CN1857291A - Externally applied liquid asiaticoside preparation and its preparing process - Google Patents
Externally applied liquid asiaticoside preparation and its preparing process Download PDFInfo
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- CN1857291A CN1857291A CN 200610050184 CN200610050184A CN1857291A CN 1857291 A CN1857291 A CN 1857291A CN 200610050184 CN200610050184 CN 200610050184 CN 200610050184 A CN200610050184 A CN 200610050184A CN 1857291 A CN1857291 A CN 1857291A
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Abstract
The externally applied liquid asiaticoside preparation has effective component comprising asiaticoside 0.1-30.0 wt% and medicinal solvent 70.0-99.9 wt%. Its preparation process includes dissolving asiaticoside in the medicinal solvent, filtering, filling, sterilizing and packing. The present invention expands the clinical application of asiaticoside, and the abacterial preparation has high medicine concentration, high medicinal effect, no wound infection, and other advantages.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly relate to a kind of externally applied liquid asiaticoside preparation and preparation method, be applicable to that preparation promotes the aseptic external used medicine of various wound healings.
Background technology
The asiaticoside external use preparation is to select for use asiatic centella total saponins formulated through science.Herba Centellae is the herb of samphire centella asiataca, and its total saponins is a kind of wound healing promoters.By wherein once isolating a plurality of saponin, its main component is an asiaticoside, or claim asiaticoside (asiaticoside), be in conjunction with the ester glycosides that forms by carboxyl in two molecule glucoses, a part rhamnose and asiatic acid (or claiming asiatic acid, the asiatia acid) molecule.With the asiaticoside (madecassoside) in addition that the asiaticoside companion deposits, also be a kind of ester glycosides.Obtaining aglycon after the hydrolysis is Madecassic acid (madecassic acide), and the structure of its sugar moieties is identical with asiaticoside, also is made up of two molecule glucoses and a part rhamnose.The saponin of other coexistences also mostly is the deutero-ester glycosides of ursolic acid greatly.
The pharmacological research of Herba Centellae total glycosides is also very extensive.The main pharmacological of Herba Centellae total glycosides is: participate in tissue repair, promote wound healing; Purify wound, absorb transudate, reduce or avoid adhesion, the old adhesion of loosening; Suppress or alleviation fibroblast and cicatrix propagation, make skin recover smooth and elasticity; Excite blood capillary regeneration, blood circulation promoting, softening old cicatrix.Secondly, Herba Centellae total glycosides also has significantly analgesia and antiinflammatory action.
Find that by clinical observation asiaticoside not only has the inhibition scar hyperplasia, softening scar tissue, and have the hyperemia of tangible alleviation cicatrix, the effect that alleviates cicatrix gargalesthesia and pain wherein reaches 96.7% to the effective percentage that alleviates the cicatrix gargalesthesia.And people such as Mao Weihan have carried out clinical research to asiaticoside treatment dermatosis, the result shows: asiaticoside is 67.9% to the keloid total effective rate, to the local scleroderma total effective rate is 89%, to the amyloidosis cutis total effective rate is 76%, in addition some other dermatosiss such as atrophic sclerosis lichen is had curative effect preferably.
This shows that asiaticoside is of many uses, medical value has very big potentiality, and market prospect is extensive, and value of exploiting and utilizing is arranged.
It is aseptic that but the preparation that is used for the human body wound surface requires, and wound surface is not polluted, and at present, the ointment in the asiaticoside preparation can't reach aseptic requirement by present working condition, and their substrate easily pollutes wound surface.
Summary of the invention
The objective of the invention is to overcome the deficiency that prior art exists, a kind of aseptic liquid preparation for external application of asiaticoside that promotes wound healing is provided, dosage form is the externally used solution agent, said preparation is made up of the medicinal solvent that effective ingredient asiaticoside and external preparation allow, wherein asiaticoside is for extracting the total saponins that obtains from the natural plants Herba Centellae, by dry product, containing asiaticoside is 20～99%, asiaticoside 0.1%～30.0% (percentage by weight) in the preparation, medicinal solvent 70.0%～99.9% (percentage by weight).
