children's extremely is ready to take, having reduced the adult advises and feeds or force to drip a trouble of feeding, not only tasty, dosage is accurate, and therapeutical effect is good, has enriched the dosage form kind, and market prospect is very wide; And, select feasible substrate and technology rationally, product appearance, good mouthfeel at the pharmaceutical properties of dextromethorphan hydrobromide.
The present invention constitutes like this: calculate according to weight, it is made into fruit jelly or soft sweet type gel oral formulations by chlorphenamine maleate 10~25mg, pseudoephedrine hydrochloride 200~400mg, dextromethorphan hydrobromide 50~150mg and an amount of substrate, and wherein: substrate can be animal glue, plant gum, microbiological gum, alginate jelly, chemical modification glue or compound gel.It can also be prepared into: injection comprises: injection, powder pin, freeze-dried powder, dispersible tablet, soft capsule, drop pill, slow releasing preparation.Pseudoephedrine hydrochloride gel preparation of the present invention, it is characterized in that: the gel preparation that the substrate that it is mixed to obtain by 1: 2 part by weight by chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg and k-carrageenan, ι-carrageenan is prepared into is semifluid or solid gel shape.The preparation method of pseudoephedrine hydrochloride gel preparation of the present invention is: will chlorphenamine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide be added to mix homogeneously in the substrate for preparing, after the sterilization promptly.
The preparation method of pseudoephedrine hydrochloride gel preparation of the present invention is: the gel in the described preparation prepares like this: by beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 1 hour, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; K-carrageenan, ι-carrageenan are pressed 1: 2 part by weight mix homogeneously, under stirring condition, 0.5% mixed-matrix is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying, promptly.
Compared with prior art, the application makes we fruit jelly or the soft sweet type gel that liked by the child, children's extremely is ready to take, having reduced the adult advises and feeds or to force to drip trouble, the dosage of feeding accurate, tasty, flu function well for control children's upper respiratory tract viral infection, treatment children's, enriched the dosage form kind, market prospect is very wide.
The applicant finds in development process, the easy moisture absorption of dextromethorphan hydrobromide, and mouthfeel is extremely bitter; And the kind of gel-type vehicle and consumption have played crucial effects to outward appearance, stability, the curative effect of product; As a kind of novel form, the release of medicine, to absorb whether desirable, gelling be key problem in technology problem of the present invention.The applicant has carried out a series of experiments, adopts beta-schardinger dextrin-: 3: 1 part by weight of acetaminophen, 3 hours mixing time, and 40 ℃ temperature, the parcel dextromethorphan hydrobromide has improved taste of medicine, stability greatly; Adopt beta-carrageenin, ι-carrageenan by 1: 2 the composite substrate of weight ratio, the product stability that makes, gel strength ideal, outward appearance is good, selects the supplementary product kind of preparation technology, use of pharmaceutical preparation provided by the invention and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.
Experimental example 1: dextromethorphan hydrobromide clathrate technical study
(1) clathrate technical study
Group medicine: beta-schardinger dextrin-mixing time enclose temperature ℃ clathrate weight g clathrate content %
1 1∶8 6 50 6.40 11.4
2 1∶8 6 40 6.17 9.5
3 1∶8 6 30 5.31 8.9
4 1∶6 3 40 7.35 21.3
5 1∶6 3 30 7.33 16.7
6 1∶6 3 50 8.02 14.4
7 1∶3 1 30 10.22 37.5
8 1∶3 1 50 10.15 30.1
9 1∶3 1 40 10.38 39.3
The result shows that the clathrate optimum process condition of preparation is: beta-schardinger dextrin-: 3: 1 part by weight of acetaminophen, 1 hour mixing time, 40 ℃ temperature.
(2) study on the stability
Experimental condition dextromethorphan hydrobromide content (%)
0d 1d 3d 5d 10d
40℃ 101.5 101.5 101.4 101.4 101.4
60℃ 101.5 101.5 101.6 101.4 101.3
80℃ 101.5 101.4 101.6 100.9 100.9
Relative humidity 75% 101.5 101.5 101.4 101.3 101.2
Relative humidity 92.5% 101.5 101.2 101.5 100.9 100.8
Illumination 101.5 101.4 101.2 101.3 100.9
Naturally place 101.5 101.5 101.5 101.5 101.8
The result shows: after cyclodextrin and medicine formed clathrate, the physicochemical property of dextromethorphan hydrobromide changed to some extent, suppressed hydrolysis, oxidation, had improved preparation stability.
