CN102755327A - Application of asiatic acid or salt thereof and injection suspension and preparation method thereof - Google Patents
Application of asiatic acid or salt thereof and injection suspension and preparation method thereof Download PDFInfo
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- CN102755327A CN102755327A CN2011101130189A CN201110113018A CN102755327A CN 102755327 A CN102755327 A CN 102755327A CN 2011101130189 A CN2011101130189 A CN 2011101130189A CN 201110113018 A CN201110113018 A CN 201110113018A CN 102755327 A CN102755327 A CN 102755327A
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Abstract
The invention discloses application of asiatic acid or a salt thereof and an injection suspension and a preparation method of the asiatic acid and the salt thereof. The application refers to application of the asiatic acid or the salt thereof to preparation of a medicament for preventing or treating body cavity adhesion. A formula of an injection suspension of the asiatic acid or the salt thereof comprises 0.5-10 percent of asiatic acid or the salt thereof, 0.1-1 percent of a suspending aid, 0.01-0.1 percent of a wetting agent, 0.0-5 percent of a preservative and the balance of water for injection, wherein the percentage refers to the mass percentage of each component in the total amount of the injection suspension. The injection suspension of the asiatic acid or the salt thereof can be used for effectively preventing or treating adhesion of body cavities including chest cavities, abdominal cavities, pleuroperitoneal cavities or joint cavities, and has a good wound healing effect.
Description
Technical field
The present invention relates to application and the injection suspension and its preparation method of asiatic acid or its salt.
Background technology
Body cavity adhesion (with " glutinous connect ") be behind the surgical operation or bacterial inflammation after be prone to the complication that produces, in general comprise body cavity adhesions such as abdominal cavity, thoracic cavity, articular cavity.Have in the prior art and use some oral formulations treatment body cavity adhesions, but do not have obvious curative effects; In view of this special disease of body cavity adhesion, membrane can't use again simultaneously, therefore demands developing the related drugs that can effectively treat the body cavity adhesion urgently.
Report asiatic acid and salt thereof can be prevented and treated the fibrotic disease of some internal organs in the prior art, but the prevention of relevant body cavity adhesion and treat and still do not have report.
Summary of the invention
Technical problem to be solved by this invention is to have overcome existing oral to use treatment body cavity adhesion medicine not have the defective of obvious curative effects; Application and the injection suspension and its preparation method of asiatic acid or its salt are provided, and the injection suspension of this asiatic acid or its salt can effectively prevent or treat the body cavity adhesion.
The present invention relates to the application in preparation prevention or treatment body cavity adhesion (with " the glutinous company ") medicine of asiatic acid or its salt.
Wherein, described Herba Centellae hydrochlorate is the conventional described Herba Centellae hydrochlorate in this area, one or more that preferable is in asiatic acid tromethane salt, asiatic acid potassium salt and the asiatic acid sodium salt, and better is asiatic acid tromethane salt.
What wherein, described body cavity adhesion was preferable is operation posterior coelom adhesion or bacillary body cavity adhesion.
What wherein, described body cavity was preferable is thoracic cavity, abdominal cavity, splanchnocoel or articular cavity etc.
For cooperating the application of asiatic acid of the present invention or its salt, the present invention provides the injection suspension of a kind of asiatic acid of the present invention or its salt especially.
The injection suspension prescription of asiatic acid of the present invention or its salt comprises 0.5%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.0%～5% antiseptic and supplies the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
Among the present invention, described asiatic acid is the conventional described asiatic acid in this area, commercially available get or extract by the asiatic acid raw material according to this area conventional method obtain.
Among the present invention, described Herba Centellae hydrochlorate is the conventional described Herba Centellae hydrochlorate in this area, one or more that preferable is in asiatic acid tromethane salt, asiatic acid potassium salt and the asiatic acid sodium salt, and better is asiatic acid tromethane salt.
