CN103860579B - A kind of compound tilmicosin injection liquid and its preparation method - Google Patents
A kind of compound tilmicosin injection liquid and its preparation method Download PDFInfo
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- CN103860579B CN103860579B CN201410077891.0A CN201410077891A CN103860579B CN 103860579 B CN103860579 B CN 103860579B CN 201410077891 A CN201410077891 A CN 201410077891A CN 103860579 B CN103860579 B CN 103860579B
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Abstract
The present invention discloses a kind of compound tilmicosin injection liquid, comprises tilmicosin 100��150 parts; Astragalus polysaccharides 5��10 parts; Glycine 5��10 parts; Amikacin 3��6 parts; 5��10 parts, N.F,USP MANNITOL; Chlorogenic acid 2��4 parts. Compound injection provided by the invention with the addition of astragalus polysaccharides, glycine, amikacin, N.F,USP MANNITOL and chlorogenic acid, security through experimental formula composite reagent improves, astragalus polysaccharides, amikacin and chlorogenic acid enhance curative effect of medication to a certain extent simultaneously, decrease the using dosage of the main medicine of tilmicosin, the present invention with the addition of glycine, N.F,USP MANNITOL and S-WAT, the stability of injection is played good promoter action, adds the stability of injection.
Description
Technical field
The present invention relates to veterinary drug tilmicosin, it is specifically related to compound tilmicosin injection liquid and its preparation method.
Background technology
Tilmicosin is by the special microbiotic of the livestock and poultry that a kind of hydrolysate of tylosin is semi-synthetic, its phosphoric acid salt medicinal. This product is for oral administration and subcutaneous injection absorption is fast, but not exclusively. Apparent volume of distribution is big, the drug level height in lung tissue. Having good tissue penetration power, can enter breast from blood rapidly and completely, Ruzhong drug level is higher, maintains the time long, and the Ruzhong transformation period reaches 1��2 day. Gram-positive microorganism, some Gram-negative bacteria, mycoplasma, spirochete etc. are all had restraining effect by tilmicosin; Pleuropneumonia actinomycetes, pasteurellosis bacillus are had the anti-microbial activity stronger than tylosin, is mainly used in control domestic animal pneumonia, infect by actinobacillus pleuropneumoniae, pasteurellosis bacillus, mycoplasma etc. and cause, the mazoitis of avian mycoplasmas disease and lactating mammal.
When Chinese veterinary pharmacopoeia version " veterinary drug instruction manual (pharmaceutical chemicals volume) " chapter 2 antimicrobial drug one in 2005 introduces tilmicosin in saving, in " untoward reaction ", hurdle explicitly points out: " this product, to the toxic action of animal mainly cardiovascular systems, can cause tachycardia and convergent force to weaken. Pig intramuscularly 10mg/kg causes breathing to increase number, vomiting and convulsions; 20mg/kg can make major part test pig dead. " when introducing tilmicosin injection liquid, its " attention " item points out that " in addition to cattle, other animal drug administration by injection are cautious use of.
From the foregoing, tilmicosin injection liquid is huge to the side effect of pig, and other animal injection liquids must be cautious use of. Consequently, it is desirable to reduce tilmicosin injection liquid to the toxic side effect of animal as far as possible, strengthen the suitability of tilmicosin injection liquid. Meanwhile, existing tilmicosin injectable liquefied composition is single so that it is stability and drug effect can not reach gratifying degree, has bigger improvement space.
In order to solve above-mentioned deficiency of the prior art, the present invention proposes a kind of new solution.
Summary of the invention
It is an object of the invention to provide a kind of security height, tilmicosin can be strengthened main drug effect power, reduce the compound tilmicosin injection liquid of injected dose.
For reaching above-mentioned purpose, the technical solution adopted in the present invention is: provides a kind of compound tilmicosin injection liquid, comprises following component be weight:
Tilmicosin 100��150 parts; Astragalus polysaccharides 5��10 parts; Glycine 5��10 parts;
Amikacin 3��6 parts; 5��10 parts, N.F,USP MANNITOL; Chlorogenic acid 2��4 parts.
