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WO2022032804A1 - Compound amino acid enteric-coated tablet for dogs and preparation method therefor - Google Patents

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

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Publication number
WO2022032804A1
WO2022032804A1 PCT/CN2020/116383 CN2020116383W WO2022032804A1 WO 2022032804 A1 WO2022032804 A1 WO 2022032804A1 CN 2020116383 W CN2020116383 W CN 2020116383W WO 2022032804 A1 WO2022032804 A1 WO 2022032804A1
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WIPO (PCT)
Prior art keywords
parts
enteric
dogs
tablet
amino acid
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PCT/CN2020/116383
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French (fr)
Chinese (zh)
Inventor
裴有志
陈淑芳
李凤英
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河北科星药业有限公司
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Publication of WO2022032804A1 publication Critical patent/WO2022032804A1/en

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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

Definitions

  • the invention belongs to the field of pharmaceutical preparations and relates to the field of animal husbandry and veterinary medicine, in particular to a compound amino acid enteric-coated tablet for dogs and a preparation method thereof.
  • the supplementary fluids used to enhance the physical fitness of dogs are mainly glucose and sodium chloride injections.
  • the injections are mainly used to supplement water and energy, and to adjust the balance of electrolytes in the body, but they cannot improve the nutritional status of dogs and supplement the body's nutritional status.
  • Amino acids are needed, and the side effects of drugs that enhance the physical strength of dogs are relatively large, especially for frail and sick dogs, which are easy to stimulate their stomachs and cause adverse reactions.
  • the object of the present invention is to provide a compound amino acid enteric-coated tablet for dogs, which can avoid irritation to the stomach of the dog while providing nutrition for the dog; another object of the present invention is to provide the above-mentioned compound amino acid enteric tablet for dogs.
  • the present invention is to realize the above-mentioned purpose, and the technical scheme adopted is as follows:
  • a compound amino acid enteric-coated tablet for dogs 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, in parts by weight, prepared as an active ingredient of the tablet core.
  • the raw material composition includes 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, Lysine hydrochloride 4-8 parts, arginine hydrochloride 4-8 parts, serine 1-3 parts, threonine 1-5 parts, histidine hydrochloride 3-8 parts, methionine 1-5 parts, 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 3 parts; the raw material for making the isolation layer is Suspension A prepared by dis
  • the raw material for making the enteric coating layer is the enteric coating powder whose mass percentage is 6% to 8%, dispersed in 80% isopropanol solution to obtain suspension B, and the tablet core is coated with After covering the isolation layer and the enteric coating layer, the weight gain is 5% to 7% on the basis of the tablet core.
  • the raw materials for making the active ingredients of the tablet core include 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 amino acid, 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 parts 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; Suspension A prepared by dispersing the coating powder in purified water, the tablet core is coated with an isolation layer, and the weight is increased by 2% on the basis of the tablet core; the raw material for making the enteric coating layer is 7% enteric
  • the present invention also provides a preparation method of the above-mentioned compound amino acid enteric-coated tablet for dogs, comprising the following steps:
  • the isolation layer take the immediate-release coating powder and uniformly disperse it in purified water to make a suspension A with a mass percentage of 9% to 11%, and spray the suspension A on the surface of the tablet core obtained in step S1 to form isolation layer, the chip core coated with the isolation layer has a weight gain of 1% to 3% on the basis of the chip core obtained in step S1, to obtain product C;
  • enteric coating layer take the enteric coating powder and uniformly disperse it in 80% isopropanol solution to make suspension B with a mass percentage of 6% to 8%, and spray the suspension B on step S2
  • the surface of the product C prepared in the step S1 forms an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 7% on the basis of the tablet core prepared in step S1, that is, compound amino acids for dogs are obtained.
  • Enteric-coated tablets take the enteric coating powder and uniformly disperse it in 80% isopropanol solution to make suspension B with a mass percentage of 6% to 8%, and spray the suspension B on step S2
  • the surface of the product C prepared in the step S1 forms an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 7% on the basis of the tablet core prepared in step S1, that is, compound amino acids for dogs are obtained.
  • Enteric-coated tablets take the enteric coating powder
  • the concentration of the sodium carboxymethyl cellulose aqueous solution in step S1 is 10%, and the mass ratio of the added part of sodium carboxymethyl starch and the external part of sodium carboxymethyl starch is 1:0.5-2.
  • the spraying temperature of the suspension A in step S2 is 35°C to 45°C.
  • the spraying temperature of the suspension B in step S3 is 35°C to 45°C.
