CN105362351A - Medicine composition for treating cutaneous pruritus disease and application thereof - Google Patents
Medicine composition for treating cutaneous pruritus disease and application thereof Download PDFInfo
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- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention relates to a medicine composition for treating a cutaneous pruritus disease and an application thereof, and belongs to the technical field of pharmacy. Active ingredients of the medicine composition are prepared from, by weight, 0.5-25 parts of tea tree oil, 0.1-10 parts of radix flavescentis extract or sophora alopecuroide extract and 0.05-5 parts of liquorice extract. The medicine composition has the sterilization function and the anti-inflammatory function; common pathogenic microorganisms such as methicillin-resistant staphylococcus aureus, candida albicans and escherichia coli can be killed or remarkably inhibited in a short period of time; the medicine composition can be directly used for the portion with injured skin; the active components of the medicine composition are all made of natural plants, itching can be rapidly relieved, swelling can be rapidly eliminated, and the effect is remarkable; meanwhile, the medicine composition has anti-bacterial activity and sterilizing activity, is safe, nontoxic, free of pollution to clothes and skin and free of human-body skin irritation and human-body skin sensitization, and can be used for a long time.
Description
Technical field
The present invention relates to pharmaceutical composition and the application thereof for the treatment of skin pruritus disease, belong to pharmaceutical technology.
Background technology
Skin pruritus is symptom common in daily life, and the position related to is from scalp until all expose portions of the human body such as anus, vola.In medical clinical practice, conventional hydrocortisone or dexamethasone isocortex steroid hormone preparation (such as: PIYANPING), antipruritic effect is pretty good, but, side effect is remarkable, alcium and phosphor metabolization in life-time service severe jamming body, require to be no more than five days service time, child preferably need not.Tradition Exterior-applied Chinese patent medicine, mainly contain calamine liniment, dampness-removing itching-relieving ointment, itch stopping and diminish inflammation water etc., antipruritic effect is limited, and product form is extensive, uses inconvenience, easily pollutes skin and medicated clothing.
As everyone knows, tea tree oil has Kang Xi Jun ﹑ Kang Zhen Jun ﹑ Kang Bing Du ﹑ immunoregulatory activity widely, and toxicologic study proves that it has very high safety, does not have zest to human body skin.The chemical composition of tea tree oil is more clearly, altogether containing 100 multiple compounds, wherein the structure of nearly 80 kinds of compounds obtains and confirms, think that principle active component is Terpinen-4-ol (Terpinen-4-ol), its international standard requires that Terpinen-4-ol content must not lower than 30%, cineole (1,8-Cineole), content must not higher than 15%.At present, tea tree oil product is widely used in Personal hygiene, such as: Cuo Chuan ﹑ Fen Ci ﹑ Dai shape Pao Zhen ﹑ Shao Tang Shang ﹑ Wen Chong Ding Yao ﹑ You Pi Fu ﹑ Shi Zhen ﹑ Ti Xuan ﹑ Jiao Xuan ﹑ muscle Guan saves the nursing field of Teng Tong ﹑ wound sterilization etc., genitourinary system, such as: the health care of the scorching ﹑ pruritus vulvae in the cloudy road of thin bacterium property ﹑ mycotic etc. and respiratory system disease, such as: sense emits ﹑ to flow sense ﹑ to roar and breathe heavily ﹑ gas pipe scorching ﹑ nose Dou Yan ﹑ and tie the core sick ﹑ daytime and cough the prevention of ﹑ chickenpox etc. and pet nursing etc.But single tea tree oil formulation is to the limited efficiency for the treatment of skin pruritus disease.
Patent CN1562218A discloses a kind of compound recipe tea tree oil pharmaceutical composition for preventing or treat human reproduction road inflammation, per unit dosage contains tea tree oil 0.1 ~ 5.0%, Radix Sophorae Flavescentis or Alkaloids From Sophora Alopecuroides L extract 0.05 ~ 2.0% or Rhizoma Coptidis or Cortex Phellodendri extract 0.05 ~ 2.0% or Huang rise alkaloid extract 0.05 ~ 2.0%, and surplus is medically acceptable solvent or adjuvant.This pharmaceutical composition is used for prevention or treatment human reproduction road inflammation.
Summary of the invention
The technical problem that the present invention solves is to provide the pharmaceutical composition being used for the treatment of skin pruritus disease.
The present invention is used for the treatment of the pharmaceutical composition of skin pruritus disease, its active component is made up of the component of following weight portion: tea tree oil 0.5 ~ 25 part, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.1 ~ 10 part, Radix Glycyrrhizae extract 0.05 ~ 5 part, wherein, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract content are in matrine or oxymatrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid or enoxolone.
