CN100574747C - A kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and preparation method thereof - Google Patents
A kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and preparation method thereof Download PDFInfo
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- CN100574747C CN100574747C CN200510060868A CN200510060868A CN100574747C CN 100574747 C CN100574747 C CN 100574747C CN 200510060868 A CN200510060868 A CN 200510060868A CN 200510060868 A CN200510060868 A CN 200510060868A CN 100574747 C CN100574747 C CN 100574747C
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- maleategel
- chlorphenzmine
- bezoar
- acetaminophen
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 85
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 57
- 238000002360 preparation method Methods 0.000 title claims abstract description 54
- 206010004542 Bezoar Diseases 0.000 title claims abstract description 28
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 claims abstract description 29
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 24
- 229920001817 Agar Polymers 0.000 claims abstract description 23
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 23
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 23
- 229930006000 Sucrose Natural products 0.000 claims abstract description 23
- 239000008272 agar Substances 0.000 claims abstract description 23
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000005720 sucrose Substances 0.000 claims abstract description 23
- 239000000499 gel Substances 0.000 claims abstract description 17
- 239000012153 distilled water Substances 0.000 claims description 18
- 230000000249 desinfective effect Effects 0.000 claims description 8
- 238000012856 packing Methods 0.000 claims description 8
- 239000012047 saturated solution Substances 0.000 claims description 8
- 230000001954 sterilising effect Effects 0.000 claims description 8
- 238000004659 sterilization and disinfection Methods 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims 5
- 239000003814 drug Substances 0.000 abstract description 16
- 238000004090 dissolution Methods 0.000 abstract description 11
- 229940079593 drug Drugs 0.000 abstract description 8
- 239000008187 granular material Substances 0.000 abstract description 5
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 239000002552 dosage form Substances 0.000 abstract description 2
- 230000000694 effects Effects 0.000 description 5
- 238000009825 accumulation Methods 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 230000003203 everyday effect Effects 0.000 description 4
- 201000009240 nasopharyngitis Diseases 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 3
- BTFTUFBNYKHSTI-UHFFFAOYSA-N 2-amino-2-(3,5-ditert-butyl-4-hydroxyphenyl)propanedioic acid Chemical compound CC(C)(C)C1=CC(C(N)(C(O)=O)C(O)=O)=CC(C(C)(C)C)=C1O BTFTUFBNYKHSTI-UHFFFAOYSA-N 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 2
- 239000005864 Sulphur Substances 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 206010022000 influenza Diseases 0.000 description 2
- 206010011224 Cough Diseases 0.000 description 1
- 206010013954 Dysphoria Diseases 0.000 description 1
- 206010028748 Nasal obstruction Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 206010039101 Rhinorrhoea Diseases 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000002804 anti-anaphylactic effect Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000005138 cryopreservation Methods 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 230000008451 emotion Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
- 210000003026 hypopharynx Anatomy 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000000116 mitigating effect Effects 0.000 description 1
- 208000010753 nasal discharge Diseases 0.000 description 1
- 235000008935 nutritious Nutrition 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000000391 smoking effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and preparation method thereof; described gel preparation quality group becomes: acetaminophen 0.05～30%; the artificial Calculus Bovis 0.005～1%; chlorphenamine maleate 0.0005～0.08%; agar 0.2～10%; sucrose 1～20%, cyclodextrin 1～10%, water 45～90%.The beneficial effect of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation of the present invention and preparation method thereof is mainly reflected in: dosage form is reasonable, it is oral to be specially adapted to child, and mouthfeel is good, is easy to swallow, result of use is good, and drug dissolution and bioavailability do not have obvious change than granule.Have bigger practical value and economic results in society.
Description
(1) technical field
The present invention relates to a kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and preparation method thereof.
(2) background technology
Xiao ' er Anfen Huangnamin is the specific drug of treatment children's common cold, acetaminophen in the prescription is the ntipyretic analgesic medicine of world health organisation recommendations, the effect of bringing down a fever is obvious, stimulate little to gastric mucosa, do not cause gastrorrhagia, the routine dose non-evident effect is the first-selected antipyretic of children's more than 2 months, be used for the heating that common cold or influenza cause, also be used to alleviate light moderate pain; Chlorphenamine maleate has antianaphylactic effect, symptoms such as the cough in the alleviation flu, nasal obstruction, watery nasal discharge; The artificial Calculus Bovis has mitigation to infantile common cold heating, laryngopharynx swelling and pain, dysphoria.