  • the present invention has the following beneficial effects:
  • the compound amino acid enteric-coated tablet for dogs provided by the present invention, comprising a tablet core, an isolation layer and an enteric coating layer, disintegrates and absorbs in the dog's intestine, reduces the disintegration and absorption of the drug in the stomach, and causes the stomach to produce
  • the adverse reaction caused by stimulation reduces the adverse effect of the drug on the dog's appetite
  • the tablet core contains 14 kinds of amino acids, which supplements the demand for amino acids in the dog; Keep the active ingredients of the drug stable, ensure a good appearance, and prolong the shelf life of the drug;
  • the preparation method of the compound amino acid enteric-coated tablet for dogs provided by the present invention has simple operation and is suitable for large-scale production.
  • the compound amino acid enteric-coated tablet for dogs provided by the present invention reduces adverse reactions caused by irritation to the stomach, reduces the adverse effects of drugs on dogs' appetite, and supplements the demand for amino acids in dogs.
  • the stability and good appearance of the active ingredients of the medicine are ensured, the shelf life of the medicine is prolonged, and the preparation method is simple to operate.
  • the preparation method provided by the invention is suitable for preparing compound amino acid enteric-coated tablets for dogs, and the prepared compound amino acid enteric-coated tablets for dogs are suitable for dogs.
  • Embodiment 1 ⁇ 6 The preparation method of compound amino acid enteric-coated tablet for dogs
  • Embodiments 1 to 6 are respectively a preparation method of compound amino acid enteric-coated tablets for dogs.
  • the composition of raw materials for making compound amino acid enteric-coated tablets for dogs is shown in Table 1.
  • the coating powders are all commercially available, and the process parameters for preparing compound amino acid enteric-coated tablets for dogs are shown in Table 2.
  • the preparation method is carried out according to the following steps:
  • isolation layer take the immediate-release coating powder and uniformly disperse it in purified water to prepare a suspension A with a mass percentage of 9% to 11%, and spray the suspension A on the step at 35°C to 45°C.
  • the surface of the chip core obtained in S1 forms an isolation layer, and the chip core coated with the isolation layer has a weight gain of 1% to 3% on the basis of the chip core obtained in step S1, to obtain product C;
  • enteric coating layer take enteric coating powder and uniformly disperse it in 80% isopropanol solution to prepare suspension B with a mass percentage of 6% to 8%. Under the condition of 45 °C, spray on the surface of the product C prepared in step S2 to form an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 5% on the basis of the tablet core prepared in step S1 7% to obtain compound amino acid enteric-coated tablets for dogs.
  • the preparation method of the compound amino acid enteric-coated tablet for dogs of the present invention is simple to operate and can be used for large-scale production.
  • a total of 90 beagle dogs clinically diagnosed with protein deficiency were selected and divided into 6 groups, namely control group 1, control group 2, control group 3, experimental group 1, experimental group 2 and experimental group 3, with 15 dogs in each group.
  • the sick dogs showed emaciation, weight loss, and loss of appetite.
  • Beagle dogs were treated according to the usage and dosage in Table 1, and were observed for 7 days. The test results are shown in Table 3.
  • the enteric-coated tablets prepared in Examples 1 to 6 had no appearance of damaged splinter in the gastric juice, and all disintegrated in the intestinal juice within 1 hour, indicating that the enteric-coated tablets prepared in Examples 1 to 6 were all disintegrated within 1 hour. Tablets are not disintegrated and absorbed in the stomach, but disintegrated and absorbed in the intestine. It can be seen that the compound amino acid enteric-coated tablet for dogs of the present invention disintegrates and absorbs in the dog's intestine, reduces the adverse reactions caused by stimulating the dog's stomach, and reduces the adverse effect of the drug on the dog's appetite.

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  • Chemical & Material Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Engineering & Computer Science (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

The present invention relates to the field of pharmaceutical preparations. Specifically disclosed is a compound amino acid enteric-coated tablet for dogs. Raw materials for preparing active ingredients of the tablet comprise leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride, methionine, phenylalanine, tryptophan, starch, sodium carboxymethyl starch, magnesium stearate, sodium carboxymethyl cellulose, a suspension A, and a suspension B. The steps for preparing the compound amino acid enteric-coated tablet for dogs comprise: preparing a tablet core, preparing an isolation layer, and preparing an enteric coating layer. The compound amino acid enteric-coated tablet for dogs reduces adverse reactions caused by stimulation to the stomach and supplements the requirements of dogs for amino acids, and the preparation method thereof is simple to operate. The preparation method is suitable for preparing the compound amino acid enteric-coated tablet for dogs, and the prepared compound amino acid enteric-coated tablet for dogs is suitable for dogs.

Description

犬用复方氨基酸肠溶片及其制备方法Compound amino acid enteric-coated tablet for dogs and preparation method thereof 技术领域technical field
本发明属于医药制剂领域，涉及畜牧兽医领域，具体地说是一种犬用复方氨基酸肠溶片及其制备方法。The invention belongs to the field of pharmaceutical preparations and relates to the field of animal husbandry and veterinary medicine, in particular to a compound amino acid enteric-coated tablet for dogs and a preparation method thereof.