Preferably, its active component is made up of the component of following weight portion: tea tree oil 2.0 ~ 20 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 5.0 part, Radix Glycyrrhizae extract 0.1 ~ 2.5 part; Preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 2.50 part, Radix Glycyrrhizae extract 0.1 ~ 1.0 part; More preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1 ~ 1.5 part, Radix Glycyrrhizae extract 0.3 ~ 0.5 part; More preferably be made up of the component of following weight portion: tea tree oil 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1.5 parts, Radix Glycyrrhizae extract 0.4 part.
Further, described pharmaceutical composition is also containing pharmaceutically acceptable adjuvant.
Wherein, described adjuvant is at least one in solvent, pH adjusting agent, essence and flavoring agent, skin coolants, transdermal enhancer, stabilizing agent, emulsifying agent, excipient.
Further, the content of described skin coolants is 0.1 ~ 2.0%, and described skin coolants is at least one in Borneolum Syntheticum, Oleum menthae, menthone glycerin ketal, menthol ethylene carbonate, menthol propylene carbonate, menthyl acetate, menthyl lactate.
Described transdermal enhancer is menthol, Borneolum Syntheticum, laurocapram, dimethyl sulfoxide, DCMS, sodium tetradecyl sulfate, isopropyl myristate or vitamin E.
The dosage form being used for the treatment of the pharmaceutical composition of skin pruritus disease of the present invention is transdermal formulation.
Wherein, described transdermal formulation is preferably tincture, water preparation, emulsion, cream, liniment, unguentum, spray, oil preparation or gel.
Further, described tea tree oil is the leaves of Camellia sinensis and the quintessence oil of twig extraction, and the Terpinen-4-ol content in tea tree oil is not less than 20%; Described Radix Sophorae Flavescentis extract is the alkaloid that Radix Sophorae Flavescentis dry root extracts; Described Herba Sophorae alopecuroidis extract is the alkaloid that Herba Sophorae alopecuroidis rhizome extracts; Described Radix Glycyrrhizae extract is that the root of Radix Glycyrrhizae or rhizome extract the extract that the main component obtained is glycyrrhizic acid and enoxolone.
The present invention also provides the application of pharmaceutical composition in treatment skin pruritus disease being used for the treatment of skin pruritus disease of the present invention.
Preferably, described skin pruritus disease is by mosquito bite or contact exogenous anaphylactogen and cause.
The present invention is used for the treatment of the pharmaceutical composition of skin pruritus disease, with tea tree oil, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract and Radix Glycyrrhizae extract for active ingredient, there is the function of sterilization, antiinflammatory, kill at short notice or significantly suppress the common causative microorganisms such as golden Pu grape sugar Qiu Jun ﹑ Bai color Nian Zhu Jun ﹑ escherichia coli, can cutaneous lesion be directly used in.
With existing with compared with antihistamine drug or the corticosteroid hormone like product that is active component, the present invention is used for the treatment of the pharmaceutical composition active component natural plant source of skin pruritus disease, energy Quick itch stopping, eliminate red and swollen, Be very effective, has Yi Jun ﹑ bactericidal activity simultaneously, safety non-toxic, not pollution clothes and skin, to human body skin nonirritant and sensitization type, can life-time service.
Detailed description of the invention
The present invention is used for the treatment of the pharmaceutical composition of skin pruritus disease, its active component is made up of the component of following weight portion: tea tree oil 0.5 ~ 25 part, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.1 ~ 10 part, Radix Glycyrrhizae extract 0.05 ~ 5 part, wherein, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract content are in matrine or oxymatrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid or enoxolone.
Further, its active component is preferably made up of the component of following weight portion: tea tree oil 2.0 ~ 20 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 5.0 part, Radix Glycyrrhizae extract 0.1 ~ 2.5 part; More preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 2.50 part, Radix Glycyrrhizae extract 0.1 ~ 1.0 part; More preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1 ~ 1.5 part, Radix Glycyrrhizae extract 0.3 ~ 0.5 part; More preferably be made up of the component of following weight portion: tea tree oil 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1.5 parts, Radix Glycyrrhizae extract 0.4 part.
Further, described pharmaceutical composition also contains pharmaceutically acceptable adjuvant, as at least one in solvent, pH adjusting agent, essence and flavoring agent, skin coolants, transdermal enhancer, stabilizing agent, emulsifying agent, excipient, described solvent is including but not limited to polyhydric alcohol such as pure water, ethanol, ethylene glycol, propylene glycol, glycerol, butanediols; Described pH adjusting agent can be sodium hydroxide, triethanolamine, hydrochloric acid, phosphoric acid, acetic acid, citric acid, lactic acid etc., and described emulsifying agent includes but not limited to sodium stearate, sodium lauryl sulphate, cocamido propyl betaine, polyoxyethylene sorbitan fatty acid ester, sorbitan fatty acid ester, polyoxyethylene aliphatic alcohol ether; Described excipient is including but not limited to hexadecanol, octadecanol, glyceryl monostearate, liquid paraffin, vaseline, white beeswax, Cera Flava, lanoline, carbomer, xanthan gum, carrageenan, hyaluronate sodium.
