CN101347522A - Nano 'Shuang Hualian' injection preparation for fowl and preparation thereof - Google Patents
Nano 'Shuang Hualian' injection preparation for fowl and preparation thereof Download PDFInfo
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- CN101347522A CN101347522A CNA2008100541399A CN200810054139A CN101347522A CN 101347522 A CN101347522 A CN 101347522A CN A2008100541399 A CNA2008100541399 A CN A2008100541399A CN 200810054139 A CN200810054139 A CN 200810054139A CN 101347522 A CN101347522 A CN 101347522A
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Abstract
The invention relates to a nano Shuanghuanglian injection used for poultry and a preparation method thereof; the nano Shuanghuanglian injection consists of 3-55% of Chinese medicinal material extracts which are taken as active ingredients and 41-90% of biodegradable medicinal high-molecular excipients which have microsphere weight and have molecular weight ranging from 4,000 to 9,000,000 by weight proportion; wherein, the weight percentage of medicinal materials is as follows: 10-42% of Chinese goldthread, 10-50% of honeysuckle, 10-40 % of forsythia and 10-38% of radix scutellariae. The medicines are prepared into microspheres by spray drying process. The invention has the benefical effects of (1) developing a new medicine for preventing and treating poultry viral diseases for clinical application; (2) reasonable prescription and strong antiviral ability; (3) advanced technique, stable preparation and long storage time; (4) broad medicine sources and no toxicity and side effect. Especially, the nano Shuanghuanglian injection has significant effect on the treatment of poultry infectious bursal disease, untypical Newcastle disease, infective bronchitis, etc.
Description
Technical field
The present invention relates to treat the field of medicaments of Animal diseases, particularly a kind of nano ' Shuang Hualian ' injection preparation for fowl and preparation method thereof.
Background technology
At present, usually based on antibiotic therapy, so not only toxic and side effects is bigger, as the hepatic and renal function to birds certain side effect is arranged, and easily causes the birds drug disposition residual aspect the treatment avian viral diseases; Simultaneously also with environmental pollution, and medical expense is higher.
Motherland's medical science thinks that Radix Scutellariae both can be used as medicine separately, also can unite use with other medical material, to reach clinical required curative effect.SHUANGHUANLIAN is a kind of Chinese medicine preparation, and Main Ingredients and Appearance is Flos Lonicerae, Rhizoma Coptidis, Fructus Forsythiae.Flos Lonicerae is exactly a Flos Lonicerae, but sweet in the mouth cold in nature, abnormal smells from the patient awns perfume (or spice), both fresh breeze using warming therapy heat can be separated the poison in the blood again, are applicable to epidemic febrile disease heating, macule, pharyngalgia.The Rhizoma Coptidis bitter in the mouth is cold in nature, in the removing pathogen in the heart after the fire, damp and hot in the bowel relieving, be applicable to excessive fire in heart, damp and hot, the damp and hot pestilent toxicity of the intestines and stomach.Fructus Forsythiae bitter in the mouth cool in nature, clearing heart fire goes the various heat symptom-complexs of the part of the body cavity above the diaphragm housing the heart and lungs, is applicable to epidemic febrile disease from the beginning of, headache, heating, excessive thirst, and the carbuncle skin ulcer that pyretic toxicity pent-up causes swells and ache, erysipelas, macule etc.
If adopt raw material of Chinese medicine to make tablet, powder etc., because the interior half-life of the Chinese crude drug water-soluble active ingredient body that has is shorter, need frequent drug administration, therefore use inconvenience; Assimilation effect is not good enough simultaneously, and therapeutic effect is not ideal enough.
Therefore, how providing that a kind of prevention effect is remarkable, technology is simply treated nano ' Shuang Hualian ' injection preparation of avian viral diseases and preparation method thereof, is one of this technical field scientific research personnel new problem of being badly in need of developing.
Summary of the invention
The object of the invention is to provide the nano ' Shuang Hualian ' injection preparation of the treatment avian viral diseases of a kind of brand-new slow release, high bioavailability.
Another object of the present invention is to provide the preparation method of the nano ' Shuang Hualian ' injection preparation of this treatment avian viral diseases.
The present invention is achieved through the following technical solutions:
A kind of nano ' Shuang Hualian ' injection preparation for fowl, it is characterized in that comprising that 3～55% the extract by Chinese crude drug is that 41～90% molecular weight ranges of active component and microsphere weight is 4,000～9000, biodegradable medicinal high polymer adjuvant between 000 is formed, the composition of its Chinese crude drug % proportioning by weight is: Rhizoma Coptidis 10%～42%, Flos Lonicerae 10%～50%, Fructus Forsythiae 10%～40%, Radix Scutellariae 10%～38%.