On the basis of above-mentioned compound tilmicosin injection, optimizing component proportion is:
Tilmicosin 120 parts; Astragalus polysaccharides 8 parts; Glycine 8 parts;
Amikacin 5 parts; 6 parts, N.F,USP MANNITOL; Chlorogenic acid 3 parts.
Preferably, seromycin 2��4 parts.
Preferably, S-WAT 2��5 parts is also comprised.
In the process for preparation of medicine, in addition it is also necessary to add solubility promoter, generally add the conventional solubility promoters such as appropriate propylene glycol or ethanol in injection liquid. For increasing solvability and the curative effect of main medicine, tilmicosin bulk drug used in the present invention is the tilmicosin of phosphoric acid salt.
The invention also discloses the preparation process of this injection liquid, comprising:
Dosage according to medicine tilmicosin main in tilmicosin injection liquid and the amount of joining, calculate the consumption of the injection water yield and each component needing preparation; Aseptically the water for injection answering part long-pending 60% is added in material-compound tank, and it is incubated to 30��40 DEG C;
The tilmicosin of formula ratio, astragalus polysaccharides, glycine, amikacin and N.F,USP MANNITOL is added successively, insulated and stirred 30 minutes in material-compound tank; Then chlorogenic acid, seromycin and S-WAT is added, insulated and stirred 30 minutes; Adding needle-use activated carbon after dissolving and stir even 15 minutes, re-use millipore filtration and filter, the aperture of micropore filtering film is 0.22um, and the water for injection using residual content washs, and adds hydrochloric acid and regulates Ph to 6.4��6.8; Get rid of the air in hay tank, be filled with carbonic acid gas, it may also be useful to ampoule encapsulation, and at 121 DEG C sterilizing 20 minutes; Leak detection, packaging.
In sum, the present invention has the following advantages:
1, compound injection provided by the invention with the addition of astragalus polysaccharides, glycine, amikacin, N.F,USP MANNITOL and chlorogenic acid, security through experimental formula composite reagent improves, astragalus polysaccharides, amikacin and chlorogenic acid enhance curative effect of medication to a certain extent simultaneously, and then decrease the using dosage of the main medicine of tilmicosin.
2, the present invention with the addition of glycine, N.F,USP MANNITOL and S-WAT, the stability of injection is played good promoter action, adds the stability of injection.
3, also adding seromycin in compound injection, seromycin is mainly used in the infection of resistance tubercule bacillus, but is through experiment, and the drug effect strengthening tilmicosin is had certain effect by seromycin.
Embodiment
Embodiment 1
The preparation amount of joining is 1000ml, and dosage is the compound tilmicosin injection liquid of 0.1g/ml.
Dosage according to medicine tilmicosin main in tilmicosin injection liquid and the amount of joining, main medicine usage quantity is 100g, it is necessary to the injection water yield of preparation is 1L. Aseptically the water for injection of 600ml is added in material-compound tank, and it is incubated to 30 DEG C;
Tilmicosin 100g, astragalus polysaccharides 5g, glycine 5g, amikacin 3g, N.F,USP MANNITOL 5g is added successively, insulated and stirred 30 minutes in material-compound tank; Then chlorogenic acid 2g, seromycin 2g and S-WAT 2g is added, insulated and stirred 30 minutes. Adding needle-use activated carbon 10g after dissolving and stir even 15 minutes, re-use millipore filtration and filter, the aperture of micropore filtering film is 0.22um, and the water for injection using residual content 400ml washs, and adds hydrochloric acid and regulates Ph to 6.4. Get rid of the air in hay tank, be filled with carbonic acid gas, it may also be useful to ampoule encapsulation, and at 121 DEG C sterilizing 20 minutes; Leak detection, packaging.
Embodiment 2
The preparation amount of joining is 1000ml, and dosage is the compound tilmicosin injection liquid of 0.12g/ml.