The existing preparation type of Xiao ' er Anfen Huangnamin mainly is a granule, though be applicable to child, because of its bitter in the mouth and amount are big, child easily produces the resistance emotion, influences result of use.So far do not see the application and the report of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel agent.
(3) summary of the invention
The present invention promptly be for provide a kind of mouthfeel good, be particularly suitable for the pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation that child takes, and preparation method thereof.
For reaching goal of the invention the technical solution used in the present invention be:
A kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation, described gel preparation is made up of quality component composed as follows:
Acetaminophen 0.05～30%
The artificial Calculus Bovis 0.005～1%
Chlorphenamine maleate 0.0005～0.08%
Agar 0.2～10%
Sucrose 1～20%
Cyclodextrin 1～10%
Water 45～90%.
Preferably, described gel preparation quality is composed as follows:
Acetaminophen 1～20%
The artificial Calculus Bovis 0.01～1.0%
Chlorphenamine maleate 0.0001～0.05%
Agar 0.2～5%
Sucrose 5～15%
Cyclodextrin 1～10%
Distilled water 50～90%.
Most preferred, described gel preparation quality is composed as follows:
Acetaminophen 1%
The artificial Calculus Bovis 0.04%
Chlorphenamine maleate 0.004%
Agar 0.46%
Sucrose 10.0%
Cyclodextrin 1.496%
Distilled water 87.0%.
A kind of preparation method of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation, become in described gel preparation quality group: acetaminophen 0.05～30%, the artificial Calculus Bovis 0.005～1%, chlorphenamine maleate 0.0005～0.08%, agar 0.2～10%, sucrose 1～20%, cyclodextrin 1～10%, water 45～90%; Described method is as follows: press the prescription proportioning; cyclodextrin joined in 80～100 ℃ of distilled water make saturated solution; slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 0.5～3 hour, add dissolving good sucrose and agar at last; filter; be cooled to room temperature, in the disinfecting container of packing into, seal; sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Preferably, described gel preparation quality group becomes: acetaminophen 1%, artificial sulfur 0.04%, chlorphenamine maleate 0.004%, agar 0.46%, sucrose 10.1%, cyclodextrin 1.496%, distilled water 87.0%; Described method is as follows: press the prescription proportioning; cyclodextrin joined in 80～100 ℃ of distilled water make saturated solution; slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 0.5～3 hour, add dissolving good sucrose and agar at last; filter; be cooled to room temperature, in the disinfecting container of packing into, seal; sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Through the drug dissolution comparative test, the dissolution rate of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation is suitable with the pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule agent.Through the bioavailability comparative test, both no significant differences.But the gel preparation children's is easy to accept, and mouthfeel is good.
Common, the pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation consumption is: children's every day 3 times, each 5～10g, adult every day 3 times, each 10～20g.
The beneficial effect of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation of the present invention and preparation method thereof is mainly reflected in: dosage form is reasonable, it is oral to be specially adapted to child, and mouthfeel is good, is easy to swallow, result of use is good, and drug dissolution and bioavailability do not have obvious change than granule.Have bigger practical value and economic results in society.
(4) description of drawings
Fig. 1 is an acetaminophen dissolution standard curve, linear equation: y=0.033x+0.0273, R
2=0.9997;
Fig. 2 is a chlorphenamine maleate dissolution standard curve, linear equation: y=0.035x-0.0199, R
2=0.9995.
