CN103230568B - Benorilate vitamin B1 particle for children and preparation process thereof - Google Patents
Benorilate vitamin B1 particle for children and preparation process thereof Download PDFInfo
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- CN103230568B CN103230568B CN201310148183.7A CN201310148183A CN103230568B CN 103230568 B CN103230568 B CN 103230568B CN 201310148183 A CN201310148183 A CN 201310148183A CN 103230568 B CN103230568 B CN 103230568B
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Abstract
The invention belongs to the field of medical technology and discloses a benorilate vitamin B1 particle for children. The benorilate vitamin B1 particle for children is prepared from 0.3kg of benorilate, 3g of vitamin B1, 2.69g of sucrose, 3g of essence and 0.25g of tartrazine. The invention also discloses a preparation method of the benorilate vitamin B1 particle for children. According to the benorilate vitamin B1 particle for children, a good curative effect is brought to cold fever, the cold fever is not easy to relapse, less toxic and side effects are caused and the preparation process is simple and feasible.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of children's's benorylate dimension B1 granule and preparation technology thereof.
Background technology
Fever is child's common disease, and the cause of disease is many to be caused by cause pathogeny imcrobe infection, causes that the pathogenic microorganism that child has a fever mainly contains antibacterial, virus and mycoplasma, chlamydia.Therapeutic Method most study to child's diseases caused by exogenous pathogenic factor fevers in prior art, mainly contains (1) Physical temperature-lowering, as warm water or alcohol bath, ice bag cooling, normal saline enema etc.; (2) drug cooling, as medicines such as oral antipyretic, Metamizole nasal drip or intramuscular injection, intravenous drip dexamethasone, takes antibiont medicine simultaneously and treats infection; (3) herbal treatment: as oral Chinese medicine preparation, the external application of Chinese medicine etc.But above-mentioned therapeutic modality all exists more defect, Physical temperature-lowering or simple Chinese medicine effect are poor, by reduction body temperature that can not be efficiently and effectively, occur again soon that body temperature gos up after bringing down a fever, and body temperature fluctuation is larger.Antibiotic therapy mainly adopts oral administration or intramuscular injection, the large approach of intravenous drip two.Infant oral antibiotic often can cause gastrointestinal reaction, the serious toxic and side effects such as also can cause allergic reaction, simultaneously infant take medicine more bothersome, difficulty or ease operation, intramuscular injection or intravenous drip antibiotic, have a big risk, operation easier is high, the infant uneasiness of crying and screaming, the utmost point is mismatched.
Benorylate dimension B1 granule is the clinical children's cold drug for abating fever of commonly using, and the heating causing for common cold or influenza, also for alleviating mild to moderate pain as headache, arthralgia, migraine, toothache, myalgia and neuralgia etc.But the shortcoming that it has general Western medicine, exists that drug effect is lasting not, the easily defect such as repeatedly of fever, need to repeatedly take medicine, and easily increases the weight of children's's liver kidney burden, brings larger side effect.
Summary of the invention
In order to overcome the deficiencies in the prior art, the pharmaceutical composition that the invention discloses a kind of rapid-action, stable curative effect, has no side effect, is specifically related to a kind of children's's benorylate dimension B1 granule and preparation technology thereof.
The present invention implements by following technical solution, a kind of children's's benorylate dimension B1 granule, and it is prepared from by following composition: benorylate 0.3kg, vitamin B
13g, sucrose 2.69kg, essence 3g and lemon yellow 0.25g.
Preferably, a kind of children's's benorylate dimension B1 granule, it is prepared from by following composition: benorylate 0.3kg, vitamin B
13g, sucrose 2.69kg, essence 3g, lemon yellow 0.25g, Caulis Mahoniae 200g, Rhizoma Chuanxiong 180g, Radix Curcumae 160g, 150 grams of the Cortexs Eucommiae, 120 grams, Flos Carthami, 120 grams of Radix Achyranthis Bidentataes, 100 grams of Radix Bupleuri, Rhizoma Coptidis 80g, 80 grams of Squama Maniss, Radix Angelicae Dahuricae 60g, Radix Ginseng 50g, Fructus Trichosanthis 30g.
The invention also discloses a kind of preparation technology of children's's benorylate dimension B1 granule.
