CN116570557A - Prescription of litsea cubeba oil oral liquid as veterinary medicine and its preparing process - Google Patents
Prescription of litsea cubeba oil oral liquid as veterinary medicine and its preparing process Download PDFInfo
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- CN116570557A CN116570557A CN202310661376.6A CN202310661376A CN116570557A CN 116570557 A CN116570557 A CN 116570557A CN 202310661376 A CN202310661376 A CN 202310661376A CN 116570557 A CN116570557 A CN 116570557A
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- litsea cubeba
- cubeba oil
- oral liquid
- mixed solvent
- polysorbate
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- 239000001289 litsea cubeba fruit oil Substances 0.000 title claims abstract description 62
- 239000007788 liquid Substances 0.000 title claims abstract description 33
- 239000003814 drug Substances 0.000 title claims abstract description 8
- 238000000034 method Methods 0.000 title claims description 6
- 230000008569 process Effects 0.000 title description 3
- 239000012046 mixed solvent Substances 0.000 claims abstract description 16
- WTEVQBCEXWBHNA-UHFFFAOYSA-N Citral Natural products CC(C)=CCCC(C)=CC=O WTEVQBCEXWBHNA-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229940043350 citral Drugs 0.000 claims abstract description 12
- WTEVQBCEXWBHNA-JXMROGBWSA-N geranial Chemical compound CC(C)=CCC\C(C)=C\C=O WTEVQBCEXWBHNA-JXMROGBWSA-N 0.000 claims abstract description 12
- 238000002360 preparation method Methods 0.000 claims abstract description 9
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 6
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 6
- 239000004094 surface-active agent Substances 0.000 claims abstract description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 22
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims description 14
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 12
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 12
- SPSPIUSUWPLVKD-UHFFFAOYSA-N 2,3-dibutyl-6-methylphenol Chemical compound CCCCC1=CC=C(C)C(O)=C1CCCC SPSPIUSUWPLVKD-UHFFFAOYSA-N 0.000 claims description 11
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- 229940068968 polysorbate 80 Drugs 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 5
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 2
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 2
- 235000005979 Citrus limon Nutrition 0.000 claims 1
- 244000131522 Citrus pyriformis Species 0.000 claims 1
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 1
- 229920002582 Polyethylene Glycol 600 Polymers 0.000 claims 1
- 229920001219 Polysorbate 40 Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 229930003427 Vitamin E Natural products 0.000 claims 1
- 235000006708 antioxidants Nutrition 0.000 claims 1
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims 1
- 229940057917 medium chain triglycerides Drugs 0.000 claims 1
- 229920001993 poloxamer 188 Polymers 0.000 claims 1
- 229940044519 poloxamer 188 Drugs 0.000 claims 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 1
- 229940101027 polysorbate 40 Drugs 0.000 claims 1
- 229940113124 polysorbate 60 Drugs 0.000 claims 1
- 235000019633 pungent taste Nutrition 0.000 claims 1
- 235000019605 sweet taste sensations Nutrition 0.000 claims 1
- 235000019165 vitamin E Nutrition 0.000 claims 1
- 229940046009 vitamin E Drugs 0.000 claims 1
- 239000011709 vitamin E Substances 0.000 claims 1
- 238000011161 development Methods 0.000 abstract description 4
- 229940079593 drug Drugs 0.000 abstract description 4
- 244000144972 livestock Species 0.000 abstract description 4
- 239000003651 drinking water Substances 0.000 abstract description 3
- 235000020188 drinking water Nutrition 0.000 abstract description 3
- 230000007774 longterm Effects 0.000 abstract description 3
- 230000014759 maintenance of location Effects 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract description 3
- 239000000273 veterinary drug Substances 0.000 abstract description 3
- 239000000341 volatile oil Substances 0.000 abstract description 3
- 239000002994 raw material Substances 0.000 abstract description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 2
- 244000144977 poultry Species 0.000 abstract 2
- 240000002262 Litsea cubeba Species 0.000 abstract 1
- 235000012854 Litsea cubeba Nutrition 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 229940126534 drug product Drugs 0.000 abstract 1
- 238000001556 precipitation Methods 0.000 abstract 1
- 238000004062 sedimentation Methods 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 230000001502 supplementing effect Effects 0.000 abstract 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 16
- 241000607142 Salmonella Species 0.000 description 11
- 238000001914 filtration Methods 0.000 description 8
- 238000011049 filling Methods 0.000 description 7
- 229920000136 polysorbate Polymers 0.000 description 6
- 229950008882 polysorbate Drugs 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 206010039438 Salmonella Infections Diseases 0.000 description 4
- 230000033001 locomotion Effects 0.000 description 4
- 206010039447 salmonellosis Diseases 0.000 description 4
- 206010059866 Drug resistance Diseases 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 241001138501 Salmonella enterica Species 0.000 description 3
