CN100420456C - Compounded Radix Bupleuri enema preparation and preparing method - Google Patents
Compounded Radix Bupleuri enema preparation and preparing method Download PDFInfo
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Abstract
The present invention relates to a compounded radix bupleuri enema preparation and a preparing method thereof. The compounded radix bupleuri enema preparation is composed of effective components of radix bupleuri, artificial bezoar and baical skullcap root. With the advantages of few impurity, high purity, high absorption rate and high rate of biological utilization, the present invention has the curative effects of removing heat, removing toxic matter, invigorating qi and solidifying exterior. The preparation has the characteristics of stable quality, convenient application for children, beautiful appearance, etc.
Description
Technical field
The present invention relates to a kind of be used for the treatment of wind-heat invading the lung and cause heating, the cough, diseases such as pharyngalgia; Upper respiratory tract infection, the heating of influenza and malaria etc.; Acute tonsillitis, diseases such as pharyngitis, onset is rapid, determined curative effect, and medicine that has no side effect and preparation method thereof relates in particular to a kind of compounded Radix Bupleuri enema preparation and preparation method thereof.Said preparation is by Chinese medicines such as artificial Calculus Bovis, Radix Bupleuri, Radix Scutellariae extracts, separates, is prepared from through nanometer film.
Technical background
Upper respiratory tract infection, the heating of influenza and malaria etc.; Acute tonsillitis, pharyngitis etc. are the high child of sickness rate and adult's commonly encountered diseases and frequently-occurring disease.In usual diseases of childhood, upper respiratory tract infection accounts for 35.4%～60.2% of gop number.The nosetiology examination confirms that 90% is viral infection.And in the respiratory virus infection, the performance of 91% infant has heating paresthesia.At present, though cold, fever is had more research both at home and abroad, mechanism still imperfectly understands, be recognized that body temperature set point theory, promptly virus, antibacterial etc. infect the release that activates pyrogen, by maincenter heating medium, act on thermotaxic centre, cause the rising of body temperature set point, cause heating.This disease of western medical treatment is only limited to Drug therapys such as antipyretic-antalgic and antiviral, can not stop the development of the state of an illness.And, more side effect such as drug resistance, gastrointestinal tract, hemopoietic system, nephrotoxicity are arranged, there especially weak sick child is had to be many unfavorable.And motherland's medical science has the understanding and the rich experience of uniqueness to the treatment of primary disease.Think that human body is the integral body of an equilibrium between yin and yang, yin and yang imbalance, excess of YANG bringing about heat syndrome.According to the reason of " heat is given birth to by poison ", method of dissipating heat and detoxifying is always emphasized in the treatment of diseases caused by exogenous pathogenic factor heat symptom-complex.The present invention is exactly according to this traditional Chinese medicine theory and long-term clinical experience composition of prescription, and confirms through animal pharmacodynamics experiment screening.Especially to children therapy, treatment by Chinese herbs can be avoided the unnecessary injury of chemical drugs side effect to the child on the basis that guarantees curative effect.
Wind-heat invading the lung is caused heating, cough, diseases such as pharyngalgia; Upper respiratory tract infection, the existing treatment Chinese medicine of the heating of influenza and malaria etc. mostly is oral medicine such as tablet, granule.This type of dosage form contains that the volume of adjuvant and impurity is bigger than normal, and absorption rate is relatively slow, and child's stadium in June～4 years old is is easily cry and screamed, general displeased taking medicine, especially bitterness, Chinese medicine that amount is big; Existing injection has injection of Radix Bupleuri, YINHUANG ZHUSHEYE can be used for above-mentioned treatment of diseases, be afraid of to have an injection but especially 1～6 years old child of patient is most, the human body that muscle or intravenous injection administration bring to infant stimulates and is spiritual significantly frightened, thereby, compliance is very poor, often influences the carrying out of normal therapeutic.For above-mentioned disease is effectively cured, simultaneously, avoid related side effects, the present invention will have heat-clearing and toxic substances removing, artificial Calculus Bovis, Radix Bupleuri and the heat-clearing and toxic substances removing Radix Scutellariae extract reasonable compatibility that induces sweat of calming the frightened used, and can bring into play the effect of many target spots.Can strengthen that it is brought down a fever, the antidotal effect, the arresting convulsion of inducing sweat effect is arranged again, be fit to very much wind-heat invading the lung and cause heating, cough, the heating of disease such as pharyngalgia and upper respiratory tract infection, influenza and malaria etc., and because of the treatment of diseases such as delirium, convulsions due to the hyperpyrexia.
