CN106491674A - A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof - Google Patents
A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof Download PDFInfo
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- CN106491674A CN106491674A CN201611081005.7A CN201611081005A CN106491674A CN 106491674 A CN106491674 A CN 106491674A CN 201611081005 A CN201611081005 A CN 201611081005A CN 106491674 A CN106491674 A CN 106491674A
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- 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)
- A61K36/19—Acanthaceae (Acanthus family)
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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
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
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Abstract
The invention belongs to veterinary medicine technical field, specifically discloses a kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof.Consisting of per 100mL injection：Herba Andrographis 5～10g of ethanol extraction, 2～5g of Propylene Glycol, 2～10g of andrographolide, 5～15g of hydroxypropyl beta cyclodextrin, 7～12g of sodium succinate, 1～5g of Poloxamer 188,0.5～2g of benzyl alcohol and appropriate pH adjusting agent, balance of water；Wherein, the consumption of pH adjusting agent is defined 7.2 ± 0.2 by the pH for adjusting injection.Adopt new technology and improve the content of andrographolide in CHUANXINLIAN ZHUSHEYE, improve thermal detoxification of dispelling, anti-inflammatory analgetic and to bacillary with viral upper respiratory tract infection effect.
Description
Technical field
The invention belongs to veterinary medicine technical field, and in particular to a kind of injection of the Herba Andrographis containing high-load andrographolide
Liquid and preparation method thereof.
Background technology
Andrographolide, the main active ingredient of natural plants Herba Andrographis, the effect of with thermal detoxification of dispelling, anti-inflammatory analgetic,
There is special efficacy to bacillary with viral upper respiratory tract infection, be described as natural antibiotics medicine.This product is diterpenes diterpenoids lactones
Compound, is insoluble in water.Existing《Veterinary drug national standard》First code with CHUANXINLIAN ZHUSHEYE, but technique employing
It is that water alcohol method extracts the sterile water solution being prepared from, because andrographolide composition is water insoluble in Herba Andrographis, therefore adopts
The CHUANXINLIAN ZHUSHEYE Determination of Andrographolide that existing process is prepared from is extremely low, does not reach expected effect during clinical practice.
Notification number discloses a kind of preparation method of CHUANXINLIAN ZHUSHEYE for CN103720929A, still uses tradition
Water alcohol method extracts the Chinese medicine injection containing several kinds of Chinese medicinal materials for preparing, and Herba Andrographis are wherein medical material simply, and content is only
20% or so is accounted for, is said on stricti jurise and can not be CHUANXINLIAN ZHUSHEYE.Moreover this big herbal mixture injection has very big clinic
Application risk, does not meet national basic veterinary drug allusion quotation regulation yet.Notification number discloses one kind for CN102058638B and treats yellow and white dysentery of piglet
Compound andrographis paniculata injection preparation method, its content of the invention includes a series of compound recipe of Chinese medicine and chemical medicine, this Chinese medicine
It is that current country prohibites that the behavior of chemical medicine is added in the inside, and in prescription, LIJUNJING, norfloxacin are that food animal disables medicine
Thing.
Content of the invention
For overcoming weak point present in existing CHUANXINLIAN ZHUSHEYE, the purpose of the present invention to aim to provide a kind of containing height
CHUANXINLIAN ZHUSHEYE of content andrographolide and preparation method thereof.
For achieving the above object, the technical scheme that the present invention takes is as follows：
A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, consisting of per 100mL injection：Herba Andrographis ethanol is carried
Take 5～10g of thing, 2～5g of Propylene Glycol, 2～10g of andrographolide, 5～15g of HP-β-CD, 7～12g of sodium succinate,
1～5g of Poloxamer 188,0.5～2g of benzyl alcohol and appropriate pH adjusting agent, balance of water；Wherein, the consumption of pH adjusting agent
It is defined 7.2 ± 0.2 by adjusting the pH of injection.
Preferably, consisting of per 100mL injection：Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide
6g, HP-β-CD 8g, sodium succinate 10g, Poloxamer 188 2g, benzyl alcohol 0.6g and appropriate pH adjusting agent, remaining
Measure as water；Wherein, the consumption of pH adjusting agent is defined 7.2 by the pH for adjusting injection.