背景技术Background technique
现在越来越多的家庭选择驯养犬类宠物，但是有的犬体弱多病，一般情况下，常表现出食欲下降、采食量减少、身体虚弱等症状，由于上述症状，犬体内的营养物质会随着时间的延长而大量流失，如果上述症状得不到及时改善，就会导致犬生长缓慢甚至死亡。Nowadays, more and more families choose to domesticate canine pets, but some dogs are weak and sickly. Under normal circumstances, they often show symptoms such as decreased appetite, reduced feed intake, and physical weakness. Due to the above symptoms, the nutrients in the dog's body will change with If the above symptoms are not improved in time, the dog will grow slowly or even die.
目前用于增强犬体能的补充液主要为葡萄糖、氯化钠注射液，所述注射液主要起补充水分和能量，以及调节机体电解质的平衡作用，但无法改善犬体营养状况和补充犬体所需氨基酸，而增强犬体能的药物副作用较大，尤其对体弱多病的犬，容易对其胃部产生刺激，进而引发不良反应。At present, the supplementary fluids used to enhance the physical fitness of dogs are mainly glucose and sodium chloride injections. The injections are mainly used to supplement water and energy, and to adjust the balance of electrolytes in the body, but they cannot improve the nutritional status of dogs and supplement the body's nutritional status. Amino acids are needed, and the side effects of drugs that enhance the physical strength of dogs are relatively large, especially for frail and sick dogs, which are easy to stimulate their stomachs and cause adverse reactions.
发明内容SUMMARY OF THE INVENTION
本发明的目的是要提供一种犬用复方氨基酸肠溶片，在为犬提供营养的同时，能够避免对犬的胃部产生刺激；本发明的另一个目的是要提供上述犬用复方氨基酸肠溶片的一种制备方法。The object of the present invention is to provide a compound amino acid enteric-coated tablet for dogs, which can avoid irritation to the stomach of the dog while providing nutrition for the dog; another object of the present invention is to provide the above-mentioned compound amino acid enteric tablet for dogs. A preparation method of dissolving tablet.
本发明为实现上述目的，所采用的技术方案如下：The present invention is to realize the above-mentioned purpose, and the technical scheme adopted is as follows:
一种犬用复方氨基酸肠溶片，包括片芯、涂覆于片芯表面的隔离层和涂覆于隔离层表面的肠溶包衣层，以重量份数计，制成片芯有效成分的原料组成包括亮氨酸5～10份、异亮氨酸1～5份、缬氨酸1～5份、甘氨酸4～8份、脯氨酸1～5份、丙氨酸1～5份、盐酸赖氨酸4～8份、盐酸精氨酸4～8份、丝氨酸1～3份、苏氨酸1～5份、盐酸组氨酸3～8份、甲硫氨酸1～5份、苯丙氨酸4～8份、色氨酸0.5～1份、淀粉1～3份、羧甲基淀粉钠1～3份、硬脂酸镁1～3份和羧甲基纤维素钠1～3份；制成隔离层的原料为质量百分比为9％～11％的速释包衣粉在纯化水中分散制成的混悬液A,片芯涂覆隔离层后在片芯的基础上增重1％～3％；制成肠溶包衣层的原料为质量百分比为6％～8％的肠溶包衣粉在80％异丙醇溶液中分散制得混悬液B，片芯涂覆隔离层和肠溶包衣层后在片芯的基础上增重5％～7％。A compound amino acid enteric-coated tablet for dogs, 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, in parts by weight, prepared as an active ingredient of the tablet core. The raw material composition includes 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, Lysine hydrochloride 4-8 parts, arginine hydrochloride 4-8 parts, serine 1-3 parts, threonine 1-5 parts, histidine hydrochloride 3-8 parts, methionine 1-5 parts, 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 3 parts; the raw material for making the isolation layer is Suspension A prepared by dispersing the immediate-release coating powder with a mass percentage of 9% to 11% in purified water. 1% to 3% by weight; the raw material for making the enteric coating layer is the enteric coating powder whose mass percentage is 6% to 8%, dispersed in 80% isopropanol solution to obtain suspension B, and the tablet core is coated with After covering the isolation layer and the enteric coating layer, the weight gain is 5% to 7% on the basis of the tablet core.
