CN1771937A - Externally applied podophyllotoxin ointment and its prepn - Google Patents
Externally applied podophyllotoxin ointment and its prepn Download PDFInfo
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- CN1771937A CN1771937A CN 200510047641 CN200510047641A CN1771937A CN 1771937 A CN1771937 A CN 1771937A CN 200510047641 CN200510047641 CN 200510047641 CN 200510047641 A CN200510047641 A CN 200510047641A CN 1771937 A CN1771937 A CN 1771937A
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Abstract
The present invention relates to externally applied podophyllotoxin ointment and its preparation process. The externally applied podophyllotoxin ointment consists of podophyllotoxin 0.5-2 wt% and ointment matrix 0.6-98 wt%, bacteriostatic agent 0.005-0.02 wt%, penetrant 1-4 wt%, propylene glycol and water medium1-2 wt%. The preparation process includes preparing podophyllotoxin liquid, preparing blank ointment and preparing the externally applied podophyllotoxin ointment. The ointment of the present invention is used to treat genital wart through transdermal absorption, and has obvious treating effect, less local toxicity, low acute skin toxicity, no irritation, weak sensitization and no systemic toxic side effect. The present invention has simple preparation process suitable for industrial production.
Description
One, technical field: the present invention relates to a kind of unguentum for the treatment of condyloma acuminatum and preparation method thereof, especially relate to a kind of unguentum as the medicine podophyllotoxin of the treatment condyloma acuminatum of effective ingredient and preparation method thereof that contains.
Two, background technology: condyloma acuminatum (Codyloma.acu minata, (A) claim genital wart or genital wart again, due to human papillomavirus (Chuman papillomavirus.HPV) infection genital skin mucosa, domestic sickness rate in recent years is in rising trend, and the relapse rate height, difficult radical cure, it wrecks health, influence family, harm society causes great physiology and mental anguish to the patient.The medicine of therefore researching and developing the treatment condyloma acuminatum of high-efficiency low-toxicity is very necessary and important social benefit and economic benefit is arranged.
Podophyllotoxin is the composition that extracts from Chinese medicine Chinese podophyllum root rhizome portion.The podophyllin treatment genital diseases of the local use 20%～30% of 1830s is used in a lot of countries, yet when using podophyllin treatment genital wart in a large number, because local toxic reaction can cause the whole body poisoning, reproductivity obviously reduces.China's researcher extracted podophyllotoxin and podophyllin ratio from the Chinese podophyllum root that produce the northwest in 1988, its determined curative effect, and toxic and side effects is little.
Pharmacological evaluation proves: podophyllotoxin can be so that the horn cells increase and decrease be few over half when concentration is 0.5% μ g/ml, and drug level increase effect is more obvious.Podophyllotoxin has obvious inhibitory action to the mitosis of CC-801 cell.Podophyllotoxin all has in various degree inhibitory action at the normal epidermis cell of In vitro culture and the unusual squamous cell of hypertrophy.
The clinical experiment exterior syndrome is bright, and podophyllotoxin treatment genital wart is evident in efficacy, and its mechanism is to suppress the mitosis of HPV virus infected cell, causes that the necrosis of genital wart body comes off.Ministry of Public Health in 1993 approval podophyllotoxin tincture official listing, podophyllotoxin be nineteen ninety world health organisation recommendations as a line medicine of treatment genital wart, the podophyllotoxin tincture was put into national essential drugs in 1994, was the unique selected medicine of skin class.
Therefore, treat condyloma acuminatum now and adopt the 29th [national drug standards WS of podophyllotoxin tincture " new drug become a full member standard " more
1-(X-044) 2002Z], but because ethanol content height in the tincture, the medication process exists zest strong, and shortcomings such as unsafe factor is big in producing, so convenience and the effect used are unsatisfactory.
Three, summary of the invention:
1, goal of the invention: the invention provides externally applied podophyllotoxin ointment and preparation method, its objective is that solution external application analgesic, anti-inflammation drugs effect in the past is bad, especially treat the podophyllotoxin tincture of condyloma acuminatum, its medication process exists zest strong, and the unsafe factor problem that aspect such as stability during as externally used paste and subcutaneous permeability exists greatly and with podophyllotoxin in producing.