The preferred weight percentage composition of described active component crude drug is: Rhizoma Coptidis 30%, Flos Lonicerae 25%, Fructus Forsythiae 15%, Radix Scutellariae 30%.
Described medicinal high polymer adjuvant is selected from polylactide-co-glycolide, polylactic acid, polyglycolic acid, poly--the 3-butyric ester, polylactic acid-polyglycolic acid, polylactic acid. glycolic, poly-adjacent ester, polylactone, polyanhydride, poly butyric ester-hydroxyl pentanoate copolymer, polyglycolic acid, polypropylene glucosan, hydroxyacetic acid, polylactic acid-polyglycol, polyglycolic acid. and Polyethylene Glycol one or more mixing wherein.
Excellent polylactide-co-glycolide, polylactic acid, the polylactic acid of being selected from of described medicinal high polymer adjuvant. one or more mixing wherein of polyglycolic acid, polylactic acid-glycollic acid, poly butyric ester-hydroxyl pentanoate copolymer.
Described medicinal high polymer adjuvant is a polylactide-co-glycolide; Its molecular weight of described polylactide-co-glycolide is between 9000～13000 dalton; Lactide and Acetic acid, hydroxy-, bimol. cyclic ester polymerization ratio are between 40: 60～60: 40 in the polylactide-co-glycolide.
The said medicine composition proportion by the weight % proportioning of use crude drug, be made into preparation need to described Rhizoma Coptidis, Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae etc. further separately or mixed extraction be processed into extract and make gel film with suitable adjuvant.Extracting method wherein generally includes: water extraction method, decoction and alcohol sedimentation technique or microwave extraction method etc.For the ease of understanding, the existing extracting method in present technique field is described below for example:
Rhizoma Coptidis microwave extraction method: get after Rhizoma Coptidis pulverizes, the flask of setting fire, and this flask put in people's microwave reactor, alcohol reflux is adjusted microwave power and is extracted, and collects extracting solution, Rhizoma Coptidis extract.
The Flos Lonicerae water extraction: the extracting honeysuckle medical material, 20 mesh sieves are pulverized, twice of extracting in water, the water logging bubble that adds for the first time 9～10 times of amounts, heating extraction 1.5 hours adds 5～7 times of water gagings, heating extraction 1 hour for the second time, merge extractive liquid,, suitably concentrate, add 95% ethanol, make to contain alcohol amount arrival 50-70%, concentrate and reclaim ethanol, get Flos Lonicerae extract.
The ethanol extraction method of Fructus Forsythiae: get the Fructus Forsythiae medical material, 20 mesh sieves are pulverized, and add the ethanol extraction three times that 7-9 doubly measures 50% concentration, reflux 8 hours, merge extractive liquid, concentrates and reclaims ethanol, Fructus Forsythiae extract.
The Radix Scutellariae water extraction alcohol sedimentation method: get Radix Scutellariae, 20 mesh sieves are pulverized, and extracting in water filters, suitably concentrate the back and adopt ethanol to precipitate, precipitate with ethanol again after supernatant suitably concentrates, supernatant reclaims ethanol, concentrate Radix Scutellariae extract.
Except that the independent extraction of above-mentioned medical material, described Rhizoma Coptidis, Flos Lonicerae, all right mixed extraction of Fructus Forsythiae are mainly: Rhizoma Coptidis, Flos Lonicerae, the Fructus Forsythiae medical material of learning from else's experience and pulverizing, and boiling water boils to be carried, filter, merging filtrate, and filtrate is suitably concentrated; Add ethanol and carry out precipitate with ethanol in concentrated solution, leave standstill, supernatant reclaims ethanol, is condensed into extractum, gets medicinal substances extract.
Nano ' Shuang Hualian ' injection preparation diameter of the present invention is 1～250 μ m, and 4,000～9000, the biodegradable medicinal high polymer adjuvant between 000 is formed by the molecular weight ranges of microsphere gross weight 41～90%.
Microsphere of the present invention can adopt the conventional preparation method of microsphere to make, promptly adopt spray drying method to make, it is characterized in that implementation step comprises that the molecular weight of mixed liquor dissolving 3～55% medicinal substances extracts formed with dichloromethane, chloroform, ethyl acetate, dioxane, ether, acetone, oxolane, glacial acetic acid and by them and derivant and 41～90% is 4,000-9000,000 daltonian biodegradable medical high-molecular additive, after stirring fully dissolving, filter, adopt spray drying method to make microsphere.