作为进一步限定：以重量份数计，制成片芯有效成分的原料组成包括亮氨酸7.58份、异亮氨酸3.40份、缬氨酸2.72份、甘氨酸6.48份、脯氨酸2.00份、丙氨酸3.76份、盐酸赖氨酸6.66份、盐酸精氨酸5.78份、丝氨酸1.34份、苏氨酸3.94份、盐酸组氨酸4.92份、甲硫氨酸2.12份、苯丙氨酸5.66份、色氨酸0.78份、淀粉2.26份、羧甲基淀粉钠2.64份、硬脂酸镁1.98份和羧甲基纤维素钠1.98份；制成隔离层的原料为质量百分比为10％的速释包衣粉在纯化水中分散制成的混悬液A,片芯涂覆有隔离层后在片芯的基础上增重2％；制成肠溶包衣层的原料为质量百分比为7％的肠溶包衣粉在80％异丙醇溶液中分散制得混悬液B，片芯涂覆有隔离层和肠溶包衣层后在片芯的基础上增重6％。As a further limitation: in parts by weight, the raw materials for making the active ingredients of the tablet core include 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 amino acid, 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 parts 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; Suspension A prepared by dispersing the coating powder in purified water, the tablet core is coated with an isolation layer, and the weight is increased by 2% on the basis of the tablet core; the raw material for making the enteric coating layer is 7% enteric The coating powder was dispersed in 80% isopropanol solution to obtain suspension B. After the tablet core was coated with an isolation layer and an enteric coating layer, the weight increased by 6% on the basis of the tablet core.
本发明还提供了上述犬用复方氨基酸肠溶片的一种制备方法，包括以下步骤：The present invention also provides a preparation method of the above-mentioned compound amino acid enteric-coated tablet for dogs, comprising the following steps:
S1、制备片芯：称取亮氨酸、异亮氨酸、缬氨酸、甘氨酸、脯氨酸、丙氨酸、盐酸赖氨酸、盐酸精氨酸、丝氨酸、苏氨酸、盐酸组氨酸、甲硫氨酸、苯丙氨酸、色氨酸、淀粉和内加部分羧甲基淀粉钠加入湿法制粒机中，再加入羧甲基纤维素钠水溶液制成软材后制粒，经过干燥、过筛、整粒制得颗粒，再加入外加部分羧甲基淀粉钠和硬脂酸镁，混合、压片，即得片芯；S1. Preparation of tablet cores: Weigh leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride Acid, methionine, phenylalanine, tryptophan, starch and a part of sodium carboxymethyl starch were added to the wet granulator, and then the aqueous solution of sodium carboxymethyl cellulose was added to make soft materials and then granulated. After drying, sieving, and granulating to obtain granules, add part of sodium carboxymethyl starch and magnesium stearate, mix and press to obtain tablet cores;
S2、制备隔离层：取速释包衣粉在纯化水中均匀分散制成质量百分比为9％～11％的混悬液A，将混悬液A喷涂于步骤S1中制得的片芯表面形成隔离层，涂覆有隔离层的片芯在步骤S1制得的片芯的基础上增重1％～3％,即得产品C；S2, prepare the isolation layer: take the immediate-release coating powder and uniformly disperse it in purified water to make a suspension A with a mass percentage of 9% to 11%, and spray the suspension A on the surface of the tablet core obtained in step S1 to form isolation layer, the chip core coated with the isolation layer has a weight gain of 1% to 3% on the basis of the chip core obtained in step S1, to obtain product C;
S3、制备肠溶包衣层：取肠溶包衣粉在80％异丙醇溶液中均匀分散制成质量百分比为6％～8％的混悬液B，将混悬液B喷涂于步骤S2中制得的产品C表面形成肠溶包衣层，涂覆有肠溶包衣层的产品C在步骤S1制得的片芯的基础上增重5％～7％，即得犬用复方氨基酸肠溶片。S3, prepare the enteric coating layer: take the enteric coating powder and uniformly disperse it in 80% isopropanol solution to make suspension B with a mass percentage of 6% to 8%, and spray the suspension B on step S2 The surface of the product C prepared in the step S1 forms an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 7% on the basis of the tablet core prepared in step S1, that is, compound amino acids for dogs are obtained. Enteric-coated tablets.
作为限定：步骤S1中羧甲基纤维素钠水溶液的浓度为10％，内加部分羧甲基淀粉钠和外加部分羧甲基淀粉钠质量比为1:0.5～2。As a limitation: the concentration of the sodium carboxymethyl cellulose aqueous solution in step S1 is 10%, and the mass ratio of the added part of sodium carboxymethyl starch and the external part of sodium carboxymethyl starch is 1:0.5-2.
作为进一步限定：步骤S2中混悬液A的喷涂温度为35℃～45℃。As a further limitation: the spraying temperature of the suspension A in step S2 is 35°C to 45°C.
作为更进一步限定：步骤S3中混悬液B的喷涂温度为35℃～45℃。As a further limitation: the spraying temperature of the suspension B in step S3 is 35°C to 45°C.