2, technical scheme: the present invention is achieved through the following technical solutions:
A kind of externally applied podophyllotoxin ointment is characterized in that: the prescription of this unguentum mainly contains the medicine of following percentage by weight:
Podophyllotoxin 0.5～2%
Substrate 90～95%
Antibacterial 0.005～0.02%
Azone 1～4%
PH regulator agent 0.2～2%
Propylene glycol 0.5～2%
Its mesostroma is natural glycerin lipid, hydro carbons, lipoid, oil-in-water type substrate and water-soluble base; Wherein natural glycerin lipid is axunge class and vegetable oil; Hydro carbons is vaseline, paraffin and ceresine; Lipoid is lanoline, lanonol, Cera Flava and spermaceti solid alcohol; Oil-in-water type substrate is monovalence soap, hexadecanol and octadecanol; Water-in-oil type substrate is bivalence or polyvalent metal soap, span or glyceride; Water-soluble base is glycerin gelatine, starch, glycerol, sodium alginate, cellulose family and poloxamer.
Antibacterial in the prescription is benzoic acid and its esters, parabens; The pH regulator agent is the alkalescence or the acid solution of sodium hydroxide solution, triethanolamine, dilute hydrochloric acid.
Benzoic acid and its esters are selected benzalkonium chloride for use, and Borax is selected in the pH regulator agent for use.
A kind of preparation method of externally applied podophyllotoxin ointment is characterized in that: this method comprises the steps:
A, to get each component by above-mentioned externally used paste prescription standby;
B, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of c, unguentum: substrate is added in right amount in the medicinal liquid of step b, be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, adding distil water reaches unguentum concentration, and stirs promptly.
A kind of externally applied podophyllotoxin gel is characterized in that: the prescription of this gel mainly contains the medicine of the white proportion by subtraction of following weight:
Podophyllotoxin 1～3%
Substrate 0.5～2%
Antibacterial 0.01～0.04%
Azone 1～6%
PH regulator agent 0.2～0.5%
Propylene glycol 1～2%
Distilled water 90～95%
Substrate in the prescription is Polyethylene Glycol, carbomer.
When substrate was carbomer, its consumption was 1.0% of a total polymer weight, and the azone in the component is 1.0% of a total polymer weight, and propylene glycol is 1.0% of a total polymer weight.
Antibacterial in the prescription is the antibacterial of benzoic acid and its esters, parabens and other types, and the pH regulator agent is sodium hydroxide solution, triethanolamine, alkaline solution.
Benzoic acid and its esters are selected benzalkonium chloride for use, and Borax is selected in the pH regulator agent for use.
A kind of preparation method of externally applied podophyllotoxin gel is characterized in that: this method comprises the steps:
A, to get each component by above-mentioned external-use gel prescription standby;
The preparation of b, blank substrate: with the two times weighings of substrate according to the prescription percentage by weight, adding water for injection swelling is standby;
C, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of d, unguentum: the substrate of b step preparation is added in the medicinal liquid of step c in right amount, be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, adding distil water reaches gel strength, and stirs promptly.
Among the above-mentioned steps d, be 6.0 with the pH value of borax soln regulator solution.
3, advantage and effect: by the enforcement of technical solution of the present invention, can solving in the past well, the podophyllotoxin tincture uses inconvenience, the shortcoming that zest is strong.The present invention makes gel or unguentum with the podophyllotoxin tincture, and is not only easy to use, and can make side effect littler, do not have any stimulation, and subcutaneous osmotic effect is obvious, has been convenient to preserve and transport and guarantee the safety when producing.
Five, the specific embodiment:
Embodiment 1:
Externally applied podophyllotoxin ointment of the present invention, the prescription of this unguentum contains the medicine of following percentage by weight:
Podophyllotoxin 0.5%
Vaseline 91%
Benzalkonium chloride 0.01%
Azone 1.2%
Borax 0.2%
Propylene glycol 1%
Other is a distilled water
The preparation method of externally applied podophyllotoxin ointment of the present invention, this method comprises the steps:
A, to get each component by above-mentioned externally used paste prescription standby;
B, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of c, unguentum: will add in right amount as the vaseline of substrate in the podophyllotoxin medicinal liquid after step b prepares, be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, add distilled water and reach unguentum concentration, and stir promptly.
