CN102614294B - Compound amoxicillin suspension injection and preparation method thereof - Google Patents
Compound amoxicillin suspension injection and preparation method thereof Download PDFInfo
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- CN102614294B CN102614294B CN201110024974.XA CN201110024974A CN102614294B CN 102614294 B CN102614294 B CN 102614294B CN 201110024974 A CN201110024974 A CN 201110024974A CN 102614294 B CN102614294 B CN 102614294B
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- amoxicillin
- injection
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- herba houttuyniae
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A40/00—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production
- Y02A40/70—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production in livestock or poultry
Abstract
The invention relates to a compound amoxicillin suspension injection. The injection is prepared from 5-20% of amoxicillin, 5-15% of Herba Houttuyniae oil, 2-5% of a suspending aid, 1-3% of a dispersant, 0.1-0.5% of an antioxidant, and the balance vegetable oil for injection. The injection has a wide antimicrobial spectrum and stable physical and chemical properties. After intramuscular injection, the Herba Houttuyniae oil rapidly reaches an effective plasma concentration after absorption and performs effects, and amoxicillin forms small storage reservoirs in the body in a particle state, the slow and continuous release guarantees the long-term above effective plasma concentration of above medicine in the body fluid, so the half life of the medicine is prolonged, the biological utilization degree is improved, the medicine resistance of bacteria to amoxicillin is reduced, and the body resistance is enhanced, thereby the injection has effects of simultaneous treatment of principal and subordinate symptoms on the control of clinical livestock and poultry diseases.
Description
Technical field
The invention belongs to pharmaceutic preparation for livestock field, particularly relate to a kind of compound amoxicillin suspension injection and preparation method thereof.
Background technology
Amoxicillin (Amoxicillin, AMO) be the semi-synthetic acid-resistant penicillin of a kind of wide spectrum, it is slightly weaker than penicillin to the antibacterial activity of most of gram positive bacteria, responsive to penicillinase, therefore invalid to penicillin-fast staphylococcus aureus, to gram negative bacteria as escherichia coli, Bacillus proteus, Salmonella, haemophilus, Brucella and pasteurellosis bacillus etc. have stronger effect, also have extraordinary curative effect to anaerobe.The urethra of the various animals for the treatment of caused by various sensitive organism can be widely used in, respiratory tract, the systemic infection such as skin and soft tissue.Herba Houttuyniae (Houttuynia cordata) is the herb of Saururaceae Herba Houttuyniae, and acrid in the mouth is cool in nature, enters liver lung two warp, can medicated diet dual-purpose, there is heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome, hemostatic analgesia, effect of cough-relieving.Herba Houttuyniae oil has antiviral, antibacterial, antiinflammatory, and analgesia, the effects such as enhancing human body immunity function are the main components applied clinically.Be that the dosage form that principle active component is produced is very general in the application of people's medicine with Herba Houttuyniae oil, but also there is not been reported in veterinary drug clinical practice.
Along with the intensivization development of livestock breeding industry, livestock and poultry performance is complicated clinically.Some bacterial diseasees are as escherichia coli, and Salmonella, staphylococcus, pasteurellosis bacillus etc. not only create serious drug resistance to some common drugs clinically and also usually cause with viral disease mixed infection disease to be difficult to cure.In this case, combined Chinese & western medicine clinical efficacy is remarkable, also becomes the focus of current medical research.Amoxicillin and Herba Houttuyniae oil use in conjunction, not only can reduce the drug resistance of antibacterial to amoxicillin, improve the antibacterial activity of amoxicillin, the antiviral of Herba Houttuyniae oil can also be given full play to, antibacterial, antiinflammatory, cough-relieving, improve the effect of immunity of organisms, the mixed infection of clinical viral bacterial disease is reached to the effect for the treatment of both the principal and secondary aspects of a disease.Amoxicillin suspension injection is made in amoxicillin and Herba Houttuyniae oil composition compound recipe by us, not only increase the medicine stability of amoxicillin and Herba Houttuyniae oil, and amoxicillin is scattered in oil for injection with graininess, reach target tissue rapidly after intramuscular injection, slow releasing reaches the effect of slow release long-acting in vivo.Amoxicillin suspension injection slow release long-acting, drug substance stable, clinical application number of times reduces, and cost reduces, and is convenient to centralization-breeding factory and uses, have large application prospect clinically.
