CN111821272A - Compound amino acid enteric-coated tablet for dogs and preparation method thereof - Google Patents

Compound amino acid enteric-coated tablet for dogs and preparation method thereof Download PDF

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CN111821272A
CN111821272A CN202010799062.9A CN202010799062A CN111821272A CN 111821272 A CN111821272 A CN 111821272A CN 202010799062 A CN202010799062 A CN 202010799062A CN 111821272 A CN111821272 A CN 111821272A
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parts
dogs
tablet core
amino acid
enteric
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裴有志
陈淑芳
李凤英
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HEBEI KEXING PHARMACEUTICAL CO Ltd
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HEBEI KEXING PHARMACEUTICAL CO Ltd
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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
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly discloses a compound amino acid enteric-coated tablet for dogs, which comprises raw materials for preparing active ingredients of leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride, methionine, phenylalanine, tryptophan, starch, sodium carboxymethyl starch, magnesium stearate, sodium carboxymethylcellulose, a suspension A and a suspension B. The preparation steps of the compound amino acid enteric-coated tablet for dogs comprise the preparation of a tablet core, the preparation of an isolating layer and the preparation of an enteric coating layer. The compound amino acid enteric-coated tablet for dogs reduces adverse reactions caused by stimulation on the stomach, supplements the requirement of dogs on amino acid, and has simple preparation method and operation. The preparation method is suitable for preparing the compound amino acid enteric-coated tablets for dogs, and the prepared compound amino acid enteric-coated tablets for dogs are suitable for dogs.

Description

Compound amino acid enteric-coated tablet for dogs and preparation method thereof
Technical Field
The invention belongs to the field of pharmaceutical preparations, relates to the field of livestock and veterinary medicine, and particularly relates to a compound amino acid enteric-coated tablet for dogs and a preparation method thereof.
Background
At present, more and more families choose to domesticate dogs, but some dogs are weak and sick, and generally show symptoms of appetite reduction, feed intake reduction, physical weakness and the like, and due to the symptoms, nutrient substances in the dogs are greatly lost along with the time, and if the symptoms are not timely improved, the dogs grow slowly and even die.
At present, a supplementing liquid for enhancing the body performance of dogs is mainly glucose and sodium chloride injection, the injection mainly plays a role in supplementing water and energy and regulating the balance of electrolyte of organisms, but cannot improve the nutritional status of the dogs and supplement amino acid required by the dogs, and the side effect of a medicine for enhancing the body performance of dogs is large, particularly to weak and sick dogs, the stomach of the dogs is easily stimulated, so that adverse reactions are caused.
Disclosure of Invention
The invention aims to provide a compound amino acid enteric-coated tablet for dogs, which can provide nutrition for dogs and simultaneously can avoid stimulation to the stomach of the dogs; the invention also aims to provide a preparation method of the compound amino acid enteric-coated tablet for dogs.
In order to achieve the purpose, the invention adopts the following technical scheme:
the compound amino acid enteric-coated tablet for dogs comprises a tablet core, an isolation layer coated on the surface of the tablet core and an enteric coating layer coated on the surface of the isolation layer, wherein raw materials for preparing effective components of the tablet core comprise, by weight, 5-10 parts of leucine, 1-5 parts of isoleucine, 1-5 parts of valine, 4-8 parts of glycine, 1-5 parts of proline, 1-5 parts of alanine, 4-8 parts of lysine hydrochloride, 4-8 parts of arginine hydrochloride, 1-3 parts of serine, 1-5 parts of threonine, 3-8 parts of histidine hydrochloride, 1-5 parts of methionine, 4-8 parts of phenylalanine, 0.5-1 part of tryptophan, 1-3 parts of starch, 1-3 parts of sodium carboxymethyl starch, 1-3 parts of magnesium stearate and 1-3 parts of sodium carboxymethyl cellulose; the raw material for preparing the isolation layer is suspension A prepared by dispersing 9-11% of quick-release coating powder in purified water, and the weight of the tablet core is increased by 1-3% on the basis of the tablet core after the isolation layer is coated on the tablet core; the raw material for preparing the enteric coating layer is that enteric coating powder with the mass percentage of 6-8 percent is dispersed in 80 percent isopropanol solution to prepare suspension B, and the weight of the tablet core is increased by 5-7 percent on the basis of the tablet core after the tablet core is coated with the isolation layer and the enteric coating layer.