Among the present invention; Described suspending agent is the conventional described suspending agent in this area; Preferable is low molecule suspending agent and/or the agent of macromolecule suspending; In better is natural gum type suspending agent, vegetable polysaccharides class suspending agent, cellulose family suspending agent, carbomer, polyvidone, polyvinyl alcohol, glucosan, silicates suspending agent and the thixotrope one or more; Further better draw glue, tamarind gum, pectin, POLY-karaya, modified starch, alginic acid, propylene glycol alginate, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, Powderd cellulose, elsinan, colloidality silicon dioxide, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, xanthan gum, aluminium-magnesium silicate, sodium starch glycol, scleroglucan, glucosan, aluminium stearate, double stearic acid aluminium, agar, Pullulan, acetyl group Pullulan, microbial alginate, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, polyvinyl methyl ethermaleic anhydride, polyvinyl alcohol, sodium polyacrylate, polyacrylic acid, polyvidone, locust bean gum, glycerol, syrup, sorbitol for ethylhydroxyethylcellulose, chitin, chitose, methylcellulose, kaolin, sesbania gum, tara gum, Ficus elastica, carbomer, Furcellaran, tragacanth, arabic gum, Bentonite, Bentonite magnesium, carrageenin, red match; In silicon Bentonite, aluminium silicate and the dextrin one or more; One or more that further better is in methylcellulose, hydroxyethylmethyl-cellulose, arabic gum, tragacanth and the glycerol, best is methylcellulose.
Among the present invention; Described wetting agent is the conventional described wetting agent in this area; Preferable is 7～11 surfactant for the HLB value; One or more that better is in Tweens surfactant, polyoxyethylene castor oil class surfactant and the poloxamer; In further better is sodium lauryl sulphate, sodium tetradecyl sulfate, sodium cetostearylsulphate, nonokynol-9-10, Hamposyl L, Hamposyl C, Semen Myristicae sarcosine, Hamposyl S, lauric isopropropanolamide, lauric acid diethyl amide, propylene glycol, propylene glycol diacetate, propylene glycol monostearate, Polyoxyethylene Sorbitan Monooleate, glycerol, isopropyl alcohol, lecithin, hydrolecithin, sodium lactate, stearic acid sodium lactate, lactic acid myristyl ester, lactic acid cetyl ester, sodium palmitate, polyvinyl alcohol, polysorbate-20, polysorbate-40, polysorbate-60, polysorbate-65, Polyoxyethylene Sorbitan Monooleate, polysorbate-85, BL-25, polyoxyethylene cetostearyl ether, polyoxyethylene (30EO) sorbitol 4 oleyl ethers, polyoxyethylene (40EO) sorbitol 4 oleyl ethers, polyoxyethylene (60EO) sorbitol 4 oleyl ethers, polyoxyethylene (60EO) sorbitol 4 stearyl ether, Emulsifier LT-60M, polyoxyethylene alkyl ether, emulsifying agent-BY, emulsifying agent-MoA, emulsifying agent-O, polyoxyethylene (10) oleyl ether, the hard ester ether of polyoxyethylene (8), the hard ester ether of polyoxyethylene (12), the hard ester ether of polyoxyethylene (24), the hard ester ether of polyoxyethylene (100), the hard ester ether of polyoxyethylene (110), the hard ester ether of polyoxyethylene (40), the hard ester ether of polyoxyethylene (50), polyoxyethylene (40) castor oil hydrogenated, polyoxyethylene (10) castor oil hydrogenated, polyoxyethylene (30) castor oil hydrogenated, polyoxyethylene (50) castor oil hydrogenated, polyoxyethylene (60) castor oil hydrogenated, polyoxyethylene (40) Oleum Ricini, polyoxyethylene (10) Oleum Ricini, polyoxyethylene (35) Oleum Ricini, polyoxyethylene (60) Oleum Ricini, polyoxyethylene (80) Oleum Ricini, polyoxyethylene (90) Oleum Ricini, polyoxyethylene (100) Oleum Ricini, the single oleyl ether of polyoxyethylene (300), the single oleyl ether of polyoxyethylene (400), the single oleyl ether of polyoxyethylene (600), sulphur Hua Oleum Ricini, sulfonation castor oil hydrogenated, sodium dioctyl sulfosuccinate, dioctyl sulphosuccinate calcium and the dioctyl sulphosuccinate potassium one or more; One or more that further better is in Polyoxyethylene Sorbitan Monooleate, sodium lauryl sulphate, glycerol, isopropyl alcohol and the lecithin, best is Polyoxyethylene Sorbitan Monooleate.
