CN1380098A - Anti-infection compound preparation and its preparation method - Google Patents
Anti-infection compound preparation and its preparation method Download PDFInfo
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- CN1380098A CN1380098A CN 02117483 CN02117483A CN1380098A CN 1380098 A CN1380098 A CN 1380098A CN 02117483 CN02117483 CN 02117483 CN 02117483 A CN02117483 A CN 02117483A CN 1380098 A CN1380098 A CN 1380098A
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Abstract
The anti-infective medicine, including powder, mixture, aerosol, capsule, injection, suppository, ointment and microcapsule, is characterized by that on the theroretical basis of combining traditional Chinese medicine and modern immunology the immunoglobulin, effective components of Chinese medicinal materials which are extracted according to the compound prescription and auxiliary preparation are combined together organically, and undergone the fine preparation process to obtain a high-efficiency, safe, stable, environment-protecting type anti-infection medicine having no toxic side effect and having no drug resistance.
Description
Technical field
The present invention relates to anti-infectives, more particularly, is a kind of anti-infectious preparation that contains herbal mixture and immunoglobulin and preparation method thereof.
Background technology
Be applied to the anti-infective medicine at present antibiotic, chemosynthesis medicine, Chinese medicine and preparation thereof and immunoglobulin preparation are arranged.
(1) antibiotic
This class anti-infectives mainly is the metabolite that is produced by Institute of Micro-biology such as antibacterial, fungus, actinomycetes, and artificial imitated synthetic or semisynthetic antibiotics.They are strong to the inhibition or the killing action of pathogenic microorganism, has a broad antifungal spectrum, and good effect is widely used in human and animal's diseases prevention and treatment.But, their toxic and side effects are big, anaphylaxis very easily takes place as natural penicillin (benzylpenicillin), semisynthetic penicillin (ampicillin, amoxicillin), cephalosporin etc., streptomycin, amikacin, gentamycin, micronomicin, kanamycin etc. very easily cause kidney and the infringement of the 8th pair of cranial nerve and to the effect of disabling of fetus and infant, oxytetracycline, tetracycline, chlortetracycline, polymyxin E, bacitracin etc. cause liver, renal damage, and lincomycin, chloromycetin etc. also has harmful effect (seeing pharmacopeia for details) to hematopoietic function.
(2) chemosynthesis medicine
This class anti-infectives mainly comprises sulfonamides, quinolones, furans etc.Their has a broad antifungal spectrum, stable in properties, determined curative effect, easy to use.But it is big to have toxic and side effects, easily residues in the body, causes liver, kidney etc. to organize irreversible infringement.
More than two class medicines except above-mentioned shortcoming, their common drawbacks also have the interference body normal flora, destroy the body microecological balance, cause microorganism species imbalance displacement, cause superinfection and other pathological changes: moreover, heavy dose is used repeatedly and can be caused drug resistance, reduce therapeutic effect, make the responsive rate of its anti-infective drop to 10-15%, and induce out highly pathogenic bacterial strain, as Japanese large-scale outbreak Escherichia coli O 157: H7 in 1996, caused the concern of whole international community; U.S. scientist in 1999 has found that in feedstuff a kind of enterococcus all has drug resistance to present all antibiotic, seriously harms human and animal's disease treatment thus.So countries in the world have been formulated a series of policies one after another, forbid in animal produces, using this two classes medicine, prolong their medical life-spans to human diseases, but this just individual way of trying to stop water from boiling by skimming it off and pouring it back.
(3) Chinese medicine and preparation thereof
Chinese medicine belongs to natural drug, has the characteristics of harmless advantage, and strengthening vital QI to eliminate pathogenic factors, integral body are adjusted and had no drug resistance, and are that antibiotics and chemosynthesis medicine are incomparable, thereby have caused the extensive attention of western developed country.At present, many anti-infective Chinese medicine preparation such as Radix Isatidis electuary, SHUANGHUANGLIAN KOUFUYE, CHUANXINLIAN ZHUSHEYE etc. are also arranged on the market.Though these medicine antibacterials spectrum is wide,, therefore in clinical practice, be greatly limited because drug effect is slow, effect is weak, consumption is big, quality standard is difficult to stable so that use factor such as inconvenience.
(4) immunoglobulin preparation
This class anti-infectives is from special animal serum and yolk antibody.Their speed of actions are fast, and curative effect is accurate, and high specificity, but antibiotic faciostenosis are invalid to mixed infection and secondary infection, have to sometimes with above-mentioned three class medicine auxiliary treatment; Moreover they belong to reactive protein, and necessary cryopreservation is easy to the degeneration inactivation in storing and use, lose medical value.Therefore, these anti-infectious preparations are difficult to operation and have lost the commodity meaning on drug market, and then have had influence on clinical practice.
Summary of the invention
The objective of the invention is to overcome the drawback of existing infection medicine, a kind of determined curative effect is provided, stable performance, without any side effect, specially good effect anti-infection compound preparation safe and convenient to use and preparation method thereof.
Main technical schemes of the present invention: adopt the pure natural preparation of raw material, effective components of Chinese medicinal and immunoglobulin are organically combined, strict control product quality is guaranteed the specificity combination ideally of antimicrobial broad spectrum activity of Chinese medicine and immunoglobulin.
Medicine components of the present invention and parts by weight thereof:
Immunoglobulin 0.10-120.00 part, compound prescription are leached Chinese medicine powder 0.05-100.00 part and are selected from a kind of, two or more adjuvant in the chemical compound of following portions by weight: sodium pyrosulfite 0.01-0.20 part, sodium sulfite 0.01-0.20 part, sodium sulfite 0.01-0.20 part, sodium thiosulfate 0.01-0.20 part, ascorbic acid 0.01-0.80 part, multivitamin 0.01-0.80 part, disodium edetate 0.01-0.80 part, cyclodextrin 0.01-0.80 part.
Compound prescription of the present invention leaches Chinese medicine powder and comprises rough leaching Chinese medicine powder or the refining Chinese medicine powder that leaches, perhaps both mix, its raw material be according to traditional tcm theory be selected from Chinese medicine detoxifcation side, the side of inducing sweat, Dingchuan side, the side of unclogging and readjusting, hemostasis side, the tonify deficiency side a kind of two or more.