本发明由于采用了上述方案，与现有技术相比，所取得的有益效果是：Compared with the prior art, the present invention has the following beneficial effects:
(1)本发明提供的犬用复方氨基酸肠溶片，包括片芯、隔离层和肠溶包衣层， 在犬肠内崩解吸收，减少因药物在胃部崩解吸收，对胃部产生刺激而引发的不良反应，降低了药物对犬食欲产生的不良影响，而且片芯中含有14种氨基酸，补充了犬体内对氨基酸的需求；此外，隔离层阻隔了药物中有效成分的渗出，使药物有效成分保持稳定，保证了良好的外观，延长了药物的保质期；(1) The compound amino acid enteric-coated tablet for dogs provided by the present invention, comprising a tablet core, an isolation layer and an enteric coating layer, disintegrates and absorbs in the dog's intestine, reduces the disintegration and absorption of the drug in the stomach, and causes the stomach to produce The adverse reaction caused by stimulation reduces the adverse effect of the drug on the dog's appetite, and the tablet core contains 14 kinds of amino acids, which supplements the demand for amino acids in the dog; Keep the active ingredients of the drug stable, ensure a good appearance, and prolong the shelf life of the drug;
(2)本发明提供的犬用复方氨基酸肠溶片的制备方法，操作简单，适用于大规模生产。(2) The preparation method of the compound amino acid enteric-coated tablet for dogs provided by the present invention has simple operation and is suitable for large-scale production.
综上所述，本发明提供的犬用复方氨基酸肠溶片，减少了对胃部产生刺激而引发的不良反应，降低了药物对犬食欲产生的不良影响，补充了犬体内对氨基酸的需求，保证了药物有效成分的稳定和良好的外观，延长了药物的保质期，而且其制备方法操作简单。To sum up, the compound amino acid enteric-coated tablet for dogs provided by the present invention reduces adverse reactions caused by irritation to the stomach, reduces the adverse effects of drugs on dogs' appetite, and supplements the demand for amino acids in dogs. The stability and good appearance of the active ingredients of the medicine are ensured, the shelf life of the medicine is prolonged, and the preparation method is simple to operate.
本发明提供的制备方法适用于制备犬用复方氨基酸肠溶片，所制犬用复方氨基酸肠溶片适用于犬。The preparation method provided by the invention is suitable for preparing compound amino acid enteric-coated tablets for dogs, and the prepared compound amino acid enteric-coated tablets for dogs are suitable for dogs.
具体实施方式detailed description
下面结合实施例对本发明作进一步说明，但本领域的技术人员应当理解，本发明并不限于以下实施例，任何在本发明具体实施例基础上做出的改进和变化都在本发明权利要求保护的范围之内。The present invention will be further described below in conjunction with the embodiments, but those skilled in the art should understand that the present invention is not limited to the following embodiments, and any improvements and changes made on the basis of the specific embodiments of the present invention are protected by the claims of the present invention within the range.
实施例1～6犬用复方氨基酸肠溶片的制备方法Embodiment 1～6 The preparation method of compound amino acid enteric-coated tablet for dogs
实施例1～6分别为一种犬用复方氨基酸肠溶片的制备方法，制成犬用复方氨基酸肠溶片的原料组成参见表1，实施例1～6中的速释包衣粉和肠溶包衣粉均为市售购买获得，制备犬用复方氨基酸肠溶片的工艺参数参见表2。Embodiments 1 to 6 are respectively a preparation method of compound amino acid enteric-coated tablets for dogs. The composition of raw materials for making compound amino acid enteric-coated tablets for dogs is shown in Table 1. The coating powders are all commercially available, and the process parameters for preparing compound amino acid enteric-coated tablets for dogs are shown in Table 2.
制备方法按照以下步骤进行：The preparation method is carried out according to the following steps:
S1、制备片芯：称取亮氨酸、异亮氨酸、缬氨酸、甘氨酸、脯氨酸、丙氨酸、盐酸赖氨酸、盐酸精氨酸、丝氨酸、苏氨酸、盐酸组氨酸、甲硫氨酸、苯丙氨酸、色氨酸、淀粉和内加部分羧甲基淀粉钠加入湿法制粒机中，再加入10％羧甲基纤维素钠水溶液制成软材后制粒，经过干燥、过筛、整粒制得颗粒，再加入外加部分羧甲基淀粉钠和硬脂酸镁，混合均匀，压片，即得片芯；S1. Preparation of tablet cores: Weigh leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride Acid, methionine, phenylalanine, tryptophan, starch and some sodium carboxymethyl starch were added to the wet granulator, and then 10% sodium carboxymethyl cellulose aqueous solution was added to make soft materials. Granules are obtained by drying, sieving and granulating, and then adding part of sodium carboxymethyl starch and magnesium stearate, mixing evenly, and compressing to obtain tablet cores;
S2、制备隔离层：取速释包衣粉在纯化水中均匀分散制成质量百分比为9％～11％的混悬液A，将混悬液A在35℃～45℃的条件下喷涂于步骤S1中制得的片芯表面形成隔离层，涂覆有隔离层的片芯在步骤S1制得的片芯的基础上增重1％～ 3％,即得产品C；S2. Preparation of isolation layer: take the immediate-release coating powder and uniformly disperse it in purified water to prepare a suspension A with a mass percentage of 9% to 11%, and spray the suspension A on the step at 35°C to 45°C. The surface of the chip core obtained in S1 forms an isolation layer, and the chip core coated with the isolation layer has a weight gain of 1% to 3% on the basis of the chip core obtained in step S1, to obtain product C;
S3、制备肠溶包衣层：取肠溶包衣粉在80％异丙醇溶液中均匀分散制成质量百分比为6％～8％的混悬液B，将混悬液B在35℃～45℃的条件下喷涂于步骤S2中制得的产品C表面形成肠溶包衣层，涂覆有肠溶包衣层的产品C在步骤S1制得的片芯的基础上增重5％～7％，即得犬用复方氨基酸肠溶片。S3. Preparation of enteric coating layer: take enteric coating powder and uniformly disperse it in 80% isopropanol solution to prepare suspension B with a mass percentage of 6% to 8%. Under the condition of 45 ℃, spray on the surface of the product C prepared in step S2 to form an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 5% on the basis of the tablet core prepared in step S1 7% to obtain compound amino acid enteric-coated tablets for dogs.
