CN100589808C - Gel agent containing centella general glycoside and sodium hyaluronate, its preparation method and uses - Google Patents
Gel agent containing centella general glycoside and sodium hyaluronate, its preparation method and uses Download PDFInfo
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- CN100589808C CN100589808C CN200410093221A CN200410093221A CN100589808C CN 100589808 C CN100589808 C CN 100589808C CN 200410093221 A CN200410093221 A CN 200410093221A CN 200410093221 A CN200410093221 A CN 200410093221A CN 100589808 C CN100589808 C CN 100589808C
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- hyaluronic acid
- solution
- acid sodium
- gel
- herba centellae
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Abstract
The present invention belongs to the field of medicine preparation technology, and is one kind of gel preparation containing asiaticoside and sodium hyaluronate. The gel preparation can speed the formation of granulation tissue in the wound, promote the healing of wound, and form transparent and ventilate film to protect the wound tissue owing to the excellent filming property of sodium hyaluronate. The present invention also provides the preparation process of the gel preparation.
Description
Technical field
The invention belongs to the medicament technical field.Be specifically related to contain the gel of centella general glycoside and hyaluronic acid sodium.
Background technology
The clinical medicine of trauma care has multiple, wherein extracting purified Herba Centellae total glycosides from Herba Centellae is pentacyclic triterpenoid, mainly contain asiaticoside (Asiaticoside) and asiaticoside (Madecassoside), its pharmacology and drug effect are studied a lot of of report at home and abroad, are applied to existing a lot of years history of repair in trauma.The clinical dosage form of having used has asiaticoside tablet, injection and cream etc., and these kinds have certain limitation at skin that is applied to wound surface or mucosal ulcer.
Hyaluronic acid sodium is a macromolecule polysaccharidase, is made up of a part acetylglucosamine and glucuronic acid.Because of its three-dimensional spatial structure has better elastic, lubricity and biocompatibility, can form smooth, gas-pervious thin film at skin surface, hyaluronic acid sodium also can promote wound healing simultaneously.
The molecular formula of hyaluronic acid sodium: (C
14H
20NNaO
11) n
Chemical structural formula is as follows:
Herba Centellae total glycosides:
The molecular formula of asiaticoside: C
48H
78O
19
Chemical structural formula: as follows, R=H
Asiaticoside molecular formula: C
48H
78O
20
Chemical structural formula: as follows, R=OH
Summary of the invention
Technical problem to be solved by this invention is to overcome the weak point of Asiaticoside preparation, designs a kind of new preparation, increases elasticity, lubricity and biocompatibility, promotes wound healing.
The invention provides a kind of gel that contains centella general glycoside and hyaluronic acid sodium, this gel is to comprise as the centella general glycoside of active component and hyaluronic acid sodium and pharmaceutic adjuvant forming.Wherein the content proportioning of active component centella general glycoside and hyaluronic acid sodium is 1: 1-8: 1; Whenever
Gel contains centella general glycoside 1-50mg, hyaluronic acid sodium 1-30mg.
The used pharmaceutic adjuvant of gel of the present invention is gel-type vehicle, antiseptic, freshener and stabilizing agent.Wherein gel-type vehicle is carbomer, sodium carboxymethylcellulose pyce, sodium carboxymethyl cellulose (or calcium), hydroxyethylmethyl-cellulose, hydroxypropyl emthylcellulose, polyvinyl alcohol, tragacanth gum or alginic acid and its esters; Antiseptic is parabens, quaternary ammonium salt, alcohols, organic mercury class, benzoic acid or sorbic acid; Freshener is Borneolum Syntheticum or Mentholum; Stabilizing agent is disodiumedetate, tween 80, ethanol, glycerol, propylene glycol or Polyethylene Glycol.
The consumption of antiseptic is that to contain antiseptic be 0.001-0.5 gram to every 100mg gel.
The drug effect that contains the gel of centella general glycoside and hyaluronic acid sodium of the present invention is studied by Ruijin Hospital Attached to Shanghai Medical Univ No.2 Shanghai digestion institute of Surgical Research, and result of study is as follows:
1. test objective:
Trauma model with rabbit carries out asiaticoside gel and asiaticoside drop pharmacodynamic study.