Described detoxifcation side, comprise in the following weight proportioning Chinese crude drug simply, two the flavor or two the flavor more than:
Radix Isatidis 0.01-10.00 part Herba Lophatheri 0.01-10.00 Folium Isatidis 0.01-10.00 part
Sugar pastes plain 0.01-10.00 part Herba Andrographis 0.01-10.00 part Flos Lonicerae 0.01-10.00 part
Herba Houttuyniae 0.01-10.00 part Fructus Forsythiae 0.01-10.00 part Artemisia anethoicles Mattf 0.01-10.00 part
Radix Et Rhizoma Rhei 0.01-10.00 part Herba Artemisiae Annuae 0.01-10.00 part Semen Plantaginis (grass) 0.01-10.00 part
Fructus Momordicae charantiae 0.01-10.00 part Fructus Gardeniae 0.01-10.00 part Radix Dichroae 0.01-10.00 part
Rhizoma Osmundae 0.01-10.00 part Rhizoma Coptidis 0.01-10.00 part Cortex Phellodendri 0.01-10.00 part
Radix Berberidis 0.01-10.00 part Radix Arnebiae (Radix Lithospermi) 0.01-10.00 part Radix Scutellariae 0.01-10.00 part
The described side of inducing sweat of dandelion 0.01-10.00 part cogongrass rhizome 0.01-10.00 part poplar flower 0.01-10.00 part Chinese bulbul 0.01-10.00 part bark of ash 0.01-10.00 part oldenlandia diffusa 0.01-10.00 part Sculellaria barbata 0.01-10.00 part Chinese lobelia root bark of tree peony 0.01-10.00 part root bark of Chinese wolf-berry 0.01-10.00 part wind-weed 0.01-10.00 part reed rhizome 0.01-10.00 part radix stellariae dichotomae 0.01-10.00 part selfheal 0.01-10.00 part gold sea sand 0.01-10.00 part; Be selected from the following weight proportioning Chinese medicine simply, more than two flavors or two were distinguished the flavor of:Chinese ephedra 0.01-10.00 part was done (life) ginger 0.01-10.00 rattletop 0.01-10.00 part radix bupleuri 0.01-10.00 part root of kudzu vine 0.01-10.00 part elscholtiza 0.01-10.00 part schizonepeta (fringe) 0.01-10.00 part great burdock achene 0.01-10.00 part windproof 0.01-10.00 part cassia twig 0.01-10.00 part subprostrate sophora 0.01-10.00 part mulberry leaf 0.01-10.00 part chrysanthemum 0.01-10.00 part root of Chinese wild ginger 0.01-10.00 part Chinese violet 0.01-10.00 part purslane 0.01-10.00 part kuh-seng 0.01-10.00 part giant knotweed 0.01-10.00 part Huangs (in vain) medicine 0.01-10.00 part root tuber of aromatic turmeric 0.01-10.00 part radix scrophulariae 0.01-10.00 part ramulus mori (leaf, fruit and white skin) 0.01-10.00 part purple perilla (leaf, son or stalk) the described Dingchuan side of 0.01-10.00 part root of Dahurain angelica 0.01-10.00 part Chinese mahonia 0.01-10.00 part felwort 0.01-10.00 part Fermented Soybean 0.01-10.00 part; Comprise in the following weight proportioning Chinese medicine simply, two the flavor or two the flavor more than: the described side of unclogging and readjusting of datura flower 0.01-10.00 part scopolia acutangula 0.01-10.00 part balloonflower root 0.01-10.00 part almond 0.01-10.00 part cow-bezoar 0.01-10.00 part bulb of fritillary 0.01-10.00 part ginkgo leaf 0.01-10.00 part rhizoma atractylodis 0.01-10.00 part wrinkled giant hyssop 0.01-10.00 part Poria cocos 0.01-10.00 part rhizoma alismatis 0.01-10.00 part akebi 0.01-10.00 part rush 0.01-10.00 part stem pith of the rice-paper plant 0.01-10.00 part root of Chinese trichosanthes 0.01-10.00 part indigo naturalis 0.01-10.00 part henbane seed 0.01-10.00 part desmodium 0.01-10.00 part Chinese cassia tree 0.01-10.00 part tuber of pinellia 0.01-10.00 part monkshood 0.01-10.00 part; Comprise in the following weight proportioning Chinese medicine simply, two flavors or more than two flavors: rhizoma cyperi 0.01-10.00 part banksia rose 0.01-10.00 part dried orange peel 0.01-10.00 part bark of official magnolia 0.01-10.00 part red sage root 0.01-10.00 part corydalis tuber 0.01-10.00 part safflower 0.01-10.00 part triangular 0.01-10.00 part curcuma zedoary 0.01-10.00 part radix paeoniae rubrathe 0.01-10.00 part coix seed 0.01-10.00 part rhizoma Gastrodiae 0.01-10.00 part polygala root 0.01-10.00 part rhizoma arisaematis 0.01-10.00 part aloe 0.01-10.00 part Ligusticum wallichii 0.01-10.00 part root of bidentate achyranthes 0.01-10.00 part motherwort 0.01-10.00 part tussilago 0.01-10.00 part honey 0.01-10.00 part belladonna (herb) 0.01-10.00 part folium sennae 0.01-10.00 part Herba Lycopi 0.01-10.00 part pyrrosia lingua 0.01-10.00 part peach kernel 0.01-10.00 part turmeric 0.01-10.00 part ring stays the described Zhixue Recipe of capable 0.01-10.00 part black nightshade 0.01-10.00 part, is selected to comprise in the weight proportion Chinese medicine simply, more than two flavors or two are distinguished the flavor of: adder-wort 0.01-10.00 part cacumen biotae 0.01-10.00 part sophora flower (angle) 0.01-10.00 part hairyvein agrimony 0.01-10.00 part pseudo-ginseng 0.01-10.00 part Artemisia stelleriana 0.01-10.00 part madder 0.01-10.00 part rhizoma nelumbinis 0.01-10.00 part eclipta 0.01-10.00 part
Radix Sanguisorbae 0.01-10.00 part Semen Nelumbinis 0.01-10.00 part Folium Pini 0.01-10.00 part
Radix Stemonae 0.01-10.00 part Olibanum 0.01-10.00 part Myrrha 0.01-10.00 part
Sanguis Draxonis 0.01-10.00 part little (greatly) Ji 0.01-10.00 part Cortex Ailanthi 0.01-10.00 part
Pollen Typhae 0.01-10.00 part Herba Sedi Aizoon 0.01-10.00 part Folium Callicarpae Formosanae 0.01-10.00 part
Described tonify deficiency side, comprise in the following weight proportioning Chinese crude drug simply, two the flavor or two the flavor more than:
Radix Ginseng 0.01-10.00 part Radix Codonopsis 0.01-10.00 part Radix Astragali 0.01-10.00 part
Rhizoma Atractylodis Macrocephalae 0.01-10.00 part Rhizoma Dioscoreae 0.01-10.00 part Radix Glycyrrhizae 0.01-10.00 part
Fructus Jujubae 0.01-10.00 part Herba Cistanches 0.01-10.00 part Radix Morindae Officinalis 0.01-10.00 part
Fructus Alpiniae Oxyphyllae 0.01-10.00 part Semen Cuscutae 0.01-10.00 part Herba Epimedii 0.01-10.00 part
Lentinus Edodes 0.01-10.00 part Polyporus 0.01-10.00 part oligosaccharide 0.01-10.00 part vegetable polysaccharides 0.01-10.00 part Fructus Lycii 0.01-10.00 part Radix Oplopanacis Elati 0.01-10.00 part
Radix Ophiopogonis 0.01-10.00 part Radix Asparagi 0.01-10.00 part Radix Paeoniae Alba 0.01-10.00 part
Radix Polygoni Multiflori 0.01-10.00 part Radix Adenophorae (Radix Glehniae) 0.01-10.00 part Bulbus Lilii 0.01-10.00 part
Rhizoma Polygonati Odorati 0.01-10.00 part Herba Dendrobii 0.01-10.00 part Massa Medicata Fermentata 0.01-10.00 part
Radix Angelicae Sinensis 0.01-10.00 part Radix Rehmanniae 0.01-10.00 part Rhizoma Polygonati 0.01-10.00 part
Cortex Eucommiae 0.01-10.00 part Radix Et Caulis Acanthopanacis Senticosi 0.01-10.00 part Herba Cynomorii 0.01-10.00 part
Radix Hedysari 0.01-10.00 part Flos Caryophylli 0.01-10.00 part Radix Ginseng Rubra 0.01-10.00 part
Pharmaceutical preparation of the present invention comprises any dosage form of powder on the pharmaceutics, mixture, aerosol, capsule, injection, suppository, unguentum, microcapsule.
Preparation method of the present invention may further comprise the steps:
1. preparation immunoglobulin
Immunoglobulin of the present invention refers to antibody, mainly is distributed in betaglobulin and the gamma globulin, also refers to the monoclonal antibody of synthetic:
(a) raise no-special pathogen (hereinafter to be referred as SPF) poultry, according to the technology that " laboratory animal and animal experiment technique " provides raise (the Miao Mingsan chief editor, China Traditional Chinese Medicine Publishing House, 1997 06 month the 1st edition, the 20-115 page or leaf);
(b) with commercially available or be inoculated in the SPF poultry according to the homemade antigen of existing method (vaccine), after this carried out the primary reinforcement immunity every 5-21 days, connect and be 2-8 time, after 14-21 days, the mammal blood sampling, birds can be taken a blood sample and also can be collected fowl egg, and institute's blood sampling is made hyper-immune serum, and the fowl egg of adopting are made high-immunity yolk;
(c) get step (b) hyper-immune serum, separation and method of purification according to immunoglobulin prepare immunoglobulin (Liu Yubin etc., " animal immunology experimental technique ", Jilin science tech publishing house, in October, 1989, the 1st edition, the 9th page and the Chinese Academy of Agricultural Sciences etc., " veterinary microbiology ", Chinese agriculture publishing house, in December, 1998, the 1st edition, the 656th page);
(d) get step (b) high-immunity yolk, prepare immunoglobulin according to water extraction, Polyethylene Glycol method or other method; (E.M.Akita and S.Nakai, Tournal of Immunological Metheds, 160＜1993〉207-214, and Journal of Food Science, Volume57, No.3,1992,629-634; Yang Hua etc., " Shanghai IMMUNOLOGY KEY WORDS INDEX 1992,12＜3 〉: 189; Yang De etc. " West China medical university journal " 1991,22＜1 〉: 17; Hou Weidong etc., " animal and veterinary magazine " 1998,17＜1 〉: 7, Chang Weishan etc., " Chinese veterinary's science and technology " 1998,28＜10〉10);
2. the preparation compound prescription leaches Chinese medicine powder
To prepare as follows after the independent or whole Chinese crude drugs merging of every flavor Chinese medicine:
1. by known method prepare rough leaching Chinese medicine powder (Xie Xiuqiong etc., " new product of Chinese medicine exploitation with use ", the People's Health Publisher, 2002 09 month the 2nd edition, P83-212);
2. press known method preparation refining leach Chinese medicine powder (the Yang Yun chief editor, " and Chemistry for Chinese Traditional Medicine composition extraction separation handbook, China Traditional Chinese Medicine Publishing House, 1998 the 1st edition; Xiao Chongyuan chief editor, " Chemistry for Chinese Traditional Medicine ", Shanghai science tech publishing house, 1997 the 1st edition);
3. herbal mixture immunoglobulin specially good effect anti-infectious preparation is synthetic
Immunoglobulin with preparation in the step (1), the compound prescription of step (2) preparation leaches Chinese medicine powder and is selected from sodium pyrosulfite, sodium sulfite, sodium sulfite, sulfo-is dredged sour sodium, ascorbic acid, multivitamin, disodium edetate, a kind of in the cyclodextrin, two or more adjuvant mix homogeneously, add sterile deionized water, make dry substance concentration reach 10-45%, at high-speed emulsifying machine, homogenate on colloid mill or the refiner, filter, dry on drying machine with centrifugal spray or freezer dryer then, make and comprise powder, mixture, aerosol, capsule, injection, suppository, unguentum, microcapsule is at any interior preparation, packing, warehouse-in.