Embodiment 2:
Externally applied podophyllotoxin gel of the present invention, the prescription of this gel contains the medicine of following percentage by weight:
Podophyllotoxin 1%
Carbomer 0.5%
Benzalkonium chloride 0.01%
Azone 1%
Borax 0.2%
Propylene glycol 1%
Other is a distilled water
The preparation method of externally applied podophyllotoxin gel of the present invention, this method comprises the steps:
A, to get each component by above-mentioned prescription standby;
The preparation of b, blank substrate: with the two times weighings of above-mentioned substrate carbomer according to the prescription percentage by weight, it is standby to add the water for injection swelling, adds in the time of can guaranteeing preparating liquid to obtain blank substrate after various compositions reach the concentration of finished product unguentum;
C, medicinal liquid preparation: take by weighing an amount of distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully in right amount;
The preparation of d, unguentum: the blank substrate of b step preparation is added in the podophyllotoxin medicinal liquid of step c in right amount, be stirred well to the homogeneous system, pH value to 6.0～7.0 with an amount of borax soln regulator solution, the pH regulator agent also can be the alkalescence or the acid solution of sodium hydroxide solution, triethanolamine, dilute hydrochloric acid, and continuing to stir promptly gets external-use gel of the present invention.
Embodiment 3:
Externally applied podophyllotoxin ointment of the present invention, the prescription of this unguentum contains the medicine of following percentage by weight:
Podophyllotoxin 0.5%
Glycerin gelatine 92%
Benzalkonium chloride 0.01%
Azone 1%
Borax 0.2%
Propylene glycol 0.7%
Other is a distilled water
The preparation method of externally applied podophyllotoxin ointment of the present invention, this method comprises the steps:
A, to get each component by above-mentioned prescription standby;
B, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of c, unguentum: will add in right amount in the podophyllotoxin medicinal liquid of step b as the glycerin gelatine of substrate, and be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, adding distil water reaches unguentum concentration, and stirs promptly.
An amount of antibacterial that adds before above-mentioned steps c, antibacterial is a benzalkonium chloride.
Externally applied podophyllotoxin ointment that the present invention relates to and gel have the characteristics of good stability, prove its good stability through accelerated test and room temperature reserved sample observing.Concrete result of the test is as follows:
Table 1 accelerated test result
| Lot number | Standing time | The investigation project | ||||
| Appearance character | Differentiate | PH value | Related substance (%) | Assay (%) | ||
| 2 0 0 3 0 6 0 3 | 0 month | The white translucent gels | Positive reaction | 4.9 | 1.39 | 99.51 |
| January | The white translucent gels | Positive reaction | 4.9 | 1.42 | 101.07 | |
| February | The white translucent gels | Positive reaction | 4.8 | 1.51 | 101.63 | |
| March | The white translucent gels | Positive reaction | 4.9 | 1.48 | 100.01 | |
| June | The white translucent gels | Positive reaction | 4.9 | 1.54 | 99.67 | |
| 2 0 0 3 0 6 0 5 | 0 month | The white translucent gels | Positive reaction | 4.8 | 1.47 | 98.81 |
| January | The white translucent gels | Positive reaction | 4.8 | 1.46 | 98.82 | |
| February | The white translucent gels | Positive reaction | 4.8 | 1.57 | 98.80 | |
| March | The white translucent gels | Positive reaction | 4.9 | 1.53 | 98.77 | |
| June | The white translucent gels | Positive reaction | 4.9 | 1.63 | 98.80 | |
| 2 0 0 3 0 6 0 7 | 0 month | The white translucent gels | Positive reaction | 4.9 | 1.46 | 99.09 |
| January | The white translucent gels | Positive reaction | 4.9 | 1.43 | 99.32 | |
| February | The white translucent gels | Positive reaction | 4.8 | 1.54 | 100.04 | |
| March | The white translucent gels | Positive reaction | 4.8 | 1.49 | 98.75 | |
| June | The white translucent gels | Positive reaction | 4.9 | 1.57 | 99.13 | |
Lot number is the product of inventor's different time and batch production in the table.