Simultaneously, the present invention will treat that this type of disease is oral, the drug administration by injection mode changes into from rectally, and patient is had in many ways benefit.Rectally belongs to the category of mucosa delivery, is a kind of traditional medication of the traditional Chinese medical science " interior disease external therapy ".Before modern two thousand years, Eastern Han Dynasty's Zhang Zhongjing just has honey suppository ball plug anus in " Treatise on Febrile and Miscellaneous Disease ", the record of the dry constipation of Fel Sus domestica soup clysmata treatment intestinal.Afterwards, the Therapeutic Method of herbal retention enema is used clinically widely inside and outside, woman, youngster.Rectal delivery is to allow medicine fully be absorbed by mucous membrane of rectum, and the person does not have rectal tenesmus and just meaning sense and be subjected to the medicine, makes the infant and the head of a family be easy to accept, and curative effect is guaranteed.Rectally has at first been eliminated the child and is afraid of to have overcome the feared state of mind of having an injection the oral administration bitterness again and easily caused reflex vomiting, and often cause the shortcoming of oral administration underdosage, and the difficulty of vein, intramuscular administration is with painful.
Intention point of the present invention is: the pharmaceutics basic research confirms, because the rectum physiological location is special, rich blood vessel, mucosal drug delivery at first herein, both can avoid the oral pessimal stimulation that brings of acid analgesic Western medicine and Chinese medicine bitterness, wound thorn and the fear that can avoid muscle, intravenous injection to bring again to infant to the infant appetite.Secondly, rectal mucosa administration absorption rate, more oral all fast with administered intramuscular approach absorption rate, and be only second to intravenous injection.The drug effect time is rapid, gentle and lasting, is beneficial to the emergent treatment of hyperpyrexia.The 3rd,, rectal mucosa absorbs the drug directly into the blood great circulation system, without the biochemical metabolism process of liver circulation and liver.Thereby, avoided biochemistry loss and the decay of liver " first pass effect " to drug effect, the bioavailability height of effective ingredient, the performance curative effect is strong.
For this reason, the invention provides compounded Radix Bupleuri enema preparation, said preparation has heat-clearing and toxic substances removing, the arresting convulsion of inducing sweat, effect, be applicable to the treatment wind-heat invading the lung and cause heating, cough disease and upper respiratory tract infection such as pharyngalgia, the febrile conditions of influenza and malaria etc.
Summary of the invention
The invention provides a kind of compound bupleuri preparation and preparation method thereof.
The present invention provides compounded Radix Bupleuri enema preparation and preparation method thereof especially.
Compounded Radix Bupleuri enema preparation of the present invention is a liquid preparation, said preparation can be a kind of liquid preparation of wider range concentration, as long as promptly be fit to make the medicine enema preparation, and again can in the valid density scope, as being rare solution, also can be relatively dense solution.Above-mentioned preparation is made into the dosage form of unit dose, packs with the packaging material that are fit to, and the amount of per unit dosage form is determined according to clinical requirement, as being 2ml packing, 4ml packing, 5ml packing, 10ml packing; The 50ml packing, 100ml packing, 500ml packing also can be the 1000ml packings.
Therefore, the present invention includes medicinal liquid and packing, wherein: described medicinal liquid is formed through extracting processing and preparing by raw material of Chinese medicine medical materials such as artificial Calculus Bovis, Radix Bupleuri, Radix Scutellariae extracts.Described packing can be any medical package material, preferably the packaging material made from the special plastics of medical poisonless.
Compounded Radix Bupleuri enema preparation of the present invention, wherein, in the medicinal liquid of every 1000ml, the prescription of active component is as follows:
Artificial Calculus Bovis 8.9-180g,
Radix Bupleuri 160-2250g,
Radix Scutellariae extract (in the pure product of baicalin) 12.6-178g.
Preferred child is as follows with prescription:
Artificial Calculus Bovis 33g,
Radix Bupleuri 600g,
Radix Scutellariae extract (in the pure product of baicalin) 47g.
Preferred adult is as follows with prescription:
Artificial Calculus Bovis 100g,
Radix Bupleuri 1800g,
Radix Scutellariae extract (in the pure product of baicalin) 142g.
