CN108785383A - A kind of antibacterial gynecology externally used pharmaceutical combination and the preparation method and application thereof - Google Patents
A kind of antibacterial gynecology externally used pharmaceutical combination and the preparation method and application thereof Download PDFInfo
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- CN108785383A CN108785383A CN201810973297.8A CN201810973297A CN108785383A CN 108785383 A CN108785383 A CN 108785383A CN 201810973297 A CN201810973297 A CN 201810973297A CN 108785383 A CN108785383 A CN 108785383A
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- 239000001632 sodium acetate Substances 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/13—Coniferophyta (gymnosperms)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/234—Cnidium (snowparsley)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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- A—HUMAN NECESSITIES
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- A61P33/00—Antiparasitic agents
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a kind of antibacterial gynecology externally used pharmaceutical combination and the preparation method and application thereof, described pharmaceutical composition includes the substance of following parts by weight：1-10 parts of Chinese yew extract, 1-10 parts of Baical Skullcap root P.E, 0.5-5 parts of shrubby sophora extract, 0.5-5 parts of common cnidium fruit P.E.Application of the present invention includes different dosage forms, and the dosage form includes the Chinese medicine composition and pharmaceutically acceptable carrier composition, and the dosage form is lotion, gelling agent, vagina effervescence.The antibacterial gynecology externally used pharmaceutical combination of the present invention, using Chinese yew as monarch drug in a prescription, using radix scutellariae as ministerial drug, assistant is with frutus cnidii, kuh-seng, both ensure that compound traditional Chinese medicine composite antibacterial and anti-inflammation functions, at the same can also removing damp-heat, desinsection be antipruritic, mass dissipating and swelling eliminating, improve drug effect, reduce cure time, quality of making the life better.The present invention has preparation process simple, and drug quality is uniform and stable.
Description
Technical field
The present invention relates to gynecologic medicine technical field more particularly to a kind of antibacterial gynecology externally used pharmaceutical combination and its preparations
Method and application.
Background technology
Gynaecological imflammation is the most common disease of women, is primarily referred to as the inflammation of female sex organs, a variety of organs of women are all
Acute and chronic inflammation can occur, specifically include female vulva inflammation, vaginitis, cervicitis, pelvic infecton；Again may be used according to pathogen
To be divided into colpomycosis, bacterial vaginitis and trichomonas vaginitis, there is incidence is high, radical cure is difficult, easily recurs etc.
Feature.
With living-pattern preservation, the factors such as work rhythm quickening, immunity degradation cause gynaecological imflammation incidence to be held
It is continuous soaring, and be in rejuvenation trend.Gynaecological imflammation not only influences women daily life, but also can endanger with itch, burning heat sensation
Health, or even involve household.
The administering mode for the treatment of gynaecological imflammation is divided into injection, oral and external application at present, due to injecting and taking orally toxic side effect
Big and action is slow, and patient is more likely to use topical drug.Topical drug is divided into as Chinese patent drug, chemical drug and Chinese and Western medicament mixture.Chemical drug
Mainly antibiotics, this kind of medicine antibacterial anti-inflammatory effects clearly, it is quick, but depend on unduly resistance to caused by antibiotic
Pharmacological property can increase treatment difficulty, and the complication to gynaecological imflammation and to no effect；Chinese patent drug is prepared by pure Chinese medicine extraction,
Complicated component, fungistatic effect are difficult to control；Chinese and Western medicament mixture be add suitable chemical drug on the basis of Chinese patent drug, this ensure that
Fungistatic effect, but the problem of still suffer from drug resistance.
Documents 1：Application No. is " CN201310233570.0 ", a kind of entitled " medicine for treating gynaecological imflammation
Compositions " are related to a kind of pharmaceutical composition for treating gynaecological imflammation, with taxus active extract, camphor, peppermint oil
For raw material, it is prepared together with pharmaceutical acceptable carrier as matrix.Pharmaceutical composition provided by the invention can both improve red
The comprehensive utilization value of beans China fir, while the anti-inflammatory effects of pharmaceutical composition obtained are more excellent.However there are red beans in the composition
The China fir drawback undesirable to gram-positive bacteria inhibition, cannot treat gynaecological imflammation complication, drug effect is to be improved substantially.
