CN1270742C - Antiseptic Chinese medicine composition and its prepn process - Google Patents
Antiseptic Chinese medicine composition and its prepn process Download PDFInfo
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Abstract
The present invention relates to traditional Chinese drug composition with antibacterial action and a preparation method, the traditional Chinese drug composition is an oral preparation composed of pharmaceutic adjuvant and the active constituent extracts of scutellaria root, phellodendron, flavescent sophora root, honeysuckle, Chinese pulsatilla and hedyotis diffusa. The traditional Chinese drug composition of the present invention is guided by the theory of traditional Chinese drugs, has reasonable compatibility of drugs, thoroughly reserves effective constituents of each traditional Chinese drugs, combines a modern extraction and analysis technology, so that the effective constituents of the preparation can be control and the preparation has the advantages of stable quality and outstanding curative effects. The present invention is especially suitable for preparing a drug curing diseases at reproductive systems and urinary systems caused by the infections of mycoplasma and chlamydia.
Description
Technical field:
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Chinese medicine composition and preparation method with antibacterial action.
Background technology:
Mycoplasma and chlamydia can cause the multisystem disease of human body.In recent years, the sickness rate of nongonococcal urethritis NGU is rising, and especially chlamydia trachomatis CT and the caused NGU of ureaplasma urealyticum UU just receive much concern.According to external popular disease investigation, teenager women's CT infection rate accounts for 40%, and Japan protects that the positive rate that detects of cervix uteri and endometrium CT is 20-40% among the report pelvic inflammatory disease patient in 1988 such as Tian Renjie.China has since nineteen ninety-five carried out the mycoplasma genitalium separation and Culture and round pcr carries out quick diagnosis research, discovers that UU is quite high at China married woman cervix uteri and vagina carrying rate, is 33-75.8%.Because, the caused a series of diseases of urinary system infection such as chlamydia, as infertility etc., brought heavy influence for society and family.For many years, being extensive use of of Western medicine antibiotics brought a slim chance of survival to the patient.Yet the use lack of standardization of antibiotics clinically at present so that the generation of Resistant strain, makes the matter worse concerning vast, chlamydia infection person only not.To this, treat by traditional Chinese medical science traditional theory prescription clinically at present, obtain good curative effect, but, bring many inconvenience to the patient because prescription confusion is clinically used trouble.
Generally there is not anxious, the severe symptoms of onset that bacterial infection causes illness clinically by mycoplasma, the caused reproductive system of chlamydia infection, urinary system illness, it is mild symptoms often, has only sense of discomfort, even non-evident sympton, the course of disease is long, general antibiotic does not have obvious curative effects, and easily outbreak repeatedly, can cause other diseases such as infertility and habitual abortion.From the theory of Chinese medical science analysis, this is that pyretic toxicity is a trouble, holds the wet stasis of blood of holding under the arm under the arm.Its evil poison gathers in the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, and is strongly fragrant and generate heat, and forms the stasis of blood for a long time.Mechanism of qi is not made, and turbid yin is uneven and the state of an illness is touching does not heal.
Summary of the invention:
Technical problem to be solved by this invention is on the basis of theory of Chinese medical science, and reasonable formula provides a kind of determined curative effect, steady quality, the Chinese medicine composition with antibacterial action that side reaction is few.
Chinese medicine composition with antibacterial action disclosed by the invention, the oral formulations of forming by active ingredient extract and the pharmaceutic adjuvant of Radix Scutellariae, Cortex Phellodendri, Radix Sophorae Flavescentis, Flos Lonicerae, the Radix Pulsatillae and Herba Hedyotidis Diffusae.
The crude drug percentage by weight prescription of active ingredient extract of the present invention is 10-30% Radix Scutellariae, 10-30% Cortex Phellodendri, 8-15% Radix Sophorae Flavescentis, 10-30% Flos Lonicerae, the 10-30% Radix Pulsatillae and 10-30% Herba Hedyotidis Diffusae.
Pharmaceutic adjuvant of the present invention is a pharmaceutic adjuvant commonly used in the preparation of pharmaceutical formulations.
Oral formulations of the present invention is that medically acceptable various dosage forms comprise granule, capsule, tablet and oral liquid etc.
Radix Scutellariae nature and flavor medicine is cold in the active ingredient prescription of the present invention, rushes down the damp and hot monarch that is, book on Chinese herbal medicine is just said: " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs of the withered person of Radix Scutellariae; the heat of the cool part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of real person ", and book on Chinese herbal medicine is just being dredged and is being said: " Radix Scutellariae is so its property is clear respectful eliminating evil; thus flavor medicine dampness, so YIN-cold can win heat, so cure mainly heat clearing away ".So be monarch.
Cortex Phellodendri, can " continent second soil damp and hot, clear second wood strongly fragrant ..., and Radix Sophorae Flavescentis has dampness, the effect of wind dispelling insecticide, the two same ministerial drug.
