CN103006773A - Traditional Chinese granule for children for clearing heat - Google Patents
Traditional Chinese granule for children for clearing heat Download PDFInfo
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Abstract
The invention discloses a traditional Chinese granule for children for clearing heat, belonging to the field of traditional Chinese medicines. The traditional Chinese medicine is prepared by taking honeysuckle, radix scutellatiae, radix bupleuri, isatis root, antelope horn powder, bezoar, buffalo horn concentration powder and borneol as raw materials through improved technology, valuable medicinal materials of antelope horn and buffalo horn are processed by low temperature superfine grinding technology, so that the powder quality of the material is improved; thermosensitive components are effectively protected from being damaged by adopting spray drying technology, so that the problems of difficulty in drying, strong hygroscopicity, poor liquidity, long drying time, uneven medicine powder color and the like of traditional granule are solved, granules which have good liquidity and low moisture content and uniform size can be obtained in shorter time, therefore, the quality of the granule for children for clearing heat is greatly improved. Through the increase of content determination terms of medicinal components such as baicalin in radix scutellariae, chlorogenic acid in honeysuckle and bilirubin in bezoar in the main drug of the formula, the quality control of the granule for children for clearing heat is greatly improved. Clinical application shows that the total effective rate achieves 94.29%, and the obvious effective rate achieves 80%.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, belong to the field of Chinese medicines, be specifically related to the peaceful Chinese medicinal granule of a kind of children clearing heat.
Background technology
Child acute upper respiratory tract infection is one of common disease in children, and its sickness rate accounts for the first place of pediatric disease.Cardinal symptom has heating, cough, and the nasal obstruction watery nasal discharge, pharyngalgia, headaches etc. cause serious complication such as pneumonia, myocarditis, encephalitis etc. and threat to life if treat untimely meeting.Drug therapy is the Main Means that department of pediatrics is prevented and cured diseases.Because the child is in the ramp stage of development, each system of body, each organ is not yet grown perfect, individual variation is large, and tolerance is poor, and the Western medicine side effect is large, therefore cure the symptoms, not the disease, select that good effect, side effect are little, the modern traditional Chinese patent medicine of taking convenience, most important to the smooth rehabilitation of infant.
Chinese medicine is the national treasure of China, and the Traditional Chinese Medicine Anti virus function is the study hotspot of China's traditional medicine, is with a wide range of applications.No matter children clearing heat is rather from pharmacodynamic study or clinical practice report, its heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, dispelling wind and heat pathogens, endogenous wind stopping spasmolytic, the sterilization disease-resistant toxic action is all very obvious, improved children's's non-specific immunity, toxemic symptoms can be alleviated rapidly, effectively control the generation of infecting, and do not found obvious untoward reaction.Xiaoer Qingrening Granula is applicable to common cold, common cold due to wind heat, viral influenza, acute pharyngolaryngitis, acute tonsillitis, the various diseases such as parotitis.Cornu Saigae Tataricae powder is for controlling liver-wind stirring up internally in the side, and the principal agent that infantile convulsion is twitched is because this product has the heat clearing away effect concurrently, therefore be usually used in that high fever does not move back, the card of thermoae wind symptom; The artificial Calculus Bovis has the effect of heat-clearing and toxic substances removing, endogenous wind stopping relieving convulsion, is used for the cards such as epidemic febrile disease and infantile convulsion, high fever coma, spasm tic; Flos Lonicerae can heat-clearing and toxic substances removing, and the effect of light a surname's evacuation is arranged; Radix Scutellariae energy heat clearing and damp drying, eliminating fire and detoxication; Radix Bupleuri has the expelling pathogenic factors from the exterior effect of purging heat to fever caused by exogenous pathogens; Radix Isatidis has antipyretic and antidote functions; Cornu Bubali powder treatment epidemic febrile disease and children's's heat syndrome are respond well; Borneolum Syntheticum can have one's ideas straightened out refreshment, clearing away heat to alleviate pain.All medicines share, and have the effect of heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, dispelling wind and heat pathogens, endogenous wind stopping spasmolytic, and the sterilization disease-resistant toxic action is more obvious.
At present, in the Xiaoer Qingrening Granula national drug standards, the preparation of the valuable animal medicated powder such as Cornu Saigae Tataricae, Cornu Bubali, what adopt is the Ordinary pulverization technology, affect the powder quality of material, and causes easily in present preparation technology that material softens, melting, even variable color, coking etc., heat-sensitive ingredients is easily destroyed, and dries difficult, the problems such as hygroscopicity is large, poor fluidity, drying time is long, the medicated powder color and luster is inhomogeneous, thereby affects the product quality of Xiaoer Qingrening Granula.
At present in the Xiaoer Qingrening Granula national drug standards; the record of assay item is not arranged; only there is the thin layer of baicalin in Scutellaria baicalensis Georgi to differentiate a quality control index; increase Chlorogenic Acid of Flos Lonicerae; the high-efficient liquid phase technique assay of the effective ingredient such as baicalin in Scutellaria baicalensis Georgi and Calculus Bovis mesobilirubin; improve the quality of Xiaoer Qingrening Granula, very necessary.Need to improve its preparation technology and quality control at present.
