WO2004002451A1 - Suppositoire a liberation controlee utilise dans un canal secreteur de lait - Google Patents

Suppositoire a liberation controlee utilise dans un canal secreteur de lait Download PDF

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Publication number
WO2004002451A1
WO2004002451A1 PCT/CN2002/000449 CN0200449W WO2004002451A1 WO 2004002451 A1 WO2004002451 A1 WO 2004002451A1 CN 0200449 W CN0200449 W CN 0200449W WO 2004002451 A1 WO2004002451 A1 WO 2004002451A1
Authority
WO
WIPO (PCT)
Prior art keywords
release
matrix
plug
milk
suppository
Prior art date
Application number
PCT/CN2002/000449
Other languages
English (en)
Chinese (zh)
Inventor
Fang Chen
Xiaoguang Xiang
Guangping Jiang
Original Assignee
Fang Chen
Xiaoguang Xiang
Guangping Jiang
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fang Chen, Xiaoguang Xiang, Guangping Jiang filed Critical Fang Chen
Priority to CNB02811969XA priority Critical patent/CN1226998C/zh
Priority to AU2002318711A priority patent/AU2002318711A1/en
Priority to PCT/CN2002/000449 priority patent/WO2004002451A1/fr
Publication of WO2004002451A1 publication Critical patent/WO2004002451A1/fr

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Classifications

    • 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
    • A61K9/0041—Mammary glands, e.g. breasts, udder; Intramammary administration
    • 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