The Flos Lonicerae sweet in the mouth is cold, kind removing toxic substances (" book on Chinese herbal medicine just "), and benefit (" book on Chinese herbal medicine meets the source ") is arranged in rushing down, and Radix Pulsatillae bitter in the mouth is thin again, closes the purport of gently dispersing clearly among the scripture, reach the purpose of heat clearing away repercussive, add the Herba Hedyotidis Diffusae eliminating damp, detoxifying, be all adjuvant, help Radix Scutellariae Cortex Phellodendri Radix Sophorae Flavescentis, reach heat-clearing and toxic substances removing, the effect of damp eliminating dissipating blood stasis.
The mutual compatibility of each crude drug of the present invention, mutually beneficial must citing.The all cold effect that heat clearing away is all arranged of this Six-element medicine property of medicine, simultaneously dry or hot damp eliminating function is arranged all again, hold on to the damp and hot etiology and pathogenesis of troubles that be, Compendium of Material Medica is said: " ... heat is wind; wet be fire also ... " play the effect of clearing heat and expelling damp, solution principal contradiction altogether.
A medicine has the multiple-effect function in this prescription simultaneously, can control the disease of holding concurrently, each property of medicine gentleness of while, and compatibility reaches the eliminating evil positive purpose of not hindering together.
Another technical problem to be solved by this invention is to provide the preparation method of above-mentioned Chinese medicine composition.
The preparation that the present invention has the Chinese medicine composition of antibacterial action comprises the following steps:
1, active ingredient extract preparation
By formula ratio Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are doubly measured the 50-80% alcohol reflux 2 times with 4-8, merging filtrate is standby, and medicinal residues add 6-10 times of water gaging with Cortex Phellodendri, Flos Lonicerae, Radix Sophorae Flavescentis and decoct secondary, get filtrate, merge twice filtrate, reclaim ethanol, be condensed into thick extractum;
2, formulation preparation
Get above-mentioned active ingredient extract, make various oral formulations according to a conventional method, preparation adopts thin layer chromatography to differentiate baicalin, chlorogenic acid, ursolic acid and matrine, measures content of baicalin with high-pressure liquid phase method, and control unit dose formulations content of baicalin is greater than 8mg.
The present invention has determined above-mentioned preparation method according to the characteristic of each crude drug:
Radix Scutellariae is the dry root of labiate Radix Scutellariae Scatellaria baicalensis Georgi.41 kinds of flavone compounds from Radix Scutellariae, have been found, wherein baicalin and wogonoside are the feature chemical constituent of Radix Scutellariae, this constituents is dissolved in hot water, ethanol, be insoluble to warm water and cold water, if with other medicine mix fry in shallow oil after, easily enter filter cake during filtration and be used as impurity and remove, lose bigger, and existing experimentation shows that when Radix Scutellariae and Cortex Phellodendri united extraction, the berberine in the Cortex Phellodendri, jateorhizine can generate the bigger water-insoluble of molecular weight with baicalin, wogonoside and separate out; Simultaneously, pharmacological evaluation proves that also precipitate truly has drug action.Therefore, Radix Scutellariae adopts ethanol extraction, and its residue is the method carried of water again.
The Radix Pulsatillae is the dry root of ranunculaceae plant Radix Pulsatillae Pulsatilla chinesis (Bge.) Regel.The master contains protoanemonin (protoanemonin), Anemonin (anemonin) etc., and these compositions are water insoluble, and extracting method is alcohol extraction usually, therefore adopts alcohol extraction, and the residue water is carried.
Herba Hedyotidis Diffusae is the herb of Rubiaceae (Rubiaceae) cerastium plant Herba Hedyotidis Diffusae Hedyotis diffusaWilid, mainly contain compositions such as ursolic acid, oleanolic acid, stigmasterol, flavonoid, experimental results show that compositions such as flavonoid, ursolic acid are soluble in organic solvents such as methanol, ethanol, ethyl acetate, its alcohol extraction efficient is apparently higher than water extraction, so Herba Hedyotidis Diffusae is adopted ethanol extraction, the method for residue reuse water extraction.
Cortex Phellodendri is the dry bark of rutaceae wampee Phellodendron chinense Schneid. or Cortex Phellodendri Phellodendron amurense Rupr..Main berberine, the jateorhizine etc. of containing belong to quaternary ammonium salt, water soluble.
Flos Lonicerae is that caprifoliaceae plant is born the dried drug flower bud of the Lonicera japoinca Thunb. of section, Flos Lonicerae Lonicera hypoglauca Miq., Flos Lonicerae Lonicera confusa DC. or hair style Radix Ophiopogonis Lonicera dasystyla Rehd. or the flower that band is just opened.The master contains chlorogenic acid, isochlorogenic acid and chlorogenic acid tetrem acyl compound etc., and dissolubility is good in water, is generally water extraction.
Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis Soophora flavescens Ait..Mainly contain multiple alkaloids such as matrine, oxymatrine and cytisine, all water-soluble.Its decoct (8%), water logging agent (1: 3) have in various degree inhibitory action external to some common skin fungus, 1% matrine all has obvious inhibitory action to dysentery bacterium, escherichia coli, Bacillus proteus, group B streptococcus and staphylococcus aureus, as seen its anti-inflammation effective ingredient is all water-soluble, and available water is extracted it.