- 230000001580 bacterial effect Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 230000003647 oxidation Effects 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 241000287828 Gallus gallus Species 0.000 description 2
- 241000533331 Salmonella bongori Species 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 244000052616 bacterial pathogen Species 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 235000013330 chicken meat Nutrition 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 241000588921 Enterobacteriaceae Species 0.000 description 1
- 241000282414 Homo sapiens Species 0.000 description 1
- 241001354013 Salmonella enterica subsp. enterica serovar Enteritidis Species 0.000 description 1
- 241000293869 Salmonella enterica subsp. enterica serovar Typhimurium Species 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 231100000517 death Toxicity 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003640 drug residue Substances 0.000 description 1
- 210000002919 epithelial cell Anatomy 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229920005555 halobutyl Polymers 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 210000002490 intestinal epithelial cell Anatomy 0.000 description 1
- 230000009545 invasion Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 210000001539 phagocyte Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000002062 proliferating effect Effects 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000005361 soda-lime glass Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 108700012359 toxins Proteins 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
Classifications
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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
- A61K9/0087—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Botany (AREA)
- Microbiology (AREA)
- Mycology (AREA)
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- Biotechnology (AREA)
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Abstract
The litsea cubeba oral liquid is a new veterinary drug product in the technical field of veterinary drugs, and in particular relates to a prescription of litsea cubeba oil oral liquid for veterinary use and a preparation method thereof. The material consists of the following raw materials in parts by weight: litsea cubeba oil (citral content 70%), surfactant 8-12, antioxidant 0.01-0.03, and mixed solvent for supplementing to 100. According to the application, by using a mixed solvent system with an optimal proportion, the solubility of compounds such as citral with poor water solubility in litsea cubeba oil is improved, the content of active ingredients is obviously improved by administration through a drinking water way, sedimentation and solid precipitation are avoided within 12 hours, the appearance property is good, the long-term sample retention stability is good, and the uniform and full drinking water of livestock and poultry can be fully ensured. The litsea cubeba oil oral liquid has simple processing technology, lower cost and good stability, is convenient for clinical group administration of livestock and poultry, and provides a brand new development idea for development, utilization and preparation development of volatile oil medicines.
Description
Technical Field
The application belongs to the field of veterinary medicine preparations, and in particular relates to litsea cubeba oil oral liquid for animals and a preparation method thereof.
Background
Salmonella (Salmonella) is a gram-negative facultative anaerobe of the Enterobacteriaceae family, and is divided into two species, salmonella bongori (S.bongori) and Salmonella enterica (S.enterica). As a common food-borne pathogenic bacteria, salmonella is various, 2600 serotypes are shared worldwide, more than 140 serotypes exist among more popular serotypes, and salmonella of many serotypes can produce toxins, especially salmonella enteritidis, salmonella typhimurium and salmonella choleraesuis, and can cause salmonellosis in various animals. Salmonella causes approximately 1200 tens of thousands of diseases annually, resulting in 23000 hospitalizations and 450 deaths, as counted by the united states food and drug administration. In China, there are over 300 tens of thousands of people infected with Salmonella each year. Meanwhile, salmonella also brings great economic loss to the livestock breeding industry, and seriously threatens public health and food safety.
At present, although antibiotics are the most commonly used methods for treating and controlling bacterial infection, most antibiotics are key elements for directly affecting bacterial survival, so that bacteria are killed, and the generation of bacterial drug resistance is induced due to extremely strong selective pressure. After entering the gastrointestinal tract of a human or animal, salmonella reaches the surface of host epithelial cells by sliding motion, and then further spreads to organs throughout the body by adhering and invading intestinal epithelial cells and surviving and proliferating within phagocytic cells. Therefore, the inhibition of salmonella movement can prevent pathogenic bacteria from reaching the infected part and prevent adhesion and invasion of cells, thereby achieving the aim of resisting salmonella infection. The selective pressure of the salmonella sliding motion inhibitor on bacteria is small, so that the generation of bacterial drug resistance is avoided.
