CN107349212B - Albendazole ivermectin premix and preparation method thereof - Google Patents
Albendazole ivermectin premix and preparation method thereof Download PDFInfo
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- CN107349212B CN107349212B CN201710499694.1A CN201710499694A CN107349212B CN 107349212 B CN107349212 B CN 107349212B CN 201710499694 A CN201710499694 A CN 201710499694A CN 107349212 B CN107349212 B CN 107349212B
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- ivermectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
Abstract
The invention discloses an albendazole ivermectin premix and a preparation method thereof, wherein the premix comprises the following components in percentage by mass: 5.5-6.5% of albendazole, 0.22-0.26% of ivermectin, 10-15% of medicinal charcoal, 5-10% of corn cob powder, 4.5-5.5% of uterus-soothing fetus-protecting plant extract and the balance of starch. When the preparation method is used, the extract essence of the Angongbao plant is added into the formula, so that the side effect of the albendazole can be reduced. The preparation method adopts an equal-density equivalent incremental mixing method, and can provide effective guarantee for safe use. The prepared albendazole ivermectin premix has small content deviation of effective components and small side effect, and can be used by pregnant animals; the preparation steps are simple and convenient, and the operation is easy; the average value of A +1.80S measured by the content uniformity of ivermectin is less than 10.0 (the national standard is that the average value of A +1.80S is less than 15.0).
Description
Technical Field
The invention relates to an albendazole ivermectin premix and a preparation method thereof, belonging to the fields of biotechnology and biomedicine.
Background
The albendazole and ivermectin premix is an antiparasitic drug. The albendazole has broad-spectrum anthelmintic activity and has strong expelling and killing effects on nematodes, tapeworms and trematodes. The action mechanism is that the drug is combined with tubulin in the worm body to prevent the drug from polymerizing with alpha-tubulin to form microtubules, thereby influencing the cell propagation processes of mitosis, protein assembly, energy metabolism and the like in the worm body.
The ivermectin has good expelling and killing effects on parasites in vivo and in vitro, particularly arthropods and internal nematodes, and is mainly used for expelling gastrointestinal nematodes, pulmonary nematodes and ectoparasites of pigs. The mechanism of anthelmintic action is to promote the release of gamma-aminobutyric acid (GABA) from presynaptic neurons, thereby opening GABA-mediated chloride channels. The chlorine ion flow can reduce the impedance of a cell membrane, cause slight depolarization of a postsynaptic membrane resting potential, and interfere with signal transmission between neuromuscular tissues, so that the polypide is relaxed and paralyzed, and the polypide is killed or discharged out of the body.
The main component albendazole of the product has teratogenesis-causing effect; the ivermectin overdose can cause poisoning, and no specific antidote is available.
Disclosure of Invention
The invention aims to solve the problems that: overcomes the defects of teratogenesis effect of albendazole and poisoning caused by ivermectin overdose ingestion in the prior art, and provides a feasible albendazole ivermectin premix and a preparation method thereof. The albendazole ivermectin premix is prepared by improving the technical formula of the albendazole ivermectin premix and adopting an equal-density equivalent incremental mixing method, so that effective guarantee can be provided for safe use of the albendazole ivermectin premix, and the method has great practical significance for production and application of the albendazole ivermectin premix.
The technical scheme for realizing the purpose of the invention is as follows:
the albendazole and ivermectin premix comprises the following components in percentage by mass:
5.5 to 6.5 percent of albendazole,
0.22 to 0.26 percent of ivermectin,
10-15% of medicinal carbon,
5-10% of corn cob meal,
4.5 to 5.5 percent of extract of the Angongbao plant,
the balance being starch.
The preparation method of the albendazole and ivermectin premix comprises the following steps:
(1) weighing the components according to the following mass percent, and respectively sieving the components through a No. 5 sieve for later use;
5.5 to 6.5 percent of albendazole,
0.22 to 0.26 percent of ivermectin,
10-15% of medicinal carbon,
5-10% of corn cob meal,
4.5 to 5.5 percent of extract of the Angongbao plant,
the balance being starch;
(2) premixing ivermectin;
mixing starch and corncob powder into an auxiliary material a with the same density as ivermectin according to the mass ratio of 5: 1-1: 1;
taking ivermectin with the formula amount and an equivalent amount of auxiliary material a to be fully and uniformly mixed to obtain an ivermectin premix 1;
then mixing starch and corncob powder into an auxiliary material b with the same density as the ivermectin premix 1 according to the mass ratio of 5: 1-1: 1;
fully and uniformly mixing the ivermectin premix 1 with the same amount of the auxiliary material b to obtain an ivermectin premix 2;
by analogy, premixing the ivermectin for 5 times by adopting an equal-density equivalent incremental mixing method to uniformly distribute the ivermectin into the auxiliary materials to obtain powder A;
(3) uniformly mixing albendazole with the same amount of starch to obtain powder B;
(4) and (3) totally mixing the powder A and the powder B with other raw and auxiliary materials to obtain the finished albendazole ivermectin premix.