The Herba Andrographis ethanol extraction being related in the present invention, can both adopt conventional ethanol extracting method（Such as 1, Zhang Jian
By force, Zhang Ling, Wang Huan, Sun Yingfa. Herba Andrographis Study on extraction [J]. food and medicine, 2005,7 (1)；2nd, Chinese traditional patent formulation system
Agent the 19th, standard number：WS3-B-3635-98, page Z19-129）Extract obtain, it is also possible to city available from.
Preparation method, step are as follows：
（a）Weigh Herba Andrographis 5～10g of ethanol extraction, 2～5g of Propylene Glycol, 2～10g of andrographolide, hydroxy propyl-Beta-ring paste
5～15g of essence, 7～12g of sodium succinate, 1～5g of Poloxamer 188,0.5～2g of benzyl alcohol and appropriate pH adjusting agent；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add the water of dissolving equivalent, 40～60 DEG C of insulations
20 ~ 30min, is down to room temperature, obtains solution I, standby；
（c）The water of dissolving equivalent is taken, 80～90 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding in Herba Andrographis
Ester, after dispersed with stirring is uniform, be incubated 30～60min, be down to room temperature, sequentially add HP-β-CD, Poloxamer 188,
Benzyl alcohol, stirring and dissolving obtain solution II, standby；
（d）Merge solution I, II, add water and be settled to 100ml, then with the triethanolamine solution of 7～8v% be adjusted to pH to 7.2 ±
0.2, obtain final product CHUANXINLIAN ZHUSHEYE.
Compared with prior art, instant invention overcomes andrographolide composition water insoluble and can not prepare high-load injection
The drawbacks of liquid, prepared the CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, with existing CHUANXINLIAN ZHUSHEYE phase
Same purposes.
Compared to the prior art, beneficial effects of the present invention：
Adopt new technology and improve the content of andrographolide in CHUANXINLIAN ZHUSHEYE, improve thermal detoxification of dispelling, anti-inflammatory analgetic and
To bacillary and viral upper respiratory tract infection effect.The injection that the present invention is provided, detects according to national basic veterinary drug allusion quotation, owns
Project meets national basic veterinary drug allusion quotation regulation, and process is simple, with low cost, and convenient big production is promoted.Compared with antibiotic, green
Noresidue；Compared with Chinese medicine compound, clear efficacy, side effect are low.
Specific embodiment
Technical scheme is described in further detail below in conjunction with specific embodiment, but the protection model of the present invention
Enclose and be not limited thereto.
Heretofore described Herba Andrographis ethanol extraction and andrographolide, are commercially available prod.Make in following embodiments
Herba Andrographis ethanol extraction and andrographolide, purchased from Sichuan, perseverance Easthome reaches bio tech ltd.
Embodiment 1
A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, preparation process are as follows：
（a）Weigh Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide 6g, HP-β-CD 8g, succinic acid
Sodium 10g, Poloxamer 188 2g, benzyl alcohol 0.6g and appropriate pH adjusting agent are 7v% triethanolamine solutions；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add 10mL waters for injection, 40 DEG C of insulations
30min（Do not stir during insulation, similarly hereinafter）, room temperature is down to, solution I is obtained, standby；
（c）20mL water is taken, 80 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding andrographolide, dispersed with stirring
After uniform, 60min is incubated, room temperature is down to, sequentially add HP-β-CD, Poloxamer 188, benzyl alcohol, stirred molten
Solution, obtains solution II, standby；
（d）Merge solution I, II, add water and be settled to 100ml, then pH is adjusted to 7.2 with 7v% triethanolamine solutions, obtains final product punching
Lotus injection.
Embodiment 2
A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, preparation process are as follows：
（a）Weigh Herba Andrographis ethanol extraction 10g, Propylene Glycol 5g, andrographolide 2g, HP-β-CD 5g, succinic acid
Sodium 7g, Poloxamer 188 1g, benzyl alcohol 0.5g and appropriate pH adjusting agent are 8v% triethanolamine solutions；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add 20mL waters for injection, 60 DEG C of insulations
20min, is down to room temperature, obtains solution I, standby；
（c）20mL water is taken, 90 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding andrographolide, dispersed with stirring
After uniform, 30min is incubated, room temperature is down to, sequentially add HP-β-CD, Poloxamer 188, benzyl alcohol, stirred molten
Solution, obtains solution II, standby；
（d）Merge solution I, II, plus water for injection is settled to 100ml, then pH to 7.2 is adjusted to 8v% triethanolamine solutions, i.e.,
Obtain CHUANXINLIAN ZHUSHEYE.