Definitions

  • the invention relates to the field of animal husbandry and veterinary medicine, in particular to a controlled-release or slow-release milk canal suppository suitable for dairy animals such as cows. Background technique
  • Another method is to use mechanical dilators to prevent the milk duct from being blocked and blocked in the milk duct.
  • mechanical expansion often induces mastitis, which will definitely affect milk production and reduce milk quality.
  • Another method is to orally administer antibiotics (sulfa drugs) as the main component, but it is easy to produce antibiotic residues, or oral preparations of Coptis chinensis, dandelion, silver flower, etc., but the effect is not significant.
  • antibiotics sulfa drugs
  • breast milk plugs for breast disease care, but the milk breast plugs do not contain pharmaceutical ingredients or antibiotics, and the length does not exceed 30 mm. Sometimes the lesions cannot be reached; only physical isolation can be achieved. Nursing effect, can not play an effective therapeutic effect.
  • the purpose of the present invention is to provide a controllable release milkway plug, which can prevent and treat mastitis of economic animals such as cows during the "lactation period” and “drying period", and can effectively treat and / or prevent (1) Adhesion to the milk duct due to intratraumatic contusion due to trauma, and (2) Adhesion to the milk duct after surgery due to a narrowed milk duct.
  • the present invention provides a controllable-release milk canal suppository, including:
  • the cross section of the plug body is circular, oval, oval, polygonal, or a combination thereof, and has a diameter of 1-5 mm.
  • the pharmaceutically active ingredients include natural plant extracts. More preferably, the plant extract is an extract selected from the following plants: Coptis chinensis, dandelion, isatis root, blood exhaustion, silver flower, forsythia, melon wilt, loofah, hibiscus leaf, or a mixture thereof.
  • the release matrix is selected from the group consisting of stearic acid, glycerin, gelatin, glycerin gelatin matrix, cocoa butter matrix, fragrant butter matrix, paraffin matrix, beeswax matrix, or a mixture thereof.
  • the length of the plug body is 30-60 mm and the diameter is 2.5-3.5 mm.
  • each release layer contains 60-90% by weight of a release matrix and 10-40% by weight of a pharmaceutically active ingredient, based on the total weight of the release matrix and the pharmaceutically active ingredient.
  • a boss-type plug cap having a diameter larger than the diameter of the plug body is provided at one end of the plug body, and a cone head is provided at the other end of the plug body.
  • the release speed of the release layer located on the outside is faster than the release layer located on the inside.
  • the shell layer is a capsule coating layer.
  • FIG. 1 is a schematic diagram of a preferred controllable-release milk duct plug of the present invention
  • FIG. 2 is a schematic cross-sectional view taken along A-A in FIG. 1. detailed description
  • the present inventors combined natural plant medicines with controlled-release dosage forms and adopted specific suppository forms, which could effectively prevent mastitis or treat contusions in the milk canal, and reduce or eliminate antibiotic residues in milk.
  • the present invention has been completed on this basis.
  • the "diameter" of the plug body refers to the diameter of the largest circle that can be accommodated in cross section.
  • the “aspect ratio” of a plug body refers to the ratio of the length of the plug body to the diameter of the plug body.
  • the plug body 1 of the lactation plug is a cylinder
  • the shape of the plug body is a slender column with a relatively large diameter such as a cylinder or a prism.
  • the length of the cylindrical plug of the controlled-release milk duct plug of the present invention is 10-70 mm, preferably 30-60 mm, and more preferably 40-60 mm; and its aspect ratio is 10-20: 1.
  • the diameter of the plug body is usually 1-5 mm, preferably 2-4 mm, and more preferably 2.5-3.5 mm.
  • one end of the bolt body is provided with a boss-type bolt cap 2 having a diameter larger than the diameter of the bolt body, and the other end of the bolt body is provided with a cone head 3, the bolt cap is convenient for manual operation, and the cone-shaped cone head Easy to insert suppositories into the milk canal.
  • the diameter of the bolt cap is usually about 5-7mm.
  • the controllable-release milk duct plug of the present invention has 1-7 layers (preferably 2-4 layers) in the body of the controllable release layer.
  • Each of the release layers contains 50-95% by weight of a sustained-release matrix and 5-50% by weight of the pharmaceutically active ingredient, based on the total weight of the release matrix and the pharmaceutically active ingredient.
  • the types and / or contents of the release matrix and the pharmaceutically active ingredient of each release layer are different, so as to provide different pharmaceutically active ingredients, or to provide the active ingredients at different release rates.
  • the controlled-release milk duct plug includes a shell layer 7, and a quick-release layer 4, a medium-speed release layer 5, and a slow-release layer 6 located within the shell layer.
  • the role of the quick release layer is to be able to release specific drugs quickly and promote drug absorption.
  • the medium and slow release layers release drugs slowly in 2-4 days and 3-8 days.
  • a preferred 3-layer controlled release milkway suppository is formulated as follows:
  • Quick-release layer, matrix formula based on the total weight of the matrix, stearic acid 80%, glycerol 10%, cocoa butter 10%, release time is about 30 minutes;
  • Slow release layer, matrix formulation Based on the total weight of the matrix, 50% stearic acid, 2% glycerol, 40% gelatin, 6% paraffin, 2% Tween, and release time is about 8 days.
  • the plant suitable for the present invention is not particularly limited, and may be any plant containing a fungicidal or bacteriostatic component.
  • Representative plants include Coptis chinensis, dandelion, isatis root, blood exhaustion, silver flower, forsythia, melon wilt, loofah, hibiscus leaf, etc., which can be used alone or in combination.
  • Preferred plants include Coptis chinensis, dandelion, isatis root, blood exhaustion and the like.
  • Pistacia is a dried rhizome of the ranunculus family Pistacia.
  • the main ingredients include berberine, berberine, methyl berberine and other alkaloids, as well as ferulic acid and other substances.
  • Coptis chinensis inhibits dysentery bacillus, typhoid bacillus, E. coli, Pseudomonas aeruginosa, staphylococcus, hemolytic streptococcus, pneumococcus, and the like. It also has inhibitory effects on influenza virus, Leptospira, amoebia and skin fungi, and can enhance the phagocytic ability of cow white blood cells.
  • Dandelions are plants in the family Asteraceae.
  • the main ingredients include: triterpene alcohol, sterol, picrin, caffeic acid, inulin, pectin, and choline.
  • Dandelion inhibits Staphylococcus aureus and various skin fungi.
  • the method for preparing a plant extract that can be used in the present invention is not particularly limited, and may be various conventional extraction methods, such as a boiling method. That is, the medicinal materials are boiled with a sufficient amount of water for several hours, and then filtered. Other extraction methods, such as extraction methods, can also be used.
  • a particularly useful pharmaceutical preferred ingredient is 8-15 parts by weight (preferably about 12 parts): Coptis chinensis extract, 4 to 8 parts by weight (preferably about 6 parts) dandelion extract, 1 to 2 parts by weight (Preferably about 14 parts) a mixture of isatis root extract and 0.2-1 part by weight (preferably about 0.6 parts) of the blood exhaustion extract.
  • the pharmaceutically active ingredient of the present invention may include additional additives such as antibiotics, antioxidants, and stabilizers.
