CN104147063A - Compound pediatric antipyretic suppository and preparation method thereof - Google Patents
Compound pediatric antipyretic suppository and preparation method thereof Download PDFInfo
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- CN104147063A CN104147063A CN201410386715.5A CN201410386715A CN104147063A CN 104147063 A CN104147063 A CN 104147063A CN 201410386715 A CN201410386715 A CN 201410386715A CN 104147063 A CN104147063 A CN 104147063A
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Abstract
The invention discloses a compound pediatric antipyretic suppository. The compound pediatric antipyretic suppository per kg comprises 5g calculus bovis factitius, 50g baphicacanthus root extract powder, 150g acetaminophen, 7g polysorbate 80, 10g alcohol containing 0.105g ethylparaben, and the balance of semisynthetic fatty glyceride. The invention further discloses a preparation method of the compound pediatric antipyretic suppository. The compound pediatric antipyretic suppository is prepared by taking the calculus bovis factitius, the baphicacanthus root extract powder and acetaminophen as a compound together with special auxiliary materials, has the advantages of quick absorption, good curative effect and quick abatement of a fever, and has the good curative effect on pediatric symptoms such as the fever in children, upper respiratory tract infection, bronchitis, palpitation due to fright, swelling and pain in a throat, lung heat, abundant expectoration and cough.
Description
Technical field
The present invention relates to pharmaceutical preparation, relate in particular to a kind of paracetamol compound suppository and preparation method thereof.
Background technology
Children's antipyretic medicine is the medicine of the infantile fever such as treatment fever of children and upper respiratory tract infection.But the kind of the children's antipyretic medicine in currently available technology is very many, formula, quality, processing technology are very different, and drug effect is unstable, and difficult quality is controlled.Oral medicament, particularly antipyretic analgesic are very large to the stimulation of harmonization of the stomach intestinal, and children's is when the symptoms such as heating infection occur, and it is suppressed that the content of its stomach is discharged, if medicine is difficult to reach absorption site, clinical therapeutic effect also will decline greatly.
Good absorbing, good effect, the fast paracetamol compound suppository of bringing down a fever can alleviate child's a misery, alleviate adult's burden.
Summary of the invention
The technical problem to be solved in the present invention is the defect that overcomes prior art, provides a kind of good absorbing, good effect, the fast paracetamol compound suppository of bringing down a fever.
In order to solve the problems of the technologies described above, the invention provides following technical scheme:
A kind of paracetamol compound suppository; this paracetamol compound suppository of each kilogram comprises artificial Calculus Bovis 5g, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g, acetaminophen 150g; 7g polyoxyethylene sorbitan monoleate and the ethanol 10g that contains 0.105g ethyl hydroxybenzoate, surplus is semi-synthetic fatty acid glyceride.
Further semi-synthetic fatty acid glyceride is tristerin or glyceryl laurate ester.
Further, the preparation method of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder is: Rhizoma Et Radix Baphicacanthis Cusiae is cleaned, and decocts with water 2 times, and collecting decoction, filters, and after decocting liquid is concentrated, adds ethanol, and wherein the volume ratio of ethanol and decocting liquid is 6:4; Stir, standing, filtrate recycling ethanol, concentrated, dry, be developed into fine powder, obtain.
The method of this paracetamol compound suppository is as follows:
By artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g, acetaminophen 150g add insulation at 45 ℃～55 ℃, semi-synthetic fatty acid glyceride in; the ethanol 10g that drips 7g polyoxyethylene sorbitan monoleate simultaneously and contain 0.105g ethyl hydroxybenzoate; limit edged stirs, and adds rear continuation and stirs 30 minutes, pours in mould; make 1000; cooling rear demoulding, packing, obtains.
Further, the temperature of the semi-synthetic fatty acid glyceride in the method is preferably 50 ℃
The instructions of taking of paracetamol compound suppository of the present invention is: rectal application, one of one to three years old children's one time, once-a-day, three to six years old one time one, twice on the one.