Consider the complexity of compound medicine composition, in order to guarantee curative effect, make extraction process more reasonable effectively, the present invention is according to contained chemical constituent of medicine and pharmacological action thereof, carry out the Preliminary screening of extraction process, designed 7 different processes, and given mouse stomach, observed the antiinflammatory action of medicine with same dose.
Medicine antagonism H
+Due to the assay method of the OD value that increases of capillary permeability: get 100 of healthy kunming mices and divide equally 10 groups at random, press 3.0g/kg dosage respectively to the mouse stomach administration, the quiet notes 1% azovan blue normal saline solution 0.1ml/10g body weight of mouse tail vein after 1 hour after the administration, lumbar injection 0.6%HAc0.2ml/ only immediately, taking off cervical vertebra after 20 minutes puts to death, divide the washing abdominal cavity 2 times with the 10ml normal saline, suction pipe sucking-off cleaning mixture, centrifugal 15 minutes of 3000rpm, getting supernatant is 590nm place colorimetric determination absorbance in the ultraviolet spectrophotometer wavelength.The results are shown in following table 1.
The gained extractum drug effect result of the different extraction processes of table 1 (each prescription is all with identical recipe quantity designing unit)
| Title | Technology one | Technology two | Technology three | Technology four | Technology five | Technology six | Technology seven |
| Radix Scutellariae Cortex Phellodendri Radix Pulsatillae Herba Hedyotidis Diffusae Flos Lonicerae Radix Sophorae Flavescentis | All water is carried, extract each 2 hours altogether 2 times. | Whole 20% alcohol extractions, extract each 2 hours altogether 2 times. | Whole 50% alcohol extractions, extract each 2 hours altogether 2 times. | Whole 80% alcohol extractions, extract each 2 hours altogether 2 times. | The Radix Pulsatillae, the Herba Hedyotidis Diffusae alcohol extraction, extract 2 times, each 2 hours, medicinal residues merge other medicines water and carry, extract each 2 hours 2 times. | The Radix Pulsatillae, Herba Hedyotidis Diffusae alcohol extraction, medicinal residues discard, other medicines water is carried, extract each 2 hours 2 times. | The Radix Pulsatillae, Herba Hedyotidis Diffusae, the Radix Scutellariae alcohol extraction, extract 2 times, each 2 hours, medicinal residues merge other medicines water and carry, extract each 2 hours 2 times. |
| Pharmacodynamics antiinflammatory index OD value | 0.129 ± 0.0 25 | 0.137 ± 0.0 18 | 0.156 ± 0.0 21 | 0.164 ± 0.0 20 | 0.124 ± 0.020 | 0.139 ± 0.030 | 0.115 ± 0.034 |
From The above results as can be known, extraction process seven the bests, therefore the present invention determines square Chinese crude drug effective ingredient is divided into two extracting section, that is: Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are used ethanol extraction, and the residue after the three flavor medicine alcohol extractions extracts with decocting in water together with other three flavors medicine Cortex Phellodendri, Radix Sophorae Flavescentis and Flos Lonicerae again.
A technical problem more to be solved by this invention is to disclose above-mentioned Chinese medicine composition to treat by the application in mycoplasma, the caused reproduction of chlamydia infection, the diseases of urinary system medicine in preparation.
Treatment of the present invention is by mycoplasma, the caused disease of chlamydia infection, refer in particular to the nongonococcal urethritis that ureaplasma urealyticum (UU) and chlamydia trachomatis (CT) cause, comprise: the non gonococcal urethritis and the fulminant leucorrhagia with yellowish discharge of urine urgency-frequency short urination abdominal distention, gynecological diseases such as nonbacterial vaginitis adnexitis such as the uncomfortable companion of vagina inferior belly gas pain.
Carry out relevant pharmacodynamics test with Chinese medicinal composition capsules agent of the present invention (anti-clothing props up capsule):
One, experiment material
1, medicine
The anti-clothing of preparation of the present invention props up capsule, lactobionic acid azithromycin for injections 1.0g/ bottle, roxithromycin capsules, 150mg/ grain, dexamethasone tablet, 0.75mg/ sheet, hydrochlorothiazide tablet, 25mg/ sheet, APC (Aspirin Phenacetin and Caffeine) 0.5g/ sheet, injection gentamycin sulfate, 80,000 units/2ml.
2, experimental strain
Ureaplasma urealyticum (UU) type strain, ATCC27618, HSPH of Southeast China University provides.26 strain urogenital tract Ct bacterial strains pick up from patient by Hospital No.1 Attached to Zhongsha Medical Science Univ.'s department of dermatologry, separate through the MeCoy cell culture.
3, culture medium
UU culture medium, the Nanjing Tetramune company that newly creates, the import packing.The MeCoy cell is provided by immunity teaching and research room of Zhongshan Medical Univ..The RPMI1640 culture medium, Gibco company produces.
4, animal
Rat: SD, body weight 130～150g, ♀ ♂ half and half is provided by Chinese Academy of Sciences's Shanghai Experimental Animal Center.
Mice: ICR, body weight 13～15g, 18～22g, ♀ ♂ half and half is provided by Chinese Academy of Sciences's Shanghai Experimental Animal Center.