Further, the content of described skin coolants is 0.1 ~ 2.0%.Described content is weight percentage.
Described skin coolants is at least one in Borneolum Syntheticum, Oleum menthae, menthone glycerin ketal, menthol ethylene carbonate, menthol propylene carbonate, menthyl acetate, menthyl lactate.
Described transdermal enhancer is menthol, Borneolum Syntheticum, laurocapram, dimethyl sulfoxide, DCMS, sodium tetradecyl sulfate, isopropyl myristate or vitamin E.
The present invention is used for the treatment of the pharmaceutical composition of skin pruritus disease, can make transdermal formulation form, such as, and tincture, water preparation, emulsion, cream, liniment, spray, unguentum, oil preparation or gel etc.
Wherein, described tea tree oil is the leaves of Camellia sinensis and the quintessence oil of twig extraction.In described tea tree oil, the content of Terpinen-4-ol (terpinen-4-ol) is not less than 20%.
Camellia sinensis of the present invention is preferably Myrtaceae (Myrtaceae) paperbark (melaleucaalternifolia) Camellia sinensis or New Zealand Camellia sinensis manuka (Leptospermumscoparium) or New Zealand Camellia sinensis Kanuka (Kunzeaericoides).
Further, the extracting method of tea tree oil is steam distillation or solvent soaking method, such as: soak with ethanol extraction method, or carbon dioxide supercritical extraction method.
Described Radix Sophorae Flavescentis extract is the alkaloid that leguminous plant Radix Sophorae Flavescentis (SophoraFlavescensAit) dry root extracts.
Radix Sophorae Flavescentis of the present invention is leguminous plant, Radix Sophorae Flavescentis main chemical compositions is containing multiple alkaloid, there is matrine (Matrine), oxymatrine (Oxymatrine), sophor-anol (Sophoranol), N-Methylcytisine (N-Methylcytisine), Anagyrine (Anagyrine), baptifoline (Baptifoline), SopHocarpine (sophocarpine Sophocarpine) etc., there is heat clearing and damp drying, parasite killing, diuresis effect, clinically for hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, the diseases such as trichomonal vaginitis.
Described Herba Sophorae alopecuroidis extract is the alkaloid that leguminous plant Herba Sophorae alopecuroidis (SophoraalOpecuroidesL.) rhizome extracts.
Herba Sophorae alopecuroidis of the present invention is cassia leguminous plant, has another name called bitter Gan Cao ﹑ bitter Dou Gen ﹑ Sophora Alopecuroides L..Medicinal Gen ﹑ Gen Jing ﹑ herb and seed, bitter in the mouth is cold in nature, has heat-clearing and toxic substances removing, wind dispelling dampness, the effects such as pain relieving parasite killing.Research in recent years finds, Herba Sophorae alopecuroidis main chemical compositions is alkaloid, such as matrine (Matrine), oxymatrine (Oxymatrine) ﹑ sophocarpine (Sophocarpine) ﹑ sophoridine (sophoridine) ﹑ sophoramine (sophoramine) ﹑ aloperine (aloperine) etc.
Described Radix Glycyrrhizae extract is that the root of Radix Glycyrrhizae or rhizome extract the extract that the main component obtained is glycyrrhizic acid and enoxolone.
Radix Glycyrrhizae of the present invention is Glycyrrhiza uralensis Fisch. (GlycyrrhizauralensisFisch), Glycyrrhiza inflata Bat. (GlycyrrhizainflataBatal.) or Glycyrrhiza glabra L. (GlycyrrhizaglabraLinn.), it is conventional Chinese herbal medicine, root and rhizome is its medicinal part, and main component is based on glycyrrhizic acid (Glycyrrhezicacid), enoxolone (GlycyrrhetinicAcid).
The present invention is used for the treatment of in the pharmaceutical composition of skin pruritus disease, tea tree oil can adopt Terpinen-4-ol to replace, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract can adopt its main active matrine or oxymatrine to replace, and Radix Glycyrrhizae extract can adopt its main active glycyrrhizic acid or enoxolone to replace.These active component can extract and obtain from corresponding plant, also can buy in market or obtained by chemical method synthesis.
The present invention is used for the treatment of the preparation method of the pharmaceutical composition of skin pruritus disease, can adopt following steps:
Be no more than the condition of 95 DEG C in temperature under, by tea tree oil, skin coolants and Radix Glycyrrhizae extract and adjuvant stirring and evenly mixing or emulsifying, obtain component A; Be no more than the condition of 95 DEG C in temperature under, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract be dissolved in the water, be fully uniformly mixed with adjuvant, reach the requirement of required preparation, then add component A, standardize solution, stir or emulsifying, obtain the pharmaceutical composition that the present invention is used for the treatment of skin pruritus disease;
Or employing following steps: be no more than the condition of 95 DEG C in temperature under, by tea tree oil and skin coolants and adjuvant stirring and evenly mixing or emulsifying, obtain component A; Be no more than the condition of 95 DEG C in temperature under, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract and Radix Glycyrrhizae extract are dissolved in the water, fully be uniformly mixed with adjuvant, reach the requirement of required preparation, add component A again, standardize solution, stirs or emulsifying, obtains the pharmaceutical composition that the present invention is used for the treatment of skin pruritus disease.