  • the release matrix suitable for the controlled-release type milk canal suppository of the present invention is not particularly limited, and may be a slow-release matrix commonly used in the art.
  • Representative examples include (but are not limited to): stearic acid, glycerin, gelatin, glycerin gelatin Base, cocoa butter base, meringue base, paraffin base, or mixtures thereof.
  • the shell material suitable for the controlled-release type milk duct plug of the present invention is not particularly limited, and may be a gelatin-based material commonly used in the art.
  • One preferred shell layer material is a capsule coating layer (gelatin + titanium dioxide). These capsule coating materials can be easily purchased from the market (such as Chengdu Haotai Capsule Material Factory (Chengdu, China), etc.).
  • the technique for manufacturing the controlled-release type milk canal suppository of the present invention is not particularly limited, and conventional techniques in the field of suppositories can be used. Taking a 3-layer controlled release milkway suppository as an example, a preparation process is as follows:
  • the controllable-release milk duct plug of the present invention is convenient to use.
  • cows develop mastitis, dry periods, and bruises in the milk canal place a controlled release milk canal plug into the milk canal.
  • the active ingredients in the suppository are continuously released in the milk duct, and all the milk duct plugs will melt and dissolve in the milk duct by themselves.
  • the controlled release milkway suppository contains natural plant medicines, so it can effectively inhibit and kill harmful bacteria in the milkway, and can also effectively prevent the invasion of external bacteria. Coupled with controlled-release drug delivery, it can ensure that the drug effectively functions.
  • According to the purpose of continuous treatment according to different treatment needs it effectively solves the problems of "lactation", "dry milk” and “dry milk” mastitis. Prevention and treatment, and milking difficulties such as milking difficulties.
  • the advantages of the present invention are:
  • the active ingredients are all natural plant extracts, with no toxic side effects and no residue.
  • Berberine is prepared in the manner of extracting berberine by the acidic ethanol method conventional in the art.
  • take the Coptis chinensis powder (passed through the No. 3 sieve) and diafiltration with an appropriate amount of 0.1% HC1 ethanol (85%), diafiltration with HC1 ethanol solution to colorless, and collect the leachate.
  • the ethanol was recovered under reduced pressure to obtain a concentrated solution, and an appropriate amount of a dilute HC1 solution was added to dissolve the solution.
  • Filter collect the filtrate, wash the residue with water, collect the washings, combine with the filtrate, release the precipitate, and filter to obtain a precipitate (berberine).
  • the precipitate was refined with chloroform and ammonia, and chloroform was evaporated to obtain a high-purity Berberine alkaloid.
  • Dandelion, isatis root, and blood exhaustion were prepared by the method of extracting extracts by infiltration method.
  • take 1000g of dandelion pulverize the coarse powder, add 7 times the amount of 75% ethanol as a solvent, and soak for 48 hours, then l ⁇ 3ml Percolate at a rapid rate, collect the initial solution, store it in another device, and continue to infiltrate until the effective ingredients are completely decanted. Collect the subsequent solution, recover the ethanol under reduced pressure at 60 ° C, concentrate the extract to the appropriate amount of extract, and dry at low temperature After sieving, pass through the No. 6 sieve to get dandelion extract. Ban GmbH and Xuejie extract are extracted in the same way as dandelion.
  • the above-mentioned plant extract When in use, the above-mentioned plant extract may be arranged in an appropriate ratio according to various treatment requirements.
  • a particularly preferred active ingredient is a mixture obtained by mixing 12 parts of Coptis chinensis extract, 6 parts of dandelion extract, 14 parts of isatis root extract, and 0.6 parts of blood exhaustion extract.
  • the body is 60 mm long, circular in cross section, and 3 mm in diameter.
  • the outer shell layer of this suppository is a commonly used capsule coating layer (the main component is gelatin plus a small amount of titanium dioxide), and there are three release layers inside the suppository, from the outside to the inside, respectively-the first layer containing the plant extract prepared in Example 30% of the content, the rest is a fast-release layer matrix (matrix formula: based on the total weight of the matrix, 80% stearic acid, 10% glycerol, 10% cocoa butter, release time is about 30 minutes.)
  • the second layer contains 25% of the plant extract prepared in Example 1, and the rest is a medium-release layer matrix (matrix formula: based on the total weight of the matrix, stearic acid 60%, glycerol 10%, gelatin 30%, release It takes about 3 days.)
  • matrix formula based on the total weight of the matrix, stearic acid 60%, glycerol 10%, gelatin 30%, release It takes about 3 days.
  • the third layer contains 35% of the plant extract prepared in Example 1, and the rest is a slow-release layer matrix (matrix formula: based on the total weight of the matrix, 50% stearic acid, 2% glycerol, 40% gelatin, paraffin 6%, Tween 2%, release time is about 8 days.)
  • matrix formula based on the total weight of the matrix, 50% stearic acid, 2% glycerol, 40% gelatin, paraffin 6%, Tween 2%, release time is about 8 days.
  • the suppository shape is shown in Figure 1.
  • the plug has a length of 55 mm, a circular cross-section, and a diameter of 3.5 mm.
  • the outer layer of the suppository is a commonly used capsule coating layer (the main component is gelatin plus a small amount of titanium dioxide).
  • the first layer contains 30% of the plant extract prepared in Example 1, and the rest is a medium-speed slow release matrix (based on the total weight of the matrix, stearic acid 60%, glycerol 10%, gelatin 30%, and the release time is about 3 Days.)
  • the second layer contains 15% of the plant extract prepared in Example 1, and the rest is a slow-release matrix (based on the total weight of the matrix, 50% stearic acid, 2% glycerol, 40% gelatin, 6% paraffin, spit The temperature is 2%, and the release time is about 8 days.)
  • Example 4 Example 4
  • a milk duct plug was prepared in the same manner as in Example 3 except that the length and diameter of the plug body were changed.
  • controllable release milk duct plugs prepared in Examples 2-4 are slowly placed into the milk duct.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un suppositoire à libération contrôlée utilisé dans un canal sécréteur de lait. Ledit suppositoire comporte un corps de suppositoire d'une longueur de 10-70 mm et présentant un rapport longueur/diamètre de 10-20:1, ainsi qu'un revêtement qui recouvre ledit corps. Le corps de suppositoire comporte 1-7 couches de libération, chaque couche contenant 50-95 % en poids d'une base de libération et 5-50 % en poids d'un principe actif pharmaceutique, cela par rapport au poids total de la base de libération et du principe actif. Ledit suppositoire peut être utilisé pour le traitement d'une mammite pendant les périodes de sécrétion de lait et de sevrage chez des animaux tels que des vaches laitières. Un tel suppositoire est également efficace pour traiter des contusions dues à une blessure ou pour empêcher une adhérence dans le canal après une stricturotomie.
PCT/CN2002/000449 2002-06-28 2002-06-28 Suppositoire a liberation controlee utilise dans un canal secreteur de lait WO2004002451A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CNB02811969XA CN1226998C (zh) 2002-06-28 2002-06-28 可控释型奶道栓
AU2002318711A AU2002318711A1 (en) 2002-06-28 2002-06-28 Controllable released suppository used in milk-secreting channel
PCT/CN2002/000449 WO2004002451A1 (fr) 2002-06-28 2002-06-28 Suppositoire a liberation controlee utilise dans un canal secreteur de lait