Two, method and result
1, bacteriostasis
1.1 external anti-UU test: with UU culture medium doubling dilution medicine to be checked and control drug, each hole amount of liquid medicine is 180ul on 96 hole polyethylene boards, and concrete drug level sees the following form.Every hole inoculum density is the UU culture 20ul of 104CCU, seals.Set up contrast of medicine background and positive and negative contrast simultaneously.Inoculation rearmounted 37 ℃, 5%CO
2In the incubator, observed result behind the 24-48h.The culture fluid color that reddens is that UU growth is positive, constant negative, illustrates that UU is suppressed, and highly diluted concentration is the minimum inhibitory concentration (MIC) of this bacterial strain in all negative holes, and repeated experiments 2 times is averaged.The results are shown in Table 2.Table 2 result shows that it is higher to the extracorporeal sensitivity of UU that anti-clothing props up capsule, and its MIC concentration is 7.81mg/ml.
Table 2, drug dilution concentration and result of the test
| Medicine | Concentration to be checked (mg/ml) | MIC (mg/ml) | |||||||||
| 250 | 125 | 62.5 | 31.25 | 15.62 | 7.81 | 3.91 | 1.95 | 0.98 | 0.49 | ||
| Anti-clothing props up capsule 1 | - | - | - | - | - | - | + | + | + | + | 7.81 |
Annotate: "+" expression UU growth, "-" expression UU is suppressed not growth.
1.2 external anti-CT test: at first with 10 times of dilution Ct bacterial strains, the dilution bacterium liquid of difference is inoculated in the preprepared monolayer MeCoy Tissue Culture Plate of 96 holes makes it under 37 ℃ of conditions, to cultivate 48h, make each hole produce 4.5 * 10 after the dyeing
3The greatest dilution of inclusion body quantity is a titration concentration.The 1st～11 hole adds the Ct type strain 50ul of above-mentioned titration concentration in forming 96 orifice plates of fine and close monolayer MeCoy cell then.This 96 orifice plate at room temperature centrifugal 1 hour rearmounted 37 ℃ of volume fractions of 2000g is 5%CO
2Hatched in the incubator 2 hours.Sop up supernatant then, with do not contain antibiotic nutritional liquid preparation by Concentraton gradient 125,62.5,31.3,15.6,7.81,3.9,1.96,0.98,0.49,0.25mg/ml the Chinese herbs decoction 100ul of totally 10 concentration add 2～11 holes respectively.The the 1st and the 12nd hole adds and does not contain antibiotic nutritional liquid, makes every hole liquid volume be 200ul.The positive contrast in the 1st hole, the negative contrast in the 12nd hole.Centrifugal 1 hour rearmounted 37 ℃ of volume fractions of 2000g are 5%CO under the entire plate room temperature
2Cultivated 48 hours in the incubator.Abandon supernatant at last, methanol is fixed, iodine staining, observed result under inverted microscope.The result judges: visible inclusion body is dyed pale brown color in cytoplasm under light microscopic, and mirror is answered the hole down and be there is no the minimal inhibitory concentration (MIC) of the minimum dilution factor of inclusion body for this Chinese medicine.Reference standard: when MIC≤7.81mg/ml crude drug concentration is higher sensitivity; When MIC is a medium sensitivity during in 7.81-125mg/ml crude drug concentration; When MIC＞125mg/ml crude drug concentration is insensitive.Trace cell culture method and micro-dilution method are measured the anti-clothing of Chinese medicine and are propped up capsule and matched group the MIC value of Ct is seen Table 3.Table 3 result shows: Ct antagonism clothing props up capsule and has higher sensitivity, its MIC≤3.91mg/ml; Ct is very responsive to contrast medicine azithromycin, MIC≤4ug/ml.
The active situation of the external desertification chlamydia oculogenitale of each medicine of table 3
| Chinese medicine | Drug level (mg/ml) | MIC (mg/ml) | ||||||||||
| 0.05 ug | 0.25 | 0.49 | 0.98 | 1.96 | 3.91 | 7.81 | 15.6 | 31.3 | 62.5 | 125 | ||
| Anti-clothing props up capsule | 0 | 0 | 0 | 2 | 16 | 24 | - | - | - | - | - | 0.98-3.91 |
| Azithromycin | 26 | - | - | - | - | - | - | - | - | - | - | - |
| Negative control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Annotate: this medicine of digitized representation repressed bacterial strain number under certain concentration in the table, "-" is non-minimum inhibitory concentration.
1.3 anti-CT test in the body: list of references is divided into six groups at random with animal: model group, normal control group, positive controls (Roxithromycin group), small dose group (1.5g/kg), middle dosage group (3.0g/kg) and heavy dose of group (5g/kg), 10 every group.Except that the normal control group, each treated animal is inoculated the 0.1mlCt inoculation liquid in intravaginal with asepsis injector, once a day, and continuous four days.Behind the zoogenetic infection the 5th day, each treated animal was pressed the gastric infusion of dosage shown in the table 4, once a day, and a continuous week.Observe animal external genital redness and secretions situation, one week the back put to death animal, cut open and get uterus, ovary etc. and do pathologic finding.The observation of symptoms of each treated animal after administration sees Table 4, and the animal pathological examination results sees Table 5.