Dosage according to medicine tilmicosin main in tilmicosin injection liquid and the amount of joining, main medicine usage quantity is 120g, it is necessary to the injection water yield of preparation is 1L. Aseptically the water for injection of 600ml is added in material-compound tank, and it is incubated to 30 DEG C;
Tilmicosin 120g, astragalus polysaccharides 8g, glycine 8g, amikacin 5g, N.F,USP MANNITOL 6g is added successively, insulated and stirred 30 minutes in material-compound tank; Then chlorogenic acid 3g, seromycin 2g and S-WAT 2g is added, insulated and stirred 30 minutes. Adding needle-use activated carbon 10g after dissolving and stir even 15 minutes, re-use millipore filtration and filter, the aperture of micropore filtering film is 0.22um, and the water for injection using residual content 400ml washs, and adds hydrochloric acid and regulates Ph to 6.6. Get rid of the air in hay tank, be filled with carbonic acid gas, it may also be useful to ampoule encapsulation, and at 121 DEG C sterilizing 20 minutes; Leak detection, packaging.
Embodiment 3
The preparation amount of joining is 1000ml, and dosage is the compound tilmicosin injection liquid of 0.15g/ml.
Dosage according to medicine tilmicosin main in tilmicosin injection liquid and the amount of joining, main medicine usage quantity is 150g, it is necessary to the injection water yield of preparation is 1L. Aseptically the water for injection of 600ml is added in material-compound tank, and it is incubated to 30 DEG C;
Tilmicosin 150g, astragalus polysaccharides 10g, glycine 10g, amikacin 6g, N.F,USP MANNITOL 10g is added successively, insulated and stirred 30 minutes in material-compound tank; Then chlorogenic acid 4g, seromycin 4g and S-WAT 5g is added, insulated and stirred 30 minutes. Adding needle-use activated carbon 13g after dissolving and stir even 15 minutes, re-use millipore filtration and filter, the aperture of micropore filtering film is 0.22um, and the water for injection using residual content 400ml washs, and adds hydrochloric acid and regulates Ph to 6.8. Get rid of the air in hay tank, be filled with carbonic acid gas, it may also be useful to ampoule encapsulation, and at 121 DEG C sterilizing 20 minutes; Leak detection, packaging.
Experimental example 1
The stability experiment of compound tilmicosin injection liquid
Compound tilmicosin injection liquid in Example 1��3, places 30d, 60d and 90 days under carrying out being placed in high temperature 60 DEG C, low temperature and high light respectively, and observes its appearance character, Ph and replace meter Sha Xing content. The concrete comparison mode of experiment 1 is such as table 1. Wherein high temperature refers to 60 DEG C, and low temperature refers to about 5 DEG C, and high light is about 4500lx.
Table 1: stability experiment
It can thus be seen that medicine proterties and physico-chemical property after preserving 30 days, 60 days and 90 days under high light, low temperature and high light detect. Illustrating that the stability of the compound tilmicosin injection liquid of the present invention is reliable, storer is longer in the presence of a harsh environment. Estimation of stability is the important indicator of Drug safety assessment, the quality guaranteed period of relation medicine, shows whether medicine easily occurs rotten, and more stable medicine, its suitability is higher, and security is higher.
Experimental example 2
The animal validity experiment of compound tilmicosin injection liquid
Control group: selecting through the sick pig 20 suffering from respiratory tract disease pneumonia made a definite diagnosis, weight range is 30��45kg, the sick time of its sick pig is about 1 week. Tilmicosin injection liquid is used to treat. Injected dose is 3mg/kg, injection twice in a week, interval injection in 3 days. Sick swine disease feelings are observed after injection.
Experimental group: selecting the sick pig 60 suffering from respiratory tract disease pneumonia with the same hurdle of control group, weight range is 30��45kg, the sick time of its sick pig is about 1 week. Experimental group is divided into three groups, uses the compound tilmicosin injection liquid in embodiment 1, embodiment 2 and embodiment 3 to treat respectively. Injected dose is 3mg/kg, injection twice in a week, interval injection in 3 days. Sick swine disease feelings are observed after injection.