Advantage of the present invention and effect:
1. preparation of the present invention is that effective components of Chinese medicinal and immunoglobulin are in intermolecular combination, (Van der Waals force and Cheng Jian etc.), immunity globulin anti-infectious specificity and middle pharmaceutically active ingredient anti-infective broad spectrum activity and the disease-resistant globality of conditioning human body self ideally cooperate, bring out the best in each other, both infect, again at secondary and mixing cause pathogeny imcrobe infection at the protopathy pathogenic microorganism; Both pathogenic microbe killing excited autoimmunity and whole disease-resistant function again; Both treating both the principal and secondary aspects of a disease was quick and durable again, thereby had embodied theory of Chinese medical science and modern immunology principle comprehensively, was a brand-new efficient medicine;
2. preparation of the present invention is the organic assembling preparation that pure natural extracts, and can make dosage forms such as powder, mixture, aerosol, capsule, injection, unguentum, suppository, microcapsule for clinical use.In vivo, their thoroughly metabolism, the nutrition that changes into that has is absorbed by body, and the histoorgans such as liver, kidney, sweat gland, intestinal, gallbladder that pass through that have are drained effectively, do not form drug residue and savings, do not have toxic and side effects, are safety and environmental protection medicines.
3. in the preparation of the present invention, middle pharmaceutically active ingredient is except the medical functions that self possesses, immunoglobulin in the preparation had good protective action, in the preparation processing process, safeguarded the level Four stereochemical structure form of immunoglobulin, overcoming immunoglobulin must preserve in low temperature environment, transportation and the shortcoming of using, immune globulin activity is stored at normal temperatures reached more than 12-18 month, therefore expanded the range of application of immunoglobulin in clinical practice most effectively, greatly having strengthened the market potential ability of antibody preparation, is the medicine of an excellent in stability;
4. preparation of the present invention can not induce pathogenic microorganism to produce drug resistance, has the permanent medical life-span, and is can people, animal shared, fundamentally solved the high investment of antibiotic and chemosynthesis medicine, fast drug resistance, short-life shortcoming;
5. the curative effect of preparation of the present invention
(1) effect and purposes
Specially good effect is killed various pathogen, improves body autoimmunity, infection and infectious disease that the control a variety of causes causes.
(2) usage and consumption
A. each per kilogram of body weight, can double to use when being in a bad way generally at 5-50mg; During prevention, use can reduce by half.
B. every day 1-2 time, 3-7 day is a course of treatment.
C. this product is according to the dosage form difference, oral administration, injection, external.
3. therapeutic effect
Use this product to improve curative effect about 20% than conventional infection medicine, effect is (P＜0.01) extremely significantly.
Comprehensively above-mentioned, preparation of the present invention is on the theoretical basis that Chinese medicine and modern immunology combine, adopt high-new biotechnology and most advanced and sophisticated physics and chemistry technology refining form a kind of efficiently, safely, the infection medicine stablizing, have no drug resistance, have the permanent medical life-span.
The specific embodiment
Further specify characteristics of the present invention below by instantiation.
Example 1
This example is a preparation herbal mixture immunoglobulin specially good effect anti-rotavirus preparation.
1. prescription composition and parts by weight thereof
0.10 kilogram of immunoglobulin
Herba Andrographis leaches 0.05 kilogram in medicated powder
0.01 kilogram in ascorbic acid
0.01 kilogram of disodium edetate
Herba Andrographis leaches medicated powder, get in the detoxifcation side Herba Andrographis simply Chinese medicine make.
2. preparation method
1. immunoglobulin preparation
A. prepare the multivalence wheel virus antigen
Get infant, calf, lamb, piglet, the rotavirus diarrhea feces of animals such as pup (detecting through ELISA is the rotavirus positive) adds isopyknic PH7.2,0.01M (130 rev/mins of PBS and an amount of bead joltings, 30 minutes), get supernatant after centrifugal 20 minutes for 3000 rev/mins, precipitate is again through repeating the above-mentioned steps secondary, the gained supernatant is merged, 8000 rev/mins centrifugal 40 minutes, get supernatant, with 100000g centrifugal 60 minutes, abandon supernatant, PH7.2,0.01M, the PBS suspended sediment, float is added to the sucrose upper strata of 40% and 60% discontinuous density gradient gently, through 100000g centrifugal 90 minutes, gets two sucrose layer mesozone band PH7.2,0.01M dialysis removes sugar behind the PBS mix homogeneously, promptly get purified multivalence rotavirus suspension, and measure protein content, again with isopyknic Fu Shi fully or Freund be mixed and made into the multivalence wheel virus antigen.
The SPF laying hen that b. will isolate the clean area raising carries out first immunisation, and method is a multi-point injection Fu Shi Freund's complete adjuvant multivalence wheel virus antigen under every Corium Gallus domesticus, with being every chicken antigenic content 100 μ g (rotavirus protein); Later on every two weeks with freund 's incomplete adjuvant multivalence wheel virus antigen reinforced immunologicals once, so repeat method and 2 to 3 times with above-mentioned.Reinforced immunological is after three weeks the last time, according to ELESA blocked method (Long Zhonger etc., " stability study of Yolk immunoglobulin ", the Chinese biological goods are learned magazine, 1997,10＜4 〉: 218) the inspection Yolk immunoglobulin is tired, and immune group is compared with non-immune group, the blocking-up rate is no less than 60%, and it is qualified to be; If defective, repeat above-mentioned reinforced immunological step till qualified, collect high-immunity egg then, sterilization, broken shell separates, and takes out high-immunity yolk.
C. the high-immunity yolk with step (b) adopts " the two-step precipitation method of fast separating and purifying specific antibody from yolk " (Yang Hua etc., " Shanghai IMMUNOLOGY KEY WORDS INDEX 1992,12＜3 〉: 189) and " with ion exchange chromatography purification egg yolk IgY ", (Yang De etc., West China medical university journal, 1991,22＜1 〉: 17), to exempt from the immunoglobulin of purifying the egg from height, on freezer dryer, pass through the cooling pre-cooling, low-temperature distillation (temperature-40 ℃) and heat up dry (temperature 40-50 ℃) three phases (Wang Mingjun etc., " veterinary biological product ", Chinese agriculture publishing house, July in 1997 the 1st edition, the 333-368 page or leaf), make the pure product of immunoglobulin;
2. Herba Andrographis leaches medicated powder (refining medicated powder) preparation
A. the Herba Andrographis raw material is cleaned, rinsing, drying, sterilization;
B. get step (a) raw material and add 8 times of decoctings and boil twice, 30 minutes for the first time, 60 minutes for the second time, collecting decoction, the deckle board filter pressing, transferring pH value is 6.5 through 14000 rev/mins of removal of impurity in centrifugal 5 minutes, concentrates 50-60 ℃ of following negative pressure and makes concentrated solution;
C. with step (b) concentrated solution, add an amount of ethanol, static, ultrafiltration, filtrate recycling ethanol makes Herba Andrographis with filtrate through the drying machine with centrifugal spray drying and leaches medicated powder.