Another object of the present invention provides the preparation method of externally applied liquid asiaticoside preparation, realize by following steps: the medicinal solvent mix homogeneously of getting about 80% volume, add the recipe quantity asiaticoside, be heated to 60～90 ℃ of stirrings and make it molten entirely, be filtered to clearly, be cooled to room temperature, add medicinal solvent to full dose, regulate medicinal liquid pH value 5.4～6.5, carry out semi-finished product after stirring evenly and detect assay 96%～104% (HPLC).Heat then to about 60 ℃, add the active carbon of medicine liquid volume amount 0.1～5% (w/v), insulation 20min naturally cools to room temperature.With G4 glass filter element coarse filtration, medicinal liquid pH value 4.5～5.0 after the control decarburization through the filter element fine straining of 0.2 μ m, is checked medicinal liquid character and clarity then, qualified back embedding, leak detection sterilization, lamp inspection, packing, product inspection, warehouse-in.
The used solvent of the present invention is water, ethanol, Polyethylene Glycol, 1,2-propylene glycol, ethylene glycol and composition thereof.
Technical scheme of the present invention treatment wound, damage, wound, knife injury, battlefield wound, be applicable to wound, damage, wound, knife injury, battlefield wound and good effect, instant effect, easy to use, the cure rate height, be on the basis of the elite that absorbs motherland's medical science, according to medical science, medicine theory, in conjunction with modern actual, through develop for many years, try out, clinical verification, adopt modern hand work, through the refining produce effects novel drugs that forms of scientific method, through clinical verification for many years, be subjected to good evaluation.
Externally applied liquid asiaticoside preparation provided by the invention, further expanded Herba Centellae extract in Clinical Application,, can avoid causing the infection of wound surface owing to be sterile preparation, messenger drug object height concentration, long concentrating maintains lesions position, gives full play to drug effect.Preparation of the present invention is reasonable in design, and method is easy, and cost is low, can improve stability of formulation, extends the expiration date, and is convenient to room temperature storage.Since aseptic and easy to use, be difficult for causing wound surface to pollute, and the patient uses compliance good.
Specific embodiments
The present invention is described further in conjunction with the embodiments, by specific embodiment given below and experimental data material, can further be well understood to liquid preparation for external application of the present invention and uses thereof.But they are not limitation of the invention.
1 one kinds of asiaticoside external use solutions of embodiment
1. preparation is formed (every 100ml consumption)
Asiaticoside 0.1g (0.1%)
Water for injection 99.9g (99.9%)
2. method for making: get about 80g water for injection, add the 0.1g asiaticoside, be heated to 60 ℃ of stirrings and make it molten entirely, be filtered to clearly, be cooled to room temperature, add to the full amount of water for injection, regulate medicinal liquid pH value 6.0, carry out semi-finished product after stirring evenly and detect assay 96%-104% (HPLC).Heat then to about 60 ℃, add the active carbon of medicine liquid volume amount 0.1% (w/v), insulation 20min naturally cools to room temperature.With G4 glass filter element coarse filtration, medicinal liquid pH value 4.5-5.0 after the control decarburization through the filter element fine straining of 0.2 μ m, checks medicinal liquid character and clarity then, qualified back embedding, 121 ℃ of sterilize 30min, lamp inspection, packing, product inspection, warehouse-ins.
The 2nd kind of embodiment of embodiment 2 asiaticoside external use solutions
1. preparation is formed (every 100ml consumption)
Asiaticoside 2g (2.0%)
Medicinal alcohol 10g (10.0%)
Sterilized water 88g (88.0%)
2. method for making: medicinal alcohol and sterilized water are mixed into medicinal solvent, get about 80% above-mentioned medicinal solvent, add the recipe quantity asiaticoside, be heated to 70 ℃ of stirrings and make it molten entirely, be filtered to clearly, be cooled to room temperature, add medicinal solvent to full dose, regulate medicinal liquid pH value 6.5, carry out semi-finished product after stirring evenly and detect.Heat then to about 60 ℃, add the active carbon of medicine liquid volume amount 0.5% (w/v), insulation 20min naturally cools to room temperature.With G4 glass filter element coarse filtration, then through the filter element fine straining of 0.2 μ m, embedding under the local laminar flow condition, lamp inspection, packing, product inspection, warehouse-in.
The 3rd kind of embodiment of embodiment 3 externally applied liquid asiaticosides
1. preparation is formed (every 100ml consumption)
Asiaticoside 30g (30%)
Propylene glycol 25g (25%)
Sterilized water 45g (45%)
2. method for making: again the 30g asiaticoside is dissolved in the mixed solvent,
Propylene glycol and sterilized water are mixed into medicinal solvent, get about 80% above-mentioned medicinal solvent, add the recipe quantity asiaticoside, be heated to 80 ℃ of stirrings and make it molten entirely, be filtered to clearly, be cooled to room temperature, add medicinal solvent to full dose, regulate medicinal liquid pH value 6.5, carry out semi-finished product after stirring evenly and detect.Heat then to about 60 ℃, add the active carbon of medicine liquid volume amount 0.5% (w/v), insulation 20min naturally cools to room temperature.Fill, the Co-60 irradiation sterilization, promptly.