Every heavy 1g, every contains ethylamino phenol 150mg, artificial Calculus Bovis 5mg.
Paracetamol compound suppository of the present invention is furnished with polyoxyethylene sorbitan monoleate, can well promote the mucous membrane of rectum of medicine to absorb.
Paracetamol compound suppository of the present invention can antipyretic-antalgic, liyan jiedu, the arresting convulsion of eliminating the phlegm.To fever of children, upper respiratory tract infection, bronchitis, palpitation with fear is uneasy, and children's's symptoms such as laryngopharynx swelling and pain and lung-heat, abundant expectoration, cough have good curative effect.
It is compound recipe that paracetamol compound suppository of the present invention be take artificial Calculus Bovis, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder, acetaminophen, is equipped with special adjuvant and makes, have advantages of absorb fast, good effect, bring down a fever fast.
The specific embodiment
Below in conjunction with preferred embodiment, the present invention will be described, should be appreciated that preferred embodiment described herein, only for description and interpretation the present invention, is not intended to limit the present invention.
Embodiment 1
A kind of paracetamol compound suppository; this paracetamol compound suppository of each kilogram comprises artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g; 7g polyoxyethylene sorbitan monoleate and the ethanol 10g that contains 0.105g ethyl hydroxybenzoate; surplus is semi-synthetic fatty acid glyceride, and wherein semi-synthetic fatty acid glyceride is tristerin.
The preparation method of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder is: get Rhizoma Et Radix Baphicacanthis Cusiae and clean, decoct with water 2 times, collecting decoction, filters, and after decocting liquid is concentrated, adds ethanol, and wherein the volume ratio of ethanol and decocting liquid is 6:4; Stir, standing, filtrate recycling ethanol, concentrated, dry, be developed into fine powder, obtain.
The concrete making step of this paracetamol compound suppository is as follows:
By artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g adds insulation in the semi-synthetic fatty acid glyceride of 45 ℃～55 ℃, the ethanol 10g that drips 7g polyoxyethylene sorbitan monoleate simultaneously and contain 0.105g ethyl hydroxybenzoate, and limit edged stirs; adding rear continuation stirs 30 minutes; pour in mould, make 1000, cooling rear demoulding; packing, obtains.
Embodiment 2
A kind of paracetamol compound suppository; this paracetamol compound suppository of each kilogram comprises artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g; 7g polyoxyethylene sorbitan monoleate and the ethanol 10g that contains 0.105g ethyl hydroxybenzoate; surplus is semi-synthetic fatty acid glyceride, and wherein semi-synthetic fatty acid glyceride is glyceryl laurate ester.
The preparation method of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder is: get Rhizoma Et Radix Baphicacanthis Cusiae and clean, decoct with water 2 times, collecting decoction, filters, and after decocting liquid is concentrated, adds ethanol, and wherein the volume ratio of ethanol and decocting liquid is 6:4; Stir, standing, filtrate recycling ethanol, concentrated, dry, be developed into fine powder, obtain.
The concrete making step of this paracetamol compound suppository is as follows:
By artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g adds insulation in the semi-synthetic fatty acid glyceride of 50 ℃, the ethanol 10g that drips 7g polyoxyethylene sorbitan monoleate simultaneously and contain 0.105g ethyl hydroxybenzoate, and limit edged stirs; adding rear continuation stirs 30 minutes; pour in mould, make 1000, cooling rear demoulding; packing, obtains.
