CN112315907A - Andrographolide oral liquid and preparation method thereof - Google Patents

Andrographolide oral liquid and preparation method thereof Download PDF

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Publication number
CN112315907A
CN112315907A CN202011501268.5A CN202011501268A CN112315907A CN 112315907 A CN112315907 A CN 112315907A CN 202011501268 A CN202011501268 A CN 202011501268A CN 112315907 A CN112315907 A CN 112315907A
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andrographolide
oral liquid
cosolvent
emulsifier
water
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Inventor
杨振豪
李攀登
王彬
吕凤霞
李灵娟
杨慧芳
张涛
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Henan Muxiang Biotechnology Co ltd
Henan Soar Veterinary Pharmaceutical Co Ltd
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Henan Muxiang Biotechnology Co ltd
Henan Soar Veterinary 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Zoology (AREA)
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  • Otolaryngology (AREA)
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Abstract

The invention belongs to the field of veterinary medicines, and discloses andrographolide oral liquid and a preparation method thereof. The 100 mL oral liquid consists of the following raw materials: 5-8 g of andrographolide, 12-20 g of cosolvent (1) dimethyl sulfoxide, 10-15 g of cosolvent (2) caprylic/capric glyceride, 5-24 g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-401, 5-32 g of emulsifier (2) tween 8015, and the balance of water. The preparation method comprises the following steps: placing andrographolide into a container, adding cosolvent (1) dimethyl sulfoxide and cosolvent (2) caprylic/capric glyceride, heating to 40-50 deg.C, and stirring to dissolve completely; then adding emulsifier (1) hydrogenated castor oil polyoxyethylene ether-40 and emulsifier (2) tween 80, stirring uniformly to form clear and transparent solution, and adding water to a constant volume. The andrographolide oral liquid prepared by the invention can be mixed with water in any proportion, can be added into drinking water for drinking, is convenient to use, is easier to absorb, and has higher bioavailability.