本发明的犬用复方氨基酸肠溶片的制备方法操作简单，可用于大规模生产。The preparation method of the compound amino acid enteric-coated tablet for dogs of the present invention is simple to operate and can be used for large-scale production.
表1实施例1-6犬用复方氨基酸肠溶片的原料Table 1 Examples 1-6 Raw materials of compound amino acid enteric-coated tablets for dogs
Figure PCTCN2020116383-appb-000001
Figure PCTCN2020116383-appb-000001
表2实施例1-6的工艺参数The technological parameters of table 2 embodiment 1-6
Figure PCTCN2020116383-appb-000002
Figure PCTCN2020116383-appb-000002
实施例7犬用复方氨基酸肠溶片有效性试验Example 7 Effectiveness test of compound amino acid enteric-coated tablets for dogs
选取经临床诊断为蛋白质缺乏症的比格犬90只，分成6组，分别为对照组1、对照组2、对照组3、试验组1、试验组2和试验组3，每组15只，病犬表现为消瘦、体重减轻、食欲不振，按表1的用法用量对比格犬进行治疗，观察7日，试验结果如表3所示。A total of 90 beagle dogs clinically diagnosed with protein deficiency were selected and divided into 6 groups, namely control group 1, control group 2, control group 3, experimental group 1, experimental group 2 and experimental group 3, with 15 dogs in each group. The sick dogs showed emaciation, weight loss, and loss of appetite. Beagle dogs were treated according to the usage and dosage in Table 1, and were observed for 7 days. The test results are shown in Table 3.
表3犬用复方氨基酸肠溶片有效性试验结果Table 3 Results of the effectiveness test of compound amino acid enteric-coated tablets for dogs
Figure PCTCN2020116383-appb-000003
Figure PCTCN2020116383-appb-000003
由表3可知，经过7日的治疗观察，对照组1～3均有犬出现呕吐反应，试验组1～3未见呕吐反应，而且试验组1～3的犬的进食量均有增加，体重也均有增长。试验结果表明，本发明的一种犬用复方氨基酸肠溶片能够补充犬体对氨基酸的需求，降低药物对患犬食欲产生的不良影响。It can be seen from Table 3 that after 7 days of treatment and observation, all dogs in the control group 1-3 showed vomiting reaction, and no vomiting reaction was found in the experimental groups 1-3, and the dogs in the experimental groups 1-3 all increased their food intake and body weight. also increased. The test results show that the compound amino acid enteric-coated tablet for dogs of the present invention can supplement the requirement of the dog's body for amino acids and reduce the adverse effect of the drug on the appetite of the dog.
实施例8犬用复方氨基酸肠溶片检测试验Example 8 Detection test of compound amino acid enteric-coated tablets for dogs
按照《中华人民共和国兽药典》2015年版二部附录0921崩解时限检查法，分别 取实施例1～6制得的肠溶片各6片，放置在人工胃液中2小时后，观察肠溶片外观有无破损、裂片情况；经少量水冲洗后，立即放入人工肠液中，肠溶片完全崩解的时间，各片均应在1小时内全部崩解。试验结果见表4。According to the disintegration time limit inspection method of the second appendix 0921 of the "Veterinary Pharmacopoeia of the People's Republic of China" 2015 edition, 6 of the enteric-coated tablets prepared in Examples 1 to 6 were taken respectively, placed in artificial gastric juice for 2 hours, and the enteric-coated tablets were observed. Whether the appearance is damaged or splintered; after washing with a small amount of water, immediately put it into artificial intestinal juice, the time for the complete disintegration of enteric-coated tablets, each tablet should be completely disintegrated within 1 hour. The test results are shown in Table 4.