Clinical data:
Paracetamol compound suppository of the present invention is carried out to antipyretic, analgesia, antiinflammatory, calmness, antiviral, antibacterial, toxicity test, and experimental result is as follows:
By body weight 3.0g/kg, to rabbit experiment, result shows that the heating due to typhoid fever, paratyphoid fever, second polyvalent vaccine is had to obvious cooling effect;
By body weight 0.5g/20g, can make after to mouse stomach 1h pain valve raise;
By body weight 0.5g/20g to mouse stomach after, the inflammatory swelling due to agar is had to obvious inhibitory action;
By body weight 0.5g/20g, to mouse stomach, can obviously extend the pentobarbital sodium hypnosis time, show sedation;
By body weight 0.5g/20g, to mouse stomach, can suppress the pulmonary lesion that influenza virus causes, bacteriostatic experiment has certain inhibitory action to multiple upper respiratory tract pathogenic bacterium;
Toxicity test has no obvious toxic-side effects.
To 500 by certain front three hospital diagnosis be infantile common cold fever, upper respiratory tract infection, tonsillitis etc. with 500 routine infants of fervescence, by randomly assigne, be divided into treatment group and matched group.Wherein treatment group is 365 examples, and matched group is 135 examples, male's infant 285 examples, women's infant 215 examples.Treatment group wherein, according to rectal application, one of one to three years old children's one time, once-a-day, three to six years old one time one, the method for twice on the one is taken paracetamol compound suppository of the present invention, matched group is taken GANMAO TUIRE KELI, Shanghai Chinese medicine three factories, lot number 980112,5-10 year each 1 bag, every day 2-3 time, within 5 years old, cut down according to the circumstance below, after meal warm boiled water.
The age distribution table of table 1 500 routine infants
Take the paracetamol compound suppository of the embodiment of the present invention 2 after one week, the Clinical efficacy comparison for the treatment of group and matched group is as shown in table 2, and wherein, " effective " refers to that body temperature obviously declines or is down to normally, and symptom substantially disappears or disappears completely; " improvement " refers to temperature decline, anesis; Unchanged or increase the weight of before after invalid finger medication.
The Clinical efficacy comparison of table 2 treatment group and matched group
Through ranking score, estimate method check, P < 0.05, there were significant differences for treatment group and matched group, and prompting treatment group is better than matched group.
Model case: week so-and-so, female, seven first quarter moons, because generating heat, within 3 days, go to a doctor, 38.9 ℃ of body temperature, P110 beat/min, R22 beat/min, tongue fur is white, and floating superficial venule of the index finger is livid purple, pharyngeal hyperemia, blood WBC18600/cubic millimeter, N70%, L30%, take paracetamol compound suppository of the present invention after body temperature decline very soon, N70%, L30%, 36.5 ℃ of second day body temperature, the 3rd day 36.3 ℃, blood WBC13000/ cubic millimeter, N70%L, 28%, M1%, the 4th day blood WBC9800/cubic millimeter, N70%, L30%, body temperature hemogram is normally fully recovered.
Liu so-and-so, man, 5 years old, because generating heat, within 2 days, accompany pharynx pain dizzy medical, 39.6 ℃ of body temperature, P110 beat/min, R23 beat/min, body of the tongue is white, thick and greasy fur, rapid pulse, pharyngeal hyperemia, tonsil is red large, blood WBC15100/cubic millimeter, N78%, L20%, M2%, stool R, T Huang is rare, WBC+R, B, a little pyocyte+urine R of C, T, blood cell a little, take after paracetamol compound suppository of the present invention, body temperature declines rapidly, second day T37.3 ℃, the 3rd day T36.7 ℃, be down to normal, WB ℃ of 8600/cubic millimeter of N63% have a blood test on the 3rd day, L36%, M1%, stool R, T Huang is rare, hemogram and stool are all normal, routine urinalysis is normally fully recovered.
Finally it should be noted that: the foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, although the present invention is had been described in detail with reference to previous embodiment, for a person skilled in the art, its technical scheme that still can record aforementioned each embodiment is modified, or part technical characterictic is wherein equal to replacement.Within the spirit and principles in the present invention all, any modification of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
Claims (5)
1. a paracetamol compound suppository, is characterized in that, this paracetamol compound suppository of each kilogram comprises artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g, 7g polyoxyethylene sorbitan monoleate and the ethanol 10g that contains 0.105g ethyl hydroxybenzoate, surplus is semi-synthetic fatty acid glyceride.
