CN101700290B - Pharmaceutical composition for preventing and treating warm-heat diseases of livestock and poultry and preparation method thereof - Google Patents
Pharmaceutical composition for preventing and treating warm-heat diseases of livestock and poultry and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for preventing and treating warm-heat diseases of livestock and poultry and a preparation method thereof. The mix proportion by weight of a variety of traditional Chinese medicines calculated by raw plant drugs and dressings in 1500ml of liquid medicine is as follows: 350-450g of fructus forsythiae, 150-250g of indigowoad root, 150-250g of honeysuckle flower, 150-250g of baical skullcap root, 150-250g of golden thread, 150-250g of commelina communis, 75-125g of liquoric root, 2-3g of benzyl alcohol and the balance of distilled water. The preparation method of the pharmaceutical composition comprises three steps of water extraction, ethanol precipitation and preparation of the liquid medicine, thereby preparing an injection. A large number of clinical uses prove that the medicine has the effects of anti-virus, anti-bacteria, anti-inflammation, clearing heat-toxin and enhancing immunity and excellent treatment effect on warm diseases which are mainly characterized by fever, and the applications thereof can play the positive role of promoting the development of the livestock and poultry industry in China.
Description
Technical field
The invention belongs to and a kind ofly prevent and treat poultry heatings and be epidemic febrile disease pharmaceutical composition of principal character and preparation method thereof.
Background technology
Along with developing rapidly of China's intensive culture industry and improving constantly of feeding and management level, the sickness rate of the common disease of various poultry decreases, and be that epidemic febrile disease (also comprising western veterinary various acute infectious disease and the infectious disease) sickness rate of feature is in rising trend with the heating, sound development as sick grievous injury livestock breeding industries such as swine flue, reproductive and respiratory syndrome, pig streptococcicosis, bird flu, bovine spongiform encephalopathy, foot and mouth disease, schistosomicide, cause serious economy loss to animal husbandry production, simultaneously human health and public health have also been caused great threat.Though the use of vaccine can be controlled such transmission of disease and outburst, but, make vaccine prevention animal infection disease warm in nature increase a lot of uncertain factors because the vaccine product R﹠D cycle is long, the portioned product quality has much room for improvement, pathogenic bacteria (poison) strain variation is accelerated and new epidemic febrile disease does not often have Seedling and specifically present situation such as can use.With Chinese herb prevention heating is that the epidemic febrile disease (infectious disease that said virus of modern medicine and antibacterial etc. cause) of feature has long history in China, has demonstrated unique curative effect in clinical practice.Therefore, development of new has the herbal medicine and the preparation thereof of the hot disease of temperature resistance, will bring new breakthrough to the control of animal epidemic febrile disease.On the other hand, because Chinese herbal medicine has kept the natural form and the biological activity of various materials, little toxic and side effects.Many in recent years countries all pay much attention to from Chinese herbal medicine or plant amedica studies new drug.Domestic animal-use drug also direction such as forward curative effect height, drug resistance is low, effect is lasting, low toxicity, low-residual develops, and Chinese herbal medicine has the trend that replaces antibiotics gradually in some field.The complexity and the compound recipe composition of the mechanism of action are difficult to quantification in animal body but owing to Chinese medicine, development and screen a kind of very effective and can clinical large-scale application, technical value added higher effective medicine is still very difficult, in the market still based on the Chinese and Western bound drug, and function singleness.
Summary of the invention
Based on current various poultry is that the epidemic febrile disease sickness rate of feature is in rising trend and both at home and abroad to preventing and treating epidemic febrile disease tcm product demands of developing with the heating, and the present invention is guidance with motherland's traditional medical theory, has developed a kind of control poultry epidemic febrile disease pharmaceutical composition.
Another object of the present invention provides control poultry epidemic febrile disease preparation of drug combination method.Pharmaceutical composition serves as the main dressing that has both with pure Chinese medicine, through water carry, precipitate with ethanol, be made into injection, be used for the treatment of and prevent the warm disease of poultry, be the disease of principal character with upper respiratory tract infection especially, the ten minutes excellent curative is arranged.
The objective of the invention is to be achieved through the following technical solutions:
A kind of control poultry epidemic febrile disease pharmaceutical composition calculates with the 1500ml medicinal liquid, contains the Chinese medicine of respectively distinguishing the flavor of with weight and the dressing weight proportion that raw medicinal herbs calculates to be:
Fructus Forsythiae 350～450g, Radix Isatidis 150～250g, Flos Lonicerae 150～250g, Radix Scutellariae 150～250g, Rhizoma Coptidis 150～250g, Tradescantia albiflora 150～250g, Radix Glycyrrhizae 75～125g, benzyl alcohol 2-3g, all the other are distilled water.
