CN102764330B - Medicine composition for treating cutaneous pruritus and preparation method thereof - Google Patents
Medicine composition for treating cutaneous pruritus and preparation method thereof Download PDFInfo
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Abstract
The invention provides a medicine composition for treating cutaneous pruritus and a preparation method of the medicine composition. The medicine composition is obtained by processing the traditional Chinese medicines and the western medicines and comprises sweet wormwood herb, periostracum cicada, flos lonicerae, fructus kochiae, radix sophorae flavescentis, fructus gardeniae, cortex phellodendri, radix scutellariae, ketoconazole and borneol. The medicine has the effects of sterilizing and relieving itching, thereby being good in treatment effect on cutaneous pruritus.
Description
[technical field]
The present invention relates to a kind of pharmaceutical composition and method for making thereof for the treatment of skin pruritus, it is made Chinese medicine and Western medicine through processing, belong to medical technical field.
[background technology]
Pruritus disease is the commonly encountered diseases of department of dermatologry, and main manifestations is for only having skin pruritus without constitutional skin lesion, and treatment is difficulty relatively, easily recurrence.Pruritus is one of main subjective symptoms of multiple dermatosis, and itching skin disease mainly comprises skin pruritus, neurodermatitis, papular urticaria, chronic eczema, tinea manus and pedis, scabies, prurigo nodularis and dermatitis aestivale etc.Because the itching skin disease cause of disease is complicated, inducement is more, is department of dermatologry common clinical, frequently-occurring disease, accounts for the more than 80% of Dermatology Outpatient Department patient, to patient, brings very big misery, and quality of life obviously declines.
China's most area is because of the multiple dermatosis of climate reasons, also easily makes original dermatosis increase the weight of.Under high hot weather, wind heat, perspiration drainage difficulty and summer another common disease-eczema etc. cause skin pruritus, due to pruritus, scratch, easily cause the infection of staphylococcus, streptococcus and fungus, skin pruritus increases the weight of, causes and fester.Clinical adopt for oral administration and external more, if the publication number Chinese patent " eczema external medicine composition " that is CN200810054324.8 is a kind of external medicine composition that is used for the treatment of the eczema due to damp and hot, be that to take Radix Sophorae Flavescentis, Cortex Phellodendri, Fructus Cnidii, Galla Chinensis, Herba Artemisiae Annuae, Flos Lonicerae, Borneolum Syntheticum, Alumen be raw material; Publication number is the Chinese patent " a kind of sterilizing and itch-relieving medicine for external use and preparation method thereof " of CN1537557, be a kind of Chinese medicine formula with sterilization, antiinflammatory, antipruritic function, by Dicranopteris dichotoma, Rhizoma Paridis, Rhizoma et radix veratri (Radix Rhizoma Veratri), Fructus seu radix camptothecae acuminatae (Fructus Camptothecae Acuminatae), angelica keiskei koidzumi, Herba Epimedii, Semen Vitis viniferae, Sanguis Draxonis, chitosan, glacial acetic acid, by certain weight proportion, adopt cell grade superfine powder technology and alcohol reflux extracting process to make; Doctor trained in Western medicine thinks that eczema is with irritated relevant, so be used for the treatment of irritated medicine, can be used for treating eczema.As some conventional antihistaminics, Cyproheptadine, hismanal etc., medicine for external use is mainly corticosteroid hormone ointment, as omcilon ointment, the happy ointment of skin, hydrocortisone butyrate ointment etc., but such medicine only can effectively suppress pruritus, and pruritus symptom easily recurs, need long-term prescription side effect obvious, human body skin is had to certain injury.
[summary of the invention]
Pharmaceutical composition of the present invention be by, Western medicine is that raw material forms, treating both the principal and secondary aspects of a disease, can reach better therapeutic effect.
One of object of the present invention be to provide a kind of take in, Western medicine is raw material, processing technique is simple, effective percentage is high, safe without toxic side effect and have the pharmaceutical composition of the treatment skin pruritus of sterilization, antipruritic function.
Another object of the present invention is to provide a kind of preparation method for the treatment of the pharmaceutical composition of skin pruritus.
Another object of the present invention is to provide the medical usage of aforementioned pharmaceutical compositions aspect treatment skin pruritus.