Among the present invention; Described antiseptic is the conventional described antiseptic in this area; Ethanol that preferable is, dehydrated alcohol, denatured ethyl alcohol, rare alcohol, cetyldimethylethylambromide bromide ammonium, Oleum Caryophylli, clove-stems oil, Folium Caryophylli oil, Flos Caryophylli tincture, chlorobutanol, sorbic acid, potassium sorbate, methyl salicylate, sodium salicylate, AT-7, hexamethylenamine, propylene glycol, propanoic acid, sodium propionate, propionic aldehyde, cresol, formic acid, sodium formate, calcium formate, ferric formate, glycerol, ethylparaben, benzyl p-hydroxybenzoate, butyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, butyl p-hydroxybenzoate calcium, methyl parahydroxybenzoate, Sodium Methyl Hydroxybenzoate, propyl p-hydroxybenzoate, Sodium Propyl Hydroxybenzoate, parachlorometacresol, isopropyl alcohol, different ascorbic acid, Sodium isoascorbiate, cinnamyl alcohol, sodium nitrite, tolu ester, tolu tincture, styracin, resorcinol, phenethanol, phenoxyethanol, benzalkonium chloride, Benza, benzalkonium bromide, benzalkonium bromide solution, benzoic acid, gentisic acid, sodium benzoate, Potassium Benzoate, benzyl alcohol, dioxo benzyl alcohol, phenol, liquefied phenol, o-phenyl phenol, o-Phenylphenol Sodium salt tetrahydrate, expoxy propane, lactic acid, liquor ammoniae fortis, ammonia water, oradol, zinc oxide, Oleum Eucalypti, eucalyptol, first Alumen, ammonia alum, oxine, oxine ketone, Sassafras oil, terpene oleyl alcohol, dehydroacetic acid, sodium dehydroacetate, hydrogenation cetyl pyridinium, mercuric chloride, chloromethane benzyl ethamine, chloroform, phemerol chloride, phemerol chloride solution, thioglycerol, sulfur press down one or more in hydrargyrum, sulfuric acid oxidation quinoline, gluconic acid delta-lactone, phenylmercuric nitrate, bromine palm fibre hydroxyl cyclammonium, chlorine palm fibre hydroxyl cyclammonium, iodine, Borax, boric acid, phenylmercuric borate, Quamonium, cetrimonium bronmide, bromination domiphen, chlorination myristyl trimethylamine, chlorination hexadecyl trimethylamine, bromination myristyl pyridine, brocide, bromination octadecyl pyridine, dodecyl bromide pyridine, povidone iodine, acetic acid, phenylmercuric acetate, chlorhexidine acetate, chlorhexidine hydrochloride, chlorhexidine gluconate, chlorhexidinium iodine, Oleum lavandula angustifolia, lavandin oil, Oleum thymi vulgaris and the thymol; Better is in benzyl alcohol, benzalkonium chloride, ethanol, sodium benzoate, benzoic acid and the ethylparaben one or more, best is benzyl alcohol and/or benzalkonium chloride.
What the injection suspension of asiatic acid of the present invention or its salt prescription was preferable is made up of 0.5%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.0%～5% antiseptic and the water for injection of supplying surplus 100%, and percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
The invention still further relates to the asiatic acid of a preferred embodiments or the injection suspension prescription of its salt and comprise 1%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.5%～5% antiseptic and supply the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
The invention still further relates to the asiatic acid of another preferred embodiments or the injection suspension prescription of its salt and comprise 5% asiatic acid or its salt, 0.5% suspending agent, 0.05% wetting agent, 1% antiseptic and supply the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
The invention still further relates to again the asiatic acid of a preferred embodiments or the injection suspension prescription of its salt and comprise 5% asiatic acid tromethane salt, 0.5% methylcellulose, 0.05% Polyoxyethylene Sorbitan Monooleate, 0.9% benzyl alcohol and 0.1% benzalkonium chloride; And the water for injection of supplying surplus 100%, percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
The injection suspension of asiatic acid of the present invention or its salt can also contain conventional various other additives that add and other active substances in the conventional injection suspension in this area, as long as it does not have antagonism or not appreciable impact injection suspension effect of the present invention.
The injection suspension of asiatic acid of the present invention or its salt can make by this area conventional method; Preferable method for preparing comprises the steps: by said prescription; Asiatic acid or its salt and wetting agent ground and mixed is even; With suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again then.