Summary of the invention
The object of the invention is existing Xiaoer Qingrening Granula preparation technology is improved, and improves the Xiaoer Qingrening Granula quality by improving its preparation technology.
Be to realize the object of the invention, it is that raw material is prepared from that Xiaoer Qingrening Granula of the present invention is selected following Chinese medicine component, and each component is in weight portion:
25 parts of Cornu Saigae Tataricae powders, 25 parts of Calculus Boviss, 3000 parts of Flos Loniceraes, 2500 parts of Radix Scutellariaes, 2500 parts of Radix Bupleuri, 3500 parts of Radix Isatidis, 250 parts of Pulvis Cornus Bubali Concentratuss, 5 parts of Borneolum Syntheticums, apple essence is an amount of.
The present invention prepares by following method:
Get the Cornu Saigae Tataricae of formula ratio; Cornu Bubali adopts the superfine comminution at low temperature technology to pulverize; formula ratio Radix Bupleuri; clean; run through, cut sheet, add 8 times of water gagings; warm macerating; extract volatile oil, the aqueous solution after the distillation in addition device is collected Flos Lonicerae; Radix Scutellariae; respectively remove impurity of Radix Isatidis; Radix Scutellariae; mix homogeneously after the Radix Isatidis section; decoct with water 2 times, for the first time 2.5h, for the second time 1.5h; filter; filtrate and above-mentioned aqueous solution merge, and this mixed liquor is concentrated into 50 ℃ under 60-80 ℃ of condition; relative density is 1.05～1.10 clear paste, and this clear paste spray drying is got dry extract; dried cream; dextrin; sucrose weight ratio is 1:1:4; dextrin; sucrose and Cornu Saigae Tataricae powder; Calculus Bovis; after the Cornu Bubali powder facing-up is even, adds dried cream and mix, add again ethanol as binding agent; granulate; granulate; dry; spray into Bing Pian ﹑ volatile oil; apple essence solution, mixing, and get final product.Specification is 8 g/bags; 4 g/bags.Adopt baicalin, chlorogenic acid and Calculus Bovis mesobilirubin content in the Syrups by HPLC product, make that per 0.5 gram contains chlorogenic acid (C in the product
16H
18O
9) be no less than 0.30 milligram; Per 0.5 gram contains baicalin (C
21H
18O
11) be no less than 3.0 milligrams; Per 0.5 gram contains bilirubin (C
33H
36N
4O
6) be no less than 0.42 milligram.
Invention advantage of the present invention and innovative point: adopt superfine comminution at low temperature technical finesse valuable medicinal Cornu Saigae Tataricae and Cornu Bubali, can make the powder body effective grain size less, particle size distribution is narrower, particle surface is more smooth, powder flowbility is improved greatly, cell has reached breaking cellular wall, more is conducive to the stripping of effective ingredient after the cell wall breaking; Operate under the low temperature, can keep the effective ingredient of material and biological activity constant, when improving crush efficiency, can avoid that material is softening, melting, even the problems such as variable color, coking, thereby improve the powder quality of material.Employing spray drying technology rate of drying is fast, the time is short; effectively the protection heat-sensitive ingredients is not destroyed; overcome the problems such as the tradition oven dry is difficult, hygroscopicity is large, poor fluidity, drying time is long, the medicated powder color and luster is inhomogeneous; obtain that good fluidity, water content are low, the granule of big or small uniformity within a short period of time, thereby the quality of Xiaoer Qingrening Granula is improved greatly.And by increasing the assay item of the active ingredient such as principal agent baicalin in Scutellaria baicalensis Georgi, Chlorogenic Acid of Flos Lonicerae and Calculus Bovis mesobilirubin in the prescription, thereby the quality control of Xiaoer Qingrening Granula is obviously improved.Through clinical practice, total effective rate reaches 94.29%, and obvious effective rate reaches 80%.