Wherein, the amount of artificial Calculus Bovis, Radix Bupleuri is calculated with crude drug, and Radix Scutellariae extract calculates with the amount of the pure product of baicalin.Described Radix Scutellariae extract records and " in the Chinese pharmacopoeia (version was an one in 2005), is being known active substance, can buying on the market, also can prepare with known method, as in order to following method: Radix Scutellariae is decocted with water secondary, each 1 hour, filter, merging filtrate, regulate pH value to 1.0-2.0 with hydrochloric acid, 80 ℃ of insulations are left standstill, the baicalin cohesion is separated out, filter.Discard filtrate, precipitate adds suitable quantity of water and stirs evenly, and with 40% sodium hydroxide solution adjust pH to 7.0, adds equivalent ethanol, stirs the companion and makes dissolving, filters.Filtrate is regulated pH value to 1.0-2.0 with hydrochloric acid, is heated to 60 ℃, leaves standstill, and baicalin is separated out, and filters.Precipitation is washed till pH value to 7.0 with suitable quantity of water and Different concentrations of alcohol successively, waves most ethanol, drying under reduced pressure, promptly.This product contains baicalin should be not less than 85.0%.
Compounded Radix Bupleuri enema prescription of the present invention, can also be according to clinical needs and pharmaceutics routine, add an amount of adjuvant, make the dosage forms such as oral liquid, cream, injection, tablet, granule, capsule, drop pill of child and adult's usefulness, the preferred enema of the present invention.
Therefore, the claimed a kind of compound bupleuri preparation of the present invention, it is formed through extracting processing and preparing by raw material of Chinese medicine medical materials such as artificial Calculus Bovis, Radix Bupleuri, Radix Scutellariae extracts.
Wherein, the child is as follows with prescription:
Artificial Calculus Bovis 8.9-89g,
Radix Bupleuri 160-1125g
Radix Scutellariae extract (in the pure product of baicalin) 12.6-89g
The adult is as follows with prescription:
Artificial Calculus Bovis 100-180g,
Radix Bupleuri 1800-2250g,
Radix Scutellariae extract (in the pure product of baicalin) 142-178g.
Compounded Radix Bupleuri enema preparation of the present invention wherein, can also add the pharmaceutical carrier that is fit to the enema needs as required, as excipient, and solubilizing agent, pH regulator agent etc.
Compounded Radix Bupleuri enema preparation of the present invention, wherein, described solubilizing agent is a tween 80, can add 4～16g in the medicinal liquid of every 1000ml, preferred 8g.
Compounded Radix Bupleuri enema preparation of the present invention, wherein, described excipient can be a water for injection.
The pH regulator agent can be conventional acid or alkaline matter, as sodium hydroxide, and hydrochloric acid etc.
Compounded Radix Bupleuri enema preparation of the present invention, its preparation method comprises the following steps:
Step 1 adds 10 times of calorimetric water with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil and reaches back the slide extracting solution;
Step 2 reaches back the slide extracting solution with three distillatory volatile oil of Radix Bupleuri, adds tween 80, and it is dissolved fully;
Step 3, the preparation Radix Scutellariae extract, method is as follows: Radix Scutellariae is decocted with water secondary, each 1 hour, filter, merging filtrate is regulated pH value to 1.0-2.0 with hydrochloric acid, and 80 ℃ of insulations are left standstill, and the baicalin cohesion is separated out, and filter.Discard filtrate, precipitate adds suitable quantity of water and stirs evenly, and with 40% sodium hydroxide solution adjust pH to 7.0, adds equivalent ethanol, stirs the companion and makes dissolving, filters.Filtrate is regulated pH value to 1.0-2.0 with hydrochloric acid, is heated to 60 ℃, leaves standstill, and baicalin is separated out, and filters.Precipitation is washed till pH value to 7.0 with suitable quantity of water and Different concentrations of alcohol successively, waves most ethanol, drying under reduced pressure, promptly.This product contains baicalin should be not less than 85.0%.
Step 4 is with the artificial Calculus Bovis, that Radix Scutellariae extract adds purified water is an amount of, transfers pH to 8.0, adds tween 80 and stirs, and makes dissolving;
Step 5, with step 4 gained medicinal liquid, the hollow-fibre membrane of via hole diameter molecular cut off 10000-100000 (quite 10-100nm) filters, and is concentrated into 400ml;
Step 6 with step 4 gained medicinal liquid, is added in the step 2 gained Radix Bupleuri extracting solution, transfers pH to 7.0, adds tween 80 and stirs, and makes dissolving;
Step 7 adds the injection water to 1000ml, embedding, and the circulation steam sterilization is made enema (concentrating); Or coloclysis solution 10000ml dilution type preparation formulation, promptly.