Concrete, can adopt and be prepared with the following method:
Under room temperature (25 ± 10 DEG C) or insulation (being no more than 90 ± 5 DEG C) condition, by tea tree oil 0.5 ~ 25.0%, or Radix Glycyrrhizae extract 0.05 ~ 5.0% (with glycyrrhizic acid or enoxolone metering), 0.1 ~ 2.0% skin coolants and solvent or adjuvant is uniformly mixed or the step of emulsifying, obtain component A;
Under room temperature (25 ± 10 DEG C) or insulation (being no more than 90 ± 5 DEG C) condition, by Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.1 ~ 10.0% (with matrine or oxymatrine metering) or Radix Glycyrrhizae extract 0.05 ~ 5.0% (with glycyrrhizic acid or enoxolone metering), be dissolved in pure water completely, fully be uniformly mixed with excipient, reach the requirement of required preparation, slowly add component A, be settled to required metering, stir or emulsifying, obtain required product.
The application of the pharmaceutical composition that the present invention also provides the present invention to be used for the treatment of skin pruritus disease in treatment skin pruritus disease.The present invention treats the pharmaceutical composition of skin pruritus disease, is particularly useful for mosquito bite and the skin pruritus disease contacting exogenous anaphylactogen and cause.During for skin, there is following effect: (1) is eliminated mosquito bite, baby's infantile eczema, diaper rash, eczema, miliaria, erythema, dermatitis, localized contact skin allergic reaction and ultraviolet fast and to be tanned severely the skin pruritus symptom caused; (2) killing rapidly or significantly suppress the susceptible pathogenic bacteria of medication skin part, there is no zest to there being skin lesion sites.
The present invention is used for the treatment of the pharmaceutical composition of skin pruritus disease, with tea tree oil, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract and Radix Glycyrrhizae extract for active ingredient, there is the function of sterilization, antiinflammatory, kill at short notice or significantly suppress the common causative microorganisms such as golden Pu grape sugar Qiu Jun ﹑ Bai color Nian Zhu Jun ﹑ escherichia coli, can cutaneous lesion be directly used in.
Below in conjunction with embodiment, the specific embodiment of the present invention is further described, does not therefore limit the present invention among described scope of embodiments.
Prepared by embodiment 1 water sample
Under room temperature (25 ± 5 DEG C) condition, take tea tree oil 2.0g, propylene glycol 10.0g, glycerol 5.0g, 5.0g Tween 80, Borneolum Syntheticum 0.6g, vitamin E 0.4g, be placed in 250 ml beakers, be slowly stirred to and dissolve completely, obtain compositions A, stand-by;
Take Radix Sophorae Flavescentis extract 1.0g, Radix Glycyrrhizae extract 0.3g, EDTA0.05g, be placed in 100 ml beakers, add appropriate amount of purified water, be slowly stirred to and dissolve completely, drip 5% sodium hydroxide solution, adjust ph to 6.5, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in matrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid.
Under agitation, compositions B is slowly added in compositions A, continue to be stirred to till mixed solution clarifies completely, supply pure water to 200 gram, obtain present composition water sample.
The sample preparation of embodiment 2 gel
Under insulation (45 ± 5 DEG C) condition, take tea tree oil 4.0g, Radix Glycyrrhizae extract 0.4g, propylene glycol 10.0g, 5.0g Tween 80, Oleum menthae 0.6g, laurocapram 2.0g, be placed in 250 ml beakers, be slowly stirred to and dissolve completely, obtain compositions A, stand-by;
Take 0.9g Acritamer 940, be placed in 250 ml beakers, dissolve in advance with pure water, drip 10% sodium hydroxide solution, adjust ph to 6.5, add Radix Sophorae Flavescentis extract 1.5g, EDTA0.05g, be slowly stirred to gel, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in matrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid.
Under agitation, compositions B is slowly transferred in compositions A, continues to be stirred to till mixed solution mixes completely, supply pure water to 200 gram, obtain present composition gel sample.
The sample preparation of embodiment 3 unguentum
Under insulation (80 ± 5 DEG C) condition, take tea tree oil 10.0g, sodium stearate 20.0g, glyceryl monostearate 15.0g, lanoline 10.0g, Oleum menthae 0.3g, Borneolum Syntheticum 0.4g, isopropyl myristate 5.0g, be placed in 250 ml beakers, slowly be stirred to and melt completely, obtain compositions A, stand-by;
Take 5.0g Tween 80, Radix Glycyrrhizae extract 0.5g, Radix Sophorae Flavescentis extract 1.5g, glycerol 10.0g, be placed in 250 ml beakers, dissolve completely with pure water 120.0g, drip 10% lactic acid solution, adjust ph to 6.5, and under being heated to (80 ± 5 DEG C) condition, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in oxymatrine, and Radix Glycyrrhizae extract content is in enoxolone.