Invention content
It is an object of the invention to overcome the defect of the prior art, a kind of antibacterial gynecology externally used pharmaceutical combination is provided,
It using Chinese yew as monarch drug in a prescription, helps with Chinese medicines such as radix scutellariae, frutus cnidii, kuh-sengs, that is, ensure that compound traditional Chinese medicine composite antibacterial anti-inflammatory is made
With, at the same can also removing damp-heat, desinsection be antipruritic, mass dissipating and swelling eliminating, improve drug effect, reduce cure time, quality of making the life better, tool
Body, using radix scutellariae as ministerial drug, the Chinese yew drawback undesirable to gram-positive bacteria inhibition is overcome, ensure that drug
Bacteriostasis property；Using kuh-seng, frutus cnidii as adjutant, auxiliary treatment gynaecological imflammation complication improves drug effect, accelerates recovery from illness.
The invention is realized in this way：
It is an object of the present invention to provide a kind of antibacterial gynecology externally used pharmaceutical combinations, under described pharmaceutical composition includes
The substance of row parts by weight：1-10 parts of Chinese yew extract, 1-10 parts of Baical Skullcap root P.E, 0.5-5 parts of shrubby sophora extract, frutus cnidii carries
Take 0.5-5 parts of object.
The second object of the present invention is to provide a kind of preparation method of antibacterial gynecology externally used pharmaceutical combination, including as follows
Step：
Step 1 takes the Chinese yew, radix scutellariae, kuh-seng and frutus cnidii respectively, is crushed after drying；
Step 2, the herb powder hot water extraction obtained by step 1, obtain the leaching liquor of different Chinese medicines；
Step 3 merges corresponding medicinal plant extraction obtained by step 2, is concentrated in vacuo, up to described after concentrate is spray-dried
Antibacterial gynecology externally used pharmaceutical combination.
The third object of the present invention is to provide dosage form prepared by the pharmaceutical composition, it includes the medicine group
Object and pharmaceutically acceptable carrier are closed, the dosage form is lotion, gelling agent, vagina effervescence, emulsion, cream, tincture, dew
Agent, liniment, plastics or spray.
Preferably, the lotion includes the material composition of following parts by weight：8-15 parts of the pharmaceutical composition, menthol
0.1-0.5 parts, 0.1-0.5 parts of borneol, 1-3 parts of ethyl alcohol.
Preferably, the gelling agent includes the material composition of following parts by weight：0.5-1.4 parts of the pharmaceutical composition,
0.05-0.2 parts of menthol, 0.05-0.2 parts of borneol, 0.5-1 parts of gel-type vehicle, 1-5 parts of ethyl alcohol.
Preferably, the vagina effervescence includes the material composition of following parts by weight：5-10 parts of the pharmaceutical composition,
25-35 parts of gas-producing disintegrant, 20-30 parts of filler, 1-5 parts of glidant, 0.2-0.6 parts of lubricant, 24-32 parts of adhesive.
Activity is as follows the effect of each primary raw material medicine in the present invention：
1, Chinese yew：Also known as Japanese yew.The branches and leaves of Chinese yew are used as medicine, and taste micro-sweet, is put down at hardship, there is dispersing swelling and dissipating binds, promoting menstruation diuresis etc.
Effect, the accumulation of Zhu Zhi wei lumps in the abdomen, oedema, the diseases such as difficult urination, arthralgia pain due to rheumatism.《Compendium of Materia Medica》Recording it has treatment cholera, typhoid fever
And toxin expelling and other effects.Modern traditional Chinese medicine finds to make it rich in bearing taxanes, polysaccharide, flavones, sequoyitol etc. in Chinese yew
Has the effects that antitumor, immunological regulation, anti-inflammatory, sterilization, antiviral, antirheumatic, hypoglycemic.
(1) anti-inflammatory is antibacterial：Contain a large amount of tannin in Chinese yew, which has antibacterial, antiinflammation, in air
A variety of harmful bacterias it is inhibited, to ephritis, hepatitis, gastritis, enteritis, sphagitis, gynaecological imflammation, prostatitis, hemorrhoid
Sore, rheumatoid etc. have the therapeutic effect of highly significant；
(2) immunity is improved：More than the 90 kinds of effective ingredient containing needed by human body in Chinese yew, can improve human body it is immune,
Anti-virus ability.Not only play the role of to hyperglycemia person it is hypoglycemic, to hypertension, hyperlipidemia, blood viscosity height, nephrosis, hepatopathy, pain
Through and other effects also highly significant, can especially reduce Urine proteins loss, human body natural functions is made to restore, immunity enhancing will be each
Kind disease is all eliminated among rudiment；
(3) antioxidant：Japanese yew fruit is given birth to rich in the several mineral materials such as Taxol-protein and calcium, phosphorus, iron and a variety of dimensions
Plain substance, best the having to find so far, which resists, natural anti-oxidation (anti-aging) substance plant；
(4) cancer preventing and treating：There is the taxol contained in southerm yew unique anticancer mechanism and higher anticancer to live
Property, the breeding of cancer cell can be prevented, inhibit the migration of tumour cell, and without apparent adverse reaction, it is to work as today to be recognized
The clinical research proof of most important anti-cancer active matter in right drug field, the U.S. has treatment outstanding to ovary and breast cancer
Effect.In addition, also having certain effect to hypertension, diabetes, coronary heart disease；
2, radix scutellariae：Root is used as medicine, bitter, cold in nature, there is heat-clearing and damp-drying drug, purging intense heat and detonicating, hemostasis, tocolysis and other effects.Cure mainly warm
Disease, the infection of the upper respiratory tract, cough with lung heat, neonatal jaundice caused by dampness-heat, pneumonia, dysentery, hemoptysis, hot eyes, fetal irritability, hypertension, carbuncle swells furuncle
The diseases such as sore.Radix scutellariae decoction has inhibition to make Escherichia coli, staphylococcus, Candida albicans, shigella dysenteriae, Candida albicans etc.