2. test material:
1) test drug:
(1) asiaticoside gel, Shanghai Institute of Pharmaceutical Industry
Lot number: 020528
(2) asiaticoside drop, Shanghai Institute of Pharmaceutical Industry
Lot number: 020819
(3) skin Kang Shuan, Baoshan Pharmaceutical Factory, Yadong medicine Corp., Shanghai medicine Industr
Lot number: 020102
2) experimental animal: Female rabbits
Body weight: 2.2kg-3.0kg
3. test method:
1) numbering and grouping:
A: rabbit number: 1,2,3,4,5
B: rabbit number: 1,2,3,4,5
C: rabbit number: 1,2,3,4,5
2) Animal Anesthesia:
The intravenous injection pentobarbital sodium
3) shave hair
4) trauma model:
With the mercurochrome telltale mark, cut respectively, wipe out the holostrome (on fascia) of circular skin, the about 1.0-2.0cm of diameter with the disinfectant minor operation.Every rabbit has six place's wounds, and the left side is the matched group without medicine, and the right is the administration group.
5) administration:
A: asiaticoside drop
B: asiaticoside colloid
C: skin Kang Shuan
Operation was administration the same day, and this be that later every morning is administered once for the first time, at every turn about the about 0.2ml of dosage, and successive administration eight days.
6) observation and record:
Measure wound area every day with slide gauge (0-15cm), promptly write down major diameter (2a), minor axis (2b), reference area in view of the above.
7) evaluation criteria of curative effect:
With measured major diameter (2a), minor axis (2b), press following formula reference area percent:
Area=π ab
The result is carried out statistics relatively (because of the accuracy of wound incrustation influence measurement in the 8th day, so calculate by the 7th day area).
4. result of the test
The asiaticoside gel of Shanghai Institute of Pharmaceutical Industry and drop are after the rabbit wound face is used, through making comparisons with not medication group (matched group), comparing, the result shows that the pharmacodynamics test that carries out compares in the trauma model of rabbit, shown that asiaticoside gel has identical curative effect with asiaticoside drop and skin Kang Shuan on the treatment repair in trauma.
5. discuss
Show that in the trauma model test of pesticide effectiveness of rabbit asiaticoside gel and asiaticoside drop have the function of tangible promotion wound healing.
The skin irritation that contains the gel of centella general glycoside and hyaluronic acid sodium of the present invention has carried out " local anaphylaxis test " by new drug Research on Safety Assessment center, national Shanghai and has reached " local excitation test ".
Result of the test:
Erythema, redness all do not appear in test sample administration group and excipient matched group, vaseline control animals; And the most of animal of positive controls excites skin after the administration in various degree erythema, edema to occur, and the sensitization rate is 70%.Show that gel of the present invention does not have ill effect to skin.
Another object of the present invention has provided the preparation method of the gel that contains centella general glycoside and hyaluronic acid sodium, and this method comprises the following steps:
1. take by weighing Herba Centellae total glycosides by formula ratio, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
2. take by weighing hyaluronic acid sodium by formula ratio, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
3. under slowly stirring, asiaticoside solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
4. it is an amount of to take by weighing gel-type vehicle by formula ratio, is scattered in the distilled water, transfers pH to neutral, makes gel;
5. with asiaticoside solution, hyaluronic acid sodium solution, gel uniform mixing;
6. be sub-packed in the flexible pipe.
Gel of the present invention adopts Asiaticoside and hyaluronic acid sodium, has played good synergism.Herba Centellae total glycosides is applied to all kinds of wounds and can the accelerated in wounds granulation tissue forms, and promotes wound healing, and can be suppressed to the unordered hypertrophy of fibrocyte, minimizing cicatrix.The colloid that asiaticoside and hyaluronic acid sodium are made can form clear films in wound surface, the protection wound face.Because of glass acid sodium is macromolecule polysaccharide, have slow releasing function again, can progressively discharge asiaticoside, thereby prolonged the action time of medicine at wound face.Simultaneously, the asiaticoside gel agent can be used after wound at once, and existing promotion wound face heals, prevents the function of inflammation, can prevent scar hyperplasia in the later stage of repair in trauma again.