The 4th kind of embodiment of embodiment 4 externally applied liquid asiaticosides
1. preparation is formed (every 100ml consumption)
Asiaticoside 2g (2)
PEG400 15g (15%)
Sterilized water 85g (85%)
2. method for making: with PEG400 and sterilized water mixing, again the 2g asiaticoside is dissolved in the mixed solvent, mixing, fill, 121 ℃ of pressure sterilizing 30min, promptly.
The 5th kind of embodiment of embodiment 5 externally applied liquid asiaticosides
1. preparation is formed (every 100ml consumption)
Asiaticoside 20g
PEG400 15g
Sterilized water 85g
2. method for making: PEG400 and sterilized water are mixed into medicinal solvent, get about 80% above-mentioned medicinal solvent, add the recipe quantity asiaticoside, be heated to 90 ℃ of stirrings and make it molten entirely, be filtered to clearly, be cooled to room temperature, add medicinal solvent to full dose, regulate medicinal liquid pH value 6.5, carry out semi-finished product after stirring evenly and detect.Heat then to about 60 ℃, add the active carbon of medicine liquid volume amount 5% (w/v), insulation 20min naturally cools to room temperature.With G4 glass filter element coarse filtration, then through the filter element fine straining of 0.2 μ m, embedding, 121 ℃ of pressure sterilizing 30min, lamp inspection, packing, product inspection, warehouse-in.
The 6th kind of embodiment of embodiment 6 externally applied liquid asiaticosides
1. preparation is formed (every 100ml consumption)
Asiaticoside 5g
Sterilized water 100g
2. method for making: sterilized water is heated to 80 ℃, again the 2g asiaticoside is dissolved in wherein, aseptic filtration, local 100 grades of fills, promptly.
Embodiment 7
Asiaticoside solution and asiaticoside frost ointment are to the curative effect and the safety comparative study of scar hyperplasia nude mice model
1, material source
(1) asiaticoside solution makes by embodiment 1.Asiaticoside frost ointment, commercially available.
(2) people's hypertrophic cicatrix Hangzhou 117 hospital's plastic surgery operations that have drawn from.
(3) nude mice, simple T lymphocyte deficiency in 6～8 weeks, is provided by experimental animal center, Zhejiang Province.
2, main agents and instrument
(1) RPMI1640 (U.S. GIBICO)
(2) calf serum (magnificent company provides)
(3) transmission electron microscope (Philps CM10)
(4) penicillin, streptomycin etc. are the general chemistry pure reagent
3, method
(1) cicatrix that downcuts of will performing the operation is cut into 5mm * 7mm * 2mm fritter, places the aseptic bottles of two anti-(penicillin 100) tissue culture mediums of RPMI1640+ immediately; Under aseptic condition, scar tissue is transplanted in the northern omoplate of 6 nude mices in age in week inboard subcutaneous behind the 3h, the back cicatrixes growth of 4 weeks also keeps primary characteristic, does not have obviously property carried out and rejection, is for experiment.
(2) the asiaticoside solution allocation is become following concentration asiaticoside sterile solution: 25mg/ml.
(3) scar tissue animal of the same size is divided into 2 groups, 18 every group, 1 group is the treatment group, gives the asiaticoside solution sterile solution of 25mg/ml; The 2nd group is matched group, gives asiaticoside frost ointment, and every day 3 times, the successive administration time is 15 days.
(4) observe and write down the cicatrix size, form and electron microscopic examination, and carry out the t check.
(5) detect cicatrix position antibacterial culturing situation, nude mice blood, routine urinalysis, blood biochemistry, function etc. before and after the medication respectively.
4, result
(1), asiaticoside solution and asiaticoside frost ointment acts on the comparative study (referring to table 1) of nude mice cicatrix
Table 1 asiaticoside solution and asiaticoside frost ointment act on the comparative study of nude mice cicatrix
| Group | Dosage regimen | Cicatrix area (mm 2) | The P value | Cicatrix position antibacterial culturing |
| 1 | Asiaticoside solution | 21.12±2.48 | ＜0.01 * | No antibacterial detects |
| 2 | Asiaticoside frost ointment | 25.25±3.28 | - | 5 detect escherichia coli |
* compare with matched group (the 2nd group).