For achieving the above object, the invention provides a kind of pharmaceutical composition for the treatment of skin pruritus, comprise that the raw material of following weight parts is made:
60～100 parts of 60～100 parts of Fructus Kochiae of 30～50 portions of Flos Loniceraes of 60～100 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
60～100 parts of 60～80 parts of Radix Scutellariaes of 60～80 portions of Cortex Phellodendris of 60～100 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1～2 part of 1～2 part of Borneolum Syntheticum of ketoconazole.
More preferably, the raw material that comprises following weight parts is made:
70～90 parts of 70～90 parts of Fructus Kochiae of 35～45 portions of Flos Loniceraes of 70～90 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
70～90 parts of 65～75 parts of Radix Scutellariaes of 65～75 portions of Cortex Phellodendris of 70～90 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.2～1.8 parts of 1.2～1.8 parts of Borneolum Syntheticums of ketoconazole.
Best, the raw material that comprises following weight parts is made:
80 parts of 80 parts of Fructus Kochiae of 40 portions of Flos Loniceraes of 80 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
80 parts of 70 parts of Radix Scutellariaes of 70 portions of Cortex Phellodendris of 80 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.6 parts of 1.5 parts of Borneolum Syntheticums of ketoconazole.
The pharmaceutical composition for the treatment of skin pruritus of the present invention can be prepared as percutaneous drug delivery dosage form, take and is prepared into emulsifiable paste, ointment, liniment as best.
The preparation method of the pharmaceutical composition for the treatment of skin pruritus of the present invention, comprises the steps:
A) Herba Artemisiae Annuae, Flos Lonicerae are broken into coarse powder jointly, after soaking, with the volatile oil of extraction by steam distillation Herba Artemisiae Annuae, Flos Lonicerae, the another device of aqueous solution after distillation is collected;
B) get the medicinal residues after distillation in Periostracum Cicadae, the Fructus Kochiae, Radix Sophorae Flavescentis, Fructus Gardeniae, Cortex Phellodendri, Radix Scutellariae Six-element medical material and step a) and jointly decoct 2 times, decoct 3 hours for the first time with 8 times of water gagings, decoct 2 hours for the second time with 6 times of water gagings, collecting decoction, filters;
C) aqueous solution after the distillation that filtrate step b) being obtained and step a) obtain merges, and being concentrated into and in the time of 80 ℃, surveying relative density is 1.10～1.30 extractum;
D) get and after ketoconazole, Borneolum Syntheticum mix, carry out micronizing and become 100 orders, the extractum making with step c) mixes, and adds the volatile oil obtaining in step a);
E) add adjuvant to make the dosage form of clinical acceptance.
The application of pharmaceutical composition of the present invention in treatment skin pruritus medicine.
The present invention can directly act on affected part, can effectively kill staphylococcus aureus, escherichia coli, Candida albicans etc., elimination is festered because of skin bacterium, the skin pruritus that eczema, wind heat, sweat stain etc. cause, reach the effect of antiphlogistic and bactericidal, clearing heat and moistening dryness, removing damp to relieve itching, elimination abnormal flavour, and have have no side effect, the feature of instant effect, short treating period.
Specification requirement > > with reference to < < study of tcm new drug, pharmaceutical composition of the present invention has been carried out to Pharmacodynamics experiment, by In vitro Bactericidal Experiments method, observed the antibacterial action to penicillium, Xu shape Biao Pi Xian bacterium, Candida albicans, microsporon gypseum, Microsporum ferrugineum, staphylococcus aureus, staphylococcus epidermidis, escherichia coli and bacillus subtilis.
One, in-vitro antibacterial experiment
Test liquid: get the extractum 20g that does not add matrix composition, add 0.9% aseptic sodium chloride solution 100ml.Be diluted to 1:10 test liquid, standby.
Measure minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC):
With agar doubling dilution, measure MIC.In the serial agar plate surface dibbling antibacterial that contains test liquid, bacterium liquid ultimate density is 10
5cFU/ml, 18h are cultivated in 37 ℃ of aerobe, and 27 ℃ of funguses are cultivated 24h, and anaerobe is put 37 ℃ of anaerobism incubators and is hatched 48h, and having no the contained least concentration for reagent in the plate of bacterial growth is its minimal inhibitory concentration (MIC, mg/L).In experiment, with staphylococcus aureus, colon bacillus is made Quality Control bacterial strain.With meat soup doubling dilution, survey MIC, get again and have no bacterial growth pipe culture fluid 0.1ml in without medicine agar plate surface, with aseptic Glass rod, push away even, cultivation (condition is measured with MIC), still the lowest drug concentration without bacterial growth is its minimum bactericidal concentration (MBC), the results are shown in Table 1.