With researcher also found that its decocting liquid has inhibiting effect to some specific inflammatories.
3, kuh-seng：Root is used as medicine, bitter, cold in nature.There is the effect of heat-clearing and damp-drying drug, desinsection is antipruritic, diuresis.For hot dysentery, have blood in stool,
Jaundice renal shutdown, leukorrhea with reddish discharge, swelling of vulva pruritus vulvae, eczema, wet sore, pruitus, mange leprosy, the diseases such as trichomonas vaginitis.Kuh-seng
Decoction has obvious inhibiting effect to shigella dysenteriae, staphylococcus aureus, Escherichia coli, tubercle bacillus etc..Trichomonas the moon is controlled outside
Road is scorching.
4, frutus cnidii：Fruit medicine, acrid flavour, hardship are warm-natured.With eliminating dampness wind-dispelling, desinsection is antipruritic, warming kidney and enhancing body and other effects.
For pruritus vulvae, mange, eczema itch, impotence, Gong Leng, morbid leucorrhoea duye, arthritis with fixed pain caused by dampness lumbago；The outer vaginal eczema, pruritus vulvae, trichomonas controlled
Vaginitis.
Compared with prior art, the invention has the advantages that and effect：
1, a kind of antibacterial gynecology externally used pharmaceutical combination provided by the invention, using Chinese yew as monarch drug in a prescription, using radix scutellariae as
Ministerial drug overcomes the Chinese yew drawback undesirable to gram-positive bacteria inhibition, ensure that drug bacteriostasis property；Chinese yew
The compounds such as peculiar yew amylose and Chinese yew flavones have anti-oxidant, raising immunity and other effects, can also promote vagina bacterium
Group's balance；Using kuh-seng, frutus cnidii as adjutant, auxiliary treatment gynaecological imflammation complication improves drug effect, accelerates recovery from illness.Both can have
Effect kills germ, Anti-Puritic and insecticidal, moreover it is possible to safeguard that vagina acid-base balance, removing damp-heat, desinsection be antipruritic, mass dissipating and swelling eliminating.Suitable for thin
Gynaecological imflammation caused by the pathogenic original such as bacterium, fungi, protozoon.
2, a kind of antibacterial gynecology externally used pharmaceutical combination provided by the invention is to Escherichia coli, staphylococcus aureus, withered
Careless bacillus, Candida albicans all have stronger inhibiting effect, and the minimum inhibitory concentration to staphylococcus aureus is only
0.8mg/ml, the minimum inhibitory concentration to Escherichia coli are only 1.6mg/ml, only to the minimum inhibitory concentration of bacillus subtilis
For 1.6mg/ml, the minimum inhibitory concentration to Candida albicans is only 0.8mg/ml；Antibacterial gynaecology external-use drug provided by the invention
Four kinds of components in compositions cooperate, synergistic so that it is to Escherichia coli, staphylococcus aureus, withered grass bud
Spore bacillus, Candida albicans minimum inhibitory concentration substantially reduce, bacteriostasis rate greatly increases.
3,1-10 parts of Chinese yew extract in Pharmaceutical composition of the present invention, 1-10 parts of Baical Skullcap root P.E, kuh-seng extraction
0.5-5 parts of object, 0.5-5 parts of common cnidium fruit P.E, each component is reasonable distribution in being formulated：Most of gynaecological imflammation be by
Caused by flora imbalance, it is top priority to kill pathogenic bacteria, maintain intravaginal colony balance, and inventor has selected biocidal property
Extraordinary Chinese yew extract is as main bacteriostatic agent, it is contemplated that Chinese yew extract is to blue by the leather of representative of Escherichia coli
Family name's negative bacterium inhibition is poor, so selecting to inhibit the preferable radix scutellariae of Escherichia coli effect as auxiliary bacteriostatic agent.Gynaecology is scorching
Disease is accompanied by the complication such as vulva and pruritus of vagina, cusalgia, redness, so inventor selects frutus cnidii and kuh-seng as auxiliary
Medication, to heat-clearing and damp-drying drug, desinsection is antipruritic, and removing toxic substances analgesic, anti-corrosion detumescence, can greatly make the life better quality.