表4犬用复方氨基酸肠溶片检测试验结果Table 4 Test results of compound amino acid enteric-coated tablets for dogs
Figure PCTCN2020116383-appb-000004
Figure PCTCN2020116383-appb-000004
由表4可知，实施例1～6制得的肠溶片在胃液中外观均无破损裂片的情况，在肠液中均在1小时内全部崩解，表明实施例1～6制得的肠溶片均不在胃部崩解吸收，而在肠内崩解吸收。由此可见，本发明的犬用复方氨基酸肠溶片，在犬肠内崩解吸收，减少了对犬胃部产生刺激而引发的不良反应，降低了药物对犬食欲产生的不良影响。As can be seen from Table 4, the enteric-coated tablets prepared in Examples 1 to 6 had no appearance of damaged splinter in the gastric juice, and all disintegrated in the intestinal juice within 1 hour, indicating that the enteric-coated tablets prepared in Examples 1 to 6 were all disintegrated within 1 hour. Tablets are not disintegrated and absorbed in the stomach, but disintegrated and absorbed in the intestine. It can be seen that the compound amino acid enteric-coated tablet for dogs of the present invention disintegrates and absorbs in the dog's intestine, reduces the adverse reactions caused by stimulating the dog's stomach, and reduces the adverse effect of the drug on the dog's appetite.

Claims (7)

  1. 一种犬用复方氨基酸肠溶片，其特征在于，包括片芯、涂覆于片芯表面的隔离层和涂覆于隔离层表面的肠溶包衣层，以重量份数计，制成片芯有效成分的原料组成包括亮氨酸5～10份、异亮氨酸1～5份、缬氨酸1～5份、甘氨酸4～8份、脯氨酸1～5份、丙氨酸1～5份、盐酸赖氨酸4～8份、盐酸精氨酸4～8份、丝氨酸1～3份、苏氨酸1～5份、盐酸组氨酸3～8份、甲硫氨酸1～5份、苯丙氨酸4～8份、色氨酸0.5～1份、淀粉1～3份、羧甲基淀粉钠1～3份、硬脂酸镁1～3份和羧甲基纤维素钠1～3份；制成隔离层的原料为质量百分比为9％～11％的速释包衣粉在纯化水中分散制成的混悬液A,片芯涂覆隔离层后在片芯的基础上增重1％～3％；制成肠溶包衣层的原料为质量百分比为6％～8％的肠溶包衣粉在80％异丙醇溶液中分散制得混悬液B，片芯涂覆隔离层和肠溶包衣层后在片芯的基础上增重5％～7％。A compound amino acid enteric-coated tablet for dogs, characterized in that it 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, in parts by weight, made into a tablet The raw material composition of the active ingredients of the core includes 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, and 1 part of alanine. ~5 parts, 4-8 parts lysine hydrochloride, 4-8 parts arginine hydrochloride, 1-3 parts serine, 1-5 parts threonine, 3-8 parts histidine hydrochloride, 1 part methionine ~5 parts, 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 carboxymethyl cellulose 1 to 3 parts of plain sodium; the raw material for making the isolation layer is the suspension A prepared by dispersing the immediate-release coating powder with a mass percentage of 9% to 11% in purified water. The raw material for making the enteric coating layer is the enteric coating powder whose mass percentage is 6% to 8% and is dispersed in 80% isopropanol solution to obtain suspension B , After the tablet core is coated with an isolation layer and an enteric coating layer, the weight of the tablet core is increased by 5% to 7% on the basis of the tablet core.
  2. 根据权利要求1所述的犬用复方氨基酸肠溶片，其特征在于，以重量份数计，制成片芯有效成分的原料组成包括亮氨酸7.58份、异亮氨酸3.40份、缬氨酸2.72份、甘氨酸6.48份、脯氨酸2.00份、丙氨酸3.76份、盐酸赖氨酸6.66份、盐酸精氨酸5.78份、丝氨酸1.34份、苏氨酸3.94份、盐酸组氨酸4.92份、甲硫氨酸2.12份、苯丙氨酸5.66份、色氨酸0.78份、淀粉2.26份、羧甲基淀粉钠2.64份、硬脂酸镁1.98份和羧甲基纤维素钠1.98份；制成隔离层的原料为质量百分比为10％的速释包衣粉在纯化水中分散制成的混悬液A,片芯涂覆隔离层后在片芯的基础上增重2％；制成肠溶包衣层的原料为质量百分比为7％的肠溶包衣粉在80％异丙醇溶液中分散制得混悬液B，片芯涂覆隔离层和肠溶包衣层后在片芯的基础上增重6％。The compound amino acid enteric-coated tablet for dogs according to claim 1, characterized in that, in parts by weight, the raw material composition of the active ingredient in the tablet core comprises 7.58 parts of leucine, 3.40 parts of isoleucine, valine 2.72 parts of acid, 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 parts 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 forming the isolation layer is Suspension A prepared by dispersing 10% by mass of the immediate-release coating powder in purified water. The raw material of the coating layer is 7% by mass of enteric coating powder dispersed in 80% isopropanol solution to obtain suspension B. After the tablet core is coated with an isolation layer and an enteric coating layer, On the basis of weight gain 6%.