SHUANGHUANLIAN microsphere of the present invention be will make the microsphere sterilized powder earlier in aseptic 0.9% normal saline solvent suspendible evenly the back intramuscular administration treat.The drug release process of most of conventional dosage forms is all undertaken by first order kinetics, and the blood drug level of its medicine might be lower than minimum effective blood drug concentration and hold time short shortcoming in treatment concentration.For reaching therapeutic purposes and reducing side effect and often take repeatedly medicining mode, the compliance that makes the patient take medicine like this descends.Slow releasing preparation has overcome the deficiency of conventional formulation just, and steady, persistent blood drug level is provided.
The invention has the beneficial effects as follows: Rhizoma Coptidis, Flos Lonicerae, Fructus Forsythiae, radix scutellariae medicinal materials are extracted the back make microsphere, can reach non-lentamente constant release, reduce and take number of times, improve the purpose of patient's compliance with suitable adjuvant.The extraction process of uses advanced is separated effective monomer in the medical material, extracts the back and makes microsphere with suitable adjuvant.Effective ingredient in the Chinese herbal medicine is slowly discharged.The effective ingredient that extracts in the prescription is the formation of blocking virus nucleic acid directly, suppress duplicating and breeding of virus, but and the humoral immunization of enhancing body and cellular immunization, this invention medicine has the body of inducing generation interferon simultaneously, enhancing antibody forms, strengthen the phagocytosis of macrophage to pathogen, thus effective kill virus.
Medicine of the present invention is external to have direct killing action to bursal disease virus of chickens; Model to artificial challenge's bursal disease virus of chickens also has significant protection and therapeutical effect.Clinical research confirmation medicine of the present invention has excellent curative to bursal disease virus of chickens, especially can remove heating that viral infection causes rapidly, improve symptom, promote sick fowl to recover to search for food, promote laying rate and egg product matter to recover, second day clinical symptoms alleviated rapidly after the general medication, recovery from illness in 3～5 days, the curative effect highly significant.
This medicine is human body immunity improving power effectively, and anti-virus ability is strong, the clinical viral diseases such as treatment poultry infectious bursal disease, atypical newcastle disease, infectious bronchitis that are mainly used in.Reasonable recipe, the variation of heat clearing away approach has taken into full account the thermotaxic characteristics of birds, and the pestilence of dispelling the heat, dispel alleviates the sense of discomfort of body, thereby alleviates the symptom of disease to a great extent, increases disease fowl appetite, promotes the rehabilitation of disease fowl.
Be summarized as follows:
(1) goes out a kind of novel formulation of preventing and treating avian viral diseases, improving body disease-resistant power for clinical development.
(2) reasonable recipe, the absorption rate height, the slow release lasting medicine, anti-virus ability is strong, and selected medicine is the efficient medicine of treatment avian viral diseases.
(3) technology advanced person, preparation is simple, preparation stabilization, lasting medicine, storage period is long.
(4) medicament sources is extensive, cost is low, safely, have no side effect, is difficult for producing drug resistance, meets the international hygiene touchstone.It is remarkable to be used in particular for treating effects such as birds infectious bursal disease, atypical newcastle disease, infectious bronchitis.
The specific embodiment
Below in conjunction with preferred embodiment, to details are as follows according to the specific embodiment provided by the invention:
Embodiment 1
Get Rhizoma Coptidis 300g, Flos Lonicerae 250g, Fructus Forsythiae 150g, Radix Scutellariae 300g will be through ground honeysuckle, Fructus Forsythiae, Rhizoma Coptidis, and decocting boils 2 times, add 7 times of water gagings at every turn, each 2 hours, merge decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, make determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol; Continue to be condensed into Flos Lonicerae, Rhizoma Coptidis, Fructus Forsythiae extract; To decoct with water 2 times through the Radix Scutellariae of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol, and continue to be condensed into Radix Scutellariae extract.
Comprise that 3～55% the extract by Chinese crude drug is that 41～90% molecular weight ranges of active component and microsphere weight is 4,000～9000, biodegradable medicinal high polymer adjuvant between 000 dalton is formed, and described medicinal high polymer adjuvant is selected from polylactide-co-glycolide, polylactic acid, polyglycolic acid, poly--the 3-butyric ester, polylactic acid-polyglycolic acid, polylactic acid. glycolic, poly-adjacent ester, polylactone, polyanhydride, poly butyric ester-hydroxyl pentanoate copolymer, polyglycolic acid, the polypropylene glucosan, hydroxyacetic acid, polylactic acid-polyglycol, polyglycolic acid. Polyethylene Glycol one or more mixing wherein.