The content deviation of the active ingredients of the prepared albendazole ivermectin premix finished product is small, and the average value of A +1.80S determined by the content uniformity of ivermectin is less than 10.0 (the national standard is that the average value of A +1.80S is less than 15.0).
The conventional albendazole and ivermectin premix is prepared from albendazole, ivermectin, activated carbon and the like in an original formula, and albendazole in the formula can be accompanied by teratocarcinosis and embryotoxicity; the essence extracted from the uterus-protecting fetus-protecting plant can protect cell membrane, regulate oxidation process of organism, promote gonad development, and prevent abortion and teratogenesis; therefore, by adding the extract of the Angongbao plant in the formula, the side effect of the albendazole can be reduced.
At present, the content of ivermectin in a standard formula is very low (containing 0.25%), the ivermectin is prepared according to a conventional mixing method, and the mixing is not uniform, so that some animals are poisoned due to the fact that the treatment effect cannot be achieved due to insufficient feed intake of medicines or the excessive feed intake is caused during medication; the invention adopts an equal-density equivalent incremental mixing method to pre-mix the ivermectin, so that the ivermectin is uniformly distributed in the auxiliary materials.
Compared with the prior art, the method of the invention has the following characteristics:
(1) the albendazole ivermectin premix finally obtained by the method has small side effect and can be used by pregnant animals;
(2) the method has simple and convenient steps and is easy to operate;
(3) the albendazole ivermectin premix prepared by the invention has small content deviation of the active ingredients of finished products, and the average value of A +1.80S determined by the content uniformity of ivermectin is less than 10.0 (the national standard is that the average value of A +1.80S is less than 15.0.
Detailed Description
The present invention will be further described with reference to the following examples, but the present invention is not limited thereto.
Example 1
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 5.8%
Ivermectin 0.24%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
2.0 percent of corncob meal
Adding starch to full amount.
The preparation method of the albendazole ivermectin premix comprises the following steps:
(1) accurately weighing the components according to the mass percentage, and respectively sieving the components by a No. 5 sieve for later use;
(2) premixing of ivermectin:
mixing starch and corncob powder into an auxiliary material a with the same density as ivermectin according to the mass ratio of 5: 1-1: 1;
taking ivermectin with the formula amount and an equivalent amount of auxiliary material a to be fully and uniformly mixed to obtain an ivermectin premix 1;
then mixing starch and corncob powder into an auxiliary material b with the same density as the ivermectin premix 1 according to the mass ratio of 5: 1-1: 1;
fully and uniformly mixing the ivermectin premix 1 with the same amount of the auxiliary material b to obtain an ivermectin premix 2;
by analogy, premixing the ivermectin for 5 times by adopting an equal-density equivalent incremental mixing method to uniformly distribute the ivermectin into the auxiliary materials to obtain powder A;
(3) uniformly mixing albendazole with starch in the same amount to obtain powder B;
(4) and (3) totally mixing the powder A and the powder B with other raw and auxiliary materials to prepare an albendazole ivermectin premix finished product.
Example 2
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 6.0%
Ivermectin 0.25%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
2.3 percent of corncob meal
Adding starch to full amount.
The preparation method is the same as example 1.
Example 3
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 6.3%
Ivermectin 0.26%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
2.6 percent of corncob meal
Adding starch to full amount.
The preparation method is the same as example 1.
Comparative example 1
Ivermectin is premixed according to the conventional equal-dose incremental method.
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 5.8%
Ivermectin 0.24%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
Adding starch to full amount.
The preparation method of the albendazole ivermectin premix comprises the following steps:
(1) accurately weighing the components according to the mass percentage, and respectively sieving the components through a No. 5 sieve for later use;
(2) premixing of ivermectin:
taking ivermectin and starch with the same quantity, and fully and uniformly mixing to obtain an ivermectin premix 1;
then, fully and uniformly mixing the ivermectin premix 1 with the same amount of starch to obtain an ivermectin premix 2;
by analogy, premixing the ivermectin for 5 times by adopting an equivalent incremental mixing method to uniformly distribute the ivermectin in the auxiliary materials to obtain powder A;
(3) uniformly mixing albendazole with starch in the same amount to obtain powder B;
(4) and (3) totally mixing the powder A and the powder B with other raw and auxiliary materials to prepare an albendazole ivermectin premix finished product.
Comparative example 2
Ivermectin is premixed according to the conventional equal-dose incremental method.
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 6.0%
Ivermectin 0.25%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
2.3 percent of corncob meal
Adding starch to full amount.
The preparation method is the same as that of comparative example 1.
Comparative example 3
Ivermectin is premixed according to the conventional equal-dose incremental method.
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 6.3%
Ivermectin 0.26%
5 percent of extracted essence of Angongbao plants
Medicinal charcoal 12%
2.6 percent of corncob meal
Adding starch to full amount.
The preparation method is the same as that of comparative example 1.
Comparative example 4
The ivermectin is prepared according to a standard formula without adding extracted essence of uterus-soothing fetus-protecting plants.