(3) herbal mixture immunoglobulin specially good effect anti-rotavirus preparation is synthetic: formula material is mixed, add sterile deionized water, dry substance concentration is reached about 30%, and even matter in high-speed emulsifying machine is crossed sieve No. 4, spray drying on Highspeedcentrifugingandsprayingdrier, make dry powder, both can further be loaded on enteric coated capsule and make capsule, can be loaded on cillin bottle again and make injectable powder, also can directly pack and make oral powder, finally make finished product.The working condition of Highspeedcentrifugingandsprayingdrier is inlet temperature 135-165 ℃, outlet temperature 65-75 ℃, and fog-spray nozzle rotating speed 〉=22000 rev/min, negative pressure 10-80 handkerchief.
3. quality inspection
(1) character
This product is yellow to yellowish-brown powder, bitter in the mouth.
(2) differentiate
A gets this product 500mg, and adding distil water 10ml adds chloroform 10ml again, shakes up, and static 1 hour, centrifugal, get chloroform layer and water evaporate to dryness, residue adds ethanol 5ml makes dissolving.Get ethanol liquid 1ml, add alkaline picric acid test, solution slowly becomes orange red; Other gets ethanol liquid 1ml, add dinitrobenzene formic acid test solution and ethanol hydrogen production potassium oxide test solution etc. molten mixed liquor 2-4 drip i.e. displaing amaranth.
B gets ethanol liquid under (a) as need testing solution.Other gets the andrographolide reference substance, adds ethanol and makes the solution that 1ml contains 5mg, in contrast product solution.According to thin layer chromatography (Pharmacopoeia of People's Republic of China, nineteen ninety version, two ones, 30 pages of appendix) test, draw need testing solution 10 μ l, reference substance solution 5 μ l, put respectively in same be on silica gel G 254 lamellaes of binding agent with the sodium carboxymethyl cellulose, with chloroform-dehydrated alcohol (10: 1) is developing solvent, saturated half an hour, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) check
The a.PH value: get this product 500mg, add normal saline 10ml, dissolving back pH value is 5.5-7.5.
B. aseptic: according to the sterility test method (Pharmacopoeia of People's Republic of China, nineteen ninety version, two ones, 109 pages of appendix) check, should be up to specification.
C. pyrogen: check according to pyrogen inspection technique (Pharmacopoeia of People's Republic of China, nineteen ninety, two ones, 106 pages of appendix), should be up to specification.
D. haemolysis and agglutination test: the first step, prepare 2% red blood cell suspension: get the rabbit cardiac blood, be equipped with in the container of bead, jolting number minute removes Deproteinization unit, make and become to take off fine blood, add normal saline, shake up, the centrifugal supernatant that inclines, sedimentary erythrocyte reuse normal saline is diluted to 2% suspension, used the same day, and the time spent shakes up.Second step, test method: get three in test tube, add test sample 0.0ml, 0.3ml, 0.3ml respectively, adding normal saline 2.5ml, 2.2ml, 2.2ml and above-mentioned red blood cell suspension 2.5ml then respectively shakes up, place in the calorstat rapidly, keep 36 ± 0.5 ℃ of temperature, observed 3 hours, haemolysis and blood coagulation phenomenon must not be arranged.If cohesion is arranged, a desirable test tube jolting that wherein is added with test sample, condensation product should be able to homodisperse.
(4) assay
A. dehydrorographolide and andrographolide assay
Get this product 500mg, precision weighing, adding distil water 10ml adds chloroform 10ml again and extracts, and divide and get chloroform layer, water bath method, residue adds anhydrous alcohol solution, is transferred in the 5ml measuring bottle, adds dehydrated alcohol to scale, shakes up, as need testing solution.Other gets dehydrorographolide, the andrographolide reference substance is an amount of, and precision weighing adds dehydrated alcohol and makes the solution that 1ml respectively contains 1mg, solution in contrast respectively.According to thin layer chromatography (Pharmacopoeia of People's Republic of China, nineteen ninety version, two ones, 30 pages of appendix) test, the accurate need testing solution 2-4 μ l that draws, above-mentioned two kinds of reference substance solution each 1 μ l and 3 μ l, respectively the cross point in same be on the silica GF254 lamellae of binding agent with the sodium carboxymethyl cellulose, with chloroform-ethyl acetate-methanol (4: 3: 0.4) is developing solvent, launch, take out airing, scan dehydrorographolide wavelength: λ according to thin layer chromatography
S=263nm, λ
R=370nm; The andrographolide wavelength X
S=228nm, λ
R=370nm; Measure test sample trap integrated value and reference substance trap integrated value, calculate, promptly.
This product is pressed dry product and is calculated, and the total amount that contains dehydrorographolide and punching chain lactone must not be less than 4%.
B. immunoglobulin content is measured
Get this product 500mg, precision weighing, adding distil water 10ml, add chloroform 10ml again, mixing left standstill 1 hour, 3000 rev/mins centrifugal 20 minutes, get supernatant as test sample, according to unidirectional agar immunoelectrophoresis method (Liu Yubin chief editor, " animal immune experimental technique ", Jilin science tech publishing house, October in 1989 the 1st edition, the 37th page) measure, calculate, promptly.
This product is pressed dry product and is calculated, and immunoglobulin content is no less than 20%.
C. immunoglobulin titration
To get test sample in (b), check according to ELISA blocked method (1. going on foot b item related content) with present embodiment 2 preparation methoies, immunoglobulin tires-and the blocking-up rate is no less than 65%.
4. act on and purposes
The specially good effect control is based on the mixed infection diarrhoea of rotavirus infection.
5. usage and usefulness
A. each per kilogram of body weight 15-30mg.When being in a bad way, multiplicable first use; During prevention, use can reduce by half.
B. every day 1-2 time, 3-5 days is a course of treatment.
C. this product has multiple usage: the first, and enteric coated capsule is swallowed; The second, directly for oral administration with an amount of cold water dilution; The 3rd, directly be diluted to transparent supernatant liquid, intramuscular injection with normal saline.
6. result of use
A. curative effect judgment criteria
In the healing-medication 4 days, times of defecation≤2 time/day, shape is normal;
After invalid-medication 4 days treatment, times of defecation＞2 time/day, shape does not have and is clearly better.
B. treating infant diarrhea effect
The adult is 100% belt wheel shape virus almost, and infant has the infection rate of 13-70%, and average out to is more than 47%.This test selects the age below 2 years old, the course of disease is within 7 days, suffer from diarrhoea every day number of times 〉=10 time, detecting through ELISA is the wheel virus antigen positive, mixed infections such as Escherichia coli are arranged through bacteriology test, be divided into this product treatment group and routine medication group (using virazole, amikacin Lei Su etc.) at random.Usage and consumption throwing clothes enteric coated capsule are in accordance with regulations organized in this product treatment, and the routine medication group is pressed the medication of medicine operation instruction.This product cure rate has improved more than 28% than conventional medicine cure rate as a result, sees following table for details:
| Group | Case load | Invalid number | Cure number | Cure rate |
| This product group | 105 | 11 | 94 | 89.52% * |
| The conventional medicine group | 98 | 38 | 60 | 61.22% |
| *This product group is extremely more remarkable than conventional medicine group curative effect raising rate, P＜0.01. | ||||
C. child care piglet diarrhea therapeutic effect
The child care piglet diarrhea is frequent, and dehydration is become thin, detect through ELISA to be the wheel virus antigen positive, and bacteriology test K88, the K99 Escherichia coli positive, the diarrhoea for mixed infection causes is divided into two groups at random with them then.425 of A groups are this product treatment group, per kilogram of body weight 20mg, intramuscular injection once-a-day, logotype 3 days.608 of B groups are the western medicine group, oral amantadine (the provisional quality standard of Hebei province's veterinary drug, in October, 2000,1-11) per kilogram of body weight 20mg; Gentamycin sulfate-the anisodamine of intramuscular injection simultaneously (the provisional quality standard of Hebei province's veterinary drug, in October, 2000,7-3) per kilogram of body weight 0.15ml, 2 times on the one, logotype 3 days.The result shows that this product cure rate has improved more than 21.4% than Western medicine cure rate, sees following table for details.
| Group | Case load | Invalid number | Cure number | Cure rate |
| The A group | 425 | 9 | 416 | 97.88% * |
| The B group | 608 | 143 | 466 | 76.48% |
| *The A group is extremely more remarkable than B group curative effect, P＜0.01. | ||||
D. treat overall merit
Through the diarrhea treatment test of infant and piglet, this product curative effect improves more than 20% than present conventional medicine, shows that this product has good medical value and market prospect.