Summary of the invention
The object of the invention is to provide a kind of compound amoxicillin suspension injection and preparation method thereof, for intramuscular administration, for the poultry infectious disease of clinical common bacteria.
The prescription of compound amoxicillin suspension injection provided by the invention, comprising amoxicillin, Herba Houttuyniae oil, suspending agent, dispersant, antioxidant, injection vegetable oil.
Described amoxicillin weight percentage is than being 5-20% (W/W).
Described Herba Houttuyniae oil weight percentage is than being 5-15% (W/W).
Described suspending agent comprises one or more combinations in aluminum foil stearate, stearic acid, Cera Flava, and weight percentage is than being 2-5% (W/W).
Described dispersant comprises the one in soybean lecithin, class of department series dehydration sorbic alcohol esters, mono stearate glyceryl ester, and weight percentage is than being 1-3% (W/W).
Described antioxidant comprises the one in vitamin E, gallic acid third methyl ester, dibenzylatiooluene, Butylated hydroxyanisole, and weight percentage is than being 0.1-0.5% (W/W).
Described injection vegetable oil comprises one or more combinations in soybean oil, Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, Semen Maydis oil, Oleum Ricini or olive oil, and weight percentage is than being 46.5-81.9% (W/W).
The preparation method of the suspensoid injectio of a kind of amoxicillin provided by the invention: it comprises the following steps:
(1) proportionally take suspending agent to add in injection vegetable oil, be placed in high heat sterilization device and be heated to 150-170 DEG C, be stirred to and dissolve completely, cool to 80-100 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stirs that within 5-10 minute, to finish solution two for subsequent use;
(3) proportionally take amoxicillin, dispersant, antioxidant adds solution two, stirs 5-10 minute after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1000-1500 handkerchief pressure condition, 10-15 minute even 3-4 time repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
The invention has the beneficial effects as follows:
A kind of compound amoxicillin suspension injection of the present invention, stable in physicochemical property, drug loading is large, after long storage periods and transport, not free settling, mobility and redispersibility good, be convenient to injection.Target tissue can be arrived rapidly after intramuscular injection, Herba Houttuyniae oil reaches effective blood drug concentration rapidly after absorbing, play antiviral, antibacterial, improve the effect of immunity, amoxicillin then forms little reservoir one by one in vivo with graininess, the release slowly continued ensures that medicine is in more than effective blood drug concentration for a long time in body fluid, not only extend the half-life of medicine, improve its bioavailability, also reduce the drug resistance of antibacterial to amoxicillin, enhance the resistance of body, reach the effect for the treatment of both the principal and secondary aspects of a disease.
Detailed description of the invention
Embodiment 1:
The prescription of compound amoxicillin suspension injection:
Compound method:
(1) proportionally take aluminum foil stearate to add in injection vegetable oil, be placed in high heat sterilization device and be heated to 150 DEG C, be stirred to and dissolve completely, cool to 80 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stirs that within 5 minutes, to finish solution two for subsequent use;
(3) proportionally take amoxicillin, class 80 of department, gallic acid third methyl ester adds solution two, stirs 5 minutes after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1000 handkerchief pressure conditions, 10 minutes even 3 times repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
Embodiment 2:
The prescription of compound amoxicillin suspension injection:
Compound method:
(1) proportionally take aluminum foil stearate to add in injection vegetable oil, be placed in high heat sterilization device and be heated to 150 DEG C, be stirred to and dissolve completely, cool to 90 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stirs that within 7 minutes, to finish solution two for subsequent use;
(3) proportionally take amoxicillin, lecithin, vitamin E adds solution two, stirs 7 minutes after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1200 handkerchief pressure conditions, 12 minutes even 3 times repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
Embodiment 3:
The prescription of compound amoxicillin suspension injection:
Compound method:
(1) proportionally take stearic acid to add in injection vegetable oil, be placed in high heat sterilization device and be heated to 160 DEG C, be stirred to and dissolve completely, cool to 100 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stirs that within 8 minutes, to finish solution two for subsequent use;
(3) proportionally take amoxicillin, lecithin, dibenzylatiooluene adds solution two, stirs 8 minutes after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1500 handkerchief pressure conditions, 15 minutes even 4 times repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
Embodiment 4:
The prescription of compound amoxicillin suspension injection:
Compound method:
(1) proportionally take Cera Flava to add in injection vegetable oil, be placed in high heat sterilization device and be heated to 170 DEG C, be stirred to and dissolve completely, cool to 100 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stirs that within 10 minutes, to finish solution two for subsequent use;
(3) proportionally take amoxicillin, mono stearate glyceryl ester, Butylated hydroxyanisole adds solution two, stirs 10 minutes after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1500 handkerchief pressure conditions, 15 minutes even 4 times repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
Embodiment 5: the extracorporeal bacteria inhibitor test of medicine of the present invention
1 test material
Test strain: staphylococcus aureus, Escherichia coli, Salmonella.