As a further limitation: the raw materials for preparing the effective components of the tablet core comprise, by weight, 7.58 parts of leucine, 3.40 parts of isoleucine, 2.72 parts of valine, 6.48 parts of glycine, 2.00 parts of proline, 3.76 parts of alanine, 6.66 parts of lysine hydrochloride, 5.78 parts of arginine hydrochloride, 1.34 parts of serine, 3.94 parts of threonine, 4.92 parts of histidine hydrochloride, 2.12 parts of methionine, 5.66 parts of phenylalanine, 0.78 part of tryptophan, 2.26 parts of starch, 2.64 parts of sodium carboxymethyl starch, 1.98 parts of magnesium stearate and 1.98 parts of sodium carboxymethyl cellulose; the raw material for preparing the isolation layer is a suspension A prepared by dispersing 10 percent of quick-release coating powder in purified water by mass percent, and the weight of a tablet core is increased by 2 percent on the basis of the tablet core after the tablet core is coated with the isolation layer; the raw material for preparing the enteric coating layer is enteric coating powder with the mass percentage of 7 percent, the enteric coating powder is dispersed in 80 percent isopropanol solution to prepare suspension B, and the weight of the tablet core is increased by 6 percent on the basis of the tablet core after the tablet core is coated with the isolating layer and the enteric coating layer.
The invention also provides a preparation method of the compound amino acid enteric-coated tablet for dogs, which comprises the following steps:
s1, preparing a tablet core: weighing leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride, methionine, phenylalanine, tryptophan, starch and an added part of sodium carboxymethyl starch, adding into a wet granulator, adding a sodium carboxymethyl cellulose aqueous solution to prepare a soft material, granulating, drying, sieving, granulating to prepare granules, adding an added part of sodium carboxymethyl starch and magnesium stearate, mixing, and tabletting to obtain a tablet core;
s2, preparing an isolating layer: uniformly dispersing the quick-release coating powder in purified water to prepare a suspension A with the mass percentage of 9-11%, spraying the suspension A on the surface of the tablet core prepared in the step S1 to form an isolation layer, and increasing the weight of the tablet core coated with the isolation layer by 1-3% on the basis of the tablet core prepared in the step S1 to obtain a product C;
s3, preparing an enteric coating layer: and (3) uniformly dispersing the enteric coating powder in 80% isopropanol solution to prepare a suspension B with the mass percentage of 6% -8%, spraying the suspension B on the surface of the product C prepared in the step S2 to form an enteric coating layer, and increasing the weight of the product C coated with the enteric coating layer by 5% -7% on the basis of the tablet core prepared in the step S1 to obtain the compound amino acid enteric coated tablet for dogs.
As a limitation: in the step S1, the concentration of the sodium carboxymethyl cellulose aqueous solution is 10%, and the mass ratio of the sodium carboxymethyl starch to the internal part of the sodium carboxymethyl starch is 1: 0.5-2.
As a further limitation: the spraying temperature of the suspension A in the step S2 is 35-45 ℃.
As a further limitation: the spraying temperature of the suspension B in the step S3 is 35-45 ℃.
Due to the adoption of the scheme, compared with the prior art, the invention has the beneficial effects that:
(1) the compound amino acid enteric-coated tablet for dogs comprises a tablet core, an isolating layer and an enteric coating layer, and is disintegrated and absorbed in the dog intestine, so that adverse reactions caused by the stimulation of the medicine on the stomach due to the disintegration and absorption in the stomach are reduced, the adverse effects of the medicine on the appetite of dogs are reduced, and the tablet core contains 14 amino acids, so that the requirement of the dogs on the amino acids in vivo is met; in addition, the isolating layer can prevent the effective components in the medicine from exuding, so that the effective components in the medicine can be kept stable, the good appearance can be ensured, and the shelf life of the medicine can be prolonged;
(2) the preparation method of the compound amino acid enteric-coated tablets for dogs, provided by the invention, is simple to operate and is suitable for large-scale production.
In conclusion, the compound amino acid enteric-coated tablet for dogs provided by the invention reduces adverse reactions caused by stomach stimulation, reduces adverse effects of drugs on dog appetite, supplements the requirements of the dogs on amino acids, ensures the stability and good appearance of active ingredients of the drugs, prolongs the shelf life of the drugs, and has a simple preparation method and simple operation.
The preparation method provided by the invention is suitable for preparing the compound amino acid enteric-coated tablets for dogs, and the prepared compound amino acid enteric-coated tablets for dogs are suitable for dogs.
Detailed Description
The present invention is further described with reference to the following examples, but it should be understood by those skilled in the art that the present invention is not limited to the following examples, and any modifications and variations based on the specific examples of the present invention are within the scope of the claims of the present invention.
Example 1-6 preparation method of compound amino acid enteric-coated tablets for dogs
Examples 1 to 6 are methods for preparing compound amino acid enteric-coated tablets for dogs, respectively, and the raw material composition for preparing the compound amino acid enteric-coated tablets for dogs is shown in table 1, the quick-release coating powder and the enteric-coated powder in examples 1 to 6 are commercially available, and the process parameters for preparing the compound amino acid enteric-coated tablets for dogs are shown in table 2.