Table 1 antibacterial experiment result
As shown in Table 1, to testing 9 test strains such as staphylococcus aureus used, there is significantly antibacterial or bactericidal action.
The pharmaceutical composition for the treatment of skin pruritus of the present invention has significant antibacterial activity, and the sterilizing rate in 15～30 minutes is more than 90%.
Two, itching-relieving action experiment:
1, histamine phosphate is caused the impact of guinea pig skin pruritus
Get 60 of Cavia porcelluss, body weight 160～400g, male and female half and half, shave hair in first 1 day right back instep of experiment, are divided at random 6 groups, 10 every group.Dosage (120mg/ml), extractum high dose (240mg/ml), Triamcinolone Acetonide Acetate Urea ointment (positive controls) and distilled water negative control group in blank matrix group, extractum low dosage (60mg/ml), extractum.Precision takes histamine phosphate reference substance and is made into 0.01%, 0.02%, 0.03%, 0.04% with distilled water ... a series of concentration is standby.Respectively at shaving hair place, evenly smear corresponding medicinal liquid, distilled water 1ml/kg.Next day, with coarse sandpaper, abrade right back instep and shave hair place, the about 1cm of area
2, part repastes medicine 1 time, drips 0.01% histamine phosphate 0.05ml in last coating after 10 minutes at wound surface place, complies with 0.01%, 0.02%, 0.03%, 0.04% every 3 minutes later ... progressive concentration is 0.05ml at every turn.Until occur that Cavia porcellus later licks right back foot, take and finally occur that it is itch-threshold that Cavia porcellus later licks the right back histamine phosphate total amount being given when sufficient, the results are shown in Table 2.
The measurement result of the antipruritic threshold value of table 2 Cavia porcellus histamine phosphate
With model group comparison, * P < 0.05
Show that extractum basic, normal, high dosage group itch-threshold and matched group comparing difference all have significance, show that the basic, normal, high dosage group of extractum can obviously improve Cavia porcellus itch-threshold due to histamine, has obvious itching-relieving action.
2, dextran is caused the impact of mouse skin pruritus
60 of healthy mices, body weight 18～22g, male and female half and half, are divided into 6 groups at random by sex body weight.Be dosage (120mg/ml), extractum high dose (240mg/ml), Triamcinolone Acetonide Acetate Urea ointment (positive controls) and distilled water negative control group in blank matrix group, extractum low dosage (60mg/ml), extractum, during experiment, with 1% sodium sulfide, animal dorsal body setae is taken off, depilation skin region area is 1.5cm
2, after 2 days for experiment.6 depilation districts, treated animal back difference partial smearing relative medicines (1ml/kg) during experiment.Continuous 5 days, after last administration 30 minutes, each mouse tail vein injection dextran 0.95mg/kg.The mice fore paw of usining is scratched one's head, and trunk is scratched by portion, rear solid end, mouth is stung each position of whole body as pruritus indication, records mice pruritus number of times in 30 minutes, and group difference relatively, the results are shown in Table 3.
Table 3 dextran causes the comparison of skin pruritus mice pruritus number of times
With model group comparison, * P < 0.05, * * P < 0.01.
As shown in Table 3, the basic, normal, high dosage group of extractum can obviously reduce the attack times of the mice pruritus of dextran induction, and above-mentioned result of the test shows, this product has good antipruritic effect to skin pruritus.
Triamcinolone Acetonide Acetate Urea ointment: Tangshan Ji Chuan Pharmaceutical Li Kang pharmaceutical Co. Ltd (lot number 20091108)
Histamine phosphate: Chinese Academy of Sciences's Shanghai Biochemical Research is produced (lot number 20090514)
Dextran: Shanghai Long March rich people pharmaceutcal corporation, Ltd produces (lot number 20090316)
Three, clinical efficacy
1, data and method
1.1,120 patients, all from Chongqing City institute of traditional Chinese medicine Dermatology Outpatient Department, are divided into two groups at random, treatment group 60 examples, matched group 60 examples.Treatment group man 36 examples wherein, female's 24 examples, 15～72 years old age, the course of disease 5 days～10 years; Matched group man 36 examples, female's 24 examples, 16～74 years old age, the course of disease 7 days～10 years.Two groups of patients there was no significant difference (P>0.05) aspect age, sex, the course of disease and pruritus degree, has comparability.