The subjective symptom of each treated animal of table 4 after administration
| Group | Dosage g/kg | Red | Swollen | Secretions | |||
| After the infection | After the administration | After the infection | After the administration | After the infection | After the administration | ||
| The anti-clothing of negative control group model control group props up the Capsules On Anti clothing and props up the Capsules On Anti clothing and prop up capsule ROX group | - - 1.5 3 5 5×10 -2 | 0 8 7 8 8 7 | 1 7 2 1 2 1 | 0 9 7 7 7 7 | 0 7 2 2 1 1 | 0 9 5 6 6 6 | 0 7 1 0 0 0 |
Table 5 pathological examination results
| Group | Dosage (g/kg) | The uterus | Ovary | Kidney |
| The anti-clothing of negative control group model control group props up the Capsules On Anti clothing and props up the Capsules On Anti clothing and prop up capsule ROX group | - - 1.5 3 5 5×10 -2 | No abnormality seen 8 cases of uterine visible inflammatory cells infiltrate, the visible intimitis cellular infiltration of visible intimitis cellular infiltration 1 example of visible intimitis cellular infiltration 1 example of visible intimitis cellular infiltration 1 example of interstitial edema 3 examples | As seen Follicles (no abnormality seen) no abnormality seen no abnormality seen no abnormality seen no abnormality seen no abnormality seen | No abnormality seen no abnormality seen no abnormality seen no abnormality seen no abnormality seen no abnormality seen |
2, antiinflammatory action
2.1 to H
+The effect that induced mice abdominal cavity capillary permeability increases
Get 50 of healthy mices and divide equally 5 groups at random, press dosage shown in the table 6 respectively to the mouse stomach administration, the quiet notes 1% azovan blue normal saline solution 0.1ml/10g body weight of mouse tail vein after 1 hour after the administration, lumbar injection 0.6%HAc0.2ml/ only immediately, take off cervical vertebra after 20 minutes and put to death, divide washing abdominal cavity, suction pipe sucking-off cleaning mixture 2 times with the 10ml normal saline, centrifugal 15 minutes of 3000rpm, getting supernatant is 590nm place colorimetric determination absorbance in the ultraviolet spectrophotometer wavelength.The results are shown in Table 6: administration group abdominal cavity cleaning mixture absorbance is low than matched group, and significant difference (P＜0.01 or 0.05) is arranged.Pointing out anti-clothing to prop up capsule, obviously to suppress H+ induced mice abdominal cavity capillary permeability hyperfunction, and tangible anti-acute inflammation effect is arranged.
The anti-clothing of table 6 prop up capsule to HAc cause the mouse peritoneal capillary permeability increase effect (X ± S, n=10)
| Group | Dosage | Number of animals | Trap |
| (g/kg) | (only) | (OD value) | |
| NS | - | 10 | 0.134±0.060 |
| Anti-clothing props up capsule | 1.5 | 10 | 0.089±0.053 * |
| Anti-clothing props up capsule | 3.0 | 10 | 0.074±0.018 ** |
| Anti-clothing props up capsule | 4.5 | 10 | 0.066±0.014 ** |
| The APC sheet | 0.01 | 10 | 0.045±0.014 ** |
2.2 to the bullate influence of rat granuloma
Get 50 of body weight 130～150g healthy rats, ♀ ♂ half and half is divided into five groups at random, presses dosage shown in the table 7 respectively to the rat oral gavage administration, and matched group is given the normal saline of Isodose, once a day, and continuous 14 days.After administration the 3rd day, each treated animal ether inhalation anesthesia, the abdominal part iodine disinfection, ethanol takes off iodine.Cut the 1cm osculum along the rat ventrimeson, hold the ophthalmology tweezer autoclaving cotton balls (dripping gentamycin 0.2ml) of 20mg is implanted a side groin place, skin suture otch from cutting.1h after the last administration, the rat etherization is opened otch, takes out cotton balls, rejects fat, weighs, and in 60 ℃ of oven dry of baking oven, weighs again, deducts the former weight of cotton balls, promptly gets granuloma weight in wet base and dry weight.The results are shown in Table 7.Table 7 result shows that rat heeling-in cotton balls promptly had granuloma to form in 11 days, and anti-clothing props up in the capsule, heavy dose of group all can obviously alleviate granulomatous hypertrophy, has compared significant difference (P＜0.01 or 0.05) with the blank group.
The anti-clothing of table 7 prop up capsule to the bullate influence of rat granuloma (X ± S, n=10)
| Group | Dosage (g/kg) | Number of animals (only) | Granulation weight in wet base (g) | Granulation dry weight (g) |
| The blank group | - | 10 | 0.294±0.029 | 0.112±0.044 |
| Anti-clothing props up capsule | 1.5 | 10 | 0.256±0.057 | 0.090±0.012 |
| Anti-clothing props up capsule | 3 | 10 | 0.233±0.068 * | 0.075±0.023 ** |
| Anti-clothing props up capsule | 4.5 | 10 | 0.185±0.058 ** | 0.086±0.020 * |
| Dexamethasone group | 0.02 | 10 | 0.161±0.034 ** | 0.044±0.012 ** |
3, diuresis
Get 50 of body weight 160～180g rats, ♀ ♂ half and half, be divided into five groups at random, gently depress the abdominal bladder emptying before the test, every rat oral gavage gives 3ml/100g (body weight) normal saline, each group is pressed the gastric infusion of dosage shown in the table 8 simultaneously, matched group is given the normal saline of Isodose, puts into metabolic cage immediately, one in a cage, collected 0～2 hour, 2～4 hours and the urine amount (ml) of 4～6 hour three time period, carry out statistical analysis.The results are shown in Table 8.Table 8 result shows, anti-clothing props up large, medium and small dose of group of capsule all in various degree diuresis, after administration 2～4 hours more obvious, with matched group significant difference (P＜0.05) is arranged relatively.