The preparation method comprises the following steps:
s1, preparing a tablet core: weighing leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride, methionine, phenylalanine, tryptophan, starch and an added part of sodium carboxymethyl starch, adding into a wet granulator, adding a 10% sodium carboxymethyl cellulose aqueous solution to prepare a soft material, granulating, drying, sieving, granulating to prepare granules, adding an added part of sodium carboxymethyl starch and magnesium stearate, uniformly mixing, and tabletting to obtain a tablet core;
s2, preparing an isolating layer: uniformly dispersing the quick-release coating powder in purified water to prepare a suspension A with the mass percentage of 9-11%, spraying the suspension A on the surface of the tablet core prepared in the step S1 at the temperature of 35-45 ℃ to form an isolation layer, and increasing the weight of the tablet core coated with the isolation layer by 1-3% on the basis of the tablet core prepared in the step S1 to obtain a product C;
s3, preparing an enteric coating layer: and (3) uniformly dispersing the enteric coating powder in 80% isopropanol solution to prepare a suspension B with the mass percentage of 6% -8%, spraying the suspension B on the surface of the product C prepared in the step S2 at the temperature of 35-45 ℃ to form an enteric coating layer, and increasing the weight of the product C coated with the enteric coating layer by 5% -7% on the basis of the tablet core prepared in the step S1 to obtain the compound amino acid enteric coated tablet for dogs.
The preparation method of the compound amino acid enteric-coated tablets for dogs is simple to operate and can be used for large-scale production.
TABLE 1 EXAMPLES 1-6 materials of enteric coated compound amino acid tablets for dogs
Figure DEST_PATH_IMAGE001
TABLE 2 Process parameters for examples 1-6
Figure 960583DEST_PATH_IMAGE002
Example 7 effectiveness test of Compound amino acid enteric-coated tablet for dogs
90 beagle dogs which are clinically diagnosed as protein deficiency are selected and divided into 6 groups, namely a control group 1, a control group 2, a control group 3, a test group 1, a test group 2 and a test group 3, wherein 15 beagle dogs show emaciation, weight loss and inappetence, the beagle dogs are treated according to the usage amount shown in the table 1, and the test results are shown in the table 3 after 7 days of observation.
TABLE 3 effectiveness test results of compound amino acid enteric-coated tablets for dogs
Figure DEST_PATH_IMAGE003
As can be seen from Table 3, through the treatment and observation for 7 days, the dogs in the control groups 1 to 3 all have vomiting reaction, the dogs in the test groups 1 to 3 have no vomiting reaction, the food intake of the dogs in the test groups 1 to 3 is increased, and the weight of the dogs is increased. Test results show that the compound amino acid enteric-coated tablet for dogs can supplement the requirement of dogs on amino acid and reduce the adverse effect of the medicine on the appetite of the sick dogs.
Example 8 detection test of Compound amino acid enteric coated tablets for dogs
According to the disintegration time limit inspection method of 0921 in the appendix of the second part of the 2015 edition of the pharmacopoeia of the people's republic of China, 6 enteric-coated tablets prepared in examples 1-6 are respectively taken and placed in the artificial gastric juice for 2 hours, and the conditions of breakage and cracking of the enteric-coated tablets are observed; after being washed by a small amount of water, the enteric-coated tablets are immediately put into the artificial intestinal juice, and the enteric-coated tablets are completely disintegrated within 1 hour. The test results are shown in Table 4.
TABLE 4 detection test results of compound amino acid enteric-coated tablets for dogs
Figure 877723DEST_PATH_IMAGE004
As is clear from Table 4, the enteric-coated tablets prepared in examples 1 to 6 were not broken and cracked in the appearance in gastric juice, and were all disintegrated in intestinal juice within 1 hour, indicating that the enteric-coated tablets prepared in examples 1 to 6 were not disintegrated and absorbed in the stomach, but in the intestine. Therefore, the compound amino acid enteric-coated tablet for dogs is disintegrated and absorbed in the intestines of dogs, reduces adverse reactions caused by stimulation on the stomach of dogs, and reduces adverse effects of medicaments on dog appetite.