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2002/000449 WO2004002451A1 (fr) 2002-06-28 2002-06-28 Suppositoire a liberation controlee utilise dans un canal secreteur de lait

Publications (1)

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WO2004002451A1 true WO2004002451A1 (fr) 2004-01-08

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CN (1) CN1226998C (fr)
AU (1) AU2002318711A1 (fr)
WO (1) WO2004002451A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8293467B2 (en) 2007-10-01 2012-10-23 Longhorn Vaccines & Diagnostics Llc Biological specimen collection and transport system and methods of use
US8652782B2 (en) 2006-09-12 2014-02-18 Longhorn Vaccines & Diagnostics, Llc Compositions and methods for detecting, identifying and quantitating mycobacterial-specific nucleic acids
US8821885B2 (en) * 2007-08-27 2014-09-02 Longhorn Vaccines & Diagnostics, Llc Immunogenic compositions and methods
CN104208013A (zh) * 2014-08-25 2014-12-17 哈尔滨欧替药业有限公司 具有高释放度的分层阴道膨胀栓剂及其制备方法
US9080204B2 (en) 2006-09-12 2015-07-14 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for rapid, real-time detection of influenza a virus (H1N1) Swine 2009
US9416416B2 (en) 2007-10-01 2016-08-16 Longhorn Vaccines And Diagnostics, Llc Biological specimen collection/transport compositions and methods
US9481912B2 (en) 2006-09-12 2016-11-01 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for detecting and identifying nucleic acid sequences in biological samples
US9598462B2 (en) 2012-01-26 2017-03-21 Longhorn Vaccines And Diagnostics, Llc Composite antigenic sequences and vaccines
US9683256B2 (en) 2007-10-01 2017-06-20 Longhorn Vaccines And Diagnostics, Llc Biological specimen collection and transport system
US9976136B2 (en) 2015-05-14 2018-05-22 Longhorn Vaccines And Diagnostics, Llc Rapid methods for the extraction of nucleic acids from biological samples
US10004799B2 (en) 2007-08-27 2018-06-26 Longhorn Vaccines And Diagnostics, Llc Composite antigenic sequences and vaccines
US11041216B2 (en) 2007-10-01 2021-06-22 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for detecting and quantifying nucleic acid sequences in blood samples
US11041215B2 (en) 2007-08-24 2021-06-22 Longhorn Vaccines And Diagnostics, Llc PCR ready compositions and methods for detecting and identifying nucleic acid sequences