  3. 权利要求1或2所述的犬用复方氨基酸肠溶片的一种制备方法，其特征在于，包括以下步骤：A kind of preparation method of compound amino acid enteric-coated tablet for dog described in claim 1 or 2, is characterized in that, comprises the following steps:
    S1、制备片芯：称取亮氨酸、异亮氨酸、缬氨酸、甘氨酸、脯氨酸、丙氨酸、盐酸赖氨酸、盐酸精氨酸、丝氨酸、苏氨酸、盐酸组氨酸、甲硫氨酸、苯丙氨酸、色氨酸、淀粉和内加部分羧甲基淀粉钠加入湿法制粒机中，再加入羧甲基纤维素钠水溶液制成软材后制粒，经过干燥、过筛、整粒制得颗粒，再加入外加部分羧甲基淀粉钠和硬脂酸镁，混合、压片，即得片芯；S1. Preparation of tablet cores: Weigh leucine, isoleucine, valine, glycine, proline, alanine, lysine hydrochloride, arginine hydrochloride, serine, threonine, histidine hydrochloride Acid, methionine, phenylalanine, tryptophan, starch and a part of sodium carboxymethyl starch were added to the wet granulator, and then the aqueous solution of sodium carboxymethyl cellulose was added to make soft materials and then granulated. After drying, sieving, and granulating to obtain granules, add part of sodium carboxymethyl starch and magnesium stearate, mix and press to obtain tablet cores;
    S2、制备隔离层：取速释包衣粉在纯化水中均匀分散制成质量百分比为9％～11％ 的混悬液A，将混悬液A喷涂于步骤S1中制得的片芯表面形成隔离层，涂覆有隔离层的片芯在步骤S1制得的片芯的基础上增重1％～3％,即得产品C；S2. Preparation of isolation layer: take the immediate-release coating powder and uniformly disperse it in purified water to prepare a suspension A with a mass percentage of 9% to 11%, and spray the suspension A on the surface of the tablet core obtained in step S1 to form a suspension A. isolation layer, the chip core coated with the isolation layer has a weight gain of 1% to 3% on the basis of the chip core obtained in step S1, to obtain product C;
    S3、制备肠溶包衣层：取肠溶包衣粉在80％异丙醇溶液中均匀分散制成质量百分比为6％～8％的混悬液B，将混悬液B喷涂于步骤S2中制得的产品C表面形成肠溶包衣层，涂覆有肠溶包衣层的产品C在步骤S1制得的片芯的基础上增重5％～7％，即得犬用复方氨基酸肠溶片。S3, prepare the enteric coating layer: take the enteric coating powder and uniformly disperse it in 80% isopropanol solution to make suspension B with a mass percentage of 6% to 8%, and spray the suspension B on step S2 The surface of the product C prepared in the step S1 forms an enteric coating layer, and the product C coated with the enteric coating layer has a weight gain of 5% to 7% on the basis of the tablet core prepared in step S1, that is, compound amino acids for dogs are obtained. Enteric-coated tablets.
  4. 根据权利要求3所述的犬用复方氨基酸肠溶片的一种制备方法，其特征在于，步骤S1中羧甲基纤维素钠水溶液的浓度为10％，内加部分羧甲基淀粉钠和外加部分羧甲基淀粉钠质量比为1:0.5～2。A kind of preparation method of compound amino acid enteric-coated tablet for dog according to claim 3, it is characterized in that, in step S1, the concentration of sodium carboxymethyl cellulose aqueous solution is 10%, adding part of sodium carboxymethyl starch and external The mass ratio of part of sodium carboxymethyl starch is 1:0.5～2.
  5. 根据权利要求3或4所述的犬用复方氨基酸肠溶片的一种制备方法，其特征在于，步骤S2中混悬液A的喷涂温度为35℃～45℃。The method for preparing a compound amino acid enteric-coated tablet for dogs according to claim 3 or 4, wherein the spraying temperature of the suspension A in step S2 is 35°C to 45°C.
  6. 根据权利要求3或4所述的犬用复方氨基酸肠溶片的一种制备方法，其特征在于，步骤S3中混悬液B的喷涂温度为35℃～45℃。The method for preparing a compound amino acid enteric-coated tablet for dogs according to claim 3 or 4, wherein the spraying temperature of the suspension B in step S3 is 35°C to 45°C.
  7. 根据权利要求5所述的犬用复方氨基酸肠溶片的一种制备方法，其特征在于，步骤S3中混悬液B的喷涂温度为35℃～45℃。The method for preparing a compound amino acid enteric-coated tablet for dogs according to claim 5, wherein the spraying temperature of the suspension B in step S3 is 35°C to 45°C.
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