Preparation method of the present invention is:
1. water is carried: get Fructus Forsythiae 350～450g, Radix Isatidis 150～250g, Flos Lonicerae 150～250g, Radix Scutellariae 150～250g, Rhizoma Coptidis 150～250g, Tradescantia albiflora 150～250g, Radix Glycyrrhizae 75～125g goes into jar, the distilled water immersion that adds for the first time 10 times of amounts of medicine is a moment slightly, is heated to boiling, keeps boiling 1.5 hours; Cross leaching filtrate; Filtering residue adds 8 times of water yields again, is heated to boiling and extracts 1 hour, filters and collects filtrate; Merge filtrate twice, heating is concentrated into 5000ml;
2. precipitate with ethanol: will 1. obtain concentrated filtrate and be cooled to below 40 ℃, and add 95% ethanol, the concentration of alcohol content that makes medicinal liquid is 75%, static 12～48 hours, and sucking filtration, filtrate recycling ethanol is to there not being the alcohol flavor.Add 95% ethanol again, making the alcohol amount of containing in the solution is 80%, static 12～48 hours, sucking filtration, filtrate recycling ethanol also concentrates, dense magma.Add water for injection to 1300ml, add 1% active carbon, ebuillition of heated 30 minutes, filter solution;
3. medicinal liquid is formulated in and 2. obtains in the solution adding 0.1% benzyl alcohol, is settled to 1500ml, is filtered to clear and brightly with No. 3 sintered glass funnels, and embedding is sterilized for 100 ℃ and promptly got product in 30 minutes.
The dosage form of product:
Injection
Physical and chemical parameter:
PH value: 6.5 ± 0.5;
Proportion: 1.05 ± 0.05;
Character: brown liquid, mildly bitter flavor.
Differentiate:
Taking liquid is as need testing solution, and other gets the chlorogenic acid reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (Pharmacopoeia of People's Republic of China appendix VI B), draw need testing solution 10 μ l～20 μ l, reference substance solution 10 μ l, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with ethyl acetate-formic acid-water (7: 2.5: 2.5) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
Assay: according to high effective liquid chromatography for measuring.
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With methanol-water-glacial acetic acid (20: 80: 1) is mobile phase; Detect wavelength 324nm.Theoretical cam curve is calculated by the chlorogenic acid peak should be not less than 6000.
It is an amount of that the chlorogenic acid reference substance is got in the preparation of reference substance solution, and accurate the title decides, and puts in the brown measuring bottle, adds water and makes the solution that every 1ml contains 40 μ g, promptly.
The preparation taking liquid 1ml of need testing solution, 2 of the HCl solution of adding 2M make its pH value be adjusted into 4.0-5.0.With the ethyl acetate extraction of 2ml 5 times, combined ethyl acetate also volatilizes, residue with dissolve with methanol and be settled to 25ml, shake up, promptly.
Accurate respectively reference substance solution 10 μ l and need testing solution 10～20 μ l of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The every 1ml of this product contains Flos Lonicerae with chlorogenic acid (C
16H
18O
9) meter, must not be less than 0.01mg.
The beneficial effect of advantage of the present invention and generation is:
It is raw material that the present invention selects plant amedica for use, has both dressing, belongs to the antipyretic and antidotal type medicine.By a large amount of clinical uses, prove that this medicine is that the epidemic febrile disease of principal character has very excellent curative with the heating, pharmaceutical dosage form is an injection, easy to use, simple to operate, it is used for control poultry acute infectious disease and infectious disease, and the development that promotes China's poultry industry will produce positive role;
This product is mainly treated and prevented poultry is the infectious epidemic febrile disease of principal character with the heating, can replace existing antibiotics, and clinical use has advantage efficient, safe, nontoxic, easy to use.