The anti-clothing of table 8 prop up capsule to the influence of water load rat urine amount (X ± S, n=10)
| Group | Dosage (g/kg) | Number of animals (only) | Urine amount (ml) after the administration | ||
| 0～2 hour | 2～4 hours | 4～6 hours | |||
| The blank group | - | 10 | 2.93±0.87 | 1.35±0.81 | 1.08±0.36 |
| Anti-clothing props up capsule | 1.5 | 10 | 3.65±1.01 | 2.04±0.66 * | 1.15±0.75 |
| Anti-clothing props up capsule | 3 | 10 | 3.70±0.76 | 2.07±0.86 * | 1.17±0.50 |
| Anti-clothing props up capsule | 4.5 | 10 | 3.60±0.81 | 2.12±0.38 * | 1.21±0.44 |
| The hydrochlorothiazide group | 0.016 | 10 | 5.86±1.55 ** | 2.20±0.68 ** | 1.22±0.35 |
3, centralizing function
4.1 influence: get 50 of healthy qualified mices, body weight 14-18g, ♀ ♂ half and half to mouse thymus, spleen weight, be divided into 5 groups at random, press dosage shown in the table 9 respectively to the mouse stomach administration, matched group is given the normal saline of Isodose, once a day, continuous 10 days.1h takes off vertebra and puts to death animal and cut open and get thymus and spleen after the last administration, weighs immediately, calculates its organ index (g/10g body weight) and carries out statistical disposition, the results are shown in Table 9.Table 9 result shows that anti-clothing props up the big or middle dosage group of capsule can make thymus index obviously increase (P＜0.01 or 0.05), and its large, medium and small dosage group all has the effect (P＜0.01 or 0.05) of obviously increasing spleen index.
The anti-clothing of table 9 prop up capsule to the influence of mouse thymus, spleen weight (X ± S, n=10)
| Group | Dosage (g/kg) | Thymus index (g/Kg body weight) | Index and spleen index (g/kg body weight) |
| The normal control group | - | 1.77±0.55 | 4.66±1.34 |
| Anti-clothing props up capsule | 1.5 | 2.29±0.46 | 6.16±1.18 * |
| Anti-clothing props up capsule | 3.0 | 2.39±0.65 * | 6.19±0.83 * |
| Anti-clothing props up capsule | 4.5 | 2.80±0.55 ** | 6.43±2.04 ** |
| 30% Radix Ginseng group | 3 | 2.66±0.70 ** | 6.12±1.03 * |
4.2 influence to the mice carbon clearance: get 50 of healthy qualified mices, body weight 18～22g, ♀ ♂ half and half is divided into 5 groups at random, presses dosage shown in the table 10 respectively to the mouse stomach administration, and matched group is given the normal saline of Isodose, once a day, continuous 10 days.1h is in the india ink 0.1ml/10g of 5 times of every caudal vein injection NS dilutions after the last administration, and after injection 1,5min gets blood 20 μ l in the mouse orbit venous plexus, dissolves in 2ml 0.1%Na
2CO
3Shake up in the solution, with the reagent blank zeroing, in 670nm place colorimetric determination OD value.Take off vertebra and put to death animal and cut open and get the liver spleen, weigh immediately, press document
[6]Method calculating K and a value.The results are shown in Table 10.Table 10 result shows, anti-clothing props up all the be significantly improved effect of mice carbon clearance rate of each administration group of capsule, has compared significant difference (P＜0.01 or 0.05) with matched group, and the effect of anti-high immunologic function is promptly arranged.
The anti-clothing of table 10 prop up capsule to the influence of mice carbon clearance (X ± S, n=10)
| Group | Dosage (g/kg) | The K value | The a value |
| The normal control group | - | 0.021±0.011 | 5.07±0.72 |
| Anti-clothing props up capsule | 1.5 | 0.037±0.013 * | 6.44±0.86 ** |
| Anti-clothing props up capsule | 3.0 | 0.037±0.022 * | 6.74±0.90 ** |
| Anti-clothing props up capsule | 4.5 | 0.044±0.019 ** | 6.54±0.79 ** |
| 30% Radix Ginseng group | 3 | 0.045±0.017 ** | 7.60±0.91 ** |
Three, discuss
Nongonococcal urethritis (NGU) is common clinically infectious disease, is this with the deficiency of spleen and stomach, and damp-heat flowing down to the urinary bladder is mark, focuses on clearing away heat-damp and promoting diuresis in treatment.Anti-clothing props up capsule and has heat clearing away, dampness removing, antiinflammatory and centralizing function.Experimental result shows: the MIC concentration that anti-clothing props up outer anti-UU of capsule body and CT is respectively 7.81mg/ml and 3.91mg/ml, and the bacteriostatic test result shows that it has the mice urinary tract inflammation effect that obviously alleviates due to the CT in the body; Anti-clothing props up each dosage group of capsule all in various degree diuresis, after the administration 2-4 hour more obvious, with matched group significant difference (P＜0.05) is arranged relatively; Anti-clothing props up capsule to H
+Acute inflammation that induced mice abdominal cavity capillary permeability increases and the chronic inflammatory disease of granuloma induced by implantation of cotton pellets rat all have obvious facilitation; Anti-clothing props up the effect that capsule promotes mouse thymus, spleen growth in addition and increases mice carbon clearance rate.