The specific embodiment
For the present invention is better illustrated, as follows for embodiment:
Embodiment 1:
Choose: Cornu Saigae Tataricae powder 2.5g, Calculus Bovis 2.5g, Flos Lonicerae 300g, Radix Scutellariae 250g, Radix Bupleuri 250g, Radix Isatidis 350g, Pulvis Cornus Bubali Concentratus 25g, Borneolum Syntheticum 0.5g, apple essence are Chinese medicine composition raw material of the present invention in right amount.Preparation method is as follows:
Get the Cornu Saigae Tataricae of formula ratio, Cornu Bubali adopts the superfine comminution at low temperature technology to pulverize (temperature :-20 ℃, time: 50min, granularity: 600 orders), formula ratio Radix Bupleuri, clean, run through, cut sheet, add 8 times of water gagings, behind warm macerating (60 ℃) 2h, extract volatile oil, distillation 6.5h, the aqueous solution after the distillation filters, device is collected in addition, Flos Lonicerae, Radix Scutellariae, Radix Isatidis is remove impurity (Radix Scutellariae respectively, the Radix Isatidis section) mix homogeneously after decocts with water 2 times, adds 8 times of amount drinking waters for the first time, decoct 2.5h, add for the second time 7 times of amount drinking waters, decoct 1.5h, filter, filtrate and above-mentioned aqueous solution merge, this mixed liquor in 60 ℃, is concentrated into relative density and is 1.06(50 ℃ of heat and survey under vacuum-0.08Mpa condition) clear paste, with this clear paste spray drying (inlet temperature: 150 ℃ that gets dry extract; Leaving air temp: 75 ℃; Nozzle bore: 0.7mm; Expulsion pressure: 180KPa; Inlet amount: 4.0 * 180ml/h), with dried cream, dextrin, the sucrose ratio with 1:1:4, after first even dextrin, sucrose and Cornu Saigae Tataricae powder, Calculus Bovis, Cornu Bubali powder facing-up, add dried cream and mix, add again ethanol (0.1kg) as binding agent, granulation, granulate, drying, spray into Bing Pian ﹑ volatile oil, apple essence solution, mixing, and get final product, pack (8 g/bags; 4 g/bags).
Adopt baicalin, chlorogenic acid and Calculus Bovis mesobilirubin content in the Syrups by HPLC product.Per 0.5 gram contains chlorogenic acid (C
16H
18O
9) 0.41 milligram; Per 0.5 gram contains baicalin (C
21H
18O
11) 3.9 milligrams; Per 0.5 gram contains bilirubin (C
33H
36N
4O
6) 0.51 milligram.
The thin layer of Chlorogenic Acid of Flos Lonicerae is differentiated:
Get this product particle powder 10g, porphyrize adds methanol 20ml, and supersound process 10min filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the chlorogenic acid reference substance, add methanol and make the solution that every 1ml contains 1mg, product solution in contrast, (an appendix VI of Chinese Pharmacopoeia B) tests according to thin layer chromatography, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same polyamide film, take ethyl acetate-formic acid-water (10:0.5:0.5) as developing solvent, launch, taking-up is dried.Put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
(1) Syrups by HPLC chlorogenic acid content:
Chromatographic condition and system suitability: be filler with octadecylsilane chemically bonded silica; Mobile phase is acetonitrile-water-phosphoric acid (80:400:1); The detection wavelength is 327nm, and flow velocity is 1.0ml/min.
The preparation of reference substance solution: precision takes by weighing low-temperature vacuum drying 24h to the chlorogenic acid reference substance 6.45mg of constant weight, be placed in the volumetric flask of 50ml, add 50% methanol and make it in right amount dissolving, add again 50% methanol to scale, both got (every 1ml contains chlorogenic acid 0.129mg).
The preparation of need testing solution: get the particle powder under this product quantity variance item, mixing, precision takes by weighing 0.50g, be placed in the volumetric flask of 25ml, add 50% methanol to scale, seal with plug, in 30 ℃ of supersound extraction 40min, take out, let cool, complement to scale with 50% methanol, shake up, filter, get subsequent filtrate, and get final product.
Algoscopy: get respectively each 20 μ l of reference substance solution and need testing solution, the injection liquid chromatography by above-mentioned chromatographic condition measure and calculation, namely gets the content of chlorogenic acid.
(2)The Syrups by HPLC content of baicalin:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; Take methanol-water-phosphoric acid (52:48:0.1) as mobile phase, the detection wavelength is 278nm, and flow velocity is 1.0ml/min.Number of theoretical plate calculates by the baicalin peak should be not less than 2000, and separating degree is greater than 1.5.
The preparation of reference substance solution: precision takes by weighing at 4 hours baicalin reference substance 50. 02mg of 60 ℃ of drying under reduced pressure, places the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, as storing solution.Precision measures 2ml and places the 25ml measuring bottle, adds methanol to scale, shakes up, and namely gets reference substance solution.
The preparation of need testing solution: get the particle powder under this product quantity variance item, porphyrize, precision takes by weighing 1g, put in the 50ml measuring bottle, add 80% methanol an amount of, supersound process 20 minutes adds methanol to scale, shake up, filter, precision measures subsequent filtrate 10ml in the 25ml measuring bottle, adds 80% methanol to scale, shake up, namely get need testing solution.
Algoscopy: precision is drawn reference substance solution and each 10 μ l of need testing solution respectively, and the injection liquid chromatography is measured, and be get final product.
(3) Syrups by HPLC content of bilirubin:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; Take methanol-chloroform-10% phosphoric acid (80:14:6) as mobile phase, the detection wavelength is 450nm, and flow velocity is 1.0ml/min.
The preparation of reference substance solution: precision takes by weighing approximately 10mg of bilirubin reference substance, puts in the 100ml measuring bottle, adds chloroform supersound process 10min and makes dissolving, and be diluted to scale with chloroform, and shaking up, precision measures 5 ml, place 100 ml measuring bottles, add chloroform and be diluted to scale, shake up, precision measures 5 ml, put in the 100 ml measuring bottles, add chloroform and be diluted to scale, shake up, namely get reference substance solution.