The specific embodiment
Below, in conjunction with pharmacological effect test, clinical trial, be example with treatment porcine respiratory syndrome clinical trial, the present invention is further described again:
Embodiment 1
1. take by weighing Fructus Forsythiae 400g, Radix Isatidis 200g, Flos Lonicerae 200g, Radix Scutellariae 200g, Rhizoma Coptidis 200g, Tradescantia albiflora 200g, Radix Glycyrrhizae 100g goes into jar, adds for the first time the distilled water immersion 15 minutes slightly of 10 times of amounts of medicine, is heated to boiling, keeps boiling 1.5 hours; Cross leaching filtrate; Filtering residue adds 8 times of water yields again, is heated to boiling and extracts 1 hour, filters and collects filtrate; Merge filtrate twice, heating is concentrated into 5000ml;
2. will 1. obtain concentrated filtrate and be cooled to below 40 ℃, and add 95% ethanol, the concentration of alcohol content that makes medicinal liquid is 75%, static 16 hours, and sucking filtration, filtrate recycling ethanol is to there not being the alcohol flavor.Add 95% ethanol again, making the alcohol amount of containing in the solution is 80%, static 16 hours, sucking filtration, filtrate recycling ethanol also concentrates, dense magma.Add water for injection to 1300ml, add 1% active carbon, ebuillition of heated 30 minutes, filter solution;
3. at the benzyl alcohol that 2. obtains adding 0.1% in the solution, be settled to 1500ml, be filtered to clear and bright with No. 3 sintered glass funnels.Embedding, 100 ℃ of sterilizations promptly got the brown-red solution product in 30 minutes.
Embodiment 2
1. water is carried and is taken by weighing Fructus Forsythiae 400g, Radix Isatidis 200g, and Flos Lonicerae 200g, Radix Scutellariae 200g, Rhizoma Coptidis 200g, Tradescantia albiflora 200g, Radix Glycyrrhizae 100g goes into jar, and the distilled water immersion that adds for the first time 7 times of amounts of medicine is a moment slightly, is heated to boiling, keeps boiling 1.5 hours; Cross leaching filtrate; Filtering residue adds 6 times of water yields again, is heated to boiling and extracts 1 hour, filters and collects filtrate; Merge filtrate twice, heating is concentrated into 4000ml;
2. precipitate with ethanol is cooled to below 40 ℃, adds 95% ethanol, and the concentration of alcohol content that makes medicinal liquid is 75%, and static 24 hours, sucking filtration, filtrate recycling ethanol is to there not being the alcohol flavor.Add 95% ethanol again, making the alcohol amount of containing in the solution is 80%, static 24 hours, sucking filtration, filtrate recycling ethanol also concentrates, dense magma.Add water for injection to 1300ml, add 0.5% active carbon, ebuillition of heated 30 minutes, filter solution;
3. medicinal liquid is formulated in and 2. obtains in the solution adding 0.1% benzyl alcohol, is settled to 1500ml, is filtered to clear and bright with No. 3 sintered glass funnels or other filters.Embedding, 100 ℃ of sterilizations promptly got the brown-red solution product in 30 minutes.
Above-mentioned two kinds of schemes all meet the product quality requirement, but from the preparation process practical operation, embodiment 1 is simpler, takes a short time, and are suitable for producing.
Test example 1
The pharmacological effect test
(1) pharmaceutical composition fungistatic effect
Adopt the Oxford agar diffusion method to carry out bacteriostatic test.On culture medium, add 0.1mL (2 * 10 under the aseptic condition
7Individual/mL) bacterium liquid, smoothen with sterilization L rod, at room temperature dry 3～5 minutes, culture medium is divided into 6 zones, with aseptic nipper the aseptic Oxford little burning of cup is placed on each zone.In the cup of Oxford, add 200 μ L (2g/mL) medicinal liquids at last, in the immigration constant incubator that culture dish is careful, cultivate 18～20h for 37 ℃, measure antibacterial circle diameter.If 3 parallel laboratory test groups, and establish medicine contrast and blank.
Table 1 herbal mixture injection fungistatic effect unit: mm
(2) antiinflammatory test
The influence of xylol induced mice auricle inflammation
Method: get 70 of mices, body weight 18～22, male and female half and half are divided into 7 groups at random by body weight, 10 every group.Promptly 1. be the normal saline group, 3.～6. 2. positive contrast medicine group is the Chinese medicine injection group.1. organize capacity normal saline (NS) such as mice lumbar injection every day; 2. organize mice lumbar injection every day SHUANGHUANGLIAN ZHUSHEYE 30g/kg; 3.～6. organize intraperitoneal injection of drugs composite injection (seeing Table 1) respectively, every day 1 time, successive administration 5d.