Example 2
This example is the anti-poultry pestilent toxicity of a preparation herbal mixture immunoglobulin specially good effect preparation
1. fill a prescription
(1) always fill a prescription composition and parts by weight thereof
50.00 kilograms of immunoglobulins.
Compound prescription leaches 10.00 kilograms of Chinese medicine powders
0.02 kilogram of sodium sulfite
0.50 kilogram of multivitamin
0.50 kilogram of edetate trisodium
(2) compound prescription leaches Chinese medicine powder (rough medicated powder)
Take off row 12 flavor Chinese medicines and make aseptic mixing leaching Chinese medicine powder, promptly get compound prescription and leach Chinese medicine powder.
A. the side of inducing sweat: 1.50 kilograms of Radix Saposhnikoviaes, 2.50 kilograms of Fructus Arctiis, 1.50 kilograms of Radix Puerariaes, 1.50 kilograms of Folium Perillaes, 1.00 kilograms of Herba Schizonepetaes.
B. detoxifcation side: 10.00 kilograms of Flos Loniceraes, 2.50 kilograms of Fructus Forsythiaes, 3.00 kilograms of Radix Scutellariaes, 3.00 kilograms of Herba Taraxacis,
C. Dingchuan side: 0.01 kilogram of Calculus Bovis, 1.00 kilograms of Radix Platycodoniss.
D. the side of unclogging and readjusting: 0.5 kilogram of Rhizoma Corydalis.
2. preparation method
1. the preparation of immunoglobulin
(1) purchases poultry pestilent toxicity antigen, the weak malicious dried Seedling (hereinafter to be referred as the pig trigeminy vaccine) of newcastle disease-infectious bronchitis of chicken-fowlpox three inactivated vaccines (hereinafter to be referred as the chicken trigeminy vaccine), swine fever-pig erysipelas-pig lung plague, exempt from pestilence-pasteurellosis bacillus-clostridieum welchii three inactivated bacteria (hereinafter to be referred as the rabbit trigeminy vaccine) and canine distemper-dog enteritis-rabies-hepatitis infectiosa canis virus-dog parainfluenza 5-linked Seedling (hereinafter to be referred as the canine penton Seedling), as the antigen of making immunoglobulin.
(2) the SPF animal (being selected from any of following animal, horse, donkey, mule, cattle, sheep, rabbit etc.) that will isolate the clean area raising carries out immunity, and every kind of antigenic consumption is each per kilogram of body weight 0.2ml, the subcutaneous or intramuscular injection of multiple spot, and its process is as follows:
The SPF animal, first immunisation chicken and pig trigeminy vaccine, immunize rabbit trigeminy vaccine and canine penton Seedling once more after 7 days; After 7 days, with chicken trigeminy vaccine and pig trigeminy vaccine time reinforced immunological, rabbit trigeminy vaccine and canine penton Seedling reinforced immunological after 7 days again.14 days afterwards or 21 days, carry out the serum immune globulin titration, according to HI test (Liu Yubin etc., " animal immunology experimental technique ", Jilin science tech publishing house, October in 1989 the 1st edition, the 111st page) HI that detects the globulin of chicken new city and pestilence tires, when both tiring reach simultaneously 〉=be qualified 1: 1280 the time;＜1: 1280 o'clock, repeat above-mentioned immune programme for children, till qualified, under aseptic condition, to take a blood sample, blood sampling volume is about per kilogram of body weight 10ml, adopt it early morning on an empty stomach, separates making hyper-immune serum at last.
(3) get step (2) hyper-immune serum, separation and method of purification (chief editor such as Chinese Academy of Agricultural Sciences according to immunoglobulin, " veterinary microbiology ", Chinese agriculture publishing house, December was the 1st edition in 1998, the 656th page) the preparation immunoglobulin, press example 1 " immunoglobulin preparation " item C money down, dry on freezer dryer, the pure product of preparation immunoglobulin.
2. compound prescription leaches the Chinese medicine powder preparation
(1) Radix Saposhnikoviae, Fructus Arctii, Radix Puerariae, Folium Perillae, Herba Schizonepetae, Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, Herba Taraxaci, Calculus Bovis, Radix Platycodonis, Rhizoma Corydalis 12 flavor Chinese medicines are cleaned separately, rinsing, drying, standby is made in sterilization.
(2) combining step (1) standby 12 flavor Chinese medicines add 10 times in water, decoct secondary, each 20 minutes, collect decocting liquid; Residue adds 8 times in water, decocts secondary again, each 1.54 hours, collects decocting liquid.Merge four times decocting liquid, filter press is transferred pH value to 6.5,14000 rev/mins centrifugal 5 minutes, get supernatant and carry out ultrafiltration and concentrated filtrate, under aseptic condition, make compound prescription then and leach Chinese medicine powder by centrifugal spray drying.
3. the anti-poultry pestilent toxicity of herbal mixture immunoglobulin specially good effect preparation is synthetic;
Formula material is mixed, add sterile deionized water, dry substance concentration is reached about 12%, and even matter on homogenizer is crossed sieve No. 4, quantitatively adorn cillin bottle, in lyophilization, pass through the cooling pre-cooling, the low-temperature distillation (40 ℃) and dry (40-50 ℃) three phases that heats up, vacuum capping, packing gets product.
3. quality inspection
(1) character
This product is the yellowish-brown powder, bitter in the mouth.
(2) differentiate
A. get this product 500mg, add ethanol 10ml, jolting 10 minutes filters, and gets filtrate 1ml, adds ferric chloride test solution 1-2 and drips, and promptly shows green.
B. get this product 500mg, add ethanol 10ml, refluxed 10 minutes, put coldly, filter, get filtrate 1ml and put in the test tube, add magnesium powder a little and hydrochloric acid 4-5 and drip, heating shows brownish red.
C. get this product 500mg, add methanol 20ml, ultrasonic Treatment 10 minutes filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the baicalin reference substance, adds methanol and makes the solution that every 1mL contains 1mg, solution in contrast.By thin layer chromatography (Pharmacopoeia of People's Republic of China, nineteen ninety version, two ones, 30 pages of appendix) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (10: 7: 5: upper solution 3) was developing solvent, launched, and took out with ethyl acetate-butanone-formic acid-water, airing, spray is with 1% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) check
Inspection item and method are checked item with example 1.
(4) assay
A. immunoglobulin content is measured
With example 1 " immunoglobulin content mensuration " item;
This product is pressed dry product and is calculated, and immunoglobulin content is no less than 45%.
B. immunoglobulin titration
Get this product 500mg, quiet close weighing, adding distil water 10ml adds chloroform 10ml again, mixing left standstill 1 hour, 3000 rev/mins centrifugal 20 minutes, get supernatant as need testing solution.Detect according to HI test (with above-mentioned related content), the HI of the immunoglobulin of newcastle disease and rabbit pestilence tire all should 〉=1: 1280.
4. act on and purposes
The hot infectious disease of various acute of specially good effect control pig, Canis familiaris L., chicken, rabbit and fleece animal.
5. usage and consumption
A. each per kilogram of body weight 10-20mg.When being in a bad way, multiplicable use; During prevention, use can reduce by half.
B. every day 1-2 time, 3-5 day is a course of treatment.
C. this product is that available cold water dilution gavages, and available again normal saline dilution is the settled solution intramuscular injection.