(2), after the effect of asiaticoside solution and asiaticoside frost ointment to nude mice blood, routine urinalysis, the mensuration of blood biochemistry, function
After the medication 15 days, 40 nude mices all survive, in the medication process local do not have fester, erythra, routine blood test, glutamate pyruvate transaminase, lactic acid dehydrogenase, creatinine, potassium, sodium etc. detect no abnormal.
20 nude mice cicatrix positions all do not have local red and swollen in the treatment group.There are 2 nude mice cicatrix positions red point to occur in the matched group.
5, discuss and analyze
By the scar hyperplasia nude mice model directly being given the comparative study of asiaticoside solution and asiaticoside frost ointment, can draw to draw a conclusion:
(1) to the improvement effect of the scar hyperplasia of scar hyperplasia nude mice model, asiaticoside solution is better than asiaticoside frost ointment, and this mainly is because asiaticoside solution has better permeability than asiaticoside frost ointment.
(2) to the untoward reaction of the scar hyperplasia of scar hyperplasia nude mice model, asiaticoside solution is better than asiaticoside frost ointment, this mainly is because asiaticoside solution is sterile preparation, has overcome the untoward reaction that asiaticoside frost ointment oleaginous base has caused the local erythema of cicatrix simultaneously.
(3) curative effect of asiaticoside solution and untoward reaction all are better than asiaticoside frost ointment.
Need not further to elaborate, believe and adopt the disclosed content in front, those skilled in the art can use the present invention to greatest extent.Therefore, the embodiment of front is interpreted as only illustrating, but not limits the scope of the invention by any way.
Claims (5)
1. externally applied liquid asiaticoside preparation, it is characterized in that: its effective ingredient is made by following materials of weight proportions: asiaticoside 0.1%～30.0%, medicinal solvent 70.0%～99.9%.
2. a kind of externally applied liquid asiaticoside preparation according to claim 1 is characterized in that: wherein asiaticoside is for extracting the total saponins that obtains from the natural plants Herba Centellae, and by dry product, containing asiaticoside is 20～99%.
3. a kind of externally applied liquid asiaticoside preparation according to claim 1 is characterized in that: the medicine of preparation is the externally used solution agent.
4. the preparation method of a kind of externally applied liquid asiaticoside preparation according to claim 1, realize by following steps: the medicinal solvent mix homogeneously of getting 80% volume, add asiaticoside, be heated to 60～90 ℃ of stirrings and make it molten entirely, be filtered to clearly, cooling, add medicinal solvent to full dose, regulate medicinal liquid pH value 5.4～6.5, carry out semi-finished product after stirring evenly and detect, measure content 96%～104%, heat then to 60 ℃, add the active carbon of medicine liquid volume amount 0.1～5% (w/v), be incubated 20 minutes, naturally cool to room temperature, coarse filtration, medicinal liquid pH value 4.5～5.0 after the control decarburization is then through the filter element fine straining of 0.2 μ m, check medicinal liquid character and clarity, qualified back embedding, the leak detection sterilization, lamp inspection, packing, product inspection, warehouse-in.
5. the preparation method of a kind of externally applied liquid asiaticoside preparation according to claim 5, it is characterized in that: used solvent is selected water, ethanol, Polyethylene Glycol, 1 for use, any or theys' mixture in 2-propylene glycol, the ethylene glycol.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610050184 CN1857291A (en) | 2006-04-04 | 2006-04-04 | Externally applied liquid asiaticoside preparation and its preparing process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191163A (en) * | 2013-04-29 | 2013-07-10 | 崔新明 | Skin wound repairing pharmaceutical composition |
| CN104826157A (en) * | 2015-05-18 | 2015-08-12 | 南京医科大学第一附属医院 | Multifunctional mitomycin-containing cotton sheet for stopping bleeding and avoiding adhesion |
-
2006
- 2006-04-04 CN CN 200610050184 patent/CN1857291A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191163A (en) * | 2013-04-29 | 2013-07-10 | 崔新明 | Skin wound repairing pharmaceutical composition |
| CN104826157A (en) * | 2015-05-18 | 2015-08-12 | 南京医科大学第一附属医院 | Multifunctional mitomycin-containing cotton sheet for stopping bleeding and avoiding adhesion |
| CN104826157B (en) * | 2015-05-18 | 2017-06-06 | 南京医科大学第一附属医院 | A kind of multi-functional bleeding stopping and adherence preventing cotton piece containing mitomycin |
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