Experimental example 2: Study on Forming
(1) selection of matrix species
The ambroxol hydrochloride gel clarity of gel relatively
Substrates quantity % gelling properties
Agar 0.8 poor flexibility
Gelatin 0.8 solidifies, melting point is low
K-carrageenan the last 0.8 and crisp, easily syneresis
ι-carrageenan 0.8 elasticity is poor slightly, can syneresis
K-carrageenan+ι-carrageenan 0.8 good springiness is difficult for syneresis
(2) screening of substrate composition and consumption
K-carrageenan: ι-carrageenan consumption % mouthfeel
1: 1 0.5 crisp, difference of hardness, poor toughness, no bite
1: 1 0.8 crisp, difference of hardness, poor toughness, no bite
1: 1 1.0 crisp, difference of hardness, poor toughness, no bite
Hardness was moderate in 1: 2 0.5, and tough good springiness has bite
Hardness was big in 1: 2 0.8, and tough elasticity has bite
Hardness was big in 1: 2 1.0, and tough elasticity is strong
Hardness was big in 1: 3 0.5, and tough elasticity is strong
Hardness was big in 1: 3 0.8, and tough elasticity is strong
Hardness was big in 1: 3 1.0, and tough elasticity is strong
The result shows: gelatin solidifies, melting point is low, and storage and preparation are all difficult; Agar poor flexibility, price are also more expensive;
ι-carrageenan is a kind of good water binding agent, but elasticity is poor slightly, is used the elasticity that can improve gel with the k-carrageenan; The best composite condition of substrate is the k-carrageenan: the part by weight of ι-carrageenan=1: 2, consumption is 0.5%.
Experimental example 3: pharmacodynamic experiment
(1) experimentation of antipyretic effect
The experiment material animal: healthy New Zealand large ear rabbit, body weight (2.4 ± 0.3) kg, male and female have concurrently; Medicine: medicine A: according to method preparation of the present invention, medicine B: pseudoephedrine hydrochloride solution; Instrument: computer numeral clinical thermometer.
Experimental technique: get 24 of health large ear rabbits, 3d before the experiment, at room temperature 22-25 ℃, humidity is that every interval was surveyed animal anus temperature in 1 hour 1 time totally 4 times under the 55%-65% ventilated environment, animal is adapted to, and the animal of selection body temperature fluctuation range in 0.4 ℃ of scope is standby.During experiment animal is divided into 4 groups at random by the body weight size, is respectively normal saline group, A group, B group.Survey rabbit anus temperature 1 time every 30min with the computer digital clinical thermometer, survey altogether 3 times, ask for its meansigma methods and be this animal basal body temperature.Press 1ml/kg administration rabbit ear edge intravenous injection deactivation escherichia coli pyrogenicity, and before pyrogenicity 30 minutes gastric infusions at twice after 30min and the pyrogenicity.After pyrogenicity 30,60,120,240 and 360min survey rabbit anus temperature respectively 5 times, calculate the difference respectively organize rabbit day part treatment back anus temperature and basal body temperature, processing takes statistics.
Each different period body temperature situation of change in treated animal treatment back
The group treatment back time (min)
30 60 120 240 360
Normal saline group 0.48 ± 0.38 1.34 ± 0.25 2.18 ± 0.03 1.59 ± 0.13 0.83 ± 0.17
Treatment A group 0.34 ± 0.19 0.81 ± 0.46 0.93 ± 0.38 0.50 ± 0.37 0.34 ± 0.21
Treatment B group 0.36 ± 0.27 0.84 ± 0.11 0.98 ± 0.29 0.53 ± 0.21 0.42 ± 0.23
The result shows: gel of the present invention has obvious antipyretic effect to escherichia coli pyrogenicity rabbit, and its effect of bringing down a fever is not less than and is better than pseudoephedrine hydrochloride solution.
(2) to the antitussive effect of experimental cough
The antitussive effect that mice ammonia is drawn the method for coughing: get 60 of mices, male and female half and half are divided into 4 groups, i.e. matched group (H at random 2O), positive drug control group (codeine), treatment A group (gel of the present invention), treatment B group (pseudoephedrine hydrochloride oral administration liquid).Every group 15.Gastric infusion, 1h after the administration, it is in the glass bell jar of 1L that 1 mice is placed volume, put a cotton balls in it, each 25%~28% ammonia 0.2ml of suction injects on the cotton balls with the 1ml syringe, the also incubation period of record mouse cough and the cough number of times in the 3min are observed in the experiment that hockets at random of each treated animal.
Mice ammonia is drawn the antitussive effect of coughing
Cough number of times in drug dose (mg/kg) n incubation period (s) 3min
H 2O - 15 21.6±12.4 118.5±18.2
Codeine 10 15 30.7 ± 14.3 85.8 ± 17.4
Treatment A organizes 10 15 30.4 ± 11.5 83.9 ± 16.3
Treatment B organizes 10 15 33.7 ± 10.6 81.0 ± 12.2
The result shows: gel of the present invention draws the tangible antitussive effect of having of the method for coughing to mice ammonia, is not less than pseudoephedrine hydrochloride oral administration solution.
Concrete embodiment:
Embodiments of the invention 1: chlorphenamine maleate 10mg, pseudoephedrine hydrochloride 200mg, dextromethorphan hydrobromide 50mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 1 hour, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; With the k-carrageenan, ι-carrageenan is pressed 1: 2 part by weight mix homogeneously, under stirring condition, 0.5% mixed-matrix is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heating, filter, filter the back and under condition of stirring, add the dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride, mix homogeneously, join rapidly in the disinfecting container, seal, sterilization is cooled to rapidly about 30 ℃, condensation, drying promptly gets gel, this product oral, three times on the one, each 2 bags, every bag of 10g.