4, in the preparation method of pharmaceutical composition provided by the invention, the effective elements of the medicine in individually extracting first, individually
Extraction can formulate different extraction temperatures and time according to the performance of Chinese medicine, it is ensured that when extraction in each traditional Chinese medicine ingredients effectively at
Divide and be not excessively impaired, while ensuring that extraction degree maximizes, reduces raw material dosage, reduce cost.Secondly, using spray drying
Method, can guarantee that extract is uniformly dispersed, be to ensure that different effective component of chinese medicine are sufficiently mixed preparing preparation, be conducive to make
At when pharmaceutical preparation active ingredient it is evenly dispersed, improve the antibacterial and anti-inflammation functions of pharmaceutical composition；The Chinese yew of offer is extracted
Object is water-soluble extractive, and the residue after extraction is still used to extract taxol, can improve the utilization rate of Chinese yew and economic effect
Benefit.
Specific implementation mode
The formula of 1 antibacterial gynecology externally used pharmaceutical combination of embodiment
One, the exploration of antibacterial gynecology externally used pharmaceutical combination ingredient
(1) extract of effective component of chinese medicine is prepared
Chinese medical extract is prepared as follows：1. after Chinese yew, kuh-seng, radix scutellariae and frutus cnidii drying, powder is respectively adopted
Broken machine crushes, and obtains Chinese medicine powder, and the control of powder diameter is 60-80 mesh；2. taking Chinese medicine powder respectively, 5 times of inventory is added
Water extracted；3 times, each 5h are extracted, extract of Chinese traditional medicine is obtained, Extracting temperature is to be adjusted according to different Chinese medicines
It is whole；It is concentrated 3. the extract of Chinese traditional medicine that step 2 obtains is driven into circulating vacuum concentration tank, controls 80 DEG C of thickening temperature, very
Reciprocal of duty cycle 0.008MPa when the density of concentrate reaches 1.0g/mL, stops concentration；4. by 120 DEG C of step 3 gained concentrate, spraying
It is dry, obtain corresponding Chinese medical extract.
(2) antibacterial experiment in vitro strain selects
Bacillus subtilis (ATCC 6633), Escherichia coli (ATCC 35218), staphylococcus aureus (ATCC
29213), Candida albicans (ATCC 10231)
(3) prepared by bacteriostatic agent
Precision weighs each 512mg of Chinese yew, radix scutellariae, frutus cnidii, shrubby sophora extract respectively, and being dissolved in water (can be added dropwise a small amount of
DMSO dissolutions solution), with 10mL volumetric flask constant volumes, shake up the Chinese medicine extract up to a concentration of 51.2mg/mL, bacteriostatic agent is only for working as
It is used.
(4) preparation of bacteria suspension
It takes 2 generation nutrient agar slopes cultures of experimental bacteria a little, is seeded in 5ml fluid nutrient mediums, suspension is made,
36 ± 1 DEG C culture 18~for 24 hours after, bacteria suspension is diluted to 0.5 Maxwell than the fluid nutrient medium with double concentration by turbidimetry
Bacterium solution is diluted to 5 × 105~5 × 106cFu/mL, this bacterium solution was used only for the same day.
(5) detection of minimum inhibitory concentration
48 sterile test tubes are taken, 4 groups of parallel tests are equally divided into, are numbered.Take first group of sterile test tube (13 × 100mm) 12
Branch, is arranged in a row, and the Chinese yew extracting solution of a concentration of 51.2mg/mL, No. 2 Guan Zhongjia water 1mL, mixing is added in No. 1 and No. 2 pipes
Uniformly after, draw 1mL to No. 3 pipe in, if method dilutes successively, No. 11 Guan Jiashui 1mL, at this time 1~No. 11 each pipe drug concentration according to
It is secondary be 51.2,25.6,12.8,6.4,3.2,1.6,0.8,0.4,0.2,0.1,0mg/mL,.Then it is added in 11 test tubes
Each 1mL of the bacteria suspension prepared is stated, is shaken up.1st pipe to the 11st pipe drug concentration is respectively 25.6,12.8,6.4,3.2,1.6,
0.8,0.4,0.2,0.1,0.05, blank broth bouillons negative control the most is added in 0mg/mL, No. 12 pipes.In 37 DEG C of insulating boxs
Culture for 24 hours, after culture, observes culture medium, record fluid nutrient medium does not occur the muddy antibacterial agent concentration of minimum, as
Minimal inhibitory concentration.