Behind the last administration 1h, ear two sides, every mice left side all is coated with dimethylbenzene 0.03ml and causes inflammation, and 30min puts to death animal, cuts auricular concha, gets the round auricle at bilateral ear symmetry place with the 6mm card punch and weighs, and represents the swelling degree with left and right sides auricle weight differential.And obtain and press down swollen rate.Press down swollen rate=(blank group swelling average-medication group swelling average)/blank group swelling average * 100%.
Date processing: SPSS statistical analysis.
The influence of table 2 xylol induced mice auricle inflammation
Cause the Mice Auricle inflammation test as can be seen from pharmaceutical composition Chinese medicine injection xylol, with the blank group relatively, pharmaceutical composition 40g/kg, 30g/kg, 20g/kg, 10g/kg dose difference are remarkable, and are dosage correlation.Compare with SHUANGHUANGLIAN ZHUSHEYE, difference is not remarkable, and effect is suitable.Show that medicine composition injection has certain antiinflammatory action.
(3) analgesic test
Pain model: acetic acid causes the pain method
Method: the grouping administration is the same.30min after the last administration, every Mus lumbar injection 0.6% acetic acid 0.2ml,
Observe each treated animal in the 30min and turn round the body number of times by what acetic acid brought out.
Date processing: SPSS statistical analysis.
The influence of table 3 Chinese medicine injection Dichlorodiphenyl Acetate induced mice pain
As can be seen from Table 3, medicine composition injection high, medium and low (10g/kg) dosage analgesic activity is extremely remarkable than blank group difference.Medicine composition injection 40g/kg and 20g/kg are than SHUANGHUANGLIAN ZHUSHEYE group significant difference.Show that the pharmaceutical composition Chinese medicine injection has certain analgesic activity.
Test example 2
Oral acute toxicity test to mice
To 70 of the Kunming white mouses of body weight 18～22g, divide 7 groups and gavage medicine composition injection, each is organized dosage and is followed successively by 10,20,30,50,60,80 and 250g/kg, the death condition of the observing mice line item of going forward side by side, The time limit of experiment is 7 days, in the test when dead mice and off-test survival mice cut open inspection, observe pathological change.Test data sees Table 2.
Table 4 chmice acute poisoning experiment
As can be seen from the above table, gastric infusion is only once irritated stomach maximal dose 1.0ml/, and promptly 30g/kg observed 7 days continuously, did not also have the phenomena of mortality.
Intraperitoneal injection: mouse peritoneal injection, the result, shot 0.8ml/ only after, the back is all dead in the mice 15 minutes, only dead 1 of 0.7ml/.It is all normal that the dissection mice is observed each internal organs, and medicinal liquid is full of the abdominal cavity.Main cause is that the single-dose amount is excessive, causes due to the abdominal cavity edema.After change 5 administrations in the lumbar injection 24 hours into, dose reaches 250g/kg does not still have death.
According to toxicology poisonous substance grade scale, should be nontoxic.Compare with clinical recommendation use amount, the per weight consumption of conversion is very little, this shows, this medicine composition injection safety range is big, and avirulence is clinical safe and reliable.
Test example 3
The clinical test of pesticide effectiveness
Medicine composition injection is prevented and treated the result of the test of swine flue
Select the sick pig of swine flue natural occurrence.The case of selecting should be diagnosed as swine flue through clinical and laboratory diagnosis.Swine flue symptom characteristic be: body temperature raises suddenly and reaches 40～41.5 ℃; It is depressed to suffer from pig spirit, loss of appetite or useless exhausted; Normal squeezing crouched together, and muscle, arthralgia are reluctant activity, scream; Breathing is urged, and cough, snivel have sneeze; The conjunctiva flushing is shed tears for two; Argol, short urination is red.With every day neopathy, qualified sick pig bring into respectively at random in 5 groups by disease and treat, 15～20 of every group of cumulative cases.If (1) dosage intramuscular injection matched group, (5) positive drug matched group in dosage group, (3) pharmaceutical composition low dose group, (4) pharmaceutical composition in pharmaceutical composition high dose group, (2) pharmaceutical composition.Route of administration and dosage: 1,2,3,5 groups are adopted acupoint injection therapy, 1 time/day, successive administration 3 days.4 groups are adopted musculi colli injection, 10ml/ time, 2 times/day, successive administration 3 days.See table 5 for details.