Technical solutions according to the invention are on the clinical experience basis of Chinese traditional treatment infantile common cold heating, the compound preparation with Chinese medicine and western medicine combination of developing in conjunction with modern pharmacy achievement.The present invention adopts the Chinese crude drug of different properties, has carried out science compatibility with traditional western medicine composition, can reach desirable therapeutic effect, and lasting medicine, is not easy repeatedly, the advantage such as toxic and side effects is little.
Tool of the present invention has the following advantages:
The cat fever curative effect of combination of Chinese and Western medicine medicine of the present invention is good, and fever is not easy repeatedly, and toxic and side effects is little.
Preparation technology's simple possible of medicine of the present invention, and cheap, can be applicable to large-scale industrialized production.
The present invention improves at existing children's's benorylate dimension B1 granule, by a large amount of experiments, add the Chinese herbal medicine of suitable species and dosage, adopt peculiar methods to prepare, obtain the splendid pharmaceutical composition of effect, bring down a fever and be greatly better than existing benorylate dimension B1 granule with analgesic effect.
The present invention, by the choose reasonable to medicine components, proportioning, has obtained desirable therapeutic effect, has both met state-promulgated pharmacopoeia to the requirement about drug dose, can ensure again good therapeutic effect, non-evident effect.
Detailed description of the invention
Below the mode that adopts specific embodiment is further explained and is set forth the present invention, still, it should be noted that it should not be construed is the restriction to initiative spirit of the present invention.
Embodiment 1
A kind of children's's benorylate dimension B1 granule, it is prepared from by following composition: benorylate 0.3kg, vitamin B
13g, sucrose 2.69kg, essence 3g and lemon yellow 0.25g.
A preparation technology for children's's benorylate dimension B1 granule, it comprises the steps:
(1) sieve: benorylate, vitamin B1 are crossed 100 mesh sieves, sucrose was pulverized 100 mesh sieves, for subsequent use;
(2) mix: take benorylate 0.3kg, vitamin B
13g and sucrose 2.69kg, first by benorylate and vitamin B
1mix homogeneously, then add sucrose mix homogeneously;
(3) soft material processed: 30% the alcoholic solution 250ml that is added with 0.25g lemon yellow is joined in the above-mentioned powder mixing to soft material processed;
(4) granulate: soft material is crossed to the wet grain of 20 mesh sieve systems;
(5) dry: the grain that will wet is placed in dry 5h at 60 DEG C;
(6) granulate: dry granule is crossed to 16 mesh sieve granulate;
(7) taste masking: 3g essence is dissolved in to the ethanol of 8ml95%, then sprays in granule and mix, airtight 4 hours;
(8) subpackage: granule is packed in compound membrane bag, and sealing, obtains 1000 bags of children's's benorylate dimension B1 granules.
Embodiment 2
A kind of children's's benorylate dimension B1 granule, it is prepared from by following composition: benorylate 0.3kg, vitamin B
13g, sucrose 2.69kg, essence 3g, lemon yellow 0.25g, Caulis Mahoniae 200g, Rhizoma Chuanxiong 180g, Radix Curcumae 160g, 150 grams of the Cortexs Eucommiae, 120 grams, Flos Carthami, 120 grams of Radix Achyranthis Bidentataes, 100 grams of Radix Bupleuri, Rhizoma Coptidis 80g, 80 grams of Squama Maniss, Radix Angelicae Dahuricae 60g, Radix Ginseng 50g, Fructus Trichosanthis 30g.