The preparation of need testing solution: get the particle powder of 10 g under this product quantity variance item, accurately weighed, porphyrize, precision takes by weighing an amount of approximately 2 g, puts in the brown measuring bottle of 50 ml, adds approximately 40ml of chloroform, supersound process 10 min let cool rapidly to room temperature, add chloroform and are diluted to scale, shake up, filter, precision measures 10 ml, put in the brown measuring bottle of 100 ml, add chloroform and be diluted to scale, shake up, namely get need testing solution.
Algoscopy: precision is drawn reference substance solution and each 10 μ l of test sample solution respectively, and the injection liquid chromatography is measured, and be get final product.
Embodiment 2:
Choose: Cornu Saigae Tataricae powder 5g, Calculus Bovis 5g, Flos Lonicerae 600g, Radix Scutellariae 500g, Radix Bupleuri 500g, Radix Isatidis 700g, Pulvis Cornus Bubali Concentratus 50g, Borneolum Syntheticum 1g, apple essence are Chinese medicine composition raw material of the present invention in right amount.Preparation method is as follows:
Get the Cornu Saigae Tataricae of formula ratio, Cornu Bubali adopt the superfine comminution at low temperature technology pulverize (temperature :-15 ℃, time: 40min, granularity: 500 orders), formula ratio Radix Bupleuri, clean, run through, cut sheet, add 8 times of water gagings, behind warm macerating (50 ℃) 2h, extract volatile oil, distillation 6.5h, aqueous solution after the distillation filters, device is collected in addition, Flos Lonicerae, Radix Scutellariae, respectively remove impurity of Radix Isatidis, Radix Scutellariae, mix homogeneously after the Radix Isatidis section, decoct with water 2 times, add for the first time 8 times of amount drinking waters, decoct 2.5h, add 7 times of amount drinking waters for the second time, decoct 1.5h, filter, filtrate and the merging of above-mentioned aqueous solution, with this mixed liquor in 60 ℃, being concentrated into relative density under vacuum-0.07Mp a condition and being 1.05(50 ℃ of heat surveys) clear paste, with this clear paste spray drying (inlet temperature: 160 ℃ that gets dry extract; Leaving air temp: 75 ℃; Nozzle bore: 0.7mm; Expulsion pressure: 190KPa; Inlet amount: 4.5 * 180ml/h), with dried cream, dextrin, the sucrose ratio with 1:1:4, after first even dextrin, Icing Sugar and Cornu Saigae Tataricae powder, Calculus Bovis, Cornu Bubali powder facing-up, add dried cream and mix, add again ethanol (0.2kg) as binding agent, granulation, granulate, drying, spray into Bing Pian ﹑ volatile oil, apple essence solution, mixing, and get final product, pack (8 g/bags; 4 g/bags).
Adopt baicalin, chlorogenic acid and Calculus Bovis mesobilirubin content in the Syrups by HPLC product.Per 0.5 gram contains chlorogenic acid (C
16H
18O
9) 0.37 milligram; Per 0.5 gram contains baicalin (C
21H
18O
11) 3.7 milligrams; Per 0.5 gram contains bilirubin (C
33H
36N
4O
6) 0.49 milligram.
Assay method is with embodiment 1.
Embodiment 3:
Choose: Cornu Saigae Tataricae powder 10g, Calculus Bovis 10g, Flos Lonicerae 1200g, Radix Scutellariae 1000g, Radix Bupleuri 1000g, Radix Isatidis 1400g, Pulvis Cornus Bubali Concentratus 100g, Borneolum Syntheticum 2g, apple essence are Chinese medicine composition raw material of the present invention in right amount.Preparation method is as follows:
Get the Cornu Saigae Tataricae of formula ratio, Cornu Bubali adopt the superfine comminution at low temperature technology pulverize (temperature :-25 ℃, time: 50min, granularity: 600 orders), formula ratio Radix Bupleuri, clean, run through, cut sheet, add 8 times of water gagings, behind warm macerating (50 ℃) 2h, extract volatile oil, distillation 6.5h, aqueous solution after the distillation filters, device is collected in addition, Flos Lonicerae, Radix Scutellariae, respectively remove impurity of Radix Isatidis, Radix Scutellariae, mix homogeneously after the Radix Isatidis section, decoct with water 2 times, add for the first time 8 times of amount drinking waters, decoct 2.5h, add 7 times of amount drinking waters for the second time, decoct 1.5h, filter, filtrate and the merging of above-mentioned aqueous solution, with this mixed liquor in 55 ℃, being concentrated into relative density under vacuum-0.09Mpa condition and being 1.06(50 ℃ of heat surveys) clear paste, with this clear paste spray drying (inlet temperature: 155 ℃ that gets dry extract; Leaving air temp: 80 ℃; Nozzle bore: 0.7mm; Expulsion pressure: 185KPa; Inlet amount: 4.0 * 180ml/h), with dried cream, dextrin, the sucrose ratio with 1:1:4, after first even dextrin, Icing Sugar and Cornu Saigae Tataricae powder, Calculus Bovis, Cornu Bubali powder facing-up, add dried cream and mix, add again ethanol (0.2kg) as binding agent, granulation, granulate, drying, spray into Bing Pian ﹑ volatile oil, apple essence solution, mixing, and get final product, pack (8 g/bags; 4 g/bags).