6. result of use
A. newcastle disease and infectious bronchitis mixed infection therapeutic effect
To breed 600 of chickens by what serological test was diagnosed as newcastle disease and infectious bronchitis mixed infection, be divided into three groups at random, 200 every group.The A group is this product treatment group, by every chicken intramuscular injection 5mg, once-a-day, logotype 5 days; The B group is celebrated big ribavirin injection (the provisional quality standard of Hebei province's veterinary drug, in October, 2000,3-8) treatment group, every chicken intramuscular injection 0.2ml, a twice-daily, logotype 5 days for compound recipe; C group is antipyretic and antitoxic powder (2000 editions veterinary drug allusion quotation two ones the 418th page) treatment group, every chicken 2-3 every day gram, and mix fodder is fed, logotype 5 days.Experimental result shows that this preparation for treating effect is apparently higher than other two groups, and survival rate can improve more than 20%.See following table for details.
| Group | Overall test chicken number | Death toll | Survive number | Survival rate |
| The A group | 200 | 26 | 174 | 87.00% * |
| The B group | 200 | 68 | 132 | 66.00% |
| The C group | 200 | 106 | 94 | 47.00% |
| *The A group is extremely more remarkable than B group and the raising of C composition motility rate, P＜0.01. | ||||
B. the therapeutic effect of swine fever and pig lung plague complication
To be diagnosed as swine fever and 185 concurrent pigs of pig lung plague by serology detection and microorganism culturing test, be divided into three groups at random.The A group is this product treatment group, by per kilogram of body weight 10mg intramuscular injection, and a twice-daily, logotype 5 days; The B group is celebrated big ribavirin injection (with the A item) treatment group, per kilogram of body weight 0.15ml intramuscular injection, a twice-daily, logotype 5 days for compound recipe; The C group is antipyretic and antitoxic powder (with the A item) treatment group, and every pig 80g every day, mix fodder feed, logotype 5 days.The survival rate of this product treatment has as a result improved more than 21% than other two groups.See following table for details:
| Group | Total treatment pig's head number | A dead number | Survive a number | Survival rate |
| The A group | 62 | 7 | 55 | 88.71% * |
| The B group | 61 | 20 | 41 | 67.21% |
| The C group | 62 | 21 | 41 | 66.13% |
| *The A group is extremely more remarkable than B group and the raising of C composition motility rate, P＜0.01. | ||||
C. resultant effect evaluation
Show that by above two examples the survival rate of this product treatment group has improved more than 20% than conventional way, has unrivaled effect.
Example 3:
This example is the anti-gastroenteritis preparation of preparation herbal mixture immunoglobulin specially good effect.
1, prescription
Total prescription composition and parts by weight thereof
120.00 kilograms of immune proteins
Compound prescription leaches 100.00 kilograms of Chinese medicine powders
0.80 kilogram of disodium edetate
0.80 kilogram of cyclodextrin
2. compound prescription leaches Chinese medicine powder (rough medicated powder)
Take off row 10 flavor Chinese medicines and merge the aseptic mixing leaching Chinese medicine powder of making, promptly get compound prescription and leach Chinese medicine powder.
A. detoxifcation side: 3.50 kilograms of Herba Hedyotidis Diffusaes, 2.00 kilograms of the Radix Pulsatillaes, 3.00 kilograms of Herba Scutellariae Barbataes, 0.01 kilogram of Herba Lobeliae Chinensis, 2.00 kilograms of Rhizoma Coptidis;
B. the side of unclogging and readjusting: 1.00 kilograms of the Radix Aucklandiae, 3.50 kilograms of Rhizoma Corydalis;
C. tonify deficiency side: 2.00 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.00 kilograms of Poria;
D. hemostasis side: 1.00 kilograms of Cacumen Platycladis.
2. preparation method
1. immunoglobulin preparation
A. prepare antigen
No. 1 antigen-Human reoviruslike agent antigen, (it is positive to detect rotavirus through ELISA, presses the method preparation of example 1 " preparation method is an a money 1. " to get infantile rotavirus enteritis feces.
No. 2 antigen-Heliobacter pylori antigens, get helicobacter pylori be seeded on cloth Lu Shi agar (Brucellaagar) culture medium cultivate 48 hours (37 ℃, gaseous environment: 5%O
2, 10%CO
2, 85%N
2).Bacterium liquid 4 ℃ of insulations 24 hours, makes it inactivation more earlier with being incubated liquid (37 ℃) in 0.5% (volume parts) formalin solution.Bacterial suspension centrifugal under room temperature (1500g, 10 minutes), the results thalline adds sterile saline, and to be prepared into concentration be 2 * 10
9The suspension of individual/ml.Before the immunity, add the complete or Freund emulsifying of equal-volume Fu Shi.
No. 3 antigen-campylobacter jejuni antigens are got campylobacter jejuni inoculation horse blood agar plate and were cultivated gaseous environment: 5%O 48 hours in 43 ℃
2, 10%CO
2, 85%N
2(being volume parts).Antibacterial is with 0.5% (volume parts) formalin solution, 24 hours inactivation treatment of 37 ℃ of insulations, the washing of reuse normal saline.Before the immunity, suspension normal saline control agent concentration to 10
9Individual/ml, and the complete or Freund emulsifying with equal-volume Fu Shi.
No. 4 antigen-Fu Shi shigella dysenteriae antigens are got the Fu Shi shigella dysenteriae and are inoculated in the Trypsin enzymolysis soybean protein juice, cultivated 18 hours for 37 ℃, and with 0.5% formalin deactivation, the results thalline, making concentration after the washing is 2 * 10
9The cell suspending liquid of individual/ml mixes with a kind of oil adjuvant.
No. 5 antigen-enterotoxigenic escherichia coli antigens are purchased commercially available heat-labile toxin antigen K88, K99, the 987P multivalence Seedling of containing.
B. prepare high-immunity yolk
The SPF laying hen that isolates the clean area raising is carried out first immunisation, and method is that No. 1, No. 2, No. 3 antigen mixed in equal amounts that a is gone on foot are A liquid, and No. 4, No. 5 the antigen mixed in equal amounts is a B liquid, every chicken muscle or the inoculation of subcutaneous multiple spot, every kind of each 1ml of antigenic solution.With above-mentioned method reinforced immunological again, immunity was once in the same way every 7 days later on after 14 days.After 21 days, carry out the immunoglobulin titration for the last time, detect the Human reoviruslike agent immunoglobulin by ELISA blocked method (1. going on foot b item related content with example 1 preparation method) and tire, its blocking-up rate is no less than 60% for qualified; Detect the enterotoxigenic escherichia coli immunoglobulin by tube agglutination test (beard letter etc., " development of the anti-swine escherichia coli yolk antibody of chicken ", Chinese poultry infectious disease, 1994 the 2nd phases, 26-27 page or leaf) and tire, its agglutination titer 〉=1: 40 is qualified.Otherwise, for defective, carry out immunity as stated above again, until qualified, collect height and exempt from egg, detoxicating, broken shell, separate, make high-immunity yolk.
C. the purification of immunoglobulin
With example 1 " preparation method is a C money 1. ".
2. compound prescription Chinese medicine powder preparation
A. Herba Hedyotidis Diffusae, the Radix Pulsatillae, Herba Scutellariae Barbatae, Herba Lobeliae Chinensis, Rhizoma Coptidis, the Radix Aucklandiae, Rhizoma Corydalis, the Rhizoma Atractylodis Macrocephalae, Poria, Cacumen Platycladi 10 flavor Chinese medicines are cleaned separately, rinsing, drying, sterilization, standby.
B. merge (a) steps 10 flavor Chinese medicine, adding water 8-10 doubly decocts three times, 25 minutes for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, centrifugal 5 minutes through 14000 rev/mins, get supernatant and transfer pH value to 7.0,40-50 ℃ of concentrating under reduced pressure, concentrated solution promptly gets compound prescription by spray drying and leaches Chinese medicine powder.
3. the anti-gastroenteritis preparation of herbal mixture immunoglobulin specially good effect is synthetic
With example 1, " preparation method is money 3. ".
At last, in gastric-dissolved capsule, or enteric coated capsule is made microcapsule with the medicated powder fill.
3. quality inspection
1. character
This product is the buff powder, and flavor is fragrant, little hardship.
2. inspection is not
A. get this product 500mg, add ethanol 20ml, jolting is extracted, and filters, and gets filtrate 2ml, puts in the small test tube, adds acetic anhydride 1ml, slowly adds concentrated sulphuric acid 1ml along tube wall again, and redness or purple colour circle appear in two liquid interfaces.
B. get this product 500mg, add methanol 20ml, jolting is extracted, filter, and the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, uses ether extraction 3 times, and each 10ml merges ether, and evaporate to dryness, residue add methanol 1ml makes dissolving, makes test liquid.Get the Rhizoma Corydalis reference substance again, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution.By thin layer chromatography (People's Republic of China (PRC) state pharmacopeia, in 1990 version, two ones, 30 pages of appendix) test, draw each 2-3 μ l of above-mentioned two kinds of solution, putting respectively on the silica gel g thin-layer plate of same usefulness 1% sodium hydroxide solution preparation, is developing solvent with normal hexane-chloroform-methanol (7.5: 4: 1), puts with in the pre-saturated expansion cylinder of developing solvent, launch, take out, dry, smoked clear with iodine vapor to the speckle colour developing.Inspect under the daylight, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, 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
4. check
Should meet every regulation relevant under the capsule item (Pharmacopoeia of People's Republic of China, in 1990 version, two ones, 8 pages of appendix).