(6) radix scutellariae, frutus cnidii and kuh-seng minimum inhibitory concentration measurement result in accordance with the law
Chinese yew, radix scutellariae, four kinds of bacteriums of frutus cnidii and kuh-seng pair minimum inhibitory concentration the results are shown in table below：
Tetra- kinds of Chinese medicinal material extract minimum inhibitory concentrations (mg/mL) of table 1-
It is tested by the MIC of four kinds of Chinese medical extracts it is found that Chinese yew, radix scutellariae, frutus cnidii and shrubby sophora extract have centainly
Biocidal property, but the biocidal property of Chinese yew and radix scutellariae is apparently higher than frutus cnidii and kuh-seng.Wherein Chinese yew extract is to withered grass
Bacillus, staphylococcus aureus and Candida albicans have extraordinary biocidal property, but to Escherichia coli (Gram-negative
Bacterium) inhibition is poor, and radix scutellariae is preferable to the inhibition of Escherichia coli.
In addition, inventor using MIC value as index, has also investigated Cortex Phellodendri, hundred steps, rough gentian, pericarpium zanthoxyli, alum, rhizoma atractylodis etc. ten
The biocidal property of multiple gynecological Chinese medicinal material extract, in addition to pericarpium zanthoxyli, the biocidal properties of other Chinese medicines cannot reach Chinese yew and
The level of Baical Skullcap root P.E, but find that pericarpium zanthoxyli carries when the experiment of progress rabbit vagina mucous membrane irritation using pericarpium zanthoxyli as composition of medicine
Object is taken to have certain irritation, so Chinese yew and Baical Skullcap root P.E are as antipathogenic composition.
Two, the exploration of antibacterial gynecology externally used pharmaceutical combination content
Table 2
As shown in Table 2, experimental group 4 is 6 parts of Chinese yew extract, 4 parts of Baical Skullcap root P.E, 2 parts of shrubby sophora extract, frutus cnidii
It is optimum proportioning when 2 parts of extract.
By the selection and collocation result of the above pharmaceutical composition it is found that antibacterial gynecology externally used pharmaceutical combination provided by the invention
In four kinds of components cooperate, it is synergistic so that it is to Escherichia coli, staphylococcus aureus, bacillus subtilis, white
The minimum inhibitory concentration of color candida albicans substantially reduces, and bacteriostasis rate greatly increases.
Most of gynaecological imflammation is caused by flora imbalance, kills pathogenic bacteria, maintenance intravaginal colony balance is
Top priority, inventor have selected the extraordinary Chinese yew extract of biocidal property as main bacteriostatic agent, it is contemplated that Chinese yew carries
Take object to poor as the Gram-negative bacteria inhibition of representative using Escherichia coli, so selection inhibits Escherichia coli effect preferable
Radix scutellariae as auxiliary bacteriostatic agent.
Gynaecological imflammation is accompanied by the complication such as vulva and pruritus of vagina, cusalgia, redness, so inventor selects frutus cnidii
With kuh-seng as adjuvant drug, to heat-clearing and damp-drying drug, desinsection is antipruritic, removing toxic substances analgesic, and anti-corrosion detumescence can greatly make the life better
Quality.
Embodiment 2：The preparation of antibacterial gynecology externally used pharmaceutical combination
One, the investigation of extraction process
1, inventor has investigated solid-liquid ratio (1 by orthogonal test:5,1:10,1:15), Extracting temperature (50 DEG C, 60 DEG C, 70
DEG C, 80 DEG C), extraction time (1,2,3) proposes the influence for extracting recovery rate and extract biocidal property in conjunction with extraction cost
The extraction process of economical and efficient, i.e. solid-liquid ratio 1:5, it extracts in three times；Extracting temperature, Chinese yew Extracting temperature is 60 DEG C, yellow
The Extracting temperature of a kind of reed mentioned in ancient books, frutus cnidii and kuh-seng is 75 DEG C.