In the preparation method of compounded Radix Bupleuri enema preparation of the present invention, wherein, the nanometer film of use is meant the various special-shaped membrane material and the accessory thereof of the preparation of macromolecular material such as polysulfones, preferably polymeric hollow fiber nanometer film and equipment thereof.The aperture of nanometer film is at 10-100nm, and holding back the material relative molecular weight is 10000-100000.
Compounded Radix Bupleuri enema preparation of the present invention and preparation method thereof, the nanometer film isolation technics is separated by adopting, the purification active component, can make that medicine active component impurity is few, purity is high, and its granularity is controlled at nanometer level, thereby, near or less than the rectum intercellular substance.Prepare oral liquid, the intramuscular dose that does not adopt this technology than conventional method, absorption rate is fast, and the drug effect time is faster.This is a remarkable innovative point of the present invention; Secondly, medicinal liquid is packed in the special non-toxic medical plastic softgel shell, change the rectally approach into, can avoid gastrointestinal upset that bitter medicine causes and the misery of having an injection and bringing because of pain, fear, normal therapeutic is carried out smoothly, the drug effect decay that makes the metabolism of medicine avoid liver " first pass effect " to bring again to patient, the bioavailability height, making the stronger therapeutic effect of medicine performance, improve patient's quality of life and treatment level, also is important intention of the present invention.
Compounded Radix Bupleuri enema preparation of the present invention, it is fast to have absorption rate, the bioavailability height, the determined curative effect of bringing down a fever, detoxify, few side effects, steady quality is convenient to child patient and is used characteristics such as appearance looks elegant.Compounded Radix Bupleuri enema provided by the invention (solution and concentrated solution) and preparation method thereof, the nanometer film isolation technics is separated by adopting, the purification active component, can make that medicine active component impurity is few, purity is high, and its granularity is controlled at nanometer level, thereby, near or less than the rectum intercellular substance.Prepare injection and the solution that does not adopt this technology than conventional method, absorption rate is fast, the bioavailability height.This compounded Radix Bupleuri enema (solution and concentrated solution) has following advantage:
Medicinal liquid is packed in the special non-toxic medical plastic softgel shell, change the rectally approach into, can avoid having an injection to patient because of pain and the frightened misery of bringing, normal therapeutic is carried out smoothly, the drug effect decay that makes the metabolism of medicine avoid liver first-pass effect to bring again, with faster, the stronger therapeutic effect of performance, improve patient's quality of life and treatment level; It is fast that this preparation has absorption rate, the bioavailability height, and the determined curative effect of bringing down a fever, detoxify, steady quality, appearance looks elegant, more convenient child patient uses.
Be understandable that, for a person skilled in the art, can be according to prescription mentality of designing of the present invention, design reorganization cost prescription constituent class is like other prescribed regimens of proportioning; According to technical scheme of the present invention and technical conceive, make the similar change and the distortion of other technologies scheme, and all these changes and distortion, all should belong to the protection domain of the accompanying claim of the present invention.
The specific embodiment
Further specify the present invention by the following examples, but not as limitation of the present invention.
The child uses embodiment 1
It is as follows to write out a prescription:
Artificial Calculus Bovis 33g
Radix Bupleuri 600g,
Radix Scutellariae extract (in the pure product of baicalin) 47g.
Preparation method:
Step 1 adds 10 times of calorimetric water with Radix Bupleuri, decocts distillation extraction three times, each 1 hour.Collect volatile oil and reach back the slide extracting solution;
Step 2 reaches back the slide extracting solution with three distillatory volatile oil of Radix Bupleuri, adds tween 80, and it is dissolved fully;
Step 3 prepares Radix Scutellariae extract by the described Radix Scutellariae extract preparation method of claim [1];
Step 4 is with the artificial Calculus Bovis, that Radix Scutellariae extract adds purified water is an amount of, transfers pH to 8.0, adds tween 80 and stirs, and makes dissolving;
Step 5, with step 4 gained medicinal liquid, the membrane filtration mistake of via hole diameter molecular cut off 10000-100000 (quite 10-100nm) is concentrated into 400ml;
Step 6 with step 4 gained medicinal liquid, is added in the step 2 gained Radix Bupleuri extracting solution, transfers pH to 7.0, adds tween 80 and stirs, and makes dissolving;
Step 7 adds the injection water to 1000ml, and embedding is in the described softgel shell of claim [1], and the circulation steam sterilization is made enema (concentrating), promptly.