Carry out acute toxicity test with Chinese medicine composition of the present invention:
Through 2 times on the one gastric infusions, all animals survived, recording mice antagonism clothing, to prop up capsular maximum dosage-feeding be 232g (living chrysanthemum)/kg, is equivalent to 774 times of clinical one day actual amount.
Carry out the rat long term toxicity test with Chinese medicine composition of the present invention:
Respectively with 25.9g (crude drug)/kg (body weight), 10.8g (crude drug)/kg (body weight), 4.5g (crude drug)/kg (body weight) carries out gastric infusion to rat, matched group gives the equal-volume distilled water, continuous 13 weeks, observe general situation every day, jede Woche is measured body weight 1 time.After 13 weeks of administration, put to death 10 animals for every group and carry out pathology, hematological examination, blood biochemistry checking.Continue to observe for 3 weeks after the drug withdrawal of residue animal (10 every group), carry out hematology, pathology and blood biochemistry checking once more.The result: activities in rats is normal, does not occur obviously unusual or dead; Hematological examination, blood biochemical are learned results such as inspection, routine urianlysis, pathological examination and shown: anti-clothing props up the capsule successive administration after 13 weeks, administration group spleen index is compared obviously with matched group and is increased (P＜0.01), in, heavy dose of group thymus index all increases (P＜0.01); After 3 weeks of drug withdrawal, each treated animal hematology, blood biochemical learn and check, the pathological examination index difference (P＞0.05) of comparing with matched group that there are no significant.Do not find the pathological change relevant, Chinese medicine composition safety non-toxic of the present invention is described with drug toxicity.
Chinese medicine composition of the present invention has fully kept the active ingredient of each medicine, and compatibility is reasonable, is guidance with the theory of Chinese medical science, combines modern extraction, analytical technology, makes the preparation active ingredient controlled, steady quality, determined curative effect.
The specific embodiment:
Embodiment 1,
Prescription
Radix Scutellariae 200g
Cortex Phellodendri 200g
Herba Hedyotidis Diffusae 200g
Flos Lonicerae 200g
Radix Sophorae Flavescentis 140g
Radix Pulsatillae 200g
Make 1000
Method for making
Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are measured 70% alcohol reflux 2 times with 6 times, each 2 hours, filter, merging filtrate is standby, and medicinal residues add 8 times of water gagings with Cortex Phellodendri, Flos Lonicerae, Radix Sophorae Flavescentis and decoct secondary, each 2 hours, filter, get filtrate, merge twice filtrate, reclaim ethanol, be condensed into thick extractum, 60 ℃ of drying under reduced pressure, pulverize, adding starch is an amount of, makes 1000 capsules, that is, every capsules contains baicalin 8mg.
Embodiment 2,
Prescription
Radix Scutellariae 120g
Cortex Phellodendri 240g
Herba Hedyotidis Diffusae 160g
Flos Lonicerae 200g
Radix Sophorae Flavescentis 140g
Radix Pulsatillae 140g
Make 1000
Method for making
Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are measured 55% alcohol reflux 2 times with 8 times, and each 2 hours, filter, merging filtrate is standby, medicinal residues add 7 times of water gagings with Cortex Phellodendri, Flos Lonicerae, Radix Sophorae Flavescentis and decoct secondary, and each 2 hours, filter, get filtrate, merge twice filtrate, reclaim ethanol, be condensed into thick extractum, drying under reduced pressure, pulverize, adding starch is an amount of, granulates, drying, granulate, tabletting, coating is made 1000 tablets, promptly.
Embodiment 3,
Prescription
Radix Scutellariae 112g
Cortex Phellodendri 72g
Herba Hedyotidis Diffusae 60g
Flos Lonicerae 40g
Radix Sophorae Flavescentis 36g
Radix Pulsatillae 80g
Make 1000ml
Method for making
Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are measured 67% alcohol reflux 2 times with 5 times, and each 2 hours, filter, merging filtrate is standby, medicinal residues add 6 times of water gagings with Cortex Phellodendri, Flos Lonicerae, Radix Sophorae Flavescentis and decoct secondary, each 2 hours, filter, get filtrate, merge twice filtrate, reclaim ethanol, be condensed into thick extractum, add sucrose 200g, benzoic acid is received 3g, stir evenly, adding distil water is made into 1000ml again, cold preservation 24 hours, filter, embedding, sterilization is promptly.