Adopt baicalin, chlorogenic acid and Calculus Bovis mesobilirubin content in the Syrups by HPLC product.Per 0.5 gram contains chlorogenic acid (C
16H
18O
9) 0.38 milligram; Per 0.5 gram contains baicalin (C
21H
18O
11) 3.9 milligrams; Per 0.5 gram contains bilirubin (C
33H
36N
4O
6) 0.50 milligram.
Assay method is with embodiment 1.
The refrigeration function research of the Xiaoer Qingrening Granula that the Xiaoer Qingrening Granula under the traditional handicraft and the present invention make
1. experiment material and method
1.1 trial drug
Former technique group: with Radix Bupleuri 250g; add 8 times of water gagings; extract volatile oil; aqueous solution after the distillation in addition device is collected; all the other are with Flos Lonicerae 300g; Radix Scutellariae 250g; Radix Isatidis 350g; three flavor medical materials decoct with water 2 times; 2.5 hours for the first time, 1.5 hours for the second time, filter; filtrate and above-mentioned aqueous solution merge; being concentrated into relative density and being 1.32～1.35(50 ℃ of heat surveys) clear paste, 1 part of qinghuo reagent adds 1 part in dextrin; 4 parts of sucrose; Pulvis Cornus Bubali Concentratus 25g; Cornu Saigae Tataricae powder 2.5g; Calculus Bovis 2.5g(three flavor medicated powder and dextrin; the cane sugar powder facing-up is even) and ethanol 0.1Kg; granulation; drying adds above-mentioned Radix Bupleuri volatile oil; Borneolum Syntheticum 0.5g and apple essence 10ml, mixing; make 1000g, and get final product.
Micronizing group of the present invention: with Pulvis Cornus Bubali Concentratus 25g, Cornu Saigae Tataricae powder 2.5g, adopt the superfine comminution at low temperature technology pulverize (temperature :-20 ℃, the time: 50min) cross behind 600 mesh sieves for subsequent use; With Radix Bupleuri 250g; add 8 times of water gagings; extract volatile oil; aqueous solution after the distillation in addition device is collected; all the other are with Flos Lonicerae 300g; Radix Scutellariae 250g; Radix Isatidis 350g; three flavor medical materials decoct with water 2 times, and 2.5 hours for the first time, 1.5 hours for the second time; filter; filtrate and above-mentioned aqueous solution merge, and being concentrated into relative density is that 1.05～1.10(50 ℃ of heat is surveyed) clear paste, this clear paste spray drying is got dry extract; get 1 part of dried cream; add 1 part in dextrin; 4 parts of sucrose; the Pulvis Cornus Bubali Concentratus of having pulverized; Cornu Saigae Tataricae powder; Calculus Bovis 2.5g(three flavor medicated powder and dextrin; the cane sugar powder facing-up is even) and ethanol 0.1Kg, granulation, drying; add above-mentioned Radix Bupleuri volatile oil; Borneolum Syntheticum 0.5g and apple essence 10ml; mixing is made 1000g, and get final product.
1.2 laboratory animal
New Zealand's large ear rabbit, body weight 2.0～2.5Kg, male and female all can, 48, Henan Condar laboratory animal company limited provides.The quality certification number: SCXK(Henan) 2011-001, raise a week in advance.
1.3 experiment reagent
2,4-DNP, Tianjin chemical reagent factory, lot number: 20111005
Bacterial endotoxin, Nat'l Pharmaceutical ﹠ Biological Products Control Institute, lot number: 2011-6
1.4 experimental apparatus
MC-3B type computer numeral formula clinical thermometer (Omron production).
1.5 experimental technique
1.5.1 2,4-DNP is caused the impact of fever in rabbits
Rabbit fever models due to the 2,4-DNP
Select body temperature in 38.0 ℃～39.0 ℃, and fluctuate＜0.3 ℃, 24 of rabbit are divided into 2 groups.Measure first rabbit anus temperature 2 times before the experiment, getting its meansigma methods is basal body temperature, each is organized ig and gives relative medicine, maximum dosage-feeding according to 14 years old child every day, determine behind the conversion dose,equivalent that dosage is: 1.4g/kg, dissolve with an amount of water during administration, give the rabbit back subcutaneous injection 2,4-DNP NaOH of family solution 20mg/kg behind the 0.5h.Then survey 1 anus temperature every 20min.Carry out altogether the mensuration in the 180min.Compare each time period fervescence value, experimental result input computer adopts the statistical disposition of t method of inspection.The results are shown in Table 1.