A preparation technology for children's's benorylate dimension B1 granule, it comprises the steps:
(1) sieve: benorylate, vitamin B1 are crossed 100 mesh sieves, sucrose was pulverized 100 mesh sieves, for subsequent use;
(2) mix: get Caulis Mahoniae 200g, Rhizoma Chuanxiong 180g, Radix Curcumae 160g, 150 grams of the Cortexs Eucommiae, 120 grams, Flos Carthami, 120 grams of Radix Achyranthis Bidentataes, 100 grams of Radix Bupleuri, Rhizoma Coptidis 80g, 80 grams of Squama Maniss, Radix Angelicae Dahuricae 60g, Radix Ginseng 50g, Fructus Trichosanthis 30g, mix, the decocting that adds 10 times of weight boils 5 hours, filter, collect filtrate, filtrate is concentrated into the clear paste that relative density is 1.1g/ml at 60 DEG C, then 70 DEG C of vacuum dryings become dry extract, pulverize 100 mesh sieves and obtain medicated powder; Finally in medicated powder, add benorylate 0.3kg, vitamin B
13g and sucrose 2.69kg, mix homogeneously;
(3) soft material processed: 30% the alcoholic solution 250ml that is added with 0.25g lemon yellow is joined in the above-mentioned powder mixing to soft material processed;
(4) granulate: soft material is crossed to the wet grain of 20 mesh sieve systems;
(5) dry: the grain that will wet is placed in dry 5h at 60 DEG C;
(6) granulate: dry granule is crossed to 16 mesh sieve granulate;
(7) taste masking: 3g essence is dissolved in to the ethanol of 8ml95%, then sprays in granule and mix, airtight 4 hours;
(8) subpackage: granule is packed in compound membrane bag, and sealing, obtains 1000 bags of children's's benorylate dimension B1 granules.
Take mode: three times on the one, one after each meal, each 0.5 bag.
Embodiment 3
The pharmacological evaluation of medicine prepared by embodiment 1 and embodiment 2
One, toxicity test:
This experiment adopts healthy SD rat, drug dose gradient prepared by oral administration embodiment 1 and embodiment 2 is 0.01g/kg and 0.1g/kg, successive administration 30 days, during observing rat administration and after drug withdrawal, within 1 week, growth of animal state, movable diet, hematology, blood biochemical, organs and tissues structure and routine urinalysis etc. all have no significant effect, and show that clinical drug safety is reliable.
Two, analgesic experiment:
BALB/c mouse acetic acid is caused to the effect of writhing response: 60 of BALB/c mouse, male and female half and half, average weight is 28.3g, is divided at random 3 groups, is respectively normal saline group, embodiment 1 medicine group, embodiment 2 medicine groups; Be administered once every day, dosage is that (experimental group gives medicine to 0.01g/kg, matched group gives the normal saline of equivalent weight), gastric infusion 3 days continuously, in last gastric infusion after 1 hour, lumbar injection 0.6% glacial acetic acid 0.2ml/ only, observes mouse writhing number of times in 20min, the results are shown in Table 1.
Table 1 mouse writhing number of times statistics
| Group | Mice number (only) | Writhing number of times (30min) |
| Normal saline group | 20 | 31.3 |
| Embodiment 1 | 20 | 13.2 |
| Embodiment 2 | 20 | 6.8 |
Conclusion: tested and can be found by mouse writhing, medicine prepared by embodiment 1 and embodiment 2 can obviously ease pain, but the analgesic effect of embodiment 2 is obviously better than embodiment 1.
Three, the experiment of bringing down a fever
Fever model is set up: 30 of kunming mices, and male and female half and half, 26-28g/ is only, be divided at random three groups, take temperature, subcutaneous injection 2 respectively, 4-dinitrophenol, 30mg/kg, after 0.5 hour, detect body temperature, it is that (experimental group gives medicine to 0.01g/kg that while gavage gives drug dose, matched group gives the normal saline of equivalent weight), after 15 minutes, detect body temperature.Concrete data see table 2.
The bring down a fever effect of table 2 medicine to mice
Embodiment 4
Clinical trial
Case type: totally 32 examples, wherein boy's 15 examples, young girl's 17 examples, 8 months-3 years old age, 1 years old 9 months mean age.Be divided at random two groups, every group of 16 people, take embodiment 1 for first group and prepare medicine, take embodiment 2 for second group and prepare medicine.
Clinical symptoms: because of affection of exogenous wind-cold, the cold symptoms such as the nasal obstruction, watery nasal discharge, cough then occurring, 38.0 DEG C-40.3 DEG C of body temperature, patient's flushed face with red ears, the uneasiness of crying and screaming.
Therapeutic Method: three times on the one, one after each meal, each 0.5 bag; Treatment three days is a course for the treatment of continuously.
Efficacy assessment standard: effective: heating paresthesia through treatment after, children's recovers normally completely, within two weeks without body temperature phenomenon repeatedly.Take a turn for the better: infant heating paresthesia disappears, the cold symptoms such as nasal obstruction, watery nasal discharge, cough do not take a turn for the better completely, within two weeks, have body temperature phenomenon repeatedly.Invalid: the state of an illness is without any improvement.Concrete data see table 3.