Two, individually extraction and mixing are extracted to antibacterial influence
1, the preparation process of Chinese yew, kuh-seng, radix scutellariae and common cnidium fruit P.E：1. Chinese yew, kuh-seng, radix scutellariae and frutus cnidii
After drying, pulverizer crushing is respectively adopted, obtains Chinese medicine powder, the control of powder diameter is 60-80 mesh；2. taking traditional Chinese medicine powder respectively
Material, the water that 5 times of inventory is added are extracted；3 times, each 5h are extracted, extract of Chinese traditional medicine is obtained, Extracting temperature is according to not
It is adjusted with Chinese medicine；It is concentrated 3. the extract of Chinese traditional medicine that step 2 obtains is driven into circulating vacuum concentration tank, control is dense
80 DEG C, vacuum degree 0.008MPa of contracting temperature when the density of concentrate reaches 1.0g/mL, stops concentration；4. by dense obtained by step 3
120 DEG C of contracting liquid, spray drying obtain corresponding Chinese medical extract；Gained Chinese medical extract is pressed into Chinese yew again：Kuh-seng：Radix scutellariae：Snake
Machine tool (6:4:2:2) ratio is uniformly mixed, spare.
2, Chinese yew, kuh-seng, radix scutellariae and frutus cnidii composite extract preparation process：1. by Chinese yew, kuh-seng, radix scutellariae and
Frutus cnidii presses 6:4:2:2 ratio mixing, is crushed with pulverizer, obtains Chinese medicine powder, and the control of powder diameter is 60-80 mesh；②
Chinese medicine powder is taken, the water that 5 times of inventory is added is extracted；3 times, each 5h are extracted, extract of Chinese traditional medicine, extraction temperature are obtained
Degree is 80 DEG C；It is concentrated 3. the extract of Chinese traditional medicine that step 2 obtains is driven into circulating vacuum concentration tank, controls thickening temperature 80
DEG C, vacuum degree 0.008MPa when the density of concentrate reaches 1.0g/mL, stops concentration；4. by step 3 gained concentrate 120
DEG C, spray drying obtains compound Chinese medicine extract.
3, the Chinese medical extract for taking two kinds of technique to obtain measures two kinds of extracts to withered by MIC methods of testing shown in comparative example 1
Careless bacillus (ATCC 6633), Escherichia coli (ATCC 35218), staphylococcus aureus (ATCC 29213), white are read
Pearl bacterium (ATCC 10231) minimum inhibitory concentration is as a result as follows：
Two kinds of compound Chinese medicine extract minimum inhibitory concentrations (mg/mL) of table 3-
By test result it is found that Chinese medicine remixes extract obtained biocidal property after indescribably taking be apparently higher than mixing extraction
Extract, therefore select Chinese medicine you can well imagine take after the mode that remixes.It extracts respectively and the ratios such as carries out after different traditional Chinese medicinal components
The mixing of example, anti-microbial property is better than raw material is blended after the Chinese medical extract that extracts, this is primarily due to be soaked respectively
The content of various traditional Chinese medicine ingredients can more accurately be controlled by carrying so that the effect between Chinese medicine highlights, and increases Chinese medicine
Drug effect.Also, due to the presence of drug matching effect, the antibacterial gynecology externally used pharmaceutical combination being prepared can also play difference
Respectively exclusive performance can be treated such as removing damp-heat, Anti-Puritic and insecticidal because of complication caused by gynecological disease Chinese medicine.
The preparation of 3 lotion of embodiment
Prepare the extract of effective component of chinese medicine, 8-15 parts of pharmaceutical composition, 0.1-0.5 parts of menthol, borneol 0.1-0.5
Part, 1-3 parts of ethyl alcohol.
As one of embodiment of above, 14 parts of pharmaceutical composition (6 parts of Chinese yew extract, 4 parts of Baical Skullcap root P.E, snake
2 parts of machine tool extract, 2 parts of shrubby sophora extract), 0.1 part of menthol, 0.1 part of borneol, 2 parts of ethyl alcohol.
It operates according to the following steps：
(1) after Chinese yew, radix scutellariae, kuh-seng and frutus cnidii drying, pulverizer crushing is respectively adopted, obtains Chinese medicine powder,
The control of powder diameter is 60-80 mesh；
(2) 10 parts of Chinese medicine powders are taken respectively, and the water that 5 times of inventory is added is extracted；3 times, each 5h are extracted, is obtained
The Extracting temperature of extract of Chinese traditional medicine, 60 DEG C of the Extracting temperature of Chinese yew, radix scutellariae, kuh-seng and frutus cnidii is 80 DEG C；
(3) the corresponding extract of Chinese traditional medicine for obtaining step (2), is driven into circulating vacuum concentration tank and concentrates, and control is dense
80 DEG C of contracting temperature (Chinese yew is 60 DEG C), vacuum degree 0.008MPa when the density of concentrate reaches 1.0g/mL, stop concentration；
(4) by corresponding 120 DEG C of spray drying of Chinese medicine concentrate obtained by step (3), corresponding Chinese medical extract is obtained.