Chinese medicinal materials inherit thousands of years in China, and are favored by developers with the advantages of multiple targets, safety, green and the like. In the early screening of the research, the litsea cubeba oil is found to be capable of obviously inhibiting the sliding movement of salmonella and has better control effect on salmonella infection of chickens. In view of the characteristics of volatile oil substances such as litsea cubeba oil and the like, such as easy volatilization, easy oxidation and poor water solubility, the clinical treatment effect can be obviously reduced by directly administering the drug through an oral route. The Cheng Shancang seed oil oral liquid is prepared by the optimal group administration mode of the drinking water way, so that the optimal research and development idea is achieved. Therefore, the application adopts a mixed solvent system, ensures that the litsea cubeba oil is fully dissolved, and simultaneously ensures that the effective components of the litsea cubeba oil are not oxidized and the content is stable in the long-term storage process, thereby providing guarantee for fully playing good clinical treatment effects.
Disclosure of Invention
Aiming at the existing technical problems, the application provides a preparation method of litsea cubeba oil oral liquid serving as a veterinary drug.
The technical scheme adopted by the application for achieving the purpose is as follows:
the application provides a litsea cubeba oil oral liquid for livestock, which is prepared from the following raw materials in parts by weight: 8-12 parts of litsea cubeba oil (the citral content is 70%), 8-12 parts of surfactant, 0.01-0.03 part of antioxidant and 100 parts of mixed solvent.
The application provides a preparation method of litsea cubeba oil oral liquid, which comprises the following specific steps: mixing the mixed solvent with polysorbate 80 as surfactant by dissolving method, adding Litsea cubeba oil and dibutyl hydroxy toluene solution as antioxidant under stirring to obtain uniform solution system, adjusting pH to 6.0 with 10% hydrochloric acid solution, stirring, filtering, and packaging.
The mixed solvent used in the application is PEG400 and ethanol.
The mass ratio of the PEG400 and the ethanol used by the application is 7:1.
the beneficial effects of the application are as follows:
(1) The litsea cubeba oil oral liquid prepared by the application is rich in a large amount of citral, has good control effect on salmonella infection of chickens, is environment-friendly and high in safety, has low drug residue, and is not easy to induce drug resistance.
(2) The mixed solvent system and the surfactant are adopted to form an amphiphilic solution system, litsea cubeba oil and an antioxidant solution are added under a uniform stirring state, and finally a uniform solution system is formed, so that volatilization and oxidation of the litsea cubeba oil can be effectively prevented, and the stability of the main component citral in the litsea cubeba oil is improved.
Drawings
And no.
Detailed Description
The application is further illustrated by the following examples, which are not intended to limit the application in any way, and any modifications or alterations to the application, which would be readily apparent to a person of ordinary skill in the art, without departing from the technical solutions of the application, are intended to fall within the scope of the claims of the application. The specific preparation method comprises the following steps:
example 1
100g of litsea cubeba oil, 100g of polysorbate, 0.1g of dibutyl hydroxy toluene, 100ml of ethanol, and fixing the volume of PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering, and filling. Wherein the content of citral in the main component of litsea cubeba oil is 71.2mg/ml. The content of each component of the litsea cubeba oil oral liquid finally prepared is within the scope of the application.
Example 2
80g of litsea cubeba oil, 80g of polysorbate, 120g of dibutyl hydroxy toluene, 100ml of ethanol, and fixing the volume of PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering and filling. Wherein the content of citral in the main component of litsea cubeba oil is 57.4mg/ml. The content of each component of the litsea cubeba oil oral liquid finally prepared is within the scope of the application.
Example 3
110g of litsea cubeba oil, 90g of polysorbate 80, 0.1g of dibutyl hydroxy toluene, 100ml of ethanol, and keeping the volume of PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering and filling. Wherein the content of citral in the main component of litsea cubeba oil is 78.4mg/ml. The content of each component of the litsea cubeba oil oral liquid finally prepared is within the scope of the application.
Example 4
120g of litsea cubeba oil, 80g of polysorbate 120g, 0.1g of dibutyl hydroxy toluene, 100ml of ethanol, and PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering and filling. Wherein the content of citral in the main component of litsea cubeba oil is 85.3mg/ml. The content of each component of the litsea cubeba oil oral liquid finally prepared is within the scope of the application.
Example 5
100g of litsea cubeba oil, 100g of polysorbate, 0.1g of dibutyl hydroxy toluene, 50ml of ethanol, and 50ml of PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering, and filling. Wherein the content of citral in the main component of litsea cubeba oil is 85.6mg/ml. Slightly opalescent, clear and transparent in appearance. The content of each component of the litsea cubeba oil oral liquid finally prepared is within the scope of the application.
Comparative example 1
130g of litsea cubeba oil, 100g of polysorbate, 0.1g of dibutyl hydroxy toluene, 100ml of ethanol, and PEG400 to 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering and filling. Wherein the content of citral in the main component of litsea cubeba oil is 85.0mg/ml. The finally prepared litsea cubeba oil oral liquid has poor stability and is easy to delaminate.