Wherein, the kind of described asiatic acid or its salt, wetting agent, suspending agent, antiseptic and water for injection and consumption are all as previously mentioned.
Wherein, the granular size of described grinding is that this area routine is used, and that preferable is 0.1 μ m～0.5 μ m.
Wherein, the preparation of described injection suspension uses equipment to be this area conventional equipment, and general a small amount of prepares available mortar, and mass production can be used dispersing emulsification machine, colloid mill etc.
Agents useful for same of the present invention and raw material are all commercially available to be got.
On the basis that meets this area general knowledge, each above-mentioned among the present invention technical characterictic optimum condition can combination in any obtain preferred embodiments.
Positive progressive effect of the present invention is: the injection suspension of asiatic acid of the present invention or its salt can effectively prevent or treat the adhesion that body cavity comprises thoracic cavity, abdominal cavity, splanchnocoel or articular cavity, and wound healing is good.
The specific embodiment
Mode through embodiment further specifies the present invention below, but does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
Method for preparing: by above-mentioned prescription, use mortar, asiatic acid or its salt is even with the wetting agent ground and mixed, and then with suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again.Wherein, the granular size of described grinding is 0.1 μ m.
Embodiment 2
Method for preparing: by above-mentioned prescription, use mortar, asiatic acid or its salt is even with the wetting agent ground and mixed, and then with suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again.Wherein, the granular size of described grinding is 0.3 μ m.
Embodiment 3
Method for preparing: by above-mentioned prescription, use mortar, asiatic acid or its salt is even with the wetting agent ground and mixed, and then with suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again.Wherein, the granular size of described grinding is 0.3 μ m.
Embodiment 4
Method for preparing: by above-mentioned prescription, use mortar, asiatic acid or its salt is even with the wetting agent ground and mixed, and then with suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again.Wherein, the granular size of described grinding is 0.5 μ m.
Embodiment 5
Method for preparing: by above-mentioned prescription, use mortar, asiatic acid or its salt is even with the wetting agent ground and mixed, and then with suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again.Wherein, the granular size of described grinding is 0.1 μ m.
Effect embodiment 1
This experiment is with rabbit row stomach operation, and in the operation back at the paries anterior gastricus otch, the postoperative injection suspension is in intraperitoneal, on every Wendesdays time.
1, test method and step
Rabbit after chlore-ammonia ketone vein paralysis, the abdominal part median incision, otch is about 6cm, makes the 2cm otch in the paries anterior gastricus seromuscular layer after entering the chamber, sews up the incision then.The suspensoid that the administration group makes with embodiment 1～3 respectively is injected in (active constituents of medicine 25mg/kg, inferior on every Wendesdays) on the paries anterior gastricus otch, layer-by-layer suture otch; Matched group is done identical operation (dose ejection water such as lumbar injection, on every Wendesdays time).
2, experimental observation
Experimental rabbit is normally taken food in the hands second day after operation, drinks water, and every treated animal was put to death the also situation of anatomic observation abdominal incision, paries anterior gastricus wound healing and adhesion in the operation back in 4 weeks, and does the pathology inspection.
To the grade scale classification of adhesion degree, adhesion is divided into the 0-4 level by both at home and abroad:
0 grade: no adhesion;
1 grade: indivedual loose, the adhesion of thin transparent lamellar;
2 grades: patchy adhesion, but the adhesion strap does not have blood vessel, can passivity separate;
3 grades: adhesion is more obvious, in a small amount of blood vessel is arranged, need the separation of sharp property;
4 grades: adhesion is tight, and boundary disappears between tissue;
Anatomic observation is judged the adhesion grade, and by 0,1,2,3,4 grade of adhesion rank 0,1,2,3,4 minute respectively, and outcome record is in table 1:
Table 1 adhesion hierarchical statistics table
Simultaneously, above-mentioned laboratory animal does not all see have unusually from the surrounding tissue of gross anatomy and histopathological examination medicine-feeding part.
Conclusion: it is evident in efficacy that the injection of asiatic acid of the present invention and salt thereof is used for the body cavity adhesion, and anatomic observation abdominal incision, paries anterior gastricus wound healing are good, and postoperative body cavity adhesion incidence rate obviously reduces.