(5) the antibacterial gynecology externally used pharmaceutical combination of lotion is prepared：The appropriate water dissolution of Chinese medical extract, by borneol, thin
Lotus brain is dissolved in ethanol in proper amount, mixing, and solution adds water to adjust to 100mL, and pH 5.5-6.5 are adjusted to lactic acid, stands, and filtration is gone out
Bacterium dispenses to obtain the final product.
The preparation of 4 gelling agent of embodiment
1, the operation that the extract of effective component of chinese medicine is prepared using embodiment 3, is prepared Chinese yew extract, radix scutellariae
Extract, shrubby sophora extract and common cnidium fruit P.E.
2, gel preparation is prepared
The raw material of the gel preparation includes 0.5-1.4 parts of pharmaceutical composition, 0.05-0.2 parts of menthol, borneol 0.05-0.2
Part, 0.5-1 parts of gel-type vehicle, 1-5 parts of ethyl alcohol.
As one of embodiment of above, 0.6 part of Chinese yew extract, 0.4 part of Baical Skullcap root P.E, shrubby sophora extract 0.2
Part, 0.2 part of frutus cnidii extraction, 0.05 part of borneol, 0.05 part of menthol, 0.5 part of Acritamer 940 (gel-type vehicle), 2 parts of ethyl alcohol.
Specific method is：It takes Acritamer 940 to be added appropriate water-swellable, after colloid, hydrochloric acid is added and is adjusted to pH 2.3-2.5；It is added four
Kind Chinese medical extract, borneol, ethyl alcohol, stir evenly, then sodium hydroxide solution is gently drained in above-mentioned solution to pH 5.5-
6.5, adjustment total amount of liquid is 100mL, is mixed thoroughly, sterilizes, dispenses to obtain the final product.
The preparation of 5 effervescent agent of embodiment
This prepares the operation of the extract of effective component of chinese medicine using embodiment 3, and Chinese yew extract, radix scutellariae is prepared
Extract, shrubby sophora extract and common cnidium fruit P.E.
The vagina effervescence includes the material composition of following parts by weight：5-10 parts of the pharmaceutical composition, effervesce collapses
Solve 25-35 parts of agent, 20-30 parts of filler, 1-5 parts of glidant, 0.2-0.6 parts of lubricant, 24-32 parts of adhesive.
The gas-producing disintegrant is made of organic bronsted lowry acids and bases bronsted lowry, specially one kind or several in citric acid, tartaric acid, fumaric acid
Kind is formed with sodium carbonate or sodium bicarbonate.
The common filler of vagina effervescence has starch, microcrystalline cellulose, dextrin etc..
Typical binders have hydroxypropyl methylcellulose (having frothing function concurrently) aqueous solution, mannitol etc.
Lubricant is divided into water-soluble and two class of water-insoluble, common soluble oil include Macrogol 4000 or
6000, dodecyl sodium sulfate, Stepanol MG, L-Leu, sodium benzoate, enuatrol, sodium chloride, sodium acetate, boron
Acid etc.；Common water-insoluble lubricant includes magnesium stearate, talcum powder, superfine silica gel powder, sucrose fatty ester, stearoyl richness horse
Sour sodium etc..
The antibacterial gynecological external use drug composition includes 3 parts of Chinese yew extract, 2 parts of Baical Skullcap root P.E, shrubby sophora extract 1
Part, 1 part of common cnidium fruit P.E, 30 parts of microcrystalline cellulose (filler), 25.5 parts of mannitol (adhesive), (effervesce collapses citric acid
Solve agent) 10 parts, 20 parts of sodium bicarbonate (gas-producing disintegrant), 5 parts of povidone (glidant), 0.5 part of magnesium stearate (lubricant).It will
Chinese medical extract, mannitol and sodium bicarbonate are uniformly mixed to obtain mixture 1, then microcrystalline cellulose and citric acid are uniformly mixed
Mixture 2；It is separately added into the aqueous solution of povidone in mixture 1 and 2, pelletizes；It is dry, whole grain；Two groups of dry particls are mixed, are added
Enter magnesium stearate, mixing, tabletting.
The bacteria resistance function of 1 antibacterial gynecology externally used pharmaceutical combination of experimental example is tested
(1) selection of strain
Selection extracorporeal bacteria inhibitor test strain be respectively：Escherichia coli (ATCC 35218), staphylococcus aureus (ATCC
And Candida albicans (ATCC 10231) 29213).Escherichia coli, staphylococcus aureus in the present invention and Candida albicans
It is purchased from Nat'l Pharmaceutical & Biological Products Control Institute.