The child uses embodiment 2
It is as follows to write out a prescription:
Artificial Calculus Bovis 8.9g,
Radix Bupleuri 160g,
Radix Scutellariae extract (in the pure product of baicalin) 12.6g,
Preparation method is with embodiment 1
The child uses embodiment 3
It is as follows to write out a prescription:
Artificial Calculus Bovis 62.5g,
Radix Bupleuri 1125g,
Radix Scutellariae extract (in the pure product of baicalin) 89g,
Tween 80 9.0g,
Make 1500ml,
Preparation method is with embodiment 1.
The child uses oral liquid embodiment 4
It is as follows to write out a prescription:
Artificial Calculus Bovis 16.5g,
Radix Bupleuri 375g,
Radix Scutellariae extract (in the pure product of baicalin) 29.4g,
Preparation method:
Step 1 adds 10 times of calorimetric water with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil and reflux extracting liquid;
Step 2 with three distillatory volatile oil of Radix Bupleuri and reflux extracting liquid, adds tween 80, and it is dissolved fully;
Step 3 prepares Radix Scutellariae extract by the described Radix Scutellariae extract preparation method of claim [1];
Step 4 is with the artificial Calculus Bovis, that Radix Scutellariae extract adds purified water is an amount of, transfers pH to 8.0, adds tween 80 and stirs, and makes dissolving;
Step 5, with step 4 gained medicinal liquid, the membrane filtration mistake of via hole diameter molecular cut off 10000-100000 (quite 10-100nm) is concentrated into 400ml;
Step 6 with step 4 gained medicinal liquid, is added in the step 2 gained Radix Bupleuri extracting solution, transfers pH to 7.0, adds tween 80 and stirs, and makes dissolving;
Step 7, it is an amount of to add Mel, and water for injection is to 1000ml; Embedding is in oral liquid one trombone slide bottle, and the circulation steam sterilization is made the oral liquid formulations dosage form, promptly.
The adult uses embodiment 6
It is as follows to write out a prescription:
Artificial Calculus Bovis 100g,
Radix Bupleuri 1800g,
Radix Scutellariae extract (in the pure product of baicalin) 142g,
Tween 80 12.5g,
Make 2000ml,
Preparation method is with embodiment 1.
The adult uses embodiment 7
It is as follows to write out a prescription:
Artificial Calculus Bovis 80g,
Radix Bupleuri 1440g,
Radix Scutellariae extract (in the pure product of baicalin) 114g,
Make 2000ml,
Preparation method is with embodiment 1.
The adult uses embodiment 8
It is as follows to write out a prescription:
Artificial Calculus Bovis 150g,
Radix Bupleuri 2700g,
Radix Scutellariae extract (in the pure product of baicalin) 214g,
Tween 80 12.5g,
Make 3000ml,
Preparation method is with embodiment 1.
The adult uses oral liquid embodiment 9
It is as follows to write out a prescription:
Artificial Calculus Bovis 50g,
Radix Bupleuri 900g,
Radix Scutellariae extract (in the pure product of baicalin) 71g,
Preparation method is with Children Oral Liquid embodiment 4.
The adult uses granule embodiment 10
It is as follows to write out a prescription:
Artificial Calculus Bovis 250g,
Radix Bupleuri 4500g,
Radix Scutellariae extract (in the pure product of baicalin) 356.3g,
Preparation method:
Step 1 adds 10 times of calorimetric water respectively with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil;
Step 2 prepares Radix Scutellariae extract by the described Radix Scutellariae extract preparation method of claim [1];
Step 3 with artificial Calculus Bovis, Radix Scutellariae extract mix homogeneously, adds an amount of dextrin, starch and stevioside, cane sugar powder right amount of auxiliary materials, and wet method is made granule;
Step 4 with step 1 gained volatile oil, is sprayed in the step 3 gained granule, cold drying, and granulate is made the granule dosage form, and packing is made 1000 bags, promptly.
The adult uses capsule embodiment 11
It is as follows to write out a prescription:
Artificial Calculus Bovis 200g,
Radix Bupleuri 3600g,
Radix Scutellariae extract (in the pure product of baicalin) 284.4g,
Preparation method:
Step 1 adds 10 times of calorimetric water respectively with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil;
Step 2 prepares Radix Scutellariae extract by the described Radix Scutellariae extract preparation method of claim [1];
Step 3 with artificial Calculus Bovis, Radix Scutellariae extract mix homogeneously, adds an amount of dextrin, starch supplementary material is an amount of, and wet method is made granule;
Step 4 with step 1 gained volatile oil, is sprayed in the step 3 gained granule, cold drying, and granulate is made granule, and packing is made 1000 seed lac wafers, promptly.