Asiaticoside-sodium hyaluronate gel can be widely used in all kinds of wounds, is suitable for suitability for industrialized production because of preparation technology is easy again, and the cost of raw material is low, and good development prospect is arranged.
The specific embodiment
Embodiment 1 asiaticoside-sodium hyaluronate gel agent:
Prescription:
Herba Centellae total glycosides 4.0g
Hyaluronic acid sodium 1.0g
Carbomer 1.0g
Essence of Niobe 0.1g
Propyl benzoate 0.01g
Polyethylene Glycol 1.0g
Distilled water 100ml
Method:
1. take by weighing Herba Centellae total glycosides by formula ratio, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
2. take by weighing hyaluronic acid sodium by formula ratio, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
3. under slowly stirring, asiaticoside solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
4. it is an amount of to take by weighing gel-type vehicle by formula ratio, is scattered in the distilled water, transfers pH to neutral, makes gel;
5. with asiaticoside solution, hyaluronic acid sodium solution, gel uniform mixing;
6. be sub-packed in the flexible pipe.
Embodiment 2 asiaticosides-sodium hyaluronate gel agent:
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 1.0g
Hyaluronic acid sodium 0.15g
Sodium carboxymethyl cellulose 1.0g
Essence of Niobe 0.05g
Ethyl benzoate 0.05g
Disodium edetate 0.06g
Borneolum Syntheticum 0.1g
Distilled water 100ml
Embodiment 3
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 5.0g
Hyaluronic acid sodium 3.0g
Hydroxyethylmethyl-cellulose 2.0g
Glycerol 3.2g
Chlorobutanol 0.5g
Propylene glycol 1.0g
Borneolum Syntheticum 0.01g
Distilled water 100ml
Embodiment 4
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 0.1g
Hyaluronic acid sodium 0.1g
Hydroxypropyl emthylcellulose 2.0g
Thimerosal 0.01g
Propylene glycol 5.0g
Borneolum Syntheticum 0.5g
Distilled water 100ml
Embodiment 5
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 1.0g
Hyaluronic acid sodium 0.5g
Sodium carboxymethyl cellulose 0.5g
Sorbic acid 0.15g
Tween-80 0.2g
Disodium edetate 0.05g
Borneolum Syntheticum 0.05g
Distilled water 100ml
Embodiment 6
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 4.0g
Hyaluronic acid sodium 0.5g
Sodium alginate 4.0g
Benzoic acid 0.05g
Disodium edetate 0.05g
Borneolum Syntheticum 0.1g
Distilled water 100ml
Embodiment 7
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 1.0g
Hyaluronic acid sodium 0.2g
Polyvinyl alcohol 1.0g
Sorbic acid 0.15g
Disodium edetate 0.05g
Mentholum 0.1g
Distilled water 100ml
Embodiment 8
Prescription: collocation method is with embodiment 1
Herba Centellae total glycosides 1.5g
Hyaluronic acid sodium 0.5g
Tragacanth gum 2.0g
Benzyl alcohol 1.0g
Ethanol 5.0g
Mentholum 0.01g
Distilled water 100ml.
Claims (7)
1. gel that contains centella general glycoside and hyaluronic acid sodium, it is characterized in that this gel is by forming as the centella general glycoside of active component and hyaluronic acid sodium and pharmaceutic adjuvant, the content proportioning of described active component centella general glycoside and hyaluronic acid sodium is 1: 1-8: 1, and every ml gel contains centella general glycoside 1-50mg and hyaluronic acid sodium 1-30mg; Described pharmaceutic adjuvant is gel-type vehicle, antiseptic, freshener, stabilizing agent and water; Institute's rapid hardening gel matrix is carbomer, sodium carboxymethylcellulose pyce, sodium carboxymethyl cellulose or carboxymethylcellulose calcium, hydroxyethylmethyl-cellulose, hydroxypropyl emthylcellulose, polyvinyl alcohol, tragacanth gum or sodium alginate; Antiseptic is parabens, quaternary ammonium salt, alcohols, organic mercury class, benzoic acid or sorbic acid; Freshener is Borneolum Syntheticum or Mentholum; Stabilizing agent is disodiumedetate, tween 80, ethanol, glycerol, propylene glycol or Polyethylene Glycol.
2, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 5.0g
Hyaluronic acid sodium 3.0g
Hydroxyethylmethyl-cellulose 2.0g
Glycerol 3.2g
Chlorobutanol 0.5g
Propylene glycol 1.0g
Borneolum Syntheticum 0.01g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
3, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 0.1g
Hyaluronic acid sodium 0.1g
Hydroxypropyl emthylcellulose 2.0g
Thimerosal 0.01g
Propylene glycol 5.0g
Borneolum Syntheticum 0.5g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
4, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 1.0g
Hyaluronic acid sodium 0.5g
Sodium carboxymethyl cellulose 0.5g
Sorbic acid 0.15g
Tween-80 0.2g
Disodium edetate 0.05g
Borneolum Syntheticum 0.05g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
5, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 4.0g
Hyaluronic acid sodium 0.5g
Sodium alginate 4.0g
Benzoic acid 0.05g
Disodium edetate 0.05g
Borneolum Syntheticum 0.1g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
6, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 1.0g
Hyaluronic acid sodium 0.2g
Polyvinyl alcohol 1.0g
Sorbic acid 0.15g
Disodium edetate 0.05g
Mentholum 0.1g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
7, a kind of preparation method that contains the gel of centella general glycoside and hyaluronic acid sodium according to claim 1 is characterized in that this method comprises the following steps:
Prescription:
Herba Centellae total glycosides 1.5g
Hyaluronic acid sodium 0.5g
Tragacanth gum 2.0g
Benzyl alcohol 1.0g
Ethanol 5.0g
Mentholum 0.01g
Distilled water 100ml
Method:
(1) get Herba Centellae total glycosides, be dissolved in the distilled water that contains stabilizing agent, freshener, treat that it dissolves fully after, solution is through aseptic process;
(2) get hyaluronic acid sodium, be dissolved in the solution that contains antiseptic, placement is spent the night, and treats to dissolve fully;
(3) under slowly stirring, Herba Centellae total glycosides solution is slowly added in the hyaluronic acid sodium solution to full and uniform;
(4) it is an amount of to get gel-type vehicle, is scattered in the distilled water, transfers pH to neutral, makes gel;
(5) with Herba Centellae total glycosides solution, hyaluronic acid sodium solution, gel uniform mixing;
(6) be sub-packed in the flexible pipe.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200410093221A CN100589808C (en) | 2004-12-17 | 2004-12-17 | Gel agent containing centella general glycoside and sodium hyaluronate, its preparation method and uses |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200410093221A CN100589808C (en) | 2004-12-17 | 2004-12-17 | Gel agent containing centella general glycoside and sodium hyaluronate, its preparation method and uses |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1788733A CN1788733A (en) | 2006-06-21 |
| CN100589808C true CN100589808C (en) | 2010-02-17 |
Family
ID=36786978
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200410093221A Expired - Fee Related CN100589808C (en) | 2004-12-17 | 2004-12-17 | Gel agent containing centella general glycoside and sodium hyaluronate, its preparation method and uses |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100589808C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113209007B (en) * | 2021-05-17 | 2022-11-25 | 海南普利制药股份有限公司 | Asiaticoside preparation for external use and its preparation method |
-
2004
- 2004-12-17 CN CN200410093221A patent/CN100589808C/en not_active Expired - Fee Related
Non-Patent Citations (4)
| Title |
|---|
| 药剂学. 毕殿州，第381页，人民卫生出版社. 2003 |
| 药剂学. 毕殿州，第381页，人民卫生出版社. 2003 * |
| 雪草甙对成纤维细胞DNA合成与胶原蛋白合成的影响. 王瑞国，王锦菊，余祥彬，王宝奎.福建中医学院学报，第11卷第2期. 2001 |
| 雪草甙对成纤维细胞DNA合成与胶原蛋白合成的影响. 王瑞国，王锦菊，余祥彬，王宝奎.福建中医学院学报，第11卷第2期. 2001 * |
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|---|---|
| CN1788733A (en) | 2006-06-21 |
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