Table 2. stability (25 ± 2 ℃ of room temperature conditions) examination result
| Lot number | Standing time | The investigation project | ||||
| Appearance character | Differentiate | PH value | Related substance (%) | Assay (%) | ||
| 2 0 0 3 0 6 0 3 | 0 month | The white translucent gels | Positive reaction | 4.9 | 1.39 | 99.51 |
| March | The white translucent gels | Positive reaction | 4.9 | 1.58 | 99.94 | |
| June | The white translucent gels | Positive reaction | 4.9 | 1.69 | 99.43 | |
| JIUYUE | The white translucent gels | Positive reaction | 4.9 | 1.49 | 104.53 | |
| December | The white translucent gels | Positive reaction | 4.8 | 1.67 | 102.37 | |
| 2 0 0 3 0 6 0 5 | 0 month | The white translucent gels | Positive reaction | 4.8 | 1.47 | 98.81 |
| March | The white translucent gels | Positive reaction | 4.8 | 1.63 | 98.77 | |
| June | The white translucent gels | Positive reaction | 4.8 | 1.77 | 98.77 | |
| JIUYUE | The white translucent gels | Positive reaction | 4.8 | 1.58 | 98.75 | |
| December | The white translucent gels | Positive reaction | 4.8 | 1.74 | 98.82 | |
| 2 0 0 3 0 6 0 7 | 0 month | The white translucent gels | Positive reaction | 4.9 | 1.46 | 99.09 |
| March | The white translucent gels | Positive reaction | 4.8 | 1.61 | 98.84 | |
| June | The white translucent gels | Positive reaction | 4.8 | 1.75 | 99.39 | |
| JIUYUE | The white translucent gels | Positive reaction | 4.8 | 1.50 | 98.66 | |
| December | The white translucent gels | Positive reaction | 4.8 | 1.71 | 98.81 | |
Conclusion: accelerated tests result shows, the podophyllotoxin gel under above-mentioned experiment condition, stable in properties such as its character, discriminating, pH value, related substance, assay.
Be report below to podophyllotoxin gel clinical research data summary:
Podophyllotoxin is the active ingredient that Berberidaceae Chinese podophyllum root platymiscium Chinese podophyllum root rhizome portion extracts.Highly purified podophyllotoxin treatment genital wart is evident in efficacy, and local side effects is little, does not produce general toxicity.
Now clinical practice is done with summary.
One, the pharmacodynamics of podophyllotoxin
According to von Krogh, give patient's external 0.5% podophyllotoxin 50ul (behind the 250ug), in serum, detect less than medicine, when consumption reaches 100-1500ul (500-7500ug), after the medication 1-2 hour, can detect medicine in the serum, blood drug level peak value 1-17ng/ml.Can be coated with all over the wart body with 100ul for the first time, the blood drug level value is 3-5ug/ml in 4 hours, can measure medicine in 12 hours in serum.
Two, the toxicity of podophyllotoxin
1, acute toxicity testing
The oral LD50 of mice is the 51.868mg/kg body weight.
The mouse fatal dose is 200mg/kg
2, chronic toxicity test
Percutaneous drug delivery was observed after 2-3 days, and administration concentration is respectively 0.1%, 0.5%, 1.0% all the scytitis reaction, increased reaction with drug level and increased the weight of.
3, irritated effect
The no teratogenesis of You Tuoxin (0.5% podophyllotoxin tincture).
4, podophyllotoxin does not have teratogenesis, and no mutation effect does not have carcinogenesis yet.
5, podophyllotoxin does not cause teratogenesis to there not being influence the fertility of rat, can make second filial generation Mus body weight light partially.
In view of above-mentioned experiment finds that the anemia of pregnant woman is forbidden this medicine.
Three, clinical practice
Podophyllotoxin is a line medicine of the treatment condyloma acuminatum of WHO recommendation.Since China's official listing, clinical effectiveness was remarkable from 1993 podophyllotoxin.
Doctor king family wall is used the unguentum external curing condyloma acuminatum of the present invention's preparation, and each coating is 1 time sooner or later, continuous use 3 days, and it is a course of treatment that drug withdrawal is observed 4, but the wart body person of not disappearing repetitive therapy amounts to and is no more than 3 courses of treatment.Treatment patient 300 examples, the result cures 270 examples (90%).Wherein cure 124 examples (41.3%) the 1st course of treatment, the 2nd the examples courses of treatment 97 (32.3%), the 3rd the examples courses of treatment 49 (16.4%), produce effects 24 examples (8%), effective 5 examples (1.7%), the no systemic adverse reactions of invalid 1 example (0.3%), mild pain is only arranged, erythema, local excitations such as erosion reaction, but the patient all can tolerate.
Doctor's section is excelled all others with gel for treating condyloma acuminatum 122 examples of the present invention preparation, is used for the wart body outward, every day secondary, successive administration 3 days, observing 4 days is a course of treatment.The result cures 108 (90%), produce effects 9 examples (7.5%), effective 3 examples (2.5%), 6 example recurrences (12.5%) are arranged, untoward reaction comprises pain (2.5%), erythema (65%), edema (35%), rotten to the corn (52.5%), and except that 2 examples need be made the Local treatment of short-term, all the other all comparatively fast recovered.