(5) specific embodiment
The present invention is described further below in conjunction with specific embodiment, but protection scope of the present invention is not limited in this:
Embodiment 1:
Prescription:
Acetaminophen 10g (1%)
Artificial Calculus Bovis 0.4g (0.04%)
Chlorphenamine maleate 0.04g (0.004%)
Agar 4.6g (0.46%)
Sucrose 100g (10%)
Cyclodextrin 14.96g (1.496%)
Distilled water 870g (87%)
Preparation:
Press the prescription proportioning; cyclodextrin joined in 95～100 ℃ of distilled water make saturated solution, slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 3 hours; add dissolving good sucrose and agar at last; filter, be cooled to room temperature, in the disinfecting container of packing into; every bag of 5g; seal, sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Embodiment 2:
Prescription:
Acetaminophen 200g (20%)
Artificial Calculus Bovis 0.8g (0.08%)
Chlorphenamine maleate 8g (0.80%)
Agar 2g (0.2%)
Sucrose 200g (20%)
Cyclodextrin 50g (5%)
Distilled water 539.2g (53.92%)
Preparation:
Press the prescription proportioning; cyclodextrin joined in 80～85 ℃ of distilled water make saturated solution, slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 1.5 hours; add dissolving good sucrose and agar at last; filter, be cooled to room temperature, in the disinfecting container of packing into; every bag of 10g; seal, sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Embodiment 3:
Prescription:
Acetaminophen 96g (9.6%)
Artificial Calculus Bovis 4g (0.4%)
Chlorphenamine maleate 0.4g (0.04%)
Agar 100g (10%)
Sucrose 150g (15%)
Cyclodextrin 100g (10%)
Distilled water 549.6g (54.96%)
Preparation:
Press the prescription proportioning; cyclodextrin joined in 85～90 ℃ of distilled water make saturated solution, slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 1.5 hours; add dissolving good sucrose and agar at last; filter, be cooled to room temperature, in the disinfecting container of packing into; every bottle of 100mL; seal, sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Embodiment 4:
Prescription:
Acetaminophen 288g (28.8%)
Artificial cattle sulphur 12g (1.2%)
Chlorphenamine maleate 1.2g (0.12%)
Agar 58.8g (5.88%)
Sucrose 50g (5%)
Cyclodextrin 100g (10%)
Distilled water 490g (49%)
Preparation:
Press the prescription proportioning; cyclodextrin joined in 95～100 ℃ of distilled water make saturated solution, slowly add acetaminophen, artificial cattle sulphur and chlorphenamine maleate, stirred 2.5 hours; add dissolving good sucrose and agar at last; be cooled to room temperature, filter, in the disinfecting container of packing into; every bottle of 100mL; seal, sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
Embodiment 5: pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation taste and curative effect investigation
It is oral that pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation is specially adapted to child, clinical in its treatment infantile common cold 20 examples, is reported as follows:
Suffer from several age distribution:
0～6 month 6 example; 6～12 months 8 examples; 1～3 year old 3 example; 3～6 years old 3 examples;
Infant sex: male 12 examples; Woman's 8 examples;
The infant course of disease: 1 week is with interior 12 examples; 1～4 all 4 examples; 4 examples more than January;
Usage and dosage: embodiment 1 gained gel preparation, oral; 0～1 year old, every day 3 times, each 5g; 1～3 year old, every day 3 times, each 10g; 100% infant need not to persuade, and can normally take medicine.
Criterion of therapeutical effect: recovery from illness: taking medicine, disease disappears in 7 days, recovers normal;
Produce effects: taking medicine, symptom obviously alleviates in 7 days;
Effectively: taking medicine, symptom alleviates to some extent in 7 days;
Invalid: symptom does not have and alleviates or the person of increasing the weight of.
Efficacy result: 20 routine infants remove 1 routine sx after treatment, adds with outside the other drug treatment, and effective 10 examples, produce effects 4 examples are cured 5 examples, total effective rate 95%.
Embodiment 6: pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and granule dissolution and bioavailability comparative test
Bioavailability compares:
(25～35 years old age, body weight 52～61kg) are divided into two groups to 12 healthy male volunteers (liver, renal function and electrocardiogram are normal) at random, 6 every group.All medicines of stopping using before the test abstain from smoking and drinking during being tried, and the volunteer is intersected respectively and taken Jiao Rang and gel, take medicine 1 week at interval for twice.Method: behind every group of experimenter's fasting 12h, one of intersection single oral Jiao Rang, or the gel of equal drug dose, the 100ml warm water delivery service, the back 2h that takes medicine advances the nutritious food of unified recipe, twice test unanimity, in the back 0.25,0.5,1 of taking medicine, 1.5,2,3,5,7,10h extracts ulnar vein blood 2ml, centrifugal 10min gets serum and places-20 ℃ of cryopreservation to measuring its blood drug level.