Embodiments of the invention 2: chlorphenamine maleate 25mg, pseudoephedrine hydrochloride 400mg, dextromethorphan hydrobromide 150mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 1 hour, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; 0.6% locust bean gum is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying promptly gets gel.
Embodiments of the invention 3: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
Get chlorphenamine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, press medicine: substrate=1: 1.3, the mixed-matrix of adding soybean oil, soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.3: 0.5, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70~80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1~2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying promptly gets soft capsule.
Embodiments of the invention 4: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
Get chlorphenamine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, splash into the ratio that adopts PEG6000 and PEG4000 and be in 3: 1 the mixed-matrix, the water dropper model adopts No. 2 water droppers, and coolant temperature is 18~22 ℃, promptly gets drop pill.
Embodiments of the invention 5: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 3 hours, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; 0.7% gelatin is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying promptly gets gel.
Embodiments of the invention 6: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 6 hours, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; 0.8% xanthan gum is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying promptly gets gel.
Embodiments of the invention 7: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 3 hours, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; 0.9% microcrystalline Cellulose is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying promptly gets gel.
Embodiments of the invention 8: chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg
By beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 6 hours, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; With 0.3% Konjac glucomannan, 0.5% carrageenan mixing, put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and under condition of stirring, add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride, mix homogeneously, join rapidly in the disinfecting container, seal, sterilization, be cooled to rapidly about 30 ℃, condensation, drying promptly gets gel.

Claims (5)

1, a kind of pseudoephedrine hydrochloride gel preparation, it is characterized in that: calculate according to weight, it is made into fruit jelly or soft sweet type gel oral formulations by chlorphenamine maleate 10~25mg, pseudoephedrine hydrochloride 200~400mg, dextromethorphan hydrobromide 50~150mg and an amount of substrate, and wherein: substrate can be animal glue, plant gum, microbiological gum, alginate jelly, chemical modification glue or compound gel.
2, according to the described pseudoephedrine hydrochloride gel preparation of claim 1, it is characterized in that: it can also be prepared into: injection comprises: injection, powder pin, freeze-dried powder, dispersible tablet, soft capsule, drop pill or slow releasing preparation.
3, according to claim 1 or 2 described pseudoephedrine hydrochloride gel preparations, it is characterized in that: the gel preparation that the substrate that it is mixed to obtain by 1: 2 part by weight by chlorphenamine maleate 20mg, pseudoephedrine hydrochloride 300mg, dextromethorphan hydrobromide 100mg and beta-carrageenin, ι-carrageenan is prepared into is semifluid or solid gel shape.
4, as the preparation method of pseudoephedrine hydrochloride gel preparation as described in the claim 1~3 any, it is characterized in that: chlorphenamine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide are added to mix homogeneously in the substrate for preparing, after the sterilization promptly.
5, preparation method according to the described pseudoephedrine hydrochloride gel preparation of claim 4, it is characterized in that: the gel in the described preparation prepares like this: by beta-schardinger dextrin-: dextromethorphan hydrobromide is that 3: 1 part by weight takes by weighing beta-schardinger dextrin-, beta-schardinger dextrin-is dissolved in 40 ℃ of thermostatted water solution, add dextromethorphan hydrobromide, after the 250rmin magnetic agitation 1 hour, drop to room temperature gradually, the clathrate suspension that forms was left standstill in refrigerator 24 hours, sucking filtration, discard filtrate, drain back 50 ℃ of cold drying with distilled water wash, must be to acetyl-amino phenol clathrate; K-carrageenan, ι-carrageenan are pressed 1: 2 part by weight mix homogeneously, under stirring condition, 0.5% mixed-matrix is put into cold water, make it to disperse, soak 20~30min, make the abundant water absorption and swelling of substrate, stir then, heat, filter, filter the back and add dextromethorphan hydrobromide clathrate, chlorphenamine maleate, pseudoephedrine hydrochloride under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying, promptly.
CN 200410040848 2004-10-11 2004-10-11 Pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleates gel formulation and its preparing process Pending CN1634059A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101596157A (en) * 2008-06-04 2009-12-09 北京科信必成医药科技发展有限公司 The compound slow release preparation of a kind of pseudoephedrine, chlorphenamine and dextromethorphan
CN103110629A (en) * 2013-02-19 2013-05-22 青岛正大海尔制药有限公司 Compound phenol caplets dropping pills and preparation method thereof
CN103536527A (en) * 2013-09-16 2014-01-29 南通丝乡丝绸有限公司 Dextromethorphan hydrobromide injection and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101596157A (en) * 2008-06-04 2009-12-09 北京科信必成医药科技发展有限公司 The compound slow release preparation of a kind of pseudoephedrine, chlorphenamine and dextromethorphan
CN103110629A (en) * 2013-02-19 2013-05-22 青岛正大海尔制药有限公司 Compound phenol caplets dropping pills and preparation method thereof
CN103536527A (en) * 2013-09-16 2014-01-29 南通丝乡丝绸有限公司 Dextromethorphan hydrobromide injection and preparation method thereof

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