Exclusion standard: oral antihistamine drug and external glucocorticoid ointment person in 1 week; Ulceration secondary infection person scratches in affected part; Not medication and timely further consultation person in accordance with regulations.
1.2, treatment group external ointment of the present invention, matched group external bufexamac ointment (Hunan Dino Pharmaceutical Co, 20090215), equal 2 times/day, evenly be applied to affected part and massage 2min, continuous use 1～4 week, further consultation is 1 time weekly, observe pruritus and improve degree and the skin lesion situation that disappears, evaluation curative effect.
1.3, observational technique first visit and the 1st, 2,3,4 weeks clinical symptoms and the sign of record patient respectively, observation index comprises pruritus degree and secondary skin lesion, by 4 grades of point systems, is undertaken: 0 is divided into without gargalesthesia, the skin lesion >90% that disappears; 1 is divided into slight pruritus, and skin lesion disappears 60%～90%; 2 are divided into moderate pruritus, and skin lesion disappears 20%～59%; 3 are divided into severe pruritus, the skin lesion <20% that disappears.Observe and record beginning and ending time and the order of severity of untoward reaction.
1.4, curative effect determinate standard is according to therapeutic index: before (before treatment after overall score-treatment overall score)/treatment, overall score x100% evaluates curative effect, cure: therapeutic index >=95%, effective: therapeutic index >=50%～94%, take a turn for the better: therapeutic index >20%～49% is invalid: therapeutic index <20%.Effective percentage adds effective note to cure.
1.5, statistical procedures application SPSS10.0 statistical software processes, and measurement data adopts t check, and enumeration data adopts X
2check.
2 results
2.1, before and after two groups of treatments, after two groups of patient treatments of integral contrast, all before treatment, take an evident turn for the better, in group, comparing difference all has statistical significance, in Table 4.
Skin lesion integration difference comparison before and after table 4 liang group patient treatment
The present invention is evident in efficacy to pruritus and secondary skin lesion.
2.2, the curative effect of two groups of patient's secondary skin lesion was treated after 4 weeks, and treatment group is compared difference with matched group have statistical significance (X
2=33.34, P<0.01), in Table 5.
The disappear comparison of degree of table 5 liang group patient secondary skin lesion
The total effective rate that pharmaceutical composition of the present invention disappears to secondary skin lesion is 83.3%.
Untoward reaction: do not observe serious adverse reaction.
[specific embodiment]
Embodiment 1 prepares extracting solution extractum
60 parts of 60 parts of Fructus Kochiae of 30 portions of Flos Loniceraes of 60 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
60 parts of 60 parts of Radix Scutellariaes of 60 portions of Cortex Phellodendris of 60 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1 part of 1 part of Borneolum Syntheticum of ketoconazole.
A) Herba Artemisiae Annuae, Flos Lonicerae are broken into coarse powder jointly, after immersion 1h, with steam distillation, extract the volatile oil of Herba Artemisiae Annuae, Flos Lonicerae, the another device of aqueous solution after distillation is collected;
B) get the medicinal residues after distillation in Periostracum Cicadae, the Fructus Kochiae, Radix Sophorae Flavescentis, Fructus Gardeniae, Cortex Phellodendri, Radix Scutellariae Six-element medical material and step a) and jointly decoct 2 times, with decocting 3 hours with 8 times of water gagings, with 6 times of water gagings, decoct 2 hours for the second time for the first time, collecting decoction, filtration;
C) aqueous solution after the distillation that filtrate step b) being obtained and step a) obtain merges, and is concentrated at 80 ℃ and surveys the extractum that relative density is 1.20;
D) get and after ketoconazole, Borneolum Syntheticum mix, carry out micronizing and become 100 orders, mix with above-mentioned extractum, and add volatile oil.
Embodiment 2 prepares extracting solution extractum
100 parts of 100 parts of Fructus Kochiae of 50 portions of Flos Loniceraes of 100 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
100 parts of 80 parts of Radix Scutellariaes of 80 portions of Cortex Phellodendris of 100 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
2 parts of 2 parts of Borneolum Syntheticums of ketoconazole.
Preparation method is with embodiment 1.
Embodiment 3 prepares extracting solution extractum
80 parts of 80 parts of Fructus Kochiae of 40 portions of Flos Loniceraes of 80 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
80 parts of 70 parts of Radix Scutellariaes of 70 portions of Cortex Phellodendris of 80 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.6 parts of 1.5 parts of Borneolum Syntheticums of ketoconazole.