The situation of every sick pig is observed after terminating by one week observing time, checks whether it recovers, and its experimental result is such as table 2.
Table 2: animal validity is tested
| Experimental quantities | Recovery from illness | Dead | The state of an illness is alleviated | Aggravation | |
| Control group | 20 | 12 | 4 | 2 | 2 |
| Embodiment 1 | 20 | 15 | 1 | 1 | 3 |
| Embodiment 2 | 20 | 16 | 0 | 3 | 1 |
| Embodiment 3 | 20 | 18 | 0 | 1 | 1 |
As seen from the above table, this compound tilmicosin injection liquid compares single product tilmicosin injection liquid, can have better curative effect when same dose, it is to increase the cure rate of sick body, reduces dead.
Claims (4)
1. a compound tilmicosin injection liquid, it is made up of following component be weight:
Tilmicosin 100 ~ 150 parts; Astragalus polysaccharides 5 ~ 10 parts; Glycine 5 ~ 10 parts;
Amikacin 3 ~ 6 parts; 5 ~ 10 parts, N.F,USP MANNITOL; Chlorogenic acid 2 ~ 4 parts;
Seromycin 2 ~ 4 parts; S-WAT 2 ~ 5 parts.
2. compound tilmicosin injection liquid as claimed in claim 1, it is characterised in that:
Tilmicosin 120 parts; Astragalus polysaccharides 8 parts; Glycine 8 parts;
Amikacin 5 parts; 6 parts, N.F,USP MANNITOL; Chlorogenic acid 3 parts.
3. preparing the method for arbitrary described compound tilmicosin injection liquid in claim 1 or 2, its preparation process comprises:
Dosage according to medicine tilmicosin main in tilmicosin injection liquid and the amount of joining, calculate the injection water yield needing preparation; Aseptically the water for injection answering part long-pending 60% is added in material-compound tank, and it is incubated to 30 ~ 40 DEG C;
The tilmicosin of formula ratio, astragalus polysaccharides, glycine, amikacin and N.F,USP MANNITOL is added successively, insulated and stirred 30 minutes in material-compound tank; Then chlorogenic acid, seromycin and S-WAT is added, insulated and stirred 30 minutes; Add needle-use activated carbon after dissolving and stir even 15 minutes, re-use millipore filtration and filter, and the water for injection using residual content washs, and adds salt acid for adjusting pH to 6.4 ~ 6.8;
Get rid of the air in hay tank, be filled with carbonic acid gas, it may also be useful to ampoule encapsulation, and at 121 DEG C sterilizing 20 minutes; Leak detection, packaging.
4. the preparation method of compound tilmicosin injection liquid as claimed in claim 3, it is characterised in that: the aperture of described micropore filtering film is 0.22um.
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| CN112843011B (en) * | 2021-02-04 | 2021-10-15 | 广州市和生堂动物药业有限公司 | Tilmicosin premix and preparation method thereof |
| CN115998814A (en) * | 2023-02-03 | 2023-04-25 | 四川新益峰生物制药有限公司 | Compound tilmicosin injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000105A (en) * | 2010-10-11 | 2011-04-06 | 西北农林科技大学 | Compound timicosin oral liquid and preparation method thereof |
| CN102657607A (en) * | 2012-05-25 | 2012-09-12 | 鼎正动物药业（天津）有限公司 | Tilmicosin stabilizing agent and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000105A (en) * | 2010-10-11 | 2011-04-06 | 西北农林科技大学 | Compound timicosin oral liquid and preparation method thereof |
| CN102657607A (en) * | 2012-05-25 | 2012-09-12 | 鼎正动物药业（天津）有限公司 | Tilmicosin stabilizing agent and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 治疗猪呼吸道疾病的用药方案;王彦玲等;《养殖技术顾问》;20070530(第05期);48-49 * |
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