Under low whipping speed is greater than the condition of 1000 revs/min, compositions B is slowly transferred in compositions A, continues to stir, until be only cooled to 40 DEG C, static, obtain present composition unguentum sample.
The sample preparation of embodiment 4 emulsion agent
Under room temperature (25 ± 5 DEG C) condition, take tea tree oil 5.0g, propylene glycol 10.0g, glycerol 5.0g, 5.0g Tween 80,2.0g sorbester p17, Oleum menthae 0.6g, laurocapram 1.5g, be placed in 250 ml beakers, be slowly stirred to and dissolve completely, obtain compositions A, stand-by;
Take Radix Sophorae Flavescentis extract 1.0g, Radix Glycyrrhizae extract 0.3g, EDTA0.05g, carbomer 0.8g, xanthan gum 0.3g, be placed in 250 ml beakers, add pure water 168.0g, slowly be stirred to and dissolve completely, drip 5% sodium hydroxide solution, adjust ph to 6.5, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in oxymatrine, and Radix Glycyrrhizae extract content is in enoxolone.
Under agitation, compositions B is slowly added in compositions A, till continuing to be stirred to mixing completely, obtain present composition emulsion agent sample.
The sample preparation of embodiment 5 tincture
Under room temperature (25 ± 5 DEG C) condition, take tea tree oil 5.0g, 95% ethanol 100.0g, glycerol 5.0g, 5.0g Tween 80, menthyl lactate 1.0g, laurocapram 1.5g, be placed in 250 ml beakers, be slowly stirred to and dissolve completely, obtain compositions A, stand-by;
Take Radix Sophorae Flavescentis extract 1.0g, Radix Glycyrrhizae extract 0.3g, EDTA0.05g, be placed in 250 ml beakers, add pure water 81.0g, be slowly stirred to and dissolve completely, drip 5% lactic acid solution, adjust ph to 6.5, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in matrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid.
Under agitation, slowly added in compositions A by compositions B, till continuing to be stirred to the clarification of complete mixed solution, standardize solution, obtains present composition tincture sample.
The sample preparation of embodiment 6 emulsion agent
Under room temperature (25 ± 5 DEG C) condition, take tea tree oil 10.0g, propylene glycol 30.0g, Radix Glycyrrhizae extract 0.4g, 5.0g Tween 80,2.0g sorbester p17, Oleum menthae 0.6g, vitamin e1 .5g, be placed in 250 ml beakers, slowly be stirred to and dissolve completely, obtain compositions A, stand-by;
Take Radix Sophorae Flavescentis extract 1.5g, carrageenan 1.0g, be placed in 250 ml beakers, add pure water 142.0g, be slowly stirred to and dissolve completely, drip 5% lactic acid solution, adjust ph to 6.5, obtain compositions B; Described Radix Sophorae Flavescentis extract content is in matrine, and Radix Glycyrrhizae extract content is in enoxolone.
Under agitation, compositions B is slowly added in compositions A, till continuing to be stirred to emulsifying completely, obtain present composition emulsion agent sample.
Test example 1 bacteriostatic experiment
According to the technical standard of products characteristics of the present invention and national sterile products, experiment selects minimal inhibitory concentration to measure and dipping experiment.
Bacterial strain: select escherichia coli (EscherichiacoliATCC8099), staphylococcus aureus (StaphylococcusaureusATCC6538), Candida albicans (CandidaalbicansATCC10231) ﹑ Pseudomonas aeruginosa (PseudomonasaeruginosaATCC15442).
1. microorganism fungus kind is used in experiment:
Culture medium: bacterial liquid culture medium, bacterium solid culture medium, husky fort fluid medium and Sha Bao solid medium.Bacteria culture media is used for colibacillary cultivation, and husky fort culture medium is used for the cultivation of Candida albicans.
(1) minimal inhibitory concentration measures--MIC:(nutrient broth dilution method)
Adopt the water sample of embodiment 1 as test sample.
By variable concentrations antibacterial mixed dissolution in culture medium, by bacterial growth whether then inoculated bacteria, determine that antibacterial suppresses the Cmin (MIC) of tested bacteria growing.This method is applicable to soluble products.
Experimental procedure:
Preparation bacterial suspension;
Antibacterial liquid distilled water is done to doubly serial dilution become variable concentrations by test solution, respectively get 2.5ml and add by test solution in the culture medium test tube of the double concentration of 2.5ml; Add in the culture medium test tube of the double concentration of 2.5ml (solvent control) with the solvent 2.5ml not containing antipathogenic composition; Getting 0.1ml is inoculated in above test tube, as experimental group sample containing the bacterial suspension of 108cfu/ml; Get 0.1ml is inoculated in not bacteriostatic agent test tube containing the bacterial suspension of 108cfu/ml, as positive control; Get 0.1ml and be inoculated in solvent control test tube, as solvent control containing the bacterial suspension of 108cfu/ml; Get 2 culture medium as negative control;
Sample sets, matched group are positioned over 37 DEG C of cultivations, observed result after 48 hours.It the results are shown in Table 1 and table 2.