Claims (7)

1. The compound amino acid enteric-coated tablet for dogs is characterized by comprising a tablet core, an isolation layer coated on the surface of the tablet core and an enteric coating layer coated on the surface of the isolation layer, wherein raw materials for preparing effective components of the tablet core comprise, by weight, 5-10 parts of leucine, 1-5 parts of isoleucine, 1-5 parts of valine, 4-8 parts of glycine, 1-5 parts of proline, 1-5 parts of alanine, 4-8 parts of lysine hydrochloride, 4-8 parts of arginine hydrochloride, 1-3 parts of serine, 1-5 parts of threonine, 3-8 parts of histidine hydrochloride, 1-5 parts of methionine, 4-8 parts of phenylalanine, 0.5-1 part of tryptophan, 1-3 parts of starch, 1-3 parts of sodium carboxymethyl starch, 1-3 parts of magnesium stearate and 1-3 parts of sodium carboxymethyl cellulose; the raw material for preparing the isolation layer is suspension A prepared by dispersing 9-11% of quick-release coating powder in purified water, and the weight of the tablet core is increased by 1-3% on the basis of the tablet core after the isolation layer is coated on the tablet core; the raw material for preparing the enteric coating layer is that enteric coating powder with the mass percentage of 6-8 percent is dispersed in 80 percent isopropanol solution to prepare suspension B, and the weight of the tablet core is increased by 5-7 percent on the basis of the tablet core after the tablet core is coated with the isolation layer and the enteric coating layer.
2. The compound amino acid enteric-coated tablet for dogs as claimed in claim 1, wherein raw materials for preparing active ingredients of the tablet core comprise, by weight, 7.58 parts of leucine, 3.40 parts of isoleucine, 2.72 parts of valine, 6.48 parts of glycine, 2.00 parts of proline, 3.76 parts of alanine, 6.66 parts of lysine hydrochloride, 5.78 parts of arginine hydrochloride, 1.34 parts of serine, 3.94 parts of threonine, 4.92 parts of histidine hydrochloride, 2.12 parts of methionine, 5.66 parts of phenylalanine, 0.78 part of tryptophan, 2.26 parts of starch, 2.64 parts of sodium carboxymethyl starch, 1.98 parts of magnesium stearate and 1.98 parts of sodium carboxymethyl cellulose; the raw material for preparing the isolation layer is a suspension A prepared by dispersing 10 percent of quick-release coating powder in purified water by mass percent, and the weight of the tablet core is increased by 2 percent after the tablet core is coated with the isolation layer; the raw material for preparing the enteric coating layer is enteric coating powder with the mass percentage of 7 percent, the enteric coating powder is dispersed in 80 percent isopropanol solution to prepare suspension B, and the weight of the tablet core is increased by 6 percent on the basis of the tablet core after the tablet core is coated with the isolating layer and the enteric coating layer.
3. A method for preparing compound amino acid enteric coated tablets for dogs as claimed in claim 1 or 2, which comprises the following steps:
s1, preparing a tablet core: weighing leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride, methionine, phenylalanine, tryptophan, starch and an added part of sodium carboxymethyl starch, adding into a wet granulator, adding a sodium carboxymethyl cellulose aqueous solution to prepare a soft material, granulating, drying, sieving, granulating to prepare granules, adding an added part of sodium carboxymethyl starch and magnesium stearate, mixing, and tabletting to obtain a tablet core;
s2, preparing an isolating layer: uniformly dispersing the quick-release coating powder in purified water to prepare a suspension A with the mass percentage of 9-11%, spraying the suspension A on the surface of the tablet core prepared in the step S1 to form an isolation layer, and increasing the weight of the tablet core coated with the isolation layer by 1-3% on the basis of the tablet core prepared in the step S1 to obtain a product C;
s3, preparing an enteric coating layer: and (3) uniformly dispersing the enteric coating powder in 80% isopropanol solution to prepare a suspension B with the mass percentage of 6% -8%, spraying the suspension B on the surface of the product C prepared in the step S2 to form an enteric coating layer, and increasing the weight of the product C coated with the enteric coating layer by 5% -7% on the basis of the tablet core prepared in the step S1 to obtain the compound amino acid enteric coated tablet for dogs.
4. The method for preparing compound amino acid enteric-coated tablets for dogs according to claim 3, wherein the concentration of the sodium carboxymethyl cellulose aqueous solution in the step S1 is 10%, and the mass ratio of the sodium carboxymethyl starch to the added part of the sodium carboxymethyl starch is 1: 0.5-2.
5. The method for preparing compound amino acid enteric coated tablets for dogs according to claim 3 or 4, wherein the spraying temperature of the suspension A in the step S2 is 35-45 ℃.
6. The method for preparing compound amino acid enteric coated tablets for dogs according to claim 3 or 4, wherein the spraying temperature of the suspension B in the step S3 is 35-45 ℃.
7. The method for preparing compound amino acid enteric coated tablets for dogs according to claim 5, wherein the spraying temperature of the suspension B in the step S3 is 35-45 ℃.
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Application publication date: 20201027