Table 5 grouping is provided with table with dosage
The result:
Table 6 acupoint injection therapy pharmaceutical composition is to the curative effect of swine flue
Remarks: the curative effect determinate standard recovery from illness: after the treatment, temperature recovery is normal, and other every indexs also recover normal; Effectively: after the treatment, temperature recovery is normal, and other every indexs have to be improved or obviously improve; Invalid: after the treatment, every index there is no to be improved or death.
Above result shows: the sick pig of each medication group is under the effect of medicine, and major part obtains curing, and best with high dose and middle dosage group especially, the administration of route of administration acupuncture point is better in addition.
The using method explanation
Function: antiviral, antibiotic, antiinflammatory, heat-clearing and toxic substances removing, enhancing immunity.
Cure mainly: the various heatings of poultry, inflammation are the epidemic febrile disease of principal character, especially upper respiratory tract and gastrointestinal infection and infectious disease.
Use metering method: pig: 10-20ml, muscle or Houhai acupoint injection, were used 3-5 days continuously at every day 1-2 time.Preventive dose reduces by half.
Specification: 10ml/ bottle.
Storage: airtight, lucifuge is put shady and cool place.
Effect duration: 2 years.
Claims (2)
1. prevent and treat poultry epidemic febrile disease pharmaceutical composition for one kind, it is characterized in that:
Calculate with the 1500ml medicinal liquid, contain the Chinese medicine of respectively distinguishing the flavor of and be with weight and the adjuvant weight proportion that raw medicinal herbs calculates:
Fructus Forsythiae 350～450g, Radix Isatidis 150～250g, Flos Lonicerae 150～250g, Radix Scutellariae 150～250g, Rhizoma Coptidis 150～250g, Tradescantia albiflora 150～250g, Radix Glycyrrhizae 75～125g, benzyl alcohol 2-3g, all the other are distilled water.
2. a kind of control poultry epidemic febrile disease preparation of pharmaceutical compositions method as claimed in claim 1 is:
1. water is carried: get Fructus Forsythiae 350～450g, Radix Isatidis 150～250g, Flos Lonicerae 150～250g, Radix Scutellariae 150～250g, Rhizoma Coptidis 150～250g, Tradescantia albiflora 150～250g, Radix Glycyrrhizae 75～125g goes into jar, the distilled water immersion that adds for the first time 10 times of amounts of medicine is a moment slightly, is heated to boiling, keeps boiling 1.5 hours; Cross leaching filtrate; Filtering residue adds 8 times of water yields again, is heated to boiling and extracts 1 hour, filters and collects filtrate; Merge filtrate twice, heating is concentrated into 5000ml;
2. precipitate with ethanol: will 1. obtain concentrated filtrate and be cooled to below 40 ℃, and add 95% ethanol, the concentration of alcohol content that makes medicinal liquid is 75%, static 12～48 hours, and sucking filtration, filtrate recycling ethanol is to there not being the alcohol flavor; Add 95% ethanol again, making the alcohol amount of containing in the solution is 80%, static 12～48 hours, sucking filtration, filtrate recycling ethanol also concentrates, dense magma; Add water for injection to 1300ml, add 1% active carbon, ebuillition of heated 30 minutes, filter solution;
3. medicinal liquid preparation: the benzyl alcohol 2. obtaining adding in the solution 0.1%, be settled to 1500ml, be filtered to clear and brightly with No. 3 sintered glass funnels, embedding is sterilized for 100 ℃ and was promptly got product in 30 minutes.
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| CN103536668B (en) * | 2013-11-08 | 2015-09-30 | 四川巴尔农牧集团有限公司 | The preparation method of dysentery relieving Chinese medicine composition |
| CN103536667B (en) * | 2013-11-08 | 2015-11-04 | 四川巴尔农牧集团有限公司 | Dysentery relieving Chinese medicine composition |
| CN103720929A (en) * | 2013-11-15 | 2014-04-16 | 北安市飞龙动物药厂 | Andrographis paniculata injection |
| CN105030929B (en) * | 2015-08-21 | 2019-01-15 | 潍坊华英生物科技有限公司 | A kind of Chinese medicine composition for preventing and treating livestock and poultry warm disease |
| CN105412254A (en) * | 2015-12-11 | 2016-03-23 | 中国农业科学院兰州畜牧与兽药研究所 | Traditional Chinese medicine composition for preventing and treating infectious diseases of respiratory tracts of livestock and preparation method thereof |
| CN109331111B (en) * | 2018-12-10 | 2021-09-28 | 河南农业大学 | Compound andrographis paniculata preparation for treating livestock and poultry epidemic febrile disease and preparation method thereof |
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