(2) carrier quantitation sterilization experiment
It presses《Disinfection technology standard》The requirement of (version in 2002) carrier quantitative germicidal test, takes the antibacterial of the gel of above-mentioned preparation
Gynecology externally used pharmaceutical combines, and acts on 5min, 10min, 60min, as a result see the table below：
Table 4
Preparation (lotion of embodiment 3, the gel of embodiment 4, reality prepared by the present invention is can be seen that from 4 test result of table
Apply the vagina effervescence of example 5) there is quick sterilization performance, can efficient sterilizing in a short time, and can be antibacterial for a long time.It needs
Illustrate, the other embodiment (unlisted) in the formula range in this present invention in embodiment 3- embodiments 5 can be real
Existing same or analogous technique effect, repeats no more herein.
2 toxicological experiment of experimental example
1, toxicological experiment is carried out to experimental animal using the preparation of embodiment 3- embodiments 5, test result is as follows：
Table 5
2, the preparation using embodiment 3- embodiments 5 is can be seen that experimental animal safety from the experimental result of table 5
Height has preferable application prospect.
It is described be only presently preferred embodiments of the present invention, be not intended to limit the invention, it is all the present invention spirit and
Within principle, any modification, equivalent replacement, improvement and so on should all include within protection scope of the present invention.
Claims (10)
1. a kind of antibacterial gynecology externally used pharmaceutical combination, which is characterized in that described pharmaceutical composition includes the object of following parts by weight
Matter：1-10 parts of Chinese yew extract, 1-10 parts of Baical Skullcap root P.E, 0.5-5 parts of shrubby sophora extract, 0.5-5 parts of common cnidium fruit P.E.
2. antibacterial gynecology externally used pharmaceutical combination as described in claim 1, which is characterized in that described pharmaceutical composition is by following
The material composition of parts by weight：4-8 parts of Chinese yew extract, 2-6 parts of Baical Skullcap root P.E, 1-3 parts of shrubby sophora extract, frutus cnidii extraction
1-3 parts of object.
3. antibacterial gynecology externally used pharmaceutical combination as described in claim 1, which is characterized in that described pharmaceutical composition is by following
The material composition of parts by weight：6 parts of Chinese yew extract, 4 parts of Baical Skullcap root P.E, 2 parts of shrubby sophora extract, 2 parts of common cnidium fruit P.E.
4. dosage form prepared by any pharmaceutical compositions of claim 1-3, it is characterised in that：It includes claim 1-3
Any pharmaceutical composition and pharmaceutically acceptable carrier, the dosage form are lotion, gelling agent, vagina effervescence, breast
Agent, cream, tincture, distillate medicinal water, liniment, plastics or spray.
5. dosage form as claimed in claim 4, which is characterized in that the lotion includes the material composition of following parts by weight：Right
It is required that any 8-15 parts of the pharmaceutical compositions of 1-3,0.1-0.5 parts of menthol, 0.1-0.5 parts of borneol, 1-3 parts of ethyl alcohol.
6. dosage form as described in claim 1, which is characterized in that the gelling agent includes the material composition of following parts by weight：Power
Profit requires any 0.5-1.4 parts of the pharmaceutical compositions of 1-3,0.05-0.2 parts of menthol, 0.05-0.2 parts of borneol, gel base
0.5-1 parts of matter, 1-5 parts of ethyl alcohol.
7. dosage form as described in claim 1, which is characterized in that the vagina effervescence includes the substance group of following parts by weight
At：Any 5-10 parts of the pharmaceutical compositions of claim 1-3,25-35 parts of gas-producing disintegrant, 20-30 parts of filler help stream
1-5 parts of agent, 0.2-0.6 parts of lubricant, 24-32 parts of adhesive.
8. a kind of preparation method of antibacterial gynecology externally used pharmaceutical combination as described in any one of claims 1-3, which is characterized in that
Include the following steps：
Step 1 takes the Chinese yew, radix scutellariae, kuh-seng and frutus cnidii respectively, is crushed after drying；
Step 2, the herb powder hot water extraction obtained by step 1, obtain the leaching liquor of different Chinese medicines；
Step 3 merges corresponding medicinal plant extraction obtained by step 2, is concentrated in vacuo, up to the antibacterial after concentrate is spray-dried
Gynecology externally used pharmaceutical combination.
9. the preparation method of antibacterial gynecology externally used pharmaceutical combination as claimed in claim 8, which is characterized in that the step 2
In, extraction hot water addition is 5-15 times of inventory；Extraction carries out for 1 time or more；Extraction temperature is 60-100 DEG C；Extraction time
For each 1h or more.
10. the preparation method of antibacterial gynecology externally used pharmaceutical combination as claimed in claim 8, which is characterized in that the step 3
In be concentrated into the density of concentrate and reach 0.9-1.1g/mL；The spray drying temperature is 100-150 DEG C.
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