Description

Andrographolide oral liquid and preparation method thereof
Technical Field
The invention belongs to the field of veterinary drugs, and particularly relates to andrographolide oral liquid and a preparation method thereof.
Background
Respiratory diseases are often caused by climate change, improper ventilation management and the like in the poultry breeding process, and are often manifested as cough and snore, severe pneumonia, pulmonary congestion and even cellulosic exudation are caused, trachea, bronchus and the like are blocked, and pericarditis, perihepatitis, peritonitis and the like are caused by secondary escherichia coli infection. This pathological change occurs in all current poultry breeders.
The current treatment is with antibiotics such as doxycycline hydrochloride, tilmicosin, enrofloxacin, tylosin. However, the method has the disadvantages that antibiotics are easy to remain in meat and eggs, and the use is limited. Common oral liquid of traditional Chinese medicine prescriptions such as fructus armeniacae amarae and gypsum rubrum oral liquid, houttuynia cordata and radix scutellariae solution, mulberry kernel lung clearing oral liquid and the like also have definite effects and have no defect of antibiotic residue, but with the shortage of land resources, the price of traditional Chinese medicinal materials is increasingly increased, and the use of traditional Chinese veterinary medicine products for economic animals is greatly limited due to economic reasons.
Andrographolide is the main effective component of herba Andrographitis. A dripping pill of andrographolide is prepared from andrographolide as main ingredient. Has the effects of clearing away heat and toxic materials, resisting bacteria and diminishing inflammation, is effective for treating pharyngalgia caused by upper respiratory tract infection wind-heat syndrome, and is praised by the majority of patients. The sore throat caused by the wind-heat type cold of the people is very similar to the initial symptoms of the respiratory tract infection of the poultry. We tried andrographolide powder dressing to treat respiratory symptoms accompanied with dysentery in poultry with some effect, but the use was inconvenient. In addition, the existing andrographis paniculata injection and andrographis paniculata powder are inconvenient to use. Therefore, attempts to make andrographolide into an aqueous solution which can be drunk together with drinking water have been made, and there is a need to improve its bioavailability and therapeutic effect.
Disclosure of Invention
The invention aims to solve the problems that the existing antibiotic medicine has more residues and the traditional Chinese medicine oral liquid has high price during poultry respiratory tract infection and dysentery, and provides an andrographolide oral liquid and a preparation method thereof.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
an andrographolide oral liquid, 100 mL oral liquid, is composed of the following raw materials: 5-8 g of andrographolide, 12-20 g of cosolvent (1) dimethyl sulfoxide, 10-15 g of cosolvent (2) caprylic/capric glyceride, 5-24 g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-401, 5-32 g of emulsifier (2) tween 8015, and the balance of water.
The preparation method comprises the following steps: placing andrographolide into a container, adding cosolvent (1) dimethyl sulfoxide and cosolvent (2) caprylic/capric glyceride, heating to 40-50 deg.C, and stirring to dissolve completely; then adding emulsifier (1) hydrogenated castor oil polyoxyethylene ether-40 and emulsifier (2) tween 80, stirring uniformly to form clear and transparent solution, and adding water to a constant volume.
Compared with the prior art, the invention has the following beneficial effects:
the andrographolide oral liquid prepared by the invention can be mixed with water in any proportion, and can be added into drinking water for drinking; compared with herba Andrographitis injection and herba Andrographitis powder, the composition has the advantages of convenient administration, easy absorption, and high bioavailability; compared with other antibiotics for treating respiratory diseases of poultry, the antibiotic is safe and has no residue; compared with other traditional Chinese medicine prescription oral liquid for treating poultry respiratory diseases, the cost is increased little, and the effectiveness, economy and convenience of andrographolide for treating poultry respiratory diseases and enteritis are met.
Detailed Description
The technical solutions of the present invention are described below with specific examples, but the scope of the present invention is not limited thereto.
Example 1
An andrographolide oral liquid comprises the following components: 5g of andrographolide, 12g of cosolvent (1) dimethyl sulfoxide, 10g of cosolvent (2) caprylic/capric glyceride, 0g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-4020 g, 8020 g of emulsifier (2) tween, and the volume of purified water is 100 mL.
Example 2
An andrographolide oral liquid comprises the following components: 8g of andrographolide, 15g of cosolvent (1) dimethyl sulfoxide, 15g of cosolvent (2) caprylic/capric glyceride, 4g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-4024 g, 8030 g of emulsifier (2) tween, and the volume of purified water is 100 mL.
Example 3
An andrographolide oral liquid comprises the following components: 5g of andrographolide, 10g of cosolvent (1) dimethyl sulfoxide, 15g of cosolvent (2) caprylic/capric glyceride, 4g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-4024, 8032 g of emulsifier (2) tween, and the volume of purified water is 100 mL.
Example 1-3 method for preparing andrographolide oral liquid: placing andrographolide into a suitable container, adding cosolvent (1) dimethyl sulfoxide and cosolvent (2) caprylic/capric glyceride, slightly heating to 40 deg.C, and stirring to dissolve completely; then adding emulsifier (1), hydrogenated castor oil polyoxyethylene ether-40 and emulsifier (2), tween 80, stirring uniformly to form clear and transparent solution, adding water with constant volume and stirring uniformly.
Clinical trial
Purpose of the test
The effect of the andrographolide oral liquid on treating the respiratory disease of the laying hens is verified.
2 test method
2.1 test materials
Test animals: the Hailan grey commercial laying hens are 1200 feather, 222 days old, and the henhouse chicken groups are in 4 rows from north to south, 300 chicken in each row are naturally attacked, the chicken groups are in a dispersed attack state, the disease attack is observed in each row, the disease incidence rate is about 10%, the attacked chicken can not have cough, and the hen is clearer after turning off the light at night. Feces have no obvious abnormality, part of the feces are sunk and piled, the food consumption of a group is slightly reduced, and the daily food consumption is reduced from 132 kg to about 90 kg.
Feed: the composition of the ration is shown in table 1.
Figure 694485DEST_PATH_IMAGE001
Medicine preparation: the andrographolide oral liquid prepared in example 1 of the present invention (pilot production of pharmaceutical company, ranchikoid, south of Henan, the specification of which is 100 mL/bottle); enrofloxacin solution (100 mL: 10g, manufactured by Guangdong Dahua agricultural Biotech Co., Ltd.).
2.2 test grouping and statistical methods
Selecting diseased chickens from a large group, wherein the inclusion criteria are as follows: the patients with cough symptoms or any symptom of nose fluid, lacrimation and eyelid redness are all sick chickens, the symptom score (shown in table 2) reaches more than 8 points, 90 sick chickens meeting the standard are selected out, the sick chickens are randomly divided into 3 groups and then marked one by one, each group comprises 30 andrographolide oral liquid groups, enrofloxacin groups and blank groups, each group is used for 5 days together as a treatment course, and the symptom score improvement condition before and after each group is treated is counted. The administration method of each group is shown in Table 3.
Figure 80467DEST_PATH_IMAGE002
Figure 198552DEST_PATH_IMAGE003
2.3 therapeutic Effect determination criteria
And (3) curing: after the medicine is used, the spirit is normal, no respiratory symptoms and other abnormal characteristics exist, or the integral improvement rate of the symptoms reaches more than 80 percent (including 80 percent);
the effect is shown: after the medicine is used, the characteristics still exist, such as cough or eye red, lacrimation and the like, and the integral improvement rate of the symptoms reaches 50-80% (80% is not included);
the method has the following advantages: after the medicine is used, the characteristics still exist, such as cough or eye red, lacrimation and the like, and the integral improvement rate of the symptoms reaches 30-50% (without 50%);
and (4) invalidation: characterization still exists, such as cough or redness of the eye, lacrimation, etc., and the rate of improvement of symptom score is less than 30% (30% is not included); the dead chickens were all considered ineffective during the administration.
Integrated improvement rate (%) = (post-treatment integration-pre-treatment integration) absolute value/pre-treatment integration 100%
Cure rate (%) = cured chicken number/group chicken number 100%
Significant efficiency (%) = number of significant chickens/number of chickens in group 100%
Effective rate (%) = effective chicken number/group chicken number 100%
Inefficiency (%) = number of ineffective chickens/number of chickens in group x 100%
2.4 data processing
Excel is adopted for collection, and SPSS statistical software is adopted for data processing. The difference is statistically significant by adopting one-way analysis of variance and comparison, and taking P <0.05 as the difference.
2.5 test results
The clinical symptom treatment effect of each test group is shown in table 4.
Figure 62603DEST_PATH_IMAGE004
2.6 mortality in each group
In the test process, the andrographolide oral liquid group has no death, and the enrofloxacin group has death1, 2 dead chickens in the blank group are subjected to cesarean examination, mainly comprising air sacculitis and peritonitis, and one of the dead chickens is judged to have secondary escherichia coli secondary infection according to a resident practicing veterinarian, and Newcastle disease and influenza (H) are identified and eliminated by a PCR detection technology9N2) And (4) infection.
2.7 summary and analysis
The andrographolide oral liquid can effectively treat cough and larynx hemorrhage caused by cold.