The adult uses tablet embodiment 12
It is as follows to write out a prescription:
Artificial Calculus Bovis 200g
Radix Bupleuri 3600g,
Radix Scutellariae extract (in the pure product of baicalin) 284.8g,
Preparation method:
Step 1 adds 10 times of calorimetric water respectively with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil;
Step 2 prepares Radix Scutellariae extract by the described Radix Scutellariae extract preparation method of claim [1];
Step 3 with artificial Calculus Bovis, Radix Scutellariae extract mix homogeneously, adds adjuvants such as appropriate amount of starch, sodium carboxymethyl cellulose, stearic acid, and wet method is made granule;
Step 4 with step 1 gained volatile oil, is sprayed in the step 3 gained granule, mixing, and cold drying, granulate, tabletting, the peplos clothing is made 1000, promptly.
The pharmacodynamic study result
The child uses the enema of embodiment 1 preparation, tests by " new Chinese medicine drug effect toxicological study guideline ":
1 compounded Radix Bupleuri enema antivirus test
Adopt the extracorporeal antivirus effect infection experiment, observe external influence FM1 influenza virus, respiratory syncytial virus.
1.1 the external depression effect method to the FM1 influenza virus of compounded Radix Bupleuri enema: the used RSV of (1) Strain goes down to posterity on the Hela cell in advance, does the appeal titration after stable the going down to posterity.Then, get 100TCID
50Be infective dose, used KL1 influenza virus is gone down to posterity on mdck cell, gets 100TCID after the titration
50Be infective dose.
(2) medicine pair cell toxicity test compounded Radix Bupleuri enema adopts 2000,1000,500,250,125,62.5 μ g/ml, cytopathic back one pipe concentration not occur is cytotoxicity boundary maximum concentration, repeat 3 times, filtering out 500 μ g/ml is the avirulence boundary.
(3) medicine is high, medium and low concentration with 500,250,125 μ g/ml respectively with the method compounded Radix Bupleuri enema of virus interaction processing.1. behind high, medium and low 3 concentration function cells 24h of elder generation, add 100TCID again
50FM1 or RSV virus.Observation 24,48,76h, medicine has or not antivirus action.2. medicine adds cell monolayer simultaneously with high, medium and low 3 concentration and virus, and observation 24,48,76h have or not antivirus action.3. medicine adds simultaneously with high, medium and low 3 concentration and virus, slowly rotates mixing, after placement is spent the night, adds cell monolayer, and then, observation 24,48,76h have or not antivirus action.Each method is set up virus control, medicine contrast, cell matched group simultaneously, and experiment repeats 2 times.
The result: compounded Radix Bupleuri enema is to the inhibition virus replication effect of influenza virus FM1, and medicine elder generation processed group has strong inhibition virus replication effect to influenza virus; Medicine and virus add cell simultaneously, and strong inhibition virus replication effect is arranged; Medicine adds virus and places the group unrestraint virus replication effect of spending the night.
Conclusion: handling cell earlier with medicine has strong inhibition virus replication effect, and medicine virus adds simultaneously very strong inhibition virus replication effect.
2.1 after compound bupleuri filling liquid is pressed the Hela infection cell to the inhibition virus replication effect of respiratory syncytial virus, produce the cytopathy index and judge.
The result: it is best that medicine elder generation processed group, virus and medicine add cell monolayer group inhibition viral effector simultaneously.In placing 4 ℃, low concentration has and suppresses the virus replication effect, and high concentration is invalid.
2 compounded Radix Bupleuri enemas are to the antipyretic effect of experimental rabbits
Adopt rabbit injection " inoculum " fever model, observe the refrigeration function of the disposable rectally of compounded Radix Bupleuri enema, compare with the dipyrone group to fever in rabbit.
2.1 experimental technique selects qualification test to use rabbit, injection Typhoid-Paratyphoid quadruple vaccine 1.0ml/kg, ear iv.Behind the 1-2h, 40 of the heating rabbits of selecting to heat up at 0.8-1.5 ℃ carry out pull-down test, be divided into 5 groups at random by body weight, mean body temperature, be respectively normal saline blank group, dipyrone positive controls (0.10g/kg), the heavy dose of group of compounded Radix Bupleuri enema (7.0g/kg), middle dosage group (3.5g/kg), small dose group (1.75g/kg), every group 8, all adopt rectally.With the body temperature of miniature pyrogen measuring instrument determination experiment rabbit, administration before measurement body temperature 2 times, getting average is body temperature before the administration; Every 15min measures 1 time after the administration, and record cooling value compares.Result's Statis software processes is made the t test evaluation.