Method for making is with embodiment 1.
Embodiment 4 prepares extract extractum
70 parts of 70 parts of Fructus Kochiae of 35 portions of Flos Loniceraes of 70 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
70 parts of 65 parts of Radix Scutellariaes of 65 portions of Cortex Phellodendris of 70 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.2 parts of 1.2 parts of Borneolum Syntheticums of ketoconazole.
Method for making is with embodiment 1.
Embodiment 5 prepares extract extractum
90 parts of 90 parts of Fructus Kochiae of 45 portions of Flos Loniceraes of 90 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
90 parts of 75 parts of Radix Scutellariaes of 75 portions of Cortex Phellodendris of 90 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.8 parts of 1.8 parts of Borneolum Syntheticums of ketoconazole.
Method for making is with embodiment 1.
The preparation of embodiment 6～10 ointment
The preparation of embodiment 11～15 emulsifiable pastes
Claims (6)
1. treat a pharmaceutical composition for skin pruritus, it is characterized in that the more excellent proportioning of described raw material is:
70～90 parts of 70～90 parts of Fructus Kochiae of 35～45 portions of Flos Loniceraes of 70～90 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
70～90 parts of 65～75 parts of Radix Scutellariaes of 65～75 portions of Cortex Phellodendris of 70～90 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.2～1.8 parts of 1.2～1.8 parts of Borneolum Syntheticums of ketoconazole.
2. a kind of pharmaceutical composition for the treatment of skin pruritus as claimed in claim 1, is characterized in that the best proportioning of described raw material is:
80 parts of 80 parts of Fructus Kochiae of 40 portions of Flos Loniceraes of 80 portions of Periostracum Cicadaes of Herba Artemisiae Annuae
80 parts of 70 parts of Radix Scutellariaes of 70 portions of Cortex Phellodendris of 80 portions of Fructus Gardeniaes of Radix Sophorae Flavescentis
1.6 parts of 1.5 parts of Borneolum Syntheticums of ketoconazole.
3. the pharmaceutical composition of the treatment skin pruritus as described in arbitrary claim in claim 1～2, is characterized in that described compositions is prepared as percutaneous drug delivery dosage form.
4. the pharmaceutical composition for the treatment of skin pruritus as claimed in claim 3, is characterized in that described compositions is prepared as emulsifiable paste, ointment, liniment.
5. the preparation method of the pharmaceutical composition of the treatment skin pruritus as described in arbitrary claim in claim 1～2, comprises the steps:
A) Herba Artemisiae Annuae, Flos Lonicerae are broken into coarse powder jointly, after soaking, with the volatile oil of extraction by steam distillation Herba Artemisiae Annuae, Flos Lonicerae, the another device of aqueous solution after distillation is collected;
B) get the medicinal residues after distillation in Periostracum Cicadae, the Fructus Kochiae, Radix Sophorae Flavescentis, Fructus Gardeniae, Cortex Phellodendri, Radix Scutellariae Six-element medical material and step a) and jointly decoct 2 times, decoct 3 hours for the first time with 8 times of water gagings, decoct 2 hours for the second time with 6 times of water gagings, collecting decoction, filters;
C) aqueous solution after the distillation that filtrate step b) being obtained and step a) obtain merges, and being concentrated into and in the time of 80 ℃, surveying relative density is 1.10～1.30 extractum;
D) ketoconazole, Borneolum Syntheticum superfine powder are broken into 100 orders, the extractum making with step c) mixes, and adds the volatile oil obtaining in step a);
E) add adjuvant to make the dosage form of clinical acceptance.
6. as the application of the pharmaceutical composition as described in arbitrary in claim 1～2 in treatment skin pruritus medicine.
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Denomination of invention: The invention relates to a pharmaceutical composition for treating skin pruritus and a preparation method thereof Effective date of registration: 20220307 Granted publication date: 20140219 Pledgee: Agricultural Bank of China Limited Chongqing Hechuan sub branch Pledgor: CHONGQING HILAN PHARMACEUTICAL Co.,Ltd. Registration number: Y2022500000010 |
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Denomination of invention: A pharmaceutical composition for treating skin itching and a preparation method thereof Effective date of registration: 20230309 Granted publication date: 20140219 Pledgee: Agricultural Bank of China Limited Chongqing Hechuan sub branch Pledgor: CHONGQING HILAN PHARMACEUTICAL Co.,Ltd. Registration number: Y2023500000019 |
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