Doctor Wu Tie uses gel (2% compound preparation) associating interferon local injection treatment condyloma acuminatum 33 examples of the present invention's preparation by force, and cure rate is 100%, and side effect is slight.
Claims (10)
1. externally applied podophyllotoxin ointment, it is characterized in that: the prescription of this unguentum mainly contains the medicine of following percentage by weight:
Podophyllotoxin 0.5～2%
Substrate 90～95%
Antibacterial 0.005～0.02%
Azone 1～4%
PH regulator agent 0.2～2%
Propylene glycol 0.5～2%
Its mesostroma is natural glycerin lipid, hydro carbons, lipoid, oil-in-water type substrate and water-soluble base; Wherein natural glycerin lipid is axunge class and vegetable oil; Hydro carbons is vaseline, paraffin and ceresine; Lipoid is lanoline, lanonol, Cera Flava and spermaceti solid alcohol; Oil-in-water type substrate is monovalence soap, hexadecanol and octadecanol; Water-in-oil type substrate is bivalence or polyvalent metal soap, span or glyceride; Water-soluble base is glycerin gelatine, starch, glycerol, sodium alginate, cellulose family and poloxamer.
2. externally applied podophyllotoxin ointment according to claim 1 is characterized in that: the antibacterial in the prescription is benzoic acid and its esters, parabens; The pH regulator agent is the alkalescence or the acid solution of sodium hydroxide solution, triethanolamine, dilute hydrochloric acid.
3. externally applied podophyllotoxin ointment according to claim 2 is characterized in that: benzoic acid and its esters are selected benzalkonium chloride for use, and Borax is selected in the pH regulator agent for use.
4. the preparation method of an externally applied podophyllotoxin ointment, it is characterized in that: this method comprises the steps:
A, to get each component by the described prescription of claim 1 standby;
B, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of c, unguentum: substrate is added in right amount in the medicinal liquid of step b, be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, adding distil water reaches unguentum concentration, and stirs promptly.
5. externally applied podophyllotoxin gel, it is characterized in that: the prescription of this gel mainly contains the medicine of following percentage by weight:
Podophyllotoxin 1～3%
Substrate 0.5～2%
Antibacterial 0.01～0.04%
Azone 1～6%
PH regulator agent 0.2～0.5%
Propylene glycol 1～2%
Distilled water 90～95%
Substrate in the prescription is Polyethylene Glycol, carbomer.
6. externally applied podophyllotoxin gel according to claim 5 is characterized in that: when substrate was carbomer, its consumption was 1.0% of a total polymer weight, and the azone in the component is 1.0% of a total polymer weight, and propylene glycol is 1.0% of a total polymer weight.
7. externally applied podophyllotoxin gel according to claim 5 is characterized in that: the antibacterial in the prescription is the antibacterial of benzoic acid and its esters, parabens and other types, and the pH regulator agent is sodium hydroxide solution, triethanolamine, alkaline solution.
8. externally applied podophyllotoxin gel according to claim 7 is characterized in that: benzoic acid and its esters are selected benzalkonium chloride for use, and Borax is selected in the pH regulator agent for use.
9. the preparation method of an externally applied podophyllotoxin gel, it is characterized in that: this method comprises the steps:
A, to get each component by the described prescription of claim 5 standby;
The preparation of b, blank substrate: with the two times weighings of substrate according to the prescription percentage by weight, adding water for injection swelling is standby;
C, medicinal liquid preparation: take by weighing distilled water adding azone, propylene glycol and benzalkonium chloride and fully dissolve evenly, take by weighing again and form the podophyllotoxin medicinal liquid after podophyllotoxin is stirred to dissolving fully;
The preparation of d, unguentum: the substrate of b step preparation is added in the medicinal liquid of step c in right amount, be stirred well to the homogeneous system, with pH value to 6.0～7.0 of borax soln regulator solution, adding distil water reaches gel strength, and stirs promptly.
10. externally applied podophyllotoxin gel according to claim 9 is characterized in that: among the above-mentioned steps d, be 6.0 with the pH value of borax soln regulator solution.
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| CN108136027A (en) * | 2015-06-19 | 2018-06-08 | 全球健康方案有限责任公司 | For the delivery system based on vaseline of active constituent |
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