4. assay
A. immunoglobulin content is measured
With example 1 " immunoglobulin content mensuration " item.
This product is pressed dry product and is calculated, and immunoglobulin content is no less than 30%.
B. immunoglobulin titration
Get this product 500mg, precision weighing, adding distil water 10ml, add chloroform 10ml again, mixing, static 1 hour, 3000 rev/mins centrifugal 20 minutes, get supernatant as test solution according to ELISA blocked method and tube agglutination test (with present embodiment 2,1., b money related content) respectively to the check of tiring of the immunoglobulin of rotavirus and enterotoxigenic escherichia coli, the blocking-up rate of rotavirus immunoglobulin is not less than 80%, enterotoxigenic escherichia coli immunoglobulin agglutination titer 〉=1: 640.
4. act on and purposes
Specially good effect control gastroenteritic ulcer, fulminant dysentery, bacillary dysentery etc. are effectively prevented the gastrointestinal canceration.
5. usage and consumption
A. each per kilogram of body weight 5-10mg.When being in a bad way, double to use; During prevention, can the amount of reducing by half.
B. every day 1-2 time, 4 weeks were a course of treatment.
C. this product is a capsule, gastropathy gastric-dissolved capsule agent, and the enteropathy enteric coated capsule, ante cibum, warm water or temperature milk took.
6. result of use
Through the gastroscopy stomach ulceration is arranged, sampling is carried out microbiology and is detected the helicobacter pylori positive, and volunteer 28 people that choosing has this symptom are divided into 2 groups, every group 14 people at random.The A group is taken the gastric-dissolved capsule agent as stated above with this product, continuous five courses of treatment; The B group is treated continuous five courses of treatment with the easypro plain film conventional medicine by specification medications such as (Pharmacopoeia of People's Republic of China, in 1990 version, two ones, 357 pages) of ranitidine hydrochloride capsules (Pharmacopoeia of People's Republic of China, in 1990 version, two ones 550 pages) stomach function regulating.After the drug withdrawal, to the gastroscopy of advancing again of stomach ulceration, the A group improves more than 21% than B group cure rate as a result.See following table for details:
| Group | Total case load | The gastric ulcer speckle routine number that heals | Cure rate |
| The A group | 14 | 11 | 78.57%* |
| The B group | 14 | 8 | 57.14% |
| * the A group is extremely more remarkable than the raising of B group curative effect, P＜0.01. | |||
The annual all kinds of diarrhoea in the whole world are sent out case load and are surpassed 1,000,000,000, and Si Wang number about 3,120,000 therefrom.The whole world has the people more than 50% once to infect helicobacter pylori approximately, has every year people more than 400,000,000 to infect campylobacter jejuni, and the people infects enterotoxigenic escherichia coli more than 400,000,000,2.5 the people infects dysentery bacterium more than hundred million, it should be noted that especially helicobacter pylori is the important biomolecule inducement of gastric cancer, highly vigilant of in addition, (horse big dragon chief editor, " biotech drug ", Science Press, February calendar year 2001 the 1st edition, 170-175), therefore, the present invention has very big social benefit and market value.
Claims (10)
1. an anti-infective medicine is characterized in that it is the medicament of being made by the following weight proportion raw material
Immunoglobulin 0.10-120.00 part
Compound prescription leaches Chinese medicine powder 0.05-100.00 part
Be selected from sodium pyrosulfite, sodium sulfite, sodium thiosulfate, sodium sulfite, ascorbic acid, multivitamin, disodium edetate ,-in the cyclodextrin a kind of, two or more, wherein:
Sodium pyrosulfite 0.01-0.20 part
Sodium sulfite 0.01-0.20 part
Sodium thiosulfate 0.01-0.20 part
Sodium sulfite 0.01-0.20 part
Ascorbic acid 0.01-0.80 part
Cyclodextrin 0.01-0.80 part
Multivitamin 0.01-0.80 part
Edetic acid Erhuang 0.01-0.80 part
2. according to the described medicine of claim 1, it is characterized in that described medicament comprises any dosage form of said powder on the pharmaceutics, mixture, aerosol, capsule, injection, suppository, unguentum, microcapsule.
3. according to the described medicine of claim 1, it is characterized in that Chinese medicine powder that described compound prescription leaches comprises rough leaching Chinese medicine powder, refiningly leaches Chinese medicine powder or both mix, its raw material be selected from Chinese medicine detoxifcation side, the side of inducing sweat, Dingchuan side, the side of unclogging and readjusting, hemostasis side, the tonify deficiency side a kind of, two or more.
4. according to the described medicine of claim 3, it is characterized in that described detoxifcation side, comprise in the following weight proportioning Chinese crude drug simply, two the flavor or two the flavor more than:
Radix Isatidis 0.01-10.00 part Herba Lophatheri 0.01-10.00 Folium Isatidis 0.01-10.00 part
Sugar pastes plain 0.01-10.00 part Herba Andrographis 0.01-10.00 part Flos Lonicerae 0.01-10.00 part
Herba Houttuyniae 0.01-10.00 part Fructus Forsythiae 0.01-10.00 part Artemisia anethoicles Mattf 0.01-10.00 part
Radix Et Rhizoma Rhei 0.01-10.00 part Herba Artemisiae Annuae 0.01-10.00 part Semen Plantaginis (grass) 0.01-10.00 part
Fructus Momordicae charantiae 0.01-10.00 part Fructus Gardeniae 0.01-10.00 part Radix Dichroae 0.01-10.00 part
Rhizoma Osmundae 0.01-10.00 part Rhizoma Coptidis 0.01-10.00 part Cortex Phellodendri 0.01-10.00 part
Radix Berberidis 0.01-10.00 part Radix Arnebiae (Radix Lithospermi) 0.01-10.00 part Radix Scutellariae 0.01-10.00 part
Herba Taraxaci 0.01-10.00 part Rhizoma Imperatae 0.01-10.00 part flower of poplar 0.01-10.00 part
Radix Pulsatillae 0.01-10.00 part Cortex Fraxini 0.01-10.00 part Herba Hedyotidis Diffusae 0.01-10.00 part
Herba Scutellariae Barbatae 0.01-10.00 part Herba Lobeliae Chinensis 0.01-10.00 part Cortex Moutan 0.01-10.00 part
Cortex Lycii 0.01-10.00 part Rhizoma Anemarrhenae 0.01-10.00 part Rhizoma Phragmitis 0.01-10.00 part
Radix Stellariae 0.01-10.00 part Spica Prunellae 0.01-10.00 part gold sea sand 0.01-10.00 part
5. according to the described medicine of claim 3, it is characterized in that the described side of inducing sweat, comprise in the following weight proportioning Chinese crude drug simply, two the flavor or two the flavor more than
Herba Ephedrae 0.01-10.00 part is done (life) Rhizoma Zingiberis Recens 0.01-10.00 Rhizoma Cimicifugae 0.01-10.00 part
Radix Bupleuri 0.01-10.00 part Radix Puerariae 0.01-10.00 part Herba Moslae 0.01-10.00 part
Fructus Arctii 0.01-10.00 part Radix Saposhnikoviae 0.01-10.00 part Ramulus Cinnamomi 0.01-10.00 part
Radix Sophorae Tonkinensis 0.01-10.00 part Folium Mori 0.01-10.00 part Flos Chrysanthemi 0.01-10.00 part
Herba Asari 0.01-10.00 part Herba Violae 0.01-10.00 part Herba Portulacae 0.01-10.00 part
Radix Sophorae Flavescentis 0.01-10.00 part Rhizoma Polygoni Cuspidati 0.01-10.00 part Huang (in vain) medicine 0.01-10.00 part
Radix Curcumae 0.01-10.00 part Radix Scrophulariae 0.01-10.00 part Radix Angelicae Dahuricae 0.01-10.00 part