Citations (2)

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CN1222081A (zh) * 1996-06-20 1999-07-07 诺瓦提斯公司 预防和治疗乳腺炎的方法
CN1051224C (zh) * 1994-07-02 2000-04-12 武汉中科康益生物制药厂 冻干栓及其制造工艺

Patent Citations (2)

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CN1051224C (zh) * 1994-07-02 2000-04-12 武汉中科康益生物制药厂 冻干栓及其制造工艺
CN1222081A (zh) * 1996-06-20 1999-07-07 诺瓦提斯公司 预防和治疗乳腺炎的方法

Cited By (20)

* Cited by examiner, † Cited by third party
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US9080204B2 (en) 2006-09-12 2015-07-14 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for rapid, real-time detection of influenza a virus (H1N1) Swine 2009
US8652782B2 (en) 2006-09-12 2014-02-18 Longhorn Vaccines & Diagnostics, Llc Compositions and methods for detecting, identifying and quantitating mycobacterial-specific nucleic acids
US9481912B2 (en) 2006-09-12 2016-11-01 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for detecting and identifying nucleic acid sequences in biological samples
US11041215B2 (en) 2007-08-24 2021-06-22 Longhorn Vaccines And Diagnostics, Llc PCR ready compositions and methods for detecting and identifying nucleic acid sequences
US10004799B2 (en) 2007-08-27 2018-06-26 Longhorn Vaccines And Diagnostics, Llc Composite antigenic sequences and vaccines
US10596250B2 (en) 2007-08-27 2020-03-24 Longhorn Vaccines And Diagnostics, Llc Methods of treating and preventing influenza infections
US8821885B2 (en) * 2007-08-27 2014-09-02 Longhorn Vaccines & Diagnostics, Llc Immunogenic compositions and methods
US9388220B2 (en) 2007-08-27 2016-07-12 Longhorn Vaccines And Diagnostics, Llc Immunogenic compositions and methods
US9777045B2 (en) 2007-08-27 2017-10-03 Longhorn Vaccines And Diagnostics, Llc Immunogenic compositions and methods
US9212399B2 (en) 2007-10-01 2015-12-15 Longhorn Vaccines And Diagnostics, Llc Biological specimen collection and transport system and method of use
US9416416B2 (en) 2007-10-01 2016-08-16 Longhorn Vaccines And Diagnostics, Llc Biological specimen collection/transport compositions and methods
US8669240B2 (en) 2007-10-01 2014-03-11 Longhorn Vaccines & Diagnostics, Llc Biological specimen collection and transport system and method of use
US8415330B2 (en) 2007-10-01 2013-04-09 Longhorn Vaccines & Diagnostics, Llc Biological specimen collection and transport system and method of use
US9683256B2 (en) 2007-10-01 2017-06-20 Longhorn Vaccines And Diagnostics, Llc Biological specimen collection and transport system
US11041216B2 (en) 2007-10-01 2021-06-22 Longhorn Vaccines And Diagnostics, Llc Compositions and methods for detecting and quantifying nucleic acid sequences in blood samples
US8293467B2 (en) 2007-10-01 2012-10-23 Longhorn Vaccines & Diagnostics Llc Biological specimen collection and transport system and methods of use
US9598462B2 (en) 2012-01-26 2017-03-21 Longhorn Vaccines And Diagnostics, Llc Composite antigenic sequences and vaccines
CN104208013A (zh) * 2014-08-25 2014-12-17 哈尔滨欧替药业有限公司 具有高释放度的分层阴道膨胀栓剂及其制备方法
US10087439B1 (en) 2015-05-14 2018-10-02 Longhorn Vaccines And Diagnostics, Llc Rapid methods for the extraction of nucleic acids from biological samples
US9976136B2 (en) 2015-05-14 2018-05-22 Longhorn Vaccines And Diagnostics, Llc Rapid methods for the extraction of nucleic acids from biological samples

Also Published As

Publication number Publication date
CN1516577A (zh) 2004-07-28
AU2002318711A1 (en) 2004-01-19
CN1226998C (zh) 2005-11-16

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