Trial drug: the compound amoxicillin suspension injection (5%) that the embodiment of the present invention one is prepared, folk prescription amoxicillin suspensoid injectio (5%), amoxicillin soluble powder (5%).
2 test methods
The antibacterial activity in vitro of compound amoxicillin suspension injection is evaluated by measuring different dosage form amoxicillin and folk prescription amoxicillin and the minimum inhibitory concentration (MIC) of amoxicillin to staphylococcus aureus, Escherichia coli, Salmonella.Test is divided into amoxicillin suspensoid group, folk prescription amoxicillin suspensoid group and amoxicillin soluble powder group.In amoxicillin, first with normal saline, 3 groups of drug level are diluted to 1000 μ g/mL, each Bacteria liquid cultured solution of broth is diluted to 10
5cFU/mL concentration.Be arranged with the sterile test tube of tampon according to tested medicine, often kind of medicine string, is often classified as 13 pipes.Often pipe Ensure Liquid meat soup 1mL, the 1st pipe adds medicinal liquid 1mL, makes doubling dilution successively to the 11st pipe, and the 12nd pipe is as bacterial controls, and medicinal liquid contrast done by the 13rd pipe, and 1-12 has managed 10 of often pipe 0.1mL
5cFU/mL concentration bacterium liquid, cultivates 24h for 37 DEG C, observes and often organize test tube, has no the minimum inhibitory concentration (MIC) that the test tube liquor strength detecting bacteria growing is this medicine.Each test repetition 3 times, results averaged.
3 result of the tests
The In Vitro Bacteriostatic evaluation of compound amoxicillin suspension injection
Conclusion: as can be seen from experimental result, for the staphylococcus aureus of clinical separation, escherichia coli, Salmonella, its minimal inhibitory concentration of amoxicillin injection that with the addition of Herba Houttuyniae oil reduces 5-10.5 doubly, antibacterial activity improves greatly, this has also confirmed the Herba Houttuyniae oil of bibliographical information from another point of view and Penicillin antibiotics is used in conjunction, effectively can eliminate the R-plasmid of the antibacterial Penicillin antibiotics being produced to drug resistance, thus there is synergistic function.
Embodiment 6: clinical efficacy contrast test
1 test material
Experimental animal selects large-scale pig farm three way cross to suffer from the little piglet of suckling of Hakuri.Clinical symptoms shows as ill piglet defecation number of times to be increased, and feces is smelt as of rotten fish, and color be light canescence or yellowish white, scattered paste shape, water sample or be toothpaste-like etc.Piglet pujos blancos is diagnosed as through clinical veterinarian.Trial drug selects the compound amoxicillin suspension injection (5%) prepared of the embodiment of the present invention one, and folk prescription amoxicillin suspensoid injectio (5%) of preparing by embodiment one method and commercially available amoxicillin soluble powder (5%) three kind of medicine are treated respectively.
2 test methods
In units of nest, be divided into 4 groups at random, often organize 30, first group does not give any Drug therapy, to affected pig clinicing symptom observation record as a control group; Second group gives amoxicillin soluble powder, in amoxicillin, for oral administration, a secondary amounts, and every kg body weight 10mg, every day 2 times, is used in conjunction 3 days; 3rd group gives folk prescription amoxicillin suspensoid injectio, intramuscular injection, and in amoxicillin, a secondary amounts, every kg body weight 5mg, once a day, is used in conjunction 3 days.4th group gives compound amoxicillin suspension injection, intramuscular injection, and in amoxicillin, a secondary amounts, every kg body weight 5mg, once a day, is used in conjunction 3 days.After medication every day observe the curative effect situation.Treat rear affected pig spiritual, normally, feces is strip or graininess in appetite recovery, anus drying, contraction, nothing redness, and in 7 days, nothing recurs is fully recover; Feces retrogradation after treatment, defecation frequency reduces, and anus redness disappears not yet completely, and spirit, appetite are improved as effectively; Affected pig spirit after treatment, appetite, feces is not improved, and even death is invalid.According to healing, effectively, the ratio that invalid head number accounts for each group of head number calculates cure rate, effective percentage and inefficiency.