Embodiment 3
A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, preparation process are as follows：
（a）Weigh Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide 10g, HP-β-CD 15g, succinum
Sour sodium 12g, Poloxamer 188 5g, benzyl alcohol 2g and appropriate pH adjusting agent are 7v% triethanolamine solutions；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add 20mL waters for injection, 50 DEG C of insulations
25min, is down to room temperature, obtains solution I, standby；
（c）60mL water is taken, 85 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding andrographolide, dispersed with stirring
After uniform, 45min is incubated, room temperature is down to, sequentially add HP-β-CD, Poloxamer 188, benzyl alcohol, stirred molten
Solution, obtains solution II, standby；
（d）Merge solution I, II, plus water for injection is settled to 100ml, then pH to 7.2 is adjusted to 7v% triethanolamine solutions, i.e.,
Obtain CHUANXINLIAN ZHUSHEYE.
Comparative examples 1
Compared with Example 1, HP-β-CD replaces with beta-schardinger dextrin-to the comparative examples, while not adding succinic acid
Sodium, comprises the following steps that：
（a）Weigh Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide 6g, beta-schardinger dextrin -8g, Poloxamer 188
2g, benzyl alcohol 0.6g and appropriate pH adjusting agent are 7v% triethanolamine solutions；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add 10mL waters for injection, 40 DEG C of insulations
30min, is down to room temperature, obtains solution I, standby；
（c）20mL water is taken, 80 DEG C are heated to, andrographolide is added, after dispersed with stirring is uniform, 60min is incubated, is down to room temperature,
Beta-schardinger dextrin-, Poloxamer 188, benzyl alcohol is sequentially added, stirring and dissolving obtains solution II, standby；
（d）Merge solution I, II, add water and be settled to 100ml, then pH is adjusted to 7.2 with 7v% triethanolamine solutions, obtain final product control
Sample 1.
As a result find：In step（c）In, andrographolide not exclusively dissolves, and the control sample 1 for preparing is not clarification shape
State.
Comparative examples 2
The comparative examples compared with Example 1, do not add Poloxamer 188 and step（c）Insulating process is not carried out, concrete step
Rapid as follows：
（a）Weigh Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide 6g, HP-β-CD 8g, succinic acid
Sodium 10g, benzyl alcohol 0.6g and appropriate pH adjusting agent are 7v% triethanolamine solutions；
（b）Take Herba Andrographis ethanol extraction and after mixed with propylene glycol stirs, add 10mL waters for injection, 40 DEG C of insulations
30min, is down to room temperature, obtains solution I, standby；
（c）20mL water is taken, 80 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding andrographolide, dispersed with stirring
After uniform, room temperature is down to, sequentially adds HP-β-CD, benzyl alcohol, stirring and dissolving obtains solution II, standby；
（d）Merge solution I, II, add water and be settled to 100ml, then pH is adjusted to 7.2 with 7v% triethanolamine solutions, obtain final product control
Sample 2.
As a result find：There is Precipitation after placing 2 hours in the control sample 2 for preparing.
Effect experiment
With CHUANXINLIAN ZHUSHEYE obtained in embodiment 1-3 as Experimental agents, to press《Veterinary drug national standard》（Chemical drugss, Chinese medicine
Volume, works out for 2013）The CHUANXINLIAN ZHUSHEYE of first technique of page 256 preparation carries out the following test of pesticide effectiveness for control drug.
1st, experimental animal packet：From certain pig farm natural occurrence and the sick pig 150 of piglet pujos blancos is diagnosed as, by body weight
5 groups are randomly divided into, 30 ± 0.5kg of average weight.Isolation is individually raised, and feeds complete feed, and free water is raised between holding group
Environment is consistent.
2nd, experimental technique：Product obtained in 1 single intramuscular injection 5ml embodiments 1 of experimental group, once a day；Experimental group 2 is single
Product obtained in secondary intramuscular injection 5ml embodiments 2, once a day；3 single intramuscular injection 5ml embodiments of experimental group, 3 obtained product
Product, once a day；Drug control group single injection 10ml control drugs, once a day；Blank control group only eats above-mentioned full price
Feedstuff, without medicine.
3rd, observation post administration is given：Treatment starts front 1d and treatment starts rear 3d, per day entry each group diet situation, body weights
And death condition.The results are shown in Table 1, wherein, invalid refer to, compared with pre-treatment, after 3d food-intake reduce, poultry weight loss or
Person occurs dead；Effectively refer to, compared with pre-treatment, poultry food-intake increased, and body weight is maintained or increases；Healing is
Refer to, compared with pre-treatment, after 3d, poultry food-intake recovers normal, and body weight increase speed recovers normal.
