CN101269192A - Chinese medicinal composition for treating gynaecologic inflammation and preparation thereof - Google Patents

Chinese medicinal composition for treating gynaecologic inflammation and preparation thereof Download PDF

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CN101269192A
CN101269192A CNA2007100136961A CN200710013696A CN101269192A CN 101269192 A CN101269192 A CN 101269192A CN A2007100136961 A CNA2007100136961 A CN A2007100136961A CN 200710013696 A CN200710013696 A CN 200710013696A CN 101269192 A CN101269192 A CN 101269192A
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谢晓涛
郭承军
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Abstract

The invention discloses a herbal composite and a preparation thereof for treating gynecological inflammation. The herbal composite is prepared of cotyledon, selinum, sophora, phellodendron, radix Stemonae, agrimonia, sanqi, borax, borneol; the weight ratios are that 3-15 portions of cotyledon, 3-15 portions of selinum, 3-15 portions of sophora, 2-10 portions of phellodendron, 2-10 portions of radix Stemonae, 2-10 portions of agrimonia, 0.2-2 portions of sanqi, 3.03-0.3 portion of borax, and 0.06-0.6 portion of borneol. The preparation can be suppository, gel, cream, solution agent, film, spray, effervescent tablets agent, and other externally used preparations. The invention adopts common herbal medicines as materials, the usage cost of a sufferer is lower, the content of the effective components are high, the stability is high, and the curative effect is notable. The herbal composite and the preparation of the invention can reduce fever, destroy the toxic properties, dry dampness, kill insect, remove rot, and produce fresh, can inhibit and kill pathogenic micro-organisms and infusorium, can improve the immunity of organism, can cure tickle and relieve pain, can accelerate metabolism, can promote the tissue to rebirth. The prescription is applicable for the sufferers with leukorrhea with reddish discharge, pruritus vulvae, cervical erosion, infusorium vaginitis, mucedine vaginitis, nonspecific vaginitis, etc.

Description

A kind of Chinese medicine composition and preparation thereof for the treatment of gynecological inflammation
1. technical field
The present invention relates to a kind of Chinese medicine composition and preparation thereof for the treatment of gynecological inflammation, belong to the pharmaceutical technology field.
2. background technology
Cervical erosion, trichomonal vaginitis, colpitis mycotica, nonspecific vaginitis are woman common diseases, sickness rate height, the course of disease are long, and how touching difficulty more, can show as uncomfortable during mild symptoms, leucorrhoea grow in quantity, pudendal pruritus, hyposexuality etc., the attention that does not cause the patient under a lot of situations can not get timely smelting treatment, and developing as one pleases, it is healthy to have a strong impact on.And current in clinical medicine commonly used chemical medicine many with to because of antifungal, anti-trichomonal, anti-inflammatory treatment, as metronidazole suppository, policresulen etc., chemical constituent is single, easily makes pathogenic microorganism produce drug resistance, causes primary disease to show effect repeatedly, and is difficult for many years.The preparation of making by Chinese medicine compound, be on clinical prescription being dispensed for many years basis, to simplify to form, add modern preparation process, make and be fit to the modern formulation that gynecological uses, traditional Chinese compound medicine has the characteristics of multicomponent, many target spots, treating both the principal and secondary aspects of a disease, though the more chemical medicine of onset is slow, the purpose that can play cures the disease digs up the roots, relapse rate is low.As the JIEERYIN XIYE of being used widely clinically etc., extensively be subjected to patient's favorable comment.But this type of compound Chinese medicinal preparation with better curative effect also seldom, can not satisfy clinical actual needs far away.
3. summary of the invention
The objective of the invention is to: for developing the advantage of compound Chinese medicinal preparation, satisfy the demand of extensive patients, invented a kind of Chinese medicine composition and preparation thereof for the treatment of gynecological inflammation, its preparation that can be made into has: suppository, gel, vagina effervescence, spray, unguentum, membrane and other are clinically or pharmaceutically acceptable any external preparation.
Through inventor's clinical practice and pharmacological testing for many years, filtering out by Herba Orostachyos, Fructus Cnidii, Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae, Herba Agrimoniae, Radix Notoginseng is that the compound Chinese medicinal preparation that principal agent is formed has curative effect preferably to the gynecological inflammation that the treatment a variety of causes causes, for obtaining clinical efficacy preferably, also can add an amount of Borax, Borneolum Syntheticum, to reach the purpose of better antipruritic, parasite killing, putrefaction removing.
The Herba Orostachyos sour in the mouth is flat, returns liver lung spleen channel, stops blooding, detoxifies, holds back skin ulcer; Fructus Cnidii acrid in the mouth, hardship, warm in nature, return kidney channel, warming the kidney to invigorate YANG, dampness, dispel the wind, parasite killing; The Radix Sophorae Flavescentis bitter in the mouth is cold in nature, GUIXIN liver stomach large intestine urinary bladder channel, heat clearing and damp drying, parasite killing; With Herba Orostachyos, Fructus Cnidii, Radix Sophorae Flavescentis three flavors is that monarch drug is to control primary symptom; Cortex Phellodendri property bitterness is cold, returns the kidney urinary bladder channel, and heat clearing and damp drying, pathogenic fire purging remove steams, detoxifies and treat skin ulcer; Radix Stemonae sweet in the mouth, hardship, tepor is returned lung meridian, nourishing the lung to keep the adverse QI downward cough-relieving parasite killing; Herba Agrimoniae bitter in the mouth, puckery, property is flat, GUIXIN Liver Channel, astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving detoxifcation; Three flavor medicines assist monarch drug to think ministerial drug jointly; Radix Notoginseng sweet in the mouth, little hardship, warm in nature, return liver stomach warp, dissipating blood stasis hemostasis, subduing swelling and relieving pain are with adjuvant drug; Borax and Borneolum Syntheticum can clearing away heat to alleviate pain, and again can perfume (or spice) scurrying has one's ideas straightened out is beneficial to all medicines and penetrates, the through disease messenger drug of doing.All medicine contracts hold heat clearing and damp drying altogether, detoxifcation parasite killing, the effect of antipruritic treatment pain.Modern study shows that Herba Orostachyos, Fructus Cnidii, Radix Sophorae Flavescentis, Cortex Phellodendri, Herba Agrimoniae, Borneolum Syntheticum all have antiinflammatory, resisting pathogenic microbes effect.Fructus Cnidii, Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae all have the effect of killing infusorian that presses down.And Radix Sophorae Flavescentis has anti-allergic effects, the generation of Cortex Phellodendri energy enhancing antibody, and the Radix Stemonae has antivirus action, and Fructus Cnidii has the local anaesthesia analgesic effect.Fructus Cnidii volatile oil has the fungicidal action of pressing down.Borneolum Syntheticum can be urged the division and the growth of neuroglia archeocyte.All medicines have share heat-clearing and toxic substances removing, removing dampness and killing parasites, and the effect of putrefaction removing and tissue regeneration promoting can reach to press down and kill pathogenic microorganism and infusorian, and human body immunity improving power is treated the pain relieving of itching, is quickened metabolism, promotes tissue new life's purpose.We can be used for leucorrhea with red and white discharge due to the damp invasion of lower energizer, pudendal pruritus; Cervical erosion, trichomonal vaginitis, colpitis mycotica, nonspecific vaginitis etc. see above-mentioned symptom person.
Through inventor's clinical practice for many years, each flavour of a drug weight proportion of the present invention all has clinical efficacy preferably in following scope:
8~10 parts of Herba Orostachyos, 8~10 parts of Fructus Cnidiis, 8~10 parts of Radix Sophorae Flavescentiss, 5~7 parts of Cortex Phellodendris, 5~7 parts of the Radixs Stemonae, 5~7 parts of Herba Agrimoniaes