2. a kind of paracetamol compound suppository as claimed in claim 1, is characterized in that, described semi-synthetic fatty acid glyceride is tristerin or glyceryl laurate ester.
3. a kind of paracetamol compound suppository as claimed in claim 1, is characterized in that, the preparation method of described Rhizoma Et Radix Baphicacanthis Cusiae extractum powder is: Rhizoma Et Radix Baphicacanthis Cusiae is cleaned, decoct with water 2 times, collecting decoction, filters, after decocting liquid is concentrated, add ethanol, wherein the volume ratio of ethanol and decocting liquid is 6:4; Stir, standing, filtrate recycling ethanol, concentrated, dry, be developed into fine powder, obtain.
4. a method of preparing paracetamol compound suppository claimed in claim 1, is characterized in that, concrete steps are as follows:
By artificial Calculus Bovis 5g; Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g; acetaminophen 150g adds insulation in the semi-synthetic fatty acid glyceride of 45 ℃～55 ℃, the ethanol 10g that drips 7g polyoxyethylene sorbitan monoleate simultaneously and contain 0.105g ethyl hydroxybenzoate, and limit edged stirs; adding rear continuation stirs 30 minutes; pour in mould, make 1000, cooling rear demoulding; packing, obtains.
5. a kind of method of preparing paracetamol compound suppository as claimed in claim 4, is characterized in that, the temperature of described semi-synthetic fatty acid glyceride is 50 ℃.
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| CN201410386715.5A CN104147063A (en) | 2014-08-07 | 2014-08-07 | Compound pediatric antipyretic suppository and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553554A (en) * | 2018-06-12 | 2018-09-21 | 江西九华药业有限公司 | A kind of suppository and preparation method thereof for treating fever in children, palpitation with fear uneasiness, lung heat many coughs of phlegm |
| CN108578477A (en) * | 2018-06-19 | 2018-09-28 | 吉林百年汉克制药有限公司 | A kind of Compound injection of paracetamol pharmaceutical composition and its preparation method and application |
| CN104800812B (en) * | 2015-05-07 | 2018-09-28 | 济南新斯诺生物技术有限公司 | A kind of suppository and preparation method thereof for treating chill cold in children |
| CN109044961A (en) * | 2018-09-29 | 2018-12-21 | 江西九华药业有限公司 | A kind of compound antifebrile suppository for children and preparation method thereof |
Citations (1)
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| CN1698688A (en) * | 2004-08-30 | 2005-11-23 | 贵州宏宇药业有限公司 | Compound defervesce foam for children |
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2014
- 2014-08-07 CN CN201410386715.5A patent/CN104147063A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1698688A (en) * | 2004-08-30 | 2005-11-23 | 贵州宏宇药业有限公司 | Compound defervesce foam for children |
Non-Patent Citations (1)
| Title |
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| 中华人民共和国卫生部药典委员会: "《中华人民共和国卫生部 药品标准 中药成方制剂（第十四册）》", 31 December 1997 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104800812B (en) * | 2015-05-07 | 2018-09-28 | 济南新斯诺生物技术有限公司 | A kind of suppository and preparation method thereof for treating chill cold in children |
| CN108553554A (en) * | 2018-06-12 | 2018-09-21 | 江西九华药业有限公司 | A kind of suppository and preparation method thereof for treating fever in children, palpitation with fear uneasiness, lung heat many coughs of phlegm |
| CN108578477A (en) * | 2018-06-19 | 2018-09-28 | 吉林百年汉克制药有限公司 | A kind of Compound injection of paracetamol pharmaceutical composition and its preparation method and application |
| CN109044961A (en) * | 2018-09-29 | 2018-12-21 | 江西九华药业有限公司 | A kind of compound antifebrile suppository for children and preparation method thereof |
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Application publication date: 20141119 |