The molecular weight that comprises mixed liquor dissolving 3～55% medicinal substances extracts formed with dichloromethane, chloroform, ethyl acetate, dioxane, ether, acetone, oxolane, glacial acetic acid and by them and derivant and 41～90% is 4,000～9000,000 daltonian biodegradable medical high-molecular additive, after stirring fully dissolving, filter.
The concrete preparation of microsphere: take by weighing above-mentioned Rhizoma Coptidis extract, Flos Lonicerae extract, Fructus Forsythiae extract, Radix Scutellariae extract altogether 1000mg (ratio is 2: 1: 1: 2), polylactide-co-glycolide (lactide: Acetic acid, hydroxy-, bimol. cyclic ester=60: 40), 4.0g in small beaker, 41ml adds methylene chloride, electromagnetic agitation adopts spray drying method to make microsphere to fully dissolving; Record particle diameter 1～50 μ m, mean diameter 13.26 μ m, sterilization, packing.
Embodiment 2
Get Rhizoma Coptidis 120g, Flos Lonicerae 160g, Fructus Forsythiae 380g, Radix Scutellariae 340g will be through ground honeysuckle, Rhizoma Coptidis, Fructus Forsythiae, and decocting boils 2 times, add 7 times of water gagings at every turn, each 2 hours, merge decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, make determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol; Continue to be condensed into Flos Lonicerae, Rhizoma Coptidis, Fructus Forsythiae extract; To decoct with water 2 times through the Radix Scutellariae of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol, and continue to be condensed into Radix Scutellariae extract.
The concrete preparation of microsphere: take by weighing above-mentioned Rhizoma Coptidis extract, Flos Lonicerae extract, Fructus Forsythiae extract, Radix Scutellariae extract altogether 1000mg (ratio is 2: 1: 1: 2), polylactide-co-glycolide (lactide: Acetic acid, hydroxy-, bimol. cyclic ester=60: 40), 4.0g in small beaker, 41ml adds methylene chloride, electromagnetic agitation adopts spray drying method to make microsphere to fully dissolving; Record particle diameter 1～50 μ m, mean diameter 13.26 μ m, sterilization, packing.
Other is with embodiment 1.
Application example
200 15 age in days broiler (aseptic through physical examination) are divided into totally 5 groups of A, B, C, D, E, test behind B, C, the strong malicious counteracting toxic substances of D, E group process artificial challenge's 0.6ml bursal disease virus of chickens.A group is healthy group, infective virus not, not administration; B organizes negative control group, infective virus, not administration; The C group is the pharmaceutical composition low dose group, presses 0.06g/ chicken/sky injection; The D group is the pharmaceutical composition high dose group, presses 0.12g/ chicken/sky injection; The E group is pressed 0.1g/ chicken/sky drug administration by injection for astragalin injection group (Dalian three instrument company limiteies).The result shows, adopts nano ' Shuang Hualian ' injection preparation treatment chicken bursal disease viral disease of the present invention that tangible curative effect is arranged.
Nano ' Shuang Hualian ' injection preparation contrast and experiment of the present invention is as follows:
| Numbering | Group | Mortality rate % | Cure rate % | Effective percentage % |
| A | Healthy group | 0 | 97.5(39/40) | 100.0(40/40) |
| B | Negative control group | 55.0(22/40) | 5.0(2/40) | 25.0(10/40) |
| C | Low dose therapy group of the present invention | 30.0(12/40) | 42.5(17/40) | 77.5(31/40) |
| D | High-dose therapy group of the present invention | 20.0(8/40) | 62.5(25/40) | 87.5(35/40) |
| E | " astragalin injection " treatment group | 25.0(10/40) | 45.0(18/40) | 80.0(32/40) |
This result of the test shows, pharmaceutical composition is low, high-dose therapy group and matched group difference highly significant (P＜0.01), illustrates that pharmaceutical composition of the present invention has significant therapeutical effect to the chicken bursal disease viral disease that virus causes; Particularly high dose is used and obviously is better than " astragalin injection " treatment group curative effect (P＜0.01).
Above-mentioned detailed description of this nano ' Shuang Hualian ' injection preparation for fowl and preparation method thereof being carried out with reference to embodiment; be illustrative rather than determinate; can list several embodiment according to institute's limited range; therefore in the variation and the modification that do not break away under the general plotting of the present invention, should belong within protection scope of the present invention.
Claims (6)
1, a kind of nano ' Shuang Hualian ' injection preparation for fowl, it is characterized in that comprising that 3～55% the extract by Chinese crude drug is that 41～90% molecular weight ranges of active component and microsphere weight is 4,000～9000, biodegradable medicinal high polymer adjuvant between 000 is formed, the composition of its Chinese crude drug % proportioning by weight is: Rhizoma Coptidis 10%～42%, Flos Lonicerae 10%～50%, Fructus Forsythiae 10%～40%, Radix Scutellariae 10%～38%.