Embodiment 4, assay
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica, and methanol-water-phosphoric acid (47: 53: 0.2) is a mobile phase, and the detection wavelength is 280nm, and number of theoretical plate calculates by the baicalin peak should be not less than 2500.
The preparation precision of reference substance solution takes by weighing at 4 hours baicalin reference substance of 60 ℃ of drying under reduced pressure an amount of, adds methanol and makes the solution that every 1ml contains 60～g, promptly.
10 of embodiment 1 capsules are got in the preparation of need testing solution, and accurate the title decided porphyrize, get fine powder 0.2g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 25ml that adds, claim to decide weight, supersound extraction 60 minutes is placed to room temperature, claim to decide weight again, supply the weight that subtracts mistake, filter, get subsequent filtrate and promptly get need testing solution through 0.45 microporous filter membrane.
Algoscopy: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Every of this product contains baicalin (C
21H
18O
H) 8mg.
Embodiment 5, accelerated stability test
The capsule that sample: embodiment 1 makes
| Time (experiment date) standard code | 0 month | 1 month | 2 months | 3 months | |
| Project | The result | ||||
| Character | (brown particle, bitter in the mouth is little sweet) | Conformance with standard | Conformance with standard | Conformance with standard | Conformance with standard |
| Differentiate | (1) speckle unanimity (baicalin) (2) speckle unanimity (chlorogenic acid) (3) speckle unanimity (ursolic acid) (4) speckle unanimity (matrine) | The consistent speckle unanimity of the consistent speckle of the consistent speckle of speckle | The consistent speckle unanimity of the consistent speckle of the consistent speckle of speckle | The consistent speckle unanimity of the consistent speckle of the consistent speckle of speckle | The consistent speckle unanimity of the consistent speckle of the consistent speckle of speckle |
| Check | (1) moisture (%) 5.0% is with in interior (2) 30 minutes disintegrations | 5.8 it is up to specification | 6.0 it is up to specification | 6.1 it is up to specification | 5.9 it is up to specification |
| Assay | Every contains baicalin and must not be less than 8.0mg | 10.2mg | 10.4mg | 10.1mg | 10.3mg |
| Health examination | Antibacterial＜1000/g mycete＜100/g pathogenic bacterium must not detect demodicid mite alive and must not detect | 200 30 do not detect | 120 40 do not detect | 180 30 do not detect | 140 20 do not detect |
Conclusion:, show that capsule tumor of the present invention is stable according to sample stability experimental observation result.
Claims (6)
1, a kind of Chinese medicine composition with antibacterial action is characterized in that said composition is the oral formulations that the active ingredient extract that makes of 10-30% Radix Scutellariae, 10-30% Cortex Phellodendri, 8-15% Radix Sophorae Flavescentis, 10-30% Flos Lonicerae, the 10-30% Radix Pulsatillae and 10-30% Herba Hedyotidis Diffusae and pharmaceutic adjuvant are formed by crude drug percentage by weight proportioning.
2, Chinese medicine composition according to claim 1 is characterized in that wherein said oral formulations is granule, capsule, tablet or oral liquid.
3, the preparation method of Chinese medicine composition according to claim 1 is characterized in that the preparation of described Chinese medicine composition comprises the following steps:
(1) active ingredient extract preparation
By proportional quantity Radix Scutellariae, the Radix Pulsatillae and Herba Hedyotidis Diffusae are doubly measured the 50-80% alcohol reflux 2 times with 4-8, merging filtrate is standby, and medicinal residues add 6-10 times of water gaging with Cortex Phellodendri, Flos Lonicerae, Radix Sophorae Flavescentis and decoct secondary, get filtrate, merge twice filtrate, reclaim ethanol, be condensed into thick extractum;
(2) formulation preparation
Get above-mentioned active ingredient extract, make various oral formulations according to a conventional method.
4, the preparation method of Chinese medicine composition according to claim 3 is characterized in that described oral formulations adopts thin layer chromatography to differentiate baicalin, chlorogenic acid, ursolic acid and matrine, measures content of baicalin with high-pressure liquid phase method.
5, Chinese medicine composition according to claim 1 is treated by the application in mycoplasma, the caused reproduction of chlamydia infection, the diseases of urinary system medicine in preparation.
6, the application of Chinese medicine composition according to claim 5 is characterized in that wherein said reproduction, diseases of urinary system are meant the nongonococcal urethritis that ureaplasma urealyticum and chlamydia trachomatis cause.
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| US8818449B2 (en) | 2005-04-28 | 2014-08-26 | Blackberry Limited | Method and device for network selection in multiple access technologies |
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2003
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8818449B2 (en) | 2005-04-28 | 2014-08-26 | Blackberry Limited | Method and device for network selection in multiple access technologies |
| US9155033B2 (en) | 2005-07-01 | 2015-10-06 | Blackberry Limited | System and method for accelerating network selection by a wireless user equipment (UE) device |
| US8744443B2 (en) | 2006-05-19 | 2014-06-03 | Blackberry Limited | System and method for facilitating accelerated network selection using a weighted network list |
| US9119139B2 (en) | 2006-05-19 | 2015-08-25 | Blackberry Limited | System and method for facilitating accelerated network selection in a radio network environment |
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