3 result of the tests
Compound amoxicillin suspension injection is to the clinical trial result of piglet pujos blancos
Conclusion: from experimental result, the powder that medicaments compound amoxicillin of the present invention suspensoid injectio is more general and folk prescription amoxicillin suspensoid injectio have obvious prevention and therapy effect, especially to there being escherichia coli, the yellow and white dysentery of piglet that Salmonella etc. cause, edema disease has good clinical therapeutic efficacy.
Claims (1)
1. a compound amoxicillin suspension injection, is characterized in that: the prescription of described suspensoid injectio is:
Compound method:
(1) proportionally take aluminum foil stearate to add in injection soybean oil, be placed in high heat sterilization device and be heated to 150 DEG C, be stirred to and dissolve completely, cool to 80 DEG C, for subsequent use as solution one;
(2) proportionally taking Herba Houttuyniae oil adds in solution one, stir 5 minutes for subsequent use as solution two;
(3) proportionally take amoxicillin, class 80 of department, propyl gallate adds solution two, stirs 5 minutes after fully stirring evenly, for subsequent use as solution three;
(4) solution three will made, under 1000 handkerchief pressure conditions, 10 minutes even 3 times repeatedly;
(5) gained suspensoid potting package under stirring, is filled with nitrogen, cobalt-60 sterilizing and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201110024974.XA CN102614294B (en) | 2011-01-27 | 2011-01-27 | Compound amoxicillin suspension injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201110024974.XA CN102614294B (en) | 2011-01-27 | 2011-01-27 | Compound amoxicillin suspension injection and preparation method thereof |
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| CN102614294A CN102614294A (en) | 2012-08-01 |
| CN102614294B true CN102614294B (en) | 2015-02-25 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528635A (en) * | 2018-12-20 | 2019-03-29 | 江西润泽药业有限公司 | The preparation method of sodium chloride injection |
| CN112618486B (en) * | 2020-12-24 | 2023-07-18 | 浙江昂利康制药股份有限公司 | Suspension oil for injection and preparation method thereof |
| CN113398069A (en) * | 2021-07-10 | 2021-09-17 | 四川成康动物药业有限公司 | Veterinary amoxicillin and sulfadiazine sodium suspension injection and preparation method and device thereof |
| CN114533852A (en) * | 2022-02-25 | 2022-05-27 | 四川恒通动保生物科技有限公司 | Compound amoxicillin and colistin sulfate suspension injection and preparation method thereof |
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| DE3705349A1 (en) * | 1986-02-20 | 1987-08-27 | Bristol Myers Co | PHARMACEUTICAL INJECTABLE AMOXICILLIN PREPARATION |
| CN1066335C (en) * | 1996-02-14 | 2001-05-30 | 雅安三九药业有限公司 | Houttuynia injection and preparation method thereof |
| JP4234320B2 (en) * | 1997-10-16 | 2009-03-04 | モトローラ・リミテッド | Background noise / contrast reduction method during handover for differences in speech coding |
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| DE3705349A1 (en) * | 1986-02-20 | 1987-08-27 | Bristol Myers Co | PHARMACEUTICAL INJECTABLE AMOXICILLIN PREPARATION |
| CN1066335C (en) * | 1996-02-14 | 2001-05-30 | 雅安三九药业有限公司 | Houttuynia injection and preparation method thereof |
| JP4234320B2 (en) * | 1997-10-16 | 2009-03-04 | モトローラ・リミテッド | Background noise / contrast reduction method during handover for differences in speech coding |
| CN101485658A (en) * | 2009-02-27 | 2009-07-22 | 江西新世纪民星动物保健品有限公司 | Method for preparing amoxicillin-ofloxacin suspension injection |
| CN101822637A (en) * | 2009-12-31 | 2010-09-08 | 天津瑞普生物技术股份有限公司 | Beta-lactam antibiotics-containing suspension injection |
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