Table 1 Cornu Saigae Tataricae and Cornu Bubali micronizing whether on 2,4-DNP cause fever in rabbits impact (
, n=12)
Annotate: compare with the basal body temperature value:
1)P＜0.05; Compare with former technique group:
2)P＜0.05.
1.5.2 the impact on fever in rabbits due to the bacterial endotoxin
Select body temperature in 38.0 ℃～39.0 ℃, and fluctuate＜0.3 ℃, 24 of rabbit are divided into 2 groups.Test the same day, after measuring basal body temperature, getting its meansigma methods is basal body temperature, and each is organized ig and gives relative medicine, according to the maximum dosage-feeding of 14 years old child every day, determine behind the conversion dose,equivalent that dosage is: 1.4g/kg, dissolve with an amount of water during administration, prepare before use for behind the 0.5h rabbit ear source intravenous injection bacterial endotoxin normal saline solution 20Eu/kg(of family), begin to measure the anus temperature behind the 0.5h, measure 1 time every half an hour later on, relatively each time period fervescence value.Experimental result adopts the statistical disposition of t method of inspection, the results are shown in Table 2.
Whether table 2 Cornu Saigae Tataricae and Cornu Bubali micronizing cause the impact of fever in rabbits on bacterial endotoxin
( 
, n=12
)
Annotate: compare with the basal body temperature value:
1)P＜0.05; Compare with former technique group:
2)P＜0.05.
2. experimental result
Former technique group and micronizing group all have obvious inhibitory action to the fervescence that 2,4-DNP and bacterial endotoxin cause fever in rabbits as can be known by table 1,2.2,4-DNP is being caused in the rabbit pyrogenic test, and the micronizing group is better than former technique group (P＜0.05) at the successful aspect the inhibition fervescence.And refrigeration function begins existing obvious cooling trend from 60min, and the persistent period reaches 180min, and the effect of former technique group is not fairly obvious.Cause in the test of fever in rabbits at bacterial endotoxin, the micronizing group is better than former technique group (P＜0.05) at the successful that suppresses aspect the fervescence, and refrigeration function just has significant refrigeration function when 1h, refrigeration function rapidly and the persistent period reach 3h.
In these 2 experimental models, test according to different Heating mechanisms: the 2,4-DNP fever model belongs to noninfectious fever; The bacterial endotoxin model belongs to infective fever.From analgesic experimental result as can be known, Xiaoer Qingrening Granula is all effective to infective fever and noninfectious fever.But the Xiaoer Qingrening Granula of the Cornu Bubali of employing micronizing and Cornu Saigae Tataricae powder preparation is more obvious to the inhibitory action of infectious and noninfectious fever, and the continuous action time is longer, the purpose of fast treating disease be can reach, thereby safety and the effectiveness of clinical application improved.
Adopt Chinese medicine composition Xiaoer Qingrening Granula (pharmaceutical formulation: granule, every bag of 8g or the 4g) clinical test results of the inventive method preparation as follows:
The clinical test results for the treatment of diseases caused by exogenous pathogenic factor pathogenic warmth, internal organs excess-heat type interior-heat hyperpyrexia:
Case is selected:
All cases is is in hospital or emergency treatment observation patient.Be divided at random treatment group and matched group.Treatment group 105 examples, male 63 examples, women 42 examples, men and women's ratio is 1.5:1, age reckling 1 years old, the maximum 14 years old; 4.34 years old ± 5.45 years old mean age, 1～2 years old 28 example accounts for 26.67%, 3～5 years old 56 example, accounts for 53.33%, 6～14 years old 21 example, accounts for 20%, and be the shortest person of course of disease half a day, the longest 3 days.Body temperature is 38.5～39.5 ℃ of person's 89 examples, 39.6～41.2 ℃ of person's 16 examples.
Therapeutic Method:
Treatment group adopts the Xiaoer Qingrening Granula treatment of the inventive method preparation, one-year-old to two years old each 4g, 2 times on the one; Three years old to five years old each 4g, three times on the one; Six years old to 14 years old each 8g, 2-3 time on the one.Three days is a course for the treatment of.
Matched group: use the flos ionicerae and fructus forsythiae infusion for detoxication treatment, one-year-old to two years old each 6g, 2 times on the one; Three years old to six years old each 12g, 2 times on the one; Seven years old to 14 years old each 12g, every day 3 times.Three days is a course for the treatment of.
Curative effect observation:
Clinical recovery: treat in 3 days, temperature recovery is normal, the pharyngeal disappearance of swelling and ache, and clinical symptoms, pathology sign all disappear.
Produce effects: treat in 3 days, temperature recovery is normal, clinical symptoms, the most of disappearance of pathology sign.
Effectively: treat in 3 days, body temperature descends than before to some extent, but does not recover normal fully; Clinical cardinal symptom pathology sign partly disappears.
Invalid: treat in 3 days, body temperature does not fall or raises on the contrary, and clinical cardinal symptom, pathology sign are without improvement.