Table 3
Although, above with general explanation and detailed description of the invention, this case being done to detailed explanation, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, the amendment done without departing from theon the basis of the spirit of the present invention or improvement, all belong to the scope of protection of present invention.
Claims (2)
1. children's's benorylate dimension B1 granule, it is prepared from by following composition: benorylate 0.3kg, vitamin B
13g, sucrose 2.69kg, essence 3g, lemon yellow 0.25g, Caulis Mahoniae 200g, Rhizoma Chuanxiong 180g, Radix Curcumae 160g, 150 grams of the Cortexs Eucommiae, 120 grams, Flos Carthami, 120 grams of Radix Achyranthis Bidentataes, 100 grams of Radix Bupleuri, Rhizoma Coptidis 80g, 80 grams of Squama Maniss, Radix Angelicae Dahuricae 60g, Radix Ginseng 50g, Fructus Trichosanthis 30g.
2. the preparation technology of children's's benorylate dimension B1 granule as claimed in claim 1, it comprises the steps:
(1) sieve: benorylate, vitamin B
1cross 100 mesh sieves, sucrose was pulverized 100 mesh sieves, for subsequent use;
(2) mix: Caulis Mahoniae 200g, Rhizoma Chuanxiong 180g, Radix Curcumae 160g, 150 grams of the Cortexs Eucommiae, 120 grams, Flos Carthami, 120 grams of Radix Achyranthis Bidentataes, 100 grams of Radix Bupleuri, Rhizoma Coptidis 80g, 80 grams of Squama Maniss, Radix Angelicae Dahuricae 60g, Radix Ginseng 50g, Fructus Trichosanthis 30g, the decocting that adds 10 times of weight boils 5 hours, filter, collect filtrate, filtrate is concentrated into the clear paste that density is 1.1g/ml at 60 DEG C, then 70 DEG C of vacuum dryings become dry extract, pulverize 100 mesh sieves and obtain medicated powder; Finally in medicated powder, add benorylate 0.3kg, vitamin B
13g and sucrose 2.69kg, mix homogeneously;
(3) soft material processed: 30% the alcoholic solution 250ml that is added with 0.25g lemon yellow is joined in the above-mentioned powder mixing to soft material processed;
(4) granulate: soft material is crossed to the wet grain of 20 mesh sieve systems;
(5) dry: the grain that will wet is placed in dry 5h at 60 DEG C;
(6) granulate: dry granule is crossed to 16 mesh sieve granulate;
(7) taste masking: 3g essence is dissolved in to the ethanol of 8ml 95%, then sprays in granule and mix, airtight 4 hours;
(8) subpackage: granule is packed in compound membrane bag, seal and get final product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310148183.7A CN103230568B (en) | 2013-04-18 | 2013-04-18 | Benorilate vitamin B1 particle for children and preparation process thereof |
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|---|---|---|---|
| CN201310148183.7A CN103230568B (en) | 2013-04-18 | 2013-04-18 | Benorilate vitamin B1 particle for children and preparation process thereof |
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| CN103230568B true CN103230568B (en) | 2014-09-17 |
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Owner name: SHANDONG XIANGYU HEALTH PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: LIN FANYOU Effective date: 20140709 |
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Effective date of registration: 20140709 Address after: 276023 No. 30, Hangzhou Road, Linyi economic and Technological Development Zone, Linyi, Shandong Applicant after: Shandong Xiangyu Health Pharmaceutical Co., Ltd. Address before: 276023 Beijing road Shandong Linyi Province, Linyi City Economic Development Zone No. 30 Shandong Xiangyu Health Pharmaceutical Co. Ltd. Applicant before: Lin Fanyou |
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Address after: 276023 No. 30, Hangzhou Road, Linyi economic and Technological Development Zone, Linyi, Shandong Patentee after: Xiang Yu Pharmaceutical limited company Address before: 276023 No. 30, Hangzhou Road, Linyi economic and Technological Development Zone, Linyi, Shandong Patentee before: Shandong Xiangyu Health Pharmaceutical Co., Ltd. |
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