Claims (13)
1. asiatic acid or its salt application in preparation prevention or treatment body cavity adhesion medicine.
2. application as claimed in claim 1 is characterized in that: described Herba Centellae hydrochlorate is one or more in asiatic acid tromethane salt, asiatic acid potassium salt and the asiatic acid sodium salt.
3. according to claim 1 or claim 2 application is characterized in that: described body cavity adhesion is operation posterior coelom adhesion or bacillary body cavity adhesion.
4. like each described application of claim 1～3, it is characterized in that: described body cavity is thoracic cavity, abdominal cavity, splanchnocoel or articular cavity.
5. the injection suspension of an asiatic acid or its salt; Its prescription comprises 0.5%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.0%～5% antiseptic and supplies the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
6. injection suspension as claimed in claim 5; It is characterized in that: the injection suspension prescription of described asiatic acid or its salt is made up of 0.5%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.0%～5% antiseptic and the water for injection of supplying surplus 100%, and percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
7. injection suspension as claimed in claim 5; It is characterized in that: the injection suspension prescription of described asiatic acid or its salt comprises 1%～10% asiatic acid or its salt, 0.1%～1% suspending agent, 0.01%～0.1% wetting agent, 0.5%～5% antiseptic and supplies the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
8. injection suspension as claimed in claim 5; It is characterized in that: the injection suspension prescription of described asiatic acid or its salt comprises 5% asiatic acid or its salt, 0.5% suspending agent, 0.05% wetting agent, 1% antiseptic and supplies the water for injection of surplus 100% that percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
9. like each described injection suspension of claim 5～8, it is characterized in that: described Herba Centellae hydrochlorate is one or more in asiatic acid tromethane salt, asiatic acid potassium salt and the asiatic acid sodium salt.
10. like each described injection suspension of claim 5～9, it is characterized in that: described suspending agent be in methylcellulose, hydroxyethylmethyl-cellulose, arabic gum, tragacanth and the glycerol one or more; And/or described wetting agent is one or more in Polyoxyethylene Sorbitan Monooleate, sodium lauryl sulphate, glycerol, isopropyl alcohol and the lecithin; And/or, described antiseptic be in benzyl alcohol, benzalkonium chloride, ethanol, sodium benzoate, benzoic acid and the ethylparaben one or more.
11. injection suspension as claimed in claim 8; It is characterized in that: the injection suspension prescription of described asiatic acid or its salt comprises 5% asiatic acid tromethane salt, 0.5% methylcellulose, 0.05% Polyoxyethylene Sorbitan Monooleate, 0.9% benzyl alcohol and 0.1% benzalkonium chloride; And the water for injection of supplying surplus 100%, percentage ratio accounts for the mass percent of injection suspension total amount for each composition.
12. injection suspension method for preparing like each described asiatic acid of claim 5～11 or its salt; It comprises the steps: by said prescription; Asiatic acid or its salt and wetting agent ground and mixed is even; With suspending agent, antiseptic and water for injection uniform mixing, grinding gets final product again then.
13. method for preparing as claimed in claim 12 is characterized in that: the granular size of described grinding is 0.1 μ m～0.5 μ m.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201110113018.9A CN102755327B (en) | 2011-04-29 | 2011-04-29 | Application of asiatic acid or salt thereof and injection suspension and preparation method thereof |
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| CN201110113018.9A CN102755327B (en) | 2011-04-29 | 2011-04-29 | Application of asiatic acid or salt thereof and injection suspension and preparation method thereof |
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| CN102755327A true CN102755327A (en) | 2012-10-31 |
| CN102755327B CN102755327B (en) | 2015-03-11 |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101969942A (en) * | 2008-01-11 | 2011-02-09 | 上海医药工业研究院 | Therapeutic formulations based on asiatic acid and selected salts thereof |
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2011
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101969942A (en) * | 2008-01-11 | 2011-02-09 | 上海医药工业研究院 | Therapeutic formulations based on asiatic acid and selected salts thereof |
Non-Patent Citations (2)
| Title |
|---|
| 于冠英等: "腹腔粘连的研究进展", 《临床小儿外科杂志》 * |
| 孟艳秋等: "积雪草酸及其衍生物的研究进展", 《化学试剂》 * |
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