Clinical test results:
Table 3: two groups of therapeutic outcomes relatively
Treatment group and matched group ratio: P＜0.05
Table 4: body temperature variation comparison after the medication (± S)
Compare with matched group: P＜0.05
Table 5: cardinal symptom, sign are improved situation after the medication
Compare with matched group: P＜0.05
Through clinical observation, the treatment group total effective rate is 94.28%, and total obvious effective rate is 80%; The matched group total effective rate is 70%, total obvious effective rate is 50%, treatment group obviously is better than matched group (P＜0.05), aspect alleviating cardinal symptom, improving sign, two groups of curative effects are all better, but treatment group is to heating, cough, laryngopharynx swelling and pain, pharyngeal congestion better efficacy, and two groups of contrast P＜0.05 obviously are better than matched group.
Find from clinical observation, it is especially good to infantile hyperpyrexia caused by exogenous pathogenic factor's effect, obviously improves clinical symptoms, and has no the side effect such as diarrhoea, is treatment diseases caused by exogenous pathogenic factor pathogenic warmth, the safely and efficiently good medicine of the interior-heat hyperpyrexia that the internal organs excess-heat causes.
The clinical test results for the treatment of infantile acute upper respiratory infection:
Case is selected:
Select altogether infantile acute upper respiratory infection case 160 examples, be divided at random two groups, treatment group 80 examples, man's 35 examples, women 45 examples, matched group 80 examples, man's 42 examples, woman's 38 examples, clinical symptoms and the promoting the circulation of blood routine examinations such as heating, cough, pharyngalgia, pharyngeal congestion, antiadoncus all appear in 160 routine infants, two groups of ages, sex, clinical symptoms difference not statistically significant.
Therapeutic Method:
The Xiaoer Qingrening Granula 4g/ bag of the oral the inventive method preparation for the treatment of group (1～5 years old, 4g, bid; 〉=6 years old, 8g, bid), the oral SHUANGHUANGLIAN KOUFUYE of matched group (1～3 years old, 10ml, tid; 〉=3 years old, 15ml, bid) two groups all not use other medicines, 3d be 1 course for the treatment of.
Curative effect observation:
Record heating, cough, pharyngalgia, pharyngeal congestion, antiadoncus improvement situation are observed two groups and are treated forward and backward clinical symptoms and physical and chemical index improvement situation.The clinical development standard: cure: in the medication 72h, temperature recovery is normal, and observe 72h and no longer go up, cough, pharyngalgia, pharyngeal congestion, antiadoncus transference cure, unusual hemogram index recovers normal; Produce effects: in the medication 72h, temperature recovery is normal, and observe 72h and no longer go up, cough, pharyngalgia, pharyngeal congestion, the most of disappearance of antiadoncus symptom, unusual hemogram index approaches normal; Effectively: medication 72h, body temperature descend to some extent or are down to normally to go up to some extent again, and cough, pharyngalgia, pharyngeal congestion, antiadoncus symptom partly disappear, and unusual hemogram index makes moderate progress; Invalid: as not meet above index.
Clinical test results:
Table 6 liang group treatment infantile acute upper respiratory infection curative effect relatively
| Group | ｎ | Cure | Produce effects | Take a turn for the better | Invalid | Effectively total |
| Treatment group | 80 | 52 | 16 | 10 | 2 | 78 |
| Matched group | 80 | 33 | 14 | 15 | 18 | 62 |
1, aspect relief of symptoms and the shortening course of disease, treatment group all obviously is better than matched group, and antipyretic effect is then more rapid.
2, degree of safety is high, and untoward reaction is few, and antibacterial, the antivirus action of Xiaoer Qingrening Granula have been avoided antibiotic abuse, have improved clinical efficacy.
3, compliance is good, and Xiaoer Qingrening Granula is pure Chinese medicinal preparation, fruit-flavor type, and infant is taken like a shot, and feeds conveniently.
Children clearing heat is rather treated the clinical test results of herpetic stomatitis:
Case is selected: select altogether case 88 examples, treatment group 46 examples wherein, male's 26 examples, women's 20 examples, matched group 42 examples, male's 25 examples, women's 17 examples.Age is 6 months～and 6 years old.
Therapeutic Method: treatment group adopts the Xiaoer Qingrening Granula (4 g/bags) of the inventive method preparation, and 6 months～1 years old, 1/3 bag, 2 times on the 1st; 1～2 year old, 1/2 bag, 2 times on the 1st; 3～6 years old, 1/2 bag, 3 times on the 1st.Matched group Moroxydine 10～15mg/ (kgd), 3 times on the 1st.Two groups are aided with compound vitamin B simultaneously
1, vitamin C treatment, add during body temperature＞39 ℃ and use the medicine cooling therapeutic, have secondary infection person to take antibiotic.
Clinical test results:
Table 7 matched group and treatment group clinical test results
| Clinical effectiveness | Treatment group | Matched group |
| The routine number (example) of bringing down a fever in 2 days | 38 | 18 |
| On average bring down a fever natural law (my god) | 2.4 | 3.8 |
| The average healing days of oral mucosa herpes ulcer (my god) | 4.2 | 6.8 |
Two groups of cases are all cured, and other symptom (agitation, curtain coating, pharyngalgia, refusing to eat etc.) often reaches again oral mucosa herpes ulcer healing with body temperature and disappears.