Comparative example 2
100g of litsea cubeba oil, 100g of polysorbate, 0.1g of dibutyl hydroxy toluene, and PEG400 with a constant volume of 1000ml, adding hydrochloric acid to adjust the pH to 6.0, filtering and filling. The obtained litsea cubeba oil oral liquid is layered, and the upper layer is floodlight.
Table 1 comparison of effective contents of Litsea cubeba oil oral liquid in Mixed solvent system
The litsea cubeba oil is added into a mixed solvent system, the treatment effect of later-stage medication is ensured, in addition, the package material and the use cost can be saved by a high-concentration product, but any system has a fixed bearing range, when the amount of the litsea cubeba oil is increased to 13%, the product is layered, the content is obviously reduced, and the maximum allowable addition amount of the final litsea cubeba oil is 12%.
Table 2 comparison of the detection index of litsea cubeba oil oral liquid obtained by a single solvent system and a mixed solvent system (1) investigation of antioxidant capacity: light test for 10 days at 25+ -2deg.C, 4500 Lx+ -500 Lx
(2) Examination of volatilization prevention ability (aluminum-plastic combined cover for oral liquid packaging material soda lime glass infusion bottle, halogenated butyl rubber plug and antibiotic bottle), high temperature test for 10 days, 40+/-2 ℃.
TABLE 3 test run of samples 12 months stability retention results
According to the research result, the application develops an optimal mixed solvent system, can effectively control volatilization and oxidation of litsea cubeba oil, and compared with a single solvent, the application highlights the unique bearing advantage of the mixed solvent on volatile oil, and the sample retention result of long-term room temperature stability for 12 months further illustrates the good stability of the litsea cubeba oil oral liquid, thereby laying a technical foundation for development of other similar products.
The foregoing is only a partial embodiment of the present application, and it should be noted that it will be apparent to those skilled in the art that modifications and adaptations can be made without departing from the principles of the present application, and such modifications and adaptations are intended to be comprehended within the scope of the present application.
Claims (10)
1. The litsea cubeba oil oral liquid is characterized in that: the traditional Chinese medicine composition comprises the following components in parts by weight: 8-12 parts of litsea cubeba oil (the content of citral is 70%), 8-12 parts of surfactant and 100 parts of mixed solvent.
2. The litsea cubeba oil oral liquid according to claim 1, comprising a surfactant, preferably polysorbate 80, polysorbate 60, polysorbate 40, poloxamer 188, more preferably polysorbate 80.
3. The litsea cubeba oil oral liquid according to claim 2, wherein the mass ratio of polysorbate 80 to litsea cubeba oil is preferably 1:1-3:1, more preferably 1:1.
4. The litsea cubeba oil oral liquid according to claim 1, further comprising an antioxidant, preferably dibutyl hydroxy toluene (BHT), butyl Hydroxy Anisole (BHA), vitamin E, more preferably dibutyl hydroxy toluene (BHT).
5. The litsea cubeba oil oral liquid according to claim 4, wherein the mass ratio of dibutyl hydroxy toluene (BHT) to litsea cubeba oil is preferably 1:400-1:1200, more preferably 1:1000.
6. The litsea cubeba oil oral liquid according to claim 1, wherein the ratio of litsea cubeba oil to mixed solvent system is preferably 1:7-1:9, more preferably 1:8.
7. The litsea cubeba oil oral liquid according to claim 2, wherein the mixed solvent system is preferably composed of PEG400, ethanol, PEG600 and medium chain triglycerides, more preferably PEG400 and ethanol. Characterized in that the mass ratio of PEG400 to ethanol is preferably 8:1,7:1,6:1, more preferably 7:1.
8. The litsea cubeba oil oral liquid according to claim 1, wherein the addition sequence is a mixed solvent system, polysorbate 80 and litsea cubeba oil.
9. The method for preparing Litsea cubeba oil oral liquid according to claim 8, wherein the preparation temperature is 25-37 ℃, the stirring speed is 15-50HZ, more preferably the preparation temperature is 25 ℃, and the stirring speed is 15-20HZ.
10. The litsea cubeba oil oral liquid prepared according to the claims 1-9 is light yellow or yellow clear viscous liquid, has the specific aroma of lemon, and has sweet and pungent taste.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310661376.6A CN116570557A (en) | 2023-06-06 | 2023-06-06 | Prescription of litsea cubeba oil oral liquid as veterinary medicine and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310661376.6A CN116570557A (en) | 2023-06-06 | 2023-06-06 | Prescription of litsea cubeba oil oral liquid as veterinary medicine and its preparing process |
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