The pharmacokinetic parameters of two kinds of system types of result is similar, and difference does not have significance statistically.The bioavailability that gel is equivalent to Jiao Rang is 103.1%.
The comparison of dissolution:
By " Chinese pharmacopoeia version dissolution determination in 2000 item is regulation down, carries out the dissolution comparative test, and the result is from accumulating the stripping percentage rate as can be seen, and the dissolution and the capsule of gel are suitable.
The standard curve of acetaminophen is seen Fig. 1, and the standard curve of chlorphenamine maleate is seen Fig. 2, and the accumulation stripping percentage rate of acetaminophen sees Table 1, and the accumulation stripping percentage rate of chlorphenamine maleate sees Table 2.
Table 1: the accumulation stripping percentage rate of acetaminophen
Remarks: T
50Be stripping 50% required time, T
dBe stripping 63.2% required time, m is a form parameter.
Table 2: the accumulation stripping percentage rate of chlorphenamine maleate
Remarks: T
50Be stripping 50% required time, T
dBe stripping 63.2% required time, m is a form parameter.
Claims (5)
1. pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation is characterized in that described gel preparation made by quality raw material composed as follows:
Acetaminophen 0.05～30%
The artificial Calculus Bovis 0.005～1%
Chlorphenamine maleate 0.0005～0.08%
Agar 0.2～10%
Sucrose 1～20%
Cyclodextrin 1～10%
Water 45～90%.
2. pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation as claimed in claim 1, the raw materials quality that it is characterized in that preparing described gel preparation is composed as follows:
Acetaminophen 1～20%
The artificial Calculus Bovis 0.01～1.0%
Chlorphenamine maleate 0.0001～0.05%
Agar 0.2～5%
Sucrose 5～15%
Cyclodextrin 1～10%
Distilled water 50～90%.
3. pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation as claimed in claim 1, the raw materials quality that it is characterized in that preparing described gel preparation is composed as follows:
Acetaminophen 1%
The artificial Calculus Bovis 0.04%
Chlorphenamine maleate 0.004%
Agar 0.46%
Sucrose 10.0%
Cyclodextrin 1.496%
Distilled water 87.0%.
4. the method for preparing pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation as claimed in claim 1, it is characterized in that the raw materials quality for preparing described gel preparation consists of: acetaminophen 0.05～30%, the artificial Calculus Bovis 0.005～1%, chlorphenamine maleate 0.0005～0.08%, agar 0.2～10%, sucrose 1～20%, cyclodextrin 1～10%, water 45～90%; Described method is as follows: press the prescription proportioning; cyclodextrin joined in 80～100 ℃ of distilled water make saturated solution; slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 0.5～3 hour, add dissolving good sucrose and agar at last; filter; be cooled to room temperature, in the disinfecting container of packing into, seal; sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
5. the preparation method of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation as claimed in claim 4, it is characterized in that the raw materials quality for preparing described gel preparation consists of: acetaminophen 1%, the artificial Calculus Bovis 0.04%, chlorphenamine maleate 0.004%, agar 0.46%, sucrose 10.0% cyclodextrin 1.496%, distilled water 87.0%; Described method is as follows: press the prescription proportioning; cyclodextrin joined in 80～100 ℃ of distilled water make saturated solution; slowly add acetaminophen, artificial Calculus Bovis and chlorphenamine maleate, stirred 0.5～3 hour, add dissolving good sucrose and agar at last; filter; be cooled to room temperature, in the disinfecting container of packing into, seal; sterilization promptly gets described pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation.
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| CN200510060868A CN100574747C (en) | 2005-09-23 | 2005-09-23 | A kind of pediatric paracetamol artifical low-bezoar and chlorphenzmine maleategel preparation and preparation method thereof |
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| CN1660134A (en) * | 2005-01-24 | 2005-08-31 | 江西中兴汉方药业有限公司 | Effervescence tablet of Xiao'er Anfen Huangnamin and preparation technique |
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| CN1660134A (en) * | 2005-01-24 | 2005-08-31 | 江西中兴汉方药业有限公司 | Effervescence tablet of Xiao'er Anfen Huangnamin and preparation technique |
Non-Patent Citations (1)
| Title |
|---|
| 浅谈中药凝胶剂的研究和应用. 林吉等.江西中医药，第36卷第7期. 2005 * |
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