2, nano ' Shuang Hualian ' injection preparation for fowl according to claim 1 is characterized in that the preferred weight percentage composition of described active component crude drug is: Rhizoma Coptidis 30%, Flos Lonicerae 25%, Fructus Forsythiae 15%, Radix Scutellariae 30%.
3, nano ' Shuang Hualian ' injection preparation for fowl according to claim 1 is characterized in that described medicinal high polymer adjuvant is selected from polylactide-co-glycolide, polylactic acid, polyglycolic acid, poly--the 3-butyric ester, polylactic acid-polyglycolic acid, polylactic acid. glycolic, poly-adjacent ester, polylactone, polyanhydride, poly butyric ester-hydroxyl pentanoate copolymer, polyglycolic acid, polypropylene glucosan, hydroxyacetic acid, polylactic acid-polyglycol, polyglycolic acid. and Polyethylene Glycol one or more mixing wherein.
4, nano ' Shuang Hualian ' injection preparation for fowl according to claim 1 is characterized in that excellent polylactide-co-glycolide, polylactic acid, the polylactic acid of being selected from of described medicinal high polymer adjuvant. one or more mixing wherein of polyglycolic acid, polylactic acid-glycollic acid, poly butyric ester-hydroxyl pentanoate copolymer.
5, the nano ' Shuang Hualian ' injection preparation of treatment avian viral diseases according to claim 1 is characterized in that described medicinal high polymer adjuvant is a polylactide-co-glycolide; Its molecular weight of described polylactide-co-glycolide is between 9000～13000 dalton; Lactide and Acetic acid, hydroxy-, bimol. cyclic ester polymerization ratio are between 40: 60～60: 40 in the polylactide-co-glycolide.
6, a kind of preparation method of nano ' Shuang Hualian ' injection preparation for fowl according to claim 1, promptly adopt spray drying method to make, it is characterized in that implementation step comprises that the molecular weight of mixed liquor dissolving 3～55% medicinal substances extracts formed with dichloromethane, chloroform, ethyl acetate, dioxane, ether, acetone, oxolane, glacial acetic acid and by them and derivant and 41～90% is 4,000～9000,000 daltonian biodegradable medical high-molecular additive, after stirring fully dissolving, filter, adopt spray drying method to make microsphere.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008100541399A CN101347522A (en) | 2008-08-15 | 2008-08-15 | Nano 'Shuang Hualian' injection preparation for fowl and preparation thereof |
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| CNA2008100541399A CN101347522A (en) | 2008-08-15 | 2008-08-15 | Nano 'Shuang Hualian' injection preparation for fowl and preparation thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988490A (en) * | 2012-11-26 | 2013-03-27 | 河南新正好生物工程有限公司 | Application of Shuanghuanglian oral liquor in preparation of medicine for treating and preventing poultry virosis |
| CN104306645A (en) * | 2014-09-30 | 2015-01-28 | 天津瑞贝特科技发展有限公司 | Injection with antibacterial and anti-inflammatory effects for livestock and poultry and preparation method thereof |
| CN106668177A (en) * | 2016-12-13 | 2017-05-17 | 四川喜亚动物药业有限公司 | Traditional Chinese medicine combination for chicken infectious bronchitis and preparation method thereof |
| CN108210586A (en) * | 2018-01-04 | 2018-06-29 | 中国农业大学 | A kind of pure natural plant ingredients additive for alleviating diarrhea of weaned piglets, improving its intestinal health |
-
2008
- 2008-08-15 CN CNA2008100541399A patent/CN101347522A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988490A (en) * | 2012-11-26 | 2013-03-27 | 河南新正好生物工程有限公司 | Application of Shuanghuanglian oral liquor in preparation of medicine for treating and preventing poultry virosis |
| CN104306645A (en) * | 2014-09-30 | 2015-01-28 | 天津瑞贝特科技发展有限公司 | Injection with antibacterial and anti-inflammatory effects for livestock and poultry and preparation method thereof |
| CN106668177A (en) * | 2016-12-13 | 2017-05-17 | 四川喜亚动物药业有限公司 | Traditional Chinese medicine combination for chicken infectious bronchitis and preparation method thereof |
| CN108210586A (en) * | 2018-01-04 | 2018-06-29 | 中国农业大学 | A kind of pure natural plant ingredients additive for alleviating diarrhea of weaned piglets, improving its intestinal health |
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Open date: 20090121 |