Folium Perillae (leaf, son or stalk) 0.01-10.00 part Mahonia fortunei (Lindl.) Fedde 0.01-10.00 part
Herba Schizonepetae (fringe) 0.01-10.00 part Ramulus Mori (leaf, fruit and Rhizoma Euonymus) 0.01-10.00 part
Radix Gentianae 0.01-10.00 part Semen Sojae Preparatum 0.01-10.00 part
6. according to the described medicine of claim 3, it is characterized in that described Dingchuan side, comprise in the former Chinese crude drug of following weight proportioning simply, two the flavor or two the flavor more than:
Flos Daturae 0.01-10.00 part Radix Anisodi Acutanguli 0.01-10.00 part Radix Platycodonis 0.01-10.00 part
Semen Armeniacae Amarum 0.01-10.00 part Calculus Bovis 0.01-10.00 part Bulbus Fritillariae Uninbracteatae 0.01-10.00 part
Folium Ginkgo 0.01-10.00 part Rhizoma Atractylodis 0.01-10.00 part Herba Pogostemonis 0.01-10.00 part
Poria 0.01-10.00 part Rhizoma Alismatis 0.01-10.00 part Caulis Akebiae 0.01-10.00 part
Medulla Junci 0.01-10.00 part Medulla Tetrapanacis 0.01-10.00 part Radix Trichosanthis 0.01-10.00 part
Indigo Naturalis 0.01-10.00 part Semen Hyoscyami 0.01-10.00 part Herba Lysimachiae 0.01-10.00 part
Cortex Cinnamomi 0.01-10.00 part Rhizoma Pinelliae 0.01-10.00 part Radix Aconiti Lateralis Preparata 0.01-10.00 part
7. according to the described medicine of claim 3, it is characterized in that the described side of unclogging and readjusting, comprise in the former Chinese crude drug of following weight proportioning simply, two the flavor or two the flavor more than:
Rhizoma Cyperi 0.01-10.00 part Radix Aucklandiae 0.01-10.00 part Pericarpium Citri Reticulatae 0.01-10.00 part
Cortex Magnoliae Officinalis 0.01-10.00 part Radix Salviae Miltiorrhizae 0.01-10.00 part Rhizoma Corydalis 0.01-10.00 part
Flos Carthami 0.01-10.00 part rhizoma sparganic 0.01-10.00 part Rhizoma Curcumae 0.01-10.00 part
Radix Paeoniae Rubra 0.01-10.00 part Semen Coicis 0.01-10.00 part Rhizoma Gastrodiae 0.01-10.00 part
Radix Polygalae 0.01-10.00 part Rhizoma Arisaematis 0.01-10.00 part Aloe 0.01-10.00 part
Rhizoma Chuanxiong 0.01-10.00 part Radix Achyranthis Bidentatae 0.01-10.00 part Herba Leonuri 0.01-10.00 part
Flos Farfarae 0.01-10.00 part Mel 0.01-10.00 part Herba Belladonnae 0.01-10.00 part
Folium Sennae 0.01-10.00 part Herba Lycopi 0.01-10.00 part Folium Pyrrosiae 0.01-10.00 part
Semen Persicae 0.01-10.00 part Rhizoma Curcumae Longae 0.01-10.00 part ring stays capable 0.01-10.00 part
Herba Solani Nigri 0.01-10.00 part
8. according to the described medicine of claim 3, it is characterized in that described hemostasis side, comprise in the former Chinese crude drug of following weight proportioning simply, two the flavor or two the flavor more than:
Rhizoma Bistortae 0.01-10.00 part Cacumen Platycladi 0.01-10.00 part Flos Sophorae (angle) 0.01-10.00 part
Herba Agrimoniae 0.01-10.00 part Radix Notoginseng 0.01-10.00 part Herba Artemisiae Sieversianae 0.01-10.00 part
Radix Rubiae 0.01-10.00 part Nodus Nelumbinis Rhizomatis 0.01-10.00 part Herba Ecliptae 0.01-10.00 part
Radix Sanguisorbae 0.01-10.00 part Semen Nelumbinis 0.01-10.00 part Folium Pini 0.01-10.00 part
Radix Stemonae 0.01-10.00 part Olibanum 0.01-10.00 part Myrrha 0.01-10.00 part
Sanguis Draxonis 0.01-10.00 part little (greatly) Ji 0.01-10.00 part Cortex Ailanthi 0.01-10.00 part
Pollen Typhae 0.01-10.00 part Herba Sedi Aizoon 0.01-10.00 part Folium Callicarpae Formosanae 0.01-10.00 part
9. according to the described medicine of claim 3, it is characterized in that described tonify deficiency side, comprise in the former Chinese crude drug of following weight proportioning simply, two the flavor or two the flavor more than:
Radix Ginseng 0.01-10.00 part Radix Codonopsis 0.01-10.00 part Radix Astragali 0.01-10.00 part
Rhizoma Atractylodis Macrocephalae 0.01-10.00 part Rhizoma Dioscoreae 0.01-10.00 part Radix Glycyrrhizae 0.01-10.00 part
Fructus Jujubae 0.01-10.00 part Herba Cistanches 0.01-10.00 part Radix Morindae Officinalis 0.01-10.00 part
Fructus Alpiniae Oxyphyllae 0.01-10.00 part Semen Cuscutae 0.01-10.00 part Herba Epimedii 0.01-10.00 part
Lentinus Edodes 0.01-10.00 part Polyporus 0.01-10.00 part oligosaccharide 0.01-10.00 part
Vegetable polysaccharides 0.01-10.00 part Fructus Lycii 0.01-10.00 part Radix Oplopanacis Elati 0.01-10.00 part
Radix Ophiopogonis 0.01-10.00 part Radix Asparagi 0.01-10.00 part Radix Paeoniae Alba 0.01-10.00 part
Radix Polygoni Multiflori 0.01-10.00 part Radix Adenophorae (Radix Glehniae) 0.01-10.00 part Bulbus Lilii 0.01-10.00 part
Rhizoma Polygonati Odorati 0.01-10.00 part Herba Dendrobii 0.01-10.00 part Massa Medicata Fermentata 0.01-10.00 part
Radix Angelicae Sinensis 0.01-10.00 part Radix Rehmanniae 0.01-10.00 part Rhizoma Polygonati 0.01-10.00 part
Cortex Eucommiae 0.01-10.00 part Radix Et Caulis Acanthopanacis Senticosi 0.01-10.00 part Herba Cynomorii 0.01-10.00 part
Radix Hedysari 0.01-10.00 part Flos Caryophylli 0.01-10.00 part Radix Ginseng Rubra 0.01-10.00 part
10. according to the described process for preparing medicine of claim 1, it is characterized in that may further comprise the steps:
1. preparation immunoglobulin
Immunoglobulin of the present invention refers to antibody, mainly is distributed in betaglobulin and the gamma globulin, also refers to the monoclonal antibody of synthetic:
(a) raise no-special pathogen (hereinafter to be referred as SPF) poultry,
(b) with commercially available or be inoculated in the SPF poultry according to the homemade antigen of existing method (vaccine), after this carried out the primary reinforcement immunity every 5-21 days, connect and be 2-8 time, after 14-21 days, the mammal blood sampling, birds can be taken a blood sample and also can be collected fowl egg, and institute's blood sampling is made hyper-immune serum, the fowl egg of adopting are made high-immunity yolk
(c) get step (b) hyper-immune serum, the separation and the method for purification of shining immunoglobulin prepare immunoglobulin,
(d) get step (b) high-immunity yolk, prepare immunoglobulin according to water extraction, Polyethylene Glycol method or other method;
2. the preparation compound prescription leaches Chinese medicine powder
Independent or the whole Chinese crude drugs of every flavor Chinese medicine are merged the back prepare rough leaching Chinese medicine powder, refining leaching Chinese medicine powder or both mixing by known method;
3. herbal mixture immunoglobulin specially good effect anti-infectious preparation is synthetic with the immunoglobulin for preparing in the step (1), the compound prescription of step (2) preparation leaches Chinese medicine powder and is selected from sodium pyrosulfite, sodium sulfite, sodium sulfite, sulfo-is dredged sour sodium, ascorbic acid, multivitamin, disodium edetate, a kind of in the cyclodextrin, two or more adjuvant mix homogeneously, add sterile deionized water, make dry substance concentration reach 10-45%, at high-speed emulsifying machine, homogenate on colloid mill or the refiner, filter, dry on drying machine with centrifugal spray or freezer dryer then, make and comprise powder, mixture, aerosol, capsule, injection, suppository, unguentum, microcapsule is at any interior preparation, packing, warehouse-in.
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