2.2 result: compounded Radix Bupleuri enema has trivial solution heat effect (P＜0.01), and presents dose-effect relationship under 1.75-7.0g/kg dosage.Greatly, intermediate two groups with the dipyrone group relatively, the 0.5th, 1.0,2.0 and during 4 of 3.0h the cooling extent difference of item do not have significance (P＞0.05); Its cooling onset is slightly slow, but holds time than the long 3h of dipyrone, and cooling extent is big.Show that compounded Radix Bupleuri enema has significant antipyretic effect.
The antiinflammatory action of 3 compounded Radix Bupleuri enemas
Use Mice Auricle " dimethylbenzene " to cause scorching model respectively and cause scorching rat paw edema model with " chondrus ocellatus Holmes ", the antiinflammatory action behind the observation compounded Radix Bupleuri enema rectally compares with the aspirin group.
3.1 the Kunming mouse of the anti-acute inflammation effect experimental selection body weight 18-20g of experimental technique (1) compounded Radix Bupleuri enema, divide 5 groups at random, every group 10, be respectively normal saline blank group, aspirin positive controls (0.1g/kg), the heavy dose of group of compounded Radix Bupleuri enema (5.0g/kg), middle dosage group (2.5g/kg), small dose group (1.25g/kg), all adopt rectally.Behind the administration 45min, evenly smear dimethylbenzene 0.1ml, make this wide swelling of picking up the ears in the wide tow sides of auris dextra.Put to death animal behind the 15min, cutting two ears along each auricle baseline, sweep away auricle (diameter 9mm) and weighing respectively in same position with card punch, is the swelling degree with the difference of left and right auricle weight divided by the percentage ratio of left side auricle weight, result of calculation, and make the t test evaluation.
(2) the anti-chronic inflammatory disease effect of compounded Radix Bupleuri enema experimental selection body weight is the SD of 100-150g rat, divide into groups 8 every group, press normal saline relative dosage, aspirin group (0.15g/kg), the heavy dose of group of compounded Radix Bupleuri enema (14.0g/kg), middle dosage group (10.5g/kg), small dose group (7.0g/kg) dosed administration, behind the 40min, in the right back sufficient sole of the foot injection 0.1ml concentration of rat is the chondrus ocellatus Holmes solution of 0.01g/ml, makes the right back pedal swelling of rat.Measure before the administration and the right back sufficient sole of the foot volume of rat of 1h, 2h, 4h and 6h behind the injection chondrus ocellatus Holmes solution with the volume determination instrument, calculate the swelling degree, with matched group relatively, make the t test evaluation.
3.2 the anti-acute inflammation effect compound Radix Bupleuri enema of result (1) compounded Radix Bupleuri enema has obvious inhibitory action (P＜0.01) to mice auricle swelling under 1.25-5.0g/kg dosage;
(2) the anti-chronic inflammatory disease effect compound of compounded Radix Bupleuri enema Radix Bupleuri enema has obvious inhibitory action (P＜0.01) to rat paw edema under 7.0-14.0g/kg dosage, and is close with the aspirin group.
Above result shows: compounded Radix Bupleuri enema has analgesic, anti-acute and chronic inflammatory effect.Its antipyretic effect time, slow than dipyrone onset time summary, but effect is lasting; And antiinflammatory action is suitable.
Clinical observation on the therapeutic effect
Compounded Radix Bupleuri enema (concentrating) is used for 1-9 year wind-heat invading the lung and causes heating, and with cough, diseases such as pharyngalgia; Be upper respiratory tract infection heating infant 96 examples, and compare observation, as a result satisfactory effect with 54 examples of SHUANGHUANGLIAN KOUFUYE treatment.
1 general clinical data
The selected 150 examples infants of being in hospital are divided into treatment at random and organize 96 examples, wherein, and male 55 examples, women 41 examples, age (3.5 ± 0.4) year.The infant disease time ,≤24h 57 examples, 25-48h 39 examples.38 ℃ of-39 ℃ of 59 examples of generating heat,＞39 ℃ of 37 example; Matched group 54 examples, wherein, male 31 examples, women 23 examples, year at age (3.4 ± 0.6).The infant disease time ,≤24h 30 examples, 25-48h 24 examples.38 ℃ of-39 ℃ of 34 examples of generating heat,＞39 ℃ of 20 example.