From the CHUANXINLIAN ZHUSHEYE instant effect that 1 experimental result of table can be seen that present invention preparation, effect is significant, after administration
3d cure rates reach 90%, and ill domestic animal diarrhoea phenomenon is clearly better, and feed intake recovers normal.Wherein 1 CHUANXINLIAN ZHUSHEYE of embodiment is controlled
Therapeutic effect no significant difference compared with control drug.CHUANXINLIAN ZHUSHEYE content prepared by the present invention is high, and dosage is tradition product
The half of product can reach suitable therapeutic effect.
Above-described embodiment is the preferred embodiment of the present invention, but embodiments of the present invention are not by above-described embodiment
Limit, other any changes that is made without departing from the present invention should be equivalent substitute mode, be included in the guarantor of the present invention
Within the scope of shield.
Claims (3)
1. a kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide, it is characterised in that per the composition of 100mL injection
For：Herba Andrographis 5～10g of ethanol extraction, 2～5g of Propylene Glycol, 2～10g of andrographolide, 5～15g of HP-β-CD,
7～12g of sodium succinate, 1～5g of Poloxamer 188,0.5～2g of benzyl alcohol and appropriate pH adjusting agent, balance of water；Wherein,
The consumption of pH adjusting agent is defined 7.2 ± 0.2 by the pH for adjusting injection.
2. the CHUANXINLIAN ZHUSHEYE containing high-load andrographolide as claimed in claim 1, it is characterised in that per 100mL
Injection is consisted of：Herba Andrographis ethanol extraction 6g, Propylene Glycol 2g, andrographolide 6g, HP-β-CD 8g, amber
Meticortene Solu-Delta-cortef 10g, Poloxamer 188 2g, benzyl alcohol 0.6g and appropriate pH adjusting agent, balance of water；Wherein, pH adjusting agent
Consumption is defined 7.2 by the pH for adjusting injection.
3. a kind of method for preparing the CHUANXINLIAN ZHUSHEYE containing high-load andrographolide as claimed in claim 1, which is special
Levy and be, step is as follows：
（a）Weigh Herba Andrographis 5～10g of ethanol extraction, 2～5g of Propylene Glycol, 2～10g of andrographolide, hydroxy propyl-Beta-ring paste
5～15g of essence, 7～12g of sodium succinate, 1～5g of Poloxamer 188,0.5～2g of benzyl alcohol and appropriate pH adjusting agent；
（b）Herba Andrographis ethanol extraction and Propylene Glycol is taken, the water of dissolving equivalent, 40～60 DEG C of guarantors after mixing and stirring, are added
20 ~ 30min of temperature, is down to room temperature, obtains solution I, standby；
（c）The water of dissolving equivalent is taken, 80～90 DEG C are heated to, adds sodium succinate, stirring and dissolving to be subsequently adding in Herba Andrographis
Ester, after dispersed with stirring is uniform, be incubated 30～60min, be down to room temperature, sequentially add HP-β-CD, Poloxamer 188,
Benzyl alcohol, stirring and dissolving obtain solution II, standby；
（d）Merge solution I, II, add water and be settled to 100ml, then with the triethanolamine solution of 7～8v% be adjusted to pH to 7.2 ±
0.2, obtain final product CHUANXINLIAN ZHUSHEYE.
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| CN201611081005.7A CN106491674A (en) | 2016-11-30 | 2016-11-30 | A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof |
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| CN201611081005.7A CN106491674A (en) | 2016-11-30 | 2016-11-30 | A kind of CHUANXINLIAN ZHUSHEYE containing high-load andrographolide and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315907A (en) * | 2020-12-18 | 2021-02-05 | 河南牧翔动物药业有限公司 | Andrographolide oral liquid and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688676A (en) * | 2013-12-10 | 2015-06-10 | 沈阳药科大学 | Andrographolide concentrated liquid and medical application thereof |
-
2016
- 2016-11-30 CN CN201611081005.7A patent/CN106491674A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688676A (en) * | 2013-12-10 | 2015-06-10 | 沈阳药科大学 | Andrographolide concentrated liquid and medical application thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315907A (en) * | 2020-12-18 | 2021-02-05 | 河南牧翔动物药业有限公司 | Andrographolide oral liquid and preparation method thereof |
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