Claims (2)

1. An andrographolide oral liquid is characterized in that 100 mL of oral liquid is composed of the following raw materials: 5-8 g of andrographolide, 12-20 g of cosolvent (1) dimethyl sulfoxide, 10-15 g of cosolvent (2) caprylic/capric glyceride, 5-24 g of emulsifier (1) hydrogenated castor oil polyoxyethylene ether-401, 5-32 g of emulsifier (2) tween 8015, and the balance of water.
2. A method for preparing the andrographolide oral liquid according to claim 1, wherein the steps of: placing andrographolide into a container, adding cosolvent (1) dimethyl sulfoxide and cosolvent (2) caprylic/capric glyceride, heating to 40-50 deg.C, and stirring to dissolve completely; then adding emulsifier (1) hydrogenated castor oil polyoxyethylene ether-40 and emulsifier (2) tween 80, stirring uniformly to form clear and transparent solution, and adding water to a constant volume.
CN202011501268.5A 2020-12-18 2020-12-18 Andrographolide oral liquid and preparation method thereof Pending CN112315907A (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1931130A (en) * 2006-09-18 2007-03-21 西北农林科技大学 Nanometer emulsion oral liquid of andrographolide and its prepn process
CN102846545A (en) * 2012-08-31 2013-01-02 郑州后羿制药有限公司 Andrographolide emulsion and preparation method thereof
CN102920656A (en) * 2011-08-10 2013-02-13 天津恒基利得生物科技发展有限公司 Moxifloxacin nanoemulsion and its preparation method
CN106491674A (en) * 2016-11-30 2017-03-15 河南牧翔动物药业有限公司 A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof
CN111658606A (en) * 2020-07-03 2020-09-15 中国农业大学 Ponazuril solution preparation and application
CN111658636A (en) * 2020-06-12 2020-09-15 桂林医学院 Application of andrographolide and dexamethasone in preparation of compound medicine for resisting acute lymphocytic leukemia
CN111714477A (en) * 2020-07-23 2020-09-29 山东迅达康兽药有限公司 Phlegm eliminating composition and preparation method of oral liquid thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1931130A (en) * 2006-09-18 2007-03-21 西北农林科技大学 Nanometer emulsion oral liquid of andrographolide and its prepn process
CN102920656A (en) * 2011-08-10 2013-02-13 天津恒基利得生物科技发展有限公司 Moxifloxacin nanoemulsion and its preparation method
CN102846545A (en) * 2012-08-31 2013-01-02 郑州后羿制药有限公司 Andrographolide emulsion and preparation method thereof
CN106491674A (en) * 2016-11-30 2017-03-15 河南牧翔动物药业有限公司 A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof
CN111658636A (en) * 2020-06-12 2020-09-15 桂林医学院 Application of andrographolide and dexamethasone in preparation of compound medicine for resisting acute lymphocytic leukemia
CN111658606A (en) * 2020-07-03 2020-09-15 中国农业大学 Ponazuril solution preparation and application
CN111714477A (en) * 2020-07-23 2020-09-29 山东迅达康兽药有限公司 Phlegm eliminating composition and preparation method of oral liquid thereof

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Application publication date: 20210205