2 diagnostic criterias
" the clinical research guideline of new Chinese medicine treatment infantile fever caused by exogenous pathogens " and industry standard " TCM Pediatrics disease diagnosis criterion of therapeutical effect " with reference to the Ministry of Public Health promulgation.
3 criterions of therapeutical effect
" the clinical research guideline of new Chinese medicine treatment infantile fever caused by exogenous pathogens " with the Ministry of Public Health promulgation serves as according to formulating.(1) recovery from illness: took medicine 24-48 hour in, temperature recovery is normal, no longer gos up, and syndrome disappears, and unusual physical and chemical index recovers normal.Produce effects: took medicine 24-48 hour in, temperature recovery is normal, no longer gos up, and main syndrome is most of to disappear, and unusual biochemical indicator is near normal.Effectively: took medicine 48-72 hour in, temperature recovery is normal, and main syndrome partly disappears, and unusual physical and chemical index makes moderate progress.Invalid: as not meet with subscript Huaihe River person.
4 therapeutic outcomes
Compounded Radix Bupleuri enema treatment group is cured 28 examples (29.2%), produce effects 31 (32.5%), effective 33 examples (34.4%), invalid 4 examples (4.2%) total effective rate 95.8%; The SHUANGHUANGLIAN KOUFUYE matched group is cured 7 examples (13.0%), produce effects 15 (27.8%), effective 24 examples (44.4%), invalid 8 examples (14.8%), total effective rate 85.2%.The compounded Radix Bupleuri enema curative effect is better than SHUANGHUANGLIAN KOUFUYE (P＜0.05).
Claims (1)
1. the preparation method of a compounded Radix Bupleuri enema preparation, described preparation is formed through extracting processing and preparing by artificial Calculus Bovis, Radix Bupleuri, Radix Scutellariae extract, and the prescription weight proportion is as follows:
Artificial Calculus Bovis 8.9-180g,
Radix Bupleuri 160-2250g,
In the Radix Scutellariae extract 12.6-178g of the pure product of baicalin,
Said method comprising the steps of:
Step 1 adds 10 times of calorimetric water respectively with Radix Bupleuri, decocts distillation three times, each 1 hour, collects volatile oil and reflux extracting liquid;
Step 2 with three distillatory volatile oil of Radix Bupleuri and reflux extracting liquid, adds tween 80, and it is dissolved fully;
Step 3, the preparation Radix Scutellariae extract, method is as follows: Radix Scutellariae is decocted with water secondary, each 1 hour, filter, merging filtrate is regulated pH value to 1.0-2.0 with hydrochloric acid, and 80 ℃ of insulations are left standstill, and the baicalin cohesion is separated out, and filter; Discard filtrate, precipitate adds suitable quantity of water and stirs evenly, and with 40% sodium hydroxide solution adjust pH to 7.0, adds equivalent ethanol, stirs the companion and makes dissolving, filters; Filtrate is regulated pH value to 1.0-2.0 with hydrochloric acid, is heated to 60 ℃, leaves standstill, and baicalin is separated out, and filters; Precipitation is washed till pH value to 7.0 with suitable quantity of water and Different concentrations of alcohol successively, waves most ethanol, drying under reduced pressure, promptly;
Step 4 is with the artificial Calculus Bovis, that Radix Scutellariae extract adds purified water is an amount of, transfers pH to 8.0, adds tween 80 and stirs, and makes dissolving;
Step 5, with step 4 gained medicinal liquid, the membrane filtration mistake of via hole diameter molecular cut off 10000-100000 is concentrated into 400ml;
Step 6 with step 4 gained medicinal liquid, is added in the step 2 gained Radix Bupleuri extracting solution, transfers pH to 7.0, adds tween 80 and stirs, and makes dissolving;
Step 7 adds the injection water to 1000ml, embedding, and the circulation steam sterilization is made the coloclysis concentrated solution, promptly.
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| 柴胡挥发油提取方法的研究. 李秀琴，孙秀燕，何仲贵，毕开顺.中国药学杂志，第39卷第2期. 2004 * |
| 黄芩苷的提取与精制. 詹国平，朝军伟，向颖.中医药信息，第23卷第2期. 2006 |
| 黄芩苷的提取与精制. 詹国平，朝军伟，向颖.中医药信息，第23卷第2期. 2006 * |
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