Pass judgment on regulation:
Positive control bacterial growth, negative control does not grow, experimental group without bacterial growth most high dilution corresponding to antibacterial concentration, for this sample is to the MIC of tested bacterium.
Result: formula property per sample, we have selected sample stock solution, sample doubling dilution and sample four times of diluents 3 samples.
Bacterial growth situation after table 124 hour
Bacterial growth situation after table 248 hour
Positive control grows, and negative control does not grow, and according to decision rule, the minimal inhibitory concentration of embodiment 1 water sample is sample doubling dilution.
(2) dipping experiment
Sample and control fabric are put into triangular flask respectively, is inoculated in sample and control fabric with the experimental bacteria liquid containing culture medium, through cultivating, respectively the antibacterial cultivated on the sample of front and back being washed down, measuring bacterial number, the percentage rate that on sample, antibacterial reduces can be calculated.The method is used in the fabric of leachability.
The preparation of sample:
Apart from more than selvedge 10cm, from cloth more than end 1cm, circular specimen and the control fabric of cutting diameter 5cm are some, get some parts of samples and control fabric is loaded on triangular flask respectively, and build bottleneck, 121 DEG C of sterilizings in 15 minutes are for subsequent use.Fabric selects non-woven fabrics.
With double culture medium and the mixing of isopyknic embodiment 1 water sample, get 1ml and be added drop-wise on aseptic fabric, available after dry.Sample used is actual is the doubling dilution of embodiment 1 water sample.
Experimental procedure:
Get 1ml bacteria suspension to be respectively added on the fabric of 3 triangular flasks, be uniformly distributed, and do not stay residual liquid, sealing vaporization prevention; In the triangular flask of 1 sample and control fabric, add 50mlPBS respectively, acutely rock 1 minute washing antibacterial, get 1ml and do 10 times of serial dilutions, and inoculate plate, as the bacterial population in " 0 " sample time of contact and control fabric; Negative control sample does not inoculate bacteria suspension, and " 0 " adds 50mlPBS time of contact, acutely rocks 1 minute, inoculation plate; Positive control gets the triangular flask that fabric is housed, and inoculation 1ml bacteria suspension, cultivates 20+2 hour, add 50mlPBS, acutely rock 1 minute, get 1ml and do 10 times of serial dilutions, and inoculate plate for 37 DEG C;
Experimental group gets the triangular flask that sample and fabric are housed, and inoculation 1ml bacteria suspension, cultivates 20+2 hour, add 50mlPBS, acutely rock 1 minute, get 1ml and do 10 times of serial dilutions, and inoculate plate for 37 DEG C; Each group of plate is put into 37 DEG C of incubators, and count after 48 hours, the time can adjust according to practical situation.
Test parallel repetition 3 times.
Result calculates:
Bacteriostasis rate (%)=[(BorCor (B+C/2))-A]/(BorCor (B+C/2)) x100
A: experimental group bacterial population; B: " 0 " sample time of contact bacterial population; C: " 0 " control fabric time of contact bacterial population
Note: B, C difference is comparatively large, gets large; B, C are more or less the same, and are averaged.
Pass judgment on rule: 1) bacterium colony of " 0 " matched group time of contact should at 1000 ~ 5000cfu/ml; 2) negative control should without bacterial growth, and positive control should be obviously more than " 0 " clump count time of contact; 3) bacteriostasis rate of each experiment all >=50%, can confirm that this print has bacteriostasis.
Experimental result:
1) bacterium colony of " 0 " matched group time of contact and sample group: escherichia coli; Staphylococcus aureus; Candida albicans; According to rule 1, Candida albicans bacteria concentration is on the low side, and result can be higher; And colibacillary concentration is higher, its result can be on the low side;
2) negative control is without growth;
3) positive control bacterium colony cannot count, and its number obviously wants many than " 0 " clump count time of contact;
4) according to calculating, the doubling dilution of the embodiment 1 water sample suppression ratio to escherichia coli, staphylococcus aureus and Candida albicans is respectively more than 90%, 73% and 63%.Candida albicans bacteria concentration is on the low side, and result will be caused higher, therefore can decline to some extent to the actual suppression ratio of Candida albicans.The phenomenon but experimentally observed in process, the doubling dilution of embodiment 1 water sample truly has obvious inhibitory action to bacterial strain uses therefor.Therefore, the conclusion obtained according to result is that the doubling dilution of embodiment 1 water sample has inhibitory action to this three strains microorganism.