The albendazole and ivermectin premix prepared by the method comprises the following components in percentage by mass:
albendazole 6.0%
Ivermectin 0.25%
Medicinal charcoal 12%
2.3 percent of corncob meal
Adding starch to full amount.
The preparation method is the same as that of comparative example 1.
Test 1
And (3) detecting content uniformity: the medicine is proved to be dispersed evenly;
the purpose of the test is as follows: the content uniformity of the albendazole ivermectin premix provided by the invention is verified whether meeting the specified requirements.
The test method comprises the following steps: ten parallel samples were taken for each batch and tested according to the content uniformity inspection method of 0941, appendix of the pharmacopoeia of Chinese beasts (2015 edition).
The results of the uniformity test of ivermectin content in example 1 are shown in table 1:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 1, the uniformity (a + 1.80S) of the ivermectin content of the albendazole ivermectin premix provided in example 1 completely meets the specification.
The results of the uniformity test of ivermectin content in comparative example 1 are shown in table 2:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 2, the ivermectin content uniformity (a + 1.80S) of the albendazole ivermectin premix provided in comparative example 1 is not in compliance.
The results of the uniformity test of ivermectin content in example 2 are shown in table 3:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 3, the ivermectin content uniformity (a + 1.80S) of the albendazole ivermectin premix provided in example 2 completely meets the specification.
The results of the uniformity test of ivermectin content of comparative example 2 are shown in table 4:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 4, the ivermectin content uniformity (a + 1.80S) of the albendazole ivermectin premix provided in comparative example 2 is not in compliance.
The results of the uniformity test of ivermectin content in example 3 are shown in table 5:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 5, the ivermectin content uniformity (a + 1.80S) of the albendazole ivermectin premix provided in example 3 completely meets the specification.
The results of the uniformity test of ivermectin content of comparative example 3 are shown in table 6:
note: the quality standard requires that the content of ivermectin is 90-110% of the marked amount, and the average value of the content uniformity (A + 1.80S) is less than 15.0.
As can be seen from the test results in table 6, the ivermectin content uniformity (a + 1.80S) of the albendazole ivermectin premix provided in comparative example 3 is not in compliance.
Test 2
And (3) safety test: the side effect of the medicine is proved to be small;
the purpose of the test is as follows: verifying whether the albendazole ivermectin premix provided by the invention is available for pregnant animals.
The test method comprises the following steps: 150 healthy pregnant sows with the same number of births were selected and randomly divided into 3 groups of 50 sows each.
The albendazole ivermectin premix prepared in the example 2 and the comparative example 4 is added with 1000g of samples per ton of feed according to the use amount specified by the standard specification, and is respectively fed to pregnant sows for one week; the control group was fed with a blank diet. The number of stillbirths, malformations and weak calves was counted during the test.
Statistics of test results, as shown in table 7:
note: the trial began on day 46 of sow pregnancy and ended after the sow was farrowing.
As can be seen from the statistical results in table 7, the albendazole/ivermectin premix provided in example 2 does not cause stillbirth, teratogenesis and frailty of sows, has no teratogenesis effect, and can be used during pregnancy of sows.
The extracted essence of the Angongbao plant used by the invention is extracted by a traditional Chinese medicine extraction workshop of the enterprise, and can be obtained by purchasing traditional Chinese medicine decoction pieces for extraction by social public; the corncob meal used may be purchased on the market or obtained by crushing corncobs.
Claims (2)
1. A preparation method of albendazole ivermectin premix is characterized by comprising the following steps:
(1) weighing the components according to the following mass percent, and respectively sieving the components through a No. 5 sieve for later use;
5.5 to 6.5 percent of albendazole,
0.22 to 0.26 percent of ivermectin,
10-15% of medicinal carbon,
5-10% of corn cob meal,
4.5 to 5.5 percent of extract of the Angongbao plant,
the balance being starch;
(2) premixing ivermectin;
mixing starch and corncob powder into an auxiliary material a with the same density as ivermectin according to the mass ratio of 5: 1-1: 1;
taking ivermectin with the formula amount and an equivalent amount of auxiliary material a to be fully and uniformly mixed to obtain an ivermectin premix 1;
then mixing starch and corncob powder into an auxiliary material b with the same density as the ivermectin premix 1 according to the mass ratio of 5: 1-1: 1;
fully and uniformly mixing the ivermectin premix 1 with the same amount of the auxiliary material b to obtain an ivermectin premix 2;
by analogy, premixing the ivermectin for 5 times by adopting an equal-density equivalent incremental mixing method to uniformly distribute the ivermectin into the auxiliary materials to obtain powder A;
(3) uniformly mixing albendazole with the same amount of starch to obtain powder B;
(4) and (3) totally mixing the powder A and the powder B with other components to obtain the finished albendazole ivermectin premix.
2. The preparation method according to claim 1, wherein the content deviation of the active ingredients of the prepared albendazole ivermectin premix finished product is small, and the average value of A +1.80S in the measurement of the content uniformity of ivermectin is less than 10.0.
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