Claims (3)
1. the peaceful Chinese medicinal granule of children clearing heat is characterized in that, it is prepared from by following raw materials according, and each component is in weight portion, 25 parts of Cornu Saigae Tataricae powders, 25 parts of Calculus Boviss, 3000 parts of Flos Loniceraes, 2500 parts of Radix Scutellariaes, 2500 parts of Radix Bupleuri, 3500 parts of Radix Isatidis, 250 parts of Pulvis Cornus Bubali Concentratuss, 5 parts of Borneolum Syntheticums; Be prepared from by the following method:
Each component is by above-mentioned formula ratio, with Cornu Saigae Tataricae, Cornu Bubali adopts the superfine comminution at low temperature technology to pulverize, with Radix Bupleuri, clean, run through, cut sheet, add 8 times of water gagings, warm macerating extracts volatile oil, aqueous solution after the distillation in addition device is collected, Flos Lonicerae, Radix Scutellariae, respectively remove impurity of Radix Isatidis, Radix Scutellariae, mix homogeneously after the Radix Isatidis section decocts with water 2 times, 2.5h for the first time, 1.5h filters for the second time, and filtrate and above-mentioned aqueous solution merge, this mixed liquor is concentrated into 50 ℃ of relative densities under 60-80 ℃ of condition be 1.05～1.10 clear paste, this clear paste spray drying is got dry extract dried cream, dextrin and sucrose weight ratio are 1:1:4, with dextrin, sucrose and Cornu Saigae Tataricae powder, Calculus Bovis, after the Cornu Bubali powder facing-up is even, adding dried cream mixes, add again ethanol as binding agent, granulate, granulate, drying sprays into Bing Pian ﹑ volatile oil, apple essence solution, mixing, and get final product; And adopt baicalin, chlorogenic acid and Calculus Bovis mesobilirubin content in the Syrups by HPLC product, make in the product per 0.5 gram contain chlorogenic acid and be no less than 0.30 milligram; Per 0.5 gram contains baicalin and is no less than 3.0 milligrams; Per 0.5 gram contains bilirubin and is no less than 0.42 milligram.
2. the peaceful Chinese medicinal granule of children clearing heat as claimed in claim 1 is characterized in that, described spray drying condition: inlet temperature: 140 ℃～160 ℃; Leaving air temp: 70～80 ℃; Nozzle bore: 0.7mm; Expulsion pressure: 170～190KPa; Inlet amount: (3.5～4.5) * 180ml/h.
3. the peaceful Chinese medicinal granule of children clearing heat as claimed in claim 1 is characterized in that, described superfine comminution at low temperature condition: temperature :-15 ℃～-25 ℃; Grinding time: 40～60min; Granularity: 400～800 orders.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104547895A (en) * | 2014-11-04 | 2015-04-29 | 姜文学 | Blood-stasis removing and collateral dredging pill |
| CN104922425A (en) * | 2015-05-22 | 2015-09-23 | 济南正骐生物科技有限公司 | Traditional Chinese medicine for treating infantile sphagitis and preparation method thereof |
| CN106620188A (en) * | 2016-12-22 | 2017-05-10 | 江西济民可信药业有限公司 | Method for preparing granules with effects of clearing heat and removing toxicity |
| CN109010050A (en) * | 2018-06-25 | 2018-12-18 | 广西圣保堂健康产业股份有限公司 | A kind of efficient preparation method for ensureing effective component energy conservation and environmental protection Chinese medicinal granule |
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| CN101697763A (en) * | 2008-04-21 | 2010-04-28 | 刘文乔 | Heat clearing and tranquillizing healthy tea for middle-aged and elderly people |
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| CN101697763A (en) * | 2008-04-21 | 2010-04-28 | 刘文乔 | Heat clearing and tranquillizing healthy tea for middle-aged and elderly people |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547895A (en) * | 2014-11-04 | 2015-04-29 | 姜文学 | Blood-stasis removing and collateral dredging pill |
| CN104922425A (en) * | 2015-05-22 | 2015-09-23 | 济南正骐生物科技有限公司 | Traditional Chinese medicine for treating infantile sphagitis and preparation method thereof |
| CN106620188A (en) * | 2016-12-22 | 2017-05-10 | 江西济民可信药业有限公司 | Method for preparing granules with effects of clearing heat and removing toxicity |
| CN106620188B (en) * | 2016-12-22 | 2018-11-20 | 江西济民可信药业有限公司 | A kind of preparation method of clearing heat and detoxicating particle |
| CN109010050A (en) * | 2018-06-25 | 2018-12-18 | 广西圣保堂健康产业股份有限公司 | A kind of efficient preparation method for ensureing effective component energy conservation and environmental protection Chinese medicinal granule |
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| CN103006773B (en) | 2014-10-15 |
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