Test example 2 carrier soaks quantitative bacteric idal experiment
One, experimental procedure:
1) make bacteria suspension, concentration is at 1x10
8~ 5x10
8cfu/ml;
2) make bacterium sheet, the clean aseptic filter paper sheet of 10mm*10mm, every sheet drips 10 μ l brand-new bacteria suspensions, for subsequent use after 30 minutes in 37 DEG C of placements;
3) carrier soaks quantitative bacteric idal experiment:
Get sterilized petri dishes, by the amount of every bacterium sheet 5ml, add disinfectant solution;
At 20+1 DEG C, place 5 minutes, put into 3 the bacterium sheets prepared respectively;
When bacterium sheet is respectively with liquid effects 10 minutes, 20 minutes and 30 minutes, moves on in the nertralizer (culture medium) containing 5.0ml respectively, fully vibrate and place more than 5 minutes, get 200 μ l and inoculate plates; Another culture medium replaces disinfectant solution, repeats above step as positive control;
Above plate is all cultivated 48 hours in 37 DEG C of incubators.
4) kill oncomelania is calculated.
Kill oncomelania=matched group viable count (cfu/ sheet) logarithm value-experimental group viable count logarithm value.
Two, result decision rule:
In the minimum activity of product and minimum action time, repeat 3 times, carrier soaks the kill oncomelania of quantitative bacteric idal experiment all >=3.00;
When the minimum activity of product and minimum action time 1.5 times, carrier soaks the kill oncomelania of quantitative bacteric idal experiment all >=3.00;
When the minimum activity of product and minimum action time 0.5 times, carrier soaks quantitative bacteric idal experiment acceptably paired different bacterium or part repeats to occur defective result in experiment;
When kill oncomelania is greater than 5.00, be expressed as >=5.00; When being less than 5.00, tool numeral should be listed.
Three, experimental result data
Carry out sterilization experiment according to above test procedure to the pharmaceutical composition prepared by embodiment 1,6, it the results are shown in Table 3.
The bactericidal effect of table 3 pharmaceutical composition of the present invention
As test sample, require to evaluate according to " disinfection technology standard ", experimental result: test sample is 0 to 4 bacterial strains such as escherichia coli, staphylococcus aureus, Candida albicans, bacillus pyocyaneus clump count in the test group of 10 minutes, 20 minutes and 30 minute three action time, therefore its logarithm value cannot be calculated, with 0 for value calculates, minimum at the kill oncomelania of each action time is 3.67.Therefore, the test sample that prepared by embodiment 1,6 all has significant killing effect.
Test example 3 clinical trial result
Using embodiment 1,6 as test sample.
With the preparation method of embodiment 1, not containing Radix Sophorae Flavescentis extract and Radix Glycyrrhizae extract in its formula, the product of preparation is control sample 11; With the preparation method of embodiment 1, not containing Radix Glycyrrhizae extract in its formula, the product prepared is control sample 12.
With the preparation method of embodiment 6, not containing Radix Sophorae Flavescentis extract and Radix Glycyrrhizae extract in its formula, the product of preparation is control sample 61; With the preparation method of embodiment 6, not containing Radix Glycyrrhizae extract in its formula, the product prepared is control sample 62.
The scope of application: mosquito bite, baby's infantile eczema, wet diaper disease, antiperspirant disease, erythema, dermatitis and ultraviolet are tanned severely the skin pruritus caused.
Using method: directly spread upon the red and swollen position of pruritus, if autonomous sensation antipruritic effect is not good or occupation mode is improper, can smear again.
Experimental data is obtained by three kinds of modes, 1) trier initiatively statement with after situation; 2) sample granting people regularly follows the tracks of or call-on back by phone; 3) third party tries out people's initiatively statement.Population ages on probation is distributed between 1 ~ 80 years old, wherein, within 1 ~ 8 years old, accounts for 17%, within 9 ~ 22 years old, accounts for 50%, within 23 ~ 60 years old, account for 33%, and all the other are more than 60 years old.Total number of persons ratio about 70% shared by women.Each control sample number of trying out is 10 people.It the results are shown in Table 4.
The clinical trial result of table 4 product of the present invention
Illustrate: significantly antipruritic referring to experiences the symptom of feeling bad less than pruritus, no longer cause the situation that user subjectivity is noted; Red and swollen elimination refers to that the protruding phenomenon that skin allergic reaction causes almost disappears, and skin color major part recovers normal condition.
Claims (10)
1. be used for the treatment of the pharmaceutical composition of skin pruritus disease, it is characterized in that, its active component is made up of the component of following weight portion: tea tree oil 0.5 ~ 25 part, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.1 ~ 10 part, Radix Glycyrrhizae extract 0.05 ~ 5 part, wherein, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract content are in matrine or oxymatrine, and Radix Glycyrrhizae extract content is in glycyrrhizic acid or enoxolone.
2. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 1, it is characterized in that, its active component is made up of the component of following weight portion: tea tree oil 2.0 ~ 20 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 5.0 part, Radix Glycyrrhizae extract 0.1 ~ 2.5 part; Preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 0.5 ~ 2.50 part, Radix Glycyrrhizae extract 0.1 ~ 1.0 part; More preferably be made up of the component of following weight portion: tea tree oil 3.0 ~ 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1 ~ 1.5 part, Radix Glycyrrhizae extract 0.3 ~ 0.5 part; More preferably be made up of the component of following weight portion: tea tree oil 10.0 parts, Radix Sophorae Flavescentis extract or Herba Sophorae alopecuroidis extract 1.5 parts, Radix Glycyrrhizae extract 0.4 part.
3. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 1, is characterized in that: described pharmaceutical composition is also containing pharmaceutically acceptable adjuvant.
4. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 3, is characterized in that: described adjuvant is at least one in solvent, pH adjusting agent, essence and flavoring agent, skin coolants, transdermal enhancer, stabilizing agent, emulsifying agent, excipient.
5. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 4, it is characterized in that: the content of described skin coolants is 0.1 ~ 2.0%, described skin coolants is at least one in Borneolum Syntheticum, Oleum menthae, menthone glycerin ketal, menthol ethylene carbonate, menthol propylene carbonate, menthyl acetate, menthyl lactate.
6. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 4, is characterized in that: described transdermal enhancer is menthol, Borneolum Syntheticum, laurocapram, dimethyl sulfoxide, DCMS, sodium tetradecyl sulfate, isopropyl myristate or vitamin E.
7. the pharmaceutical composition being used for the treatment of skin pruritus disease according to any one of claim 1 ~ 6, is characterized in that: described in be used for the treatment of the pharmaceutical composition of skin pruritus disease dosage form be transdermal formulation.
8. the pharmaceutical composition being used for the treatment of skin pruritus disease according to claim 7, is characterized in that: described transdermal formulation is tincture, water preparation, emulsion, cream, liniment, unguentum, spray, oil preparation or gel.
9. the pharmaceutical composition being used for the treatment of skin pruritus disease according to any one of claim 1 ~ 8, is characterized in that: described tea tree oil is the leaves of Camellia sinensis and the quintessence oil of twig extraction, and the Terpinen-4-ol content in tea tree oil is not less than 20%;
Described Radix Sophorae Flavescentis extract is the alkaloid that Radix Sophorae Flavescentis dry root extracts;
Described Herba Sophorae alopecuroidis extract is the alkaloid that Herba Sophorae alopecuroidis rhizome extracts;
Described Radix Glycyrrhizae extract is that the root of Radix Glycyrrhizae or rhizome extract the extract that the main component obtained is glycyrrhizic acid and enoxolone.
10. the application of the pharmaceutical composition being used for the treatment of skin pruritus disease described in any one of claim 1 ~ 9 in treatment skin pruritus disease, preferred described skin pruritus disease is by mosquito bite or contact exogenous anaphylactogen and cause.
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| CN201510944032.1A CN105362351A (en) | 2015-12-16 | 2015-12-16 | Medicine composition for treating cutaneous pruritus disease and application thereof |
| PCT/CN2016/109958 WO2017101790A1 (en) | 2015-12-16 | 2016-12-14 | Pharmaceutical composition for treating cutaneous pruritus and use thereof |
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| CN108404201A (en) * | 2018-04-27 | 2018-08-17 | 泰州市榕兴医疗用品股份有限公司 | A kind of anti-bacterial, anti-itching dressing and preparation method thereof containing tea oil |
| CN108578466A (en) * | 2018-07-06 | 2018-09-28 | 兰州大学第医院 | A kind of ointment for treating beriberi and tinea pedis foot odour |
| CN110870886A (en) * | 2018-08-31 | 2020-03-10 | 西南民族大学 | Application of perilla in preparing product for treating skin pruritus and/or eczema and composition thereof |
| CN110693832A (en) * | 2019-10-12 | 2020-01-17 | 嘉应学院 | Cinnamomum camphora extract microemulsion gel and preparation method thereof |
| CN112675093A (en) * | 2021-01-11 | 2021-04-20 | 广东成烨泰生物科技有限公司 | Plant scalp care composition, scalp care solution and preparation method thereof |
| CN113081928A (en) * | 2021-04-29 | 2021-07-09 | 云南赛森生物科技有限公司 | Plant bacteriostatic gel and preparation method and application thereof |
| CN113081928B (en) * | 2021-04-29 | 2023-06-06 | 云南赛森生物科技有限公司 | Plant antibacterial gel and preparation method and application thereof |
| CN115607608A (en) * | 2022-09-09 | 2023-01-17 | 贵州大学 | Compound pepper ointment and preparation method thereof |
| CN115607608B (en) * | 2022-09-09 | 2023-11-28 | 贵州大学 | Compound Chinese prickly ash ointment and preparation method thereof |
| CN116407587A (en) * | 2023-05-19 | 2023-07-11 | 北京中医药大学 | A Chinese medicinal composition for treating insect bite, and its preparation method |
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|---|---|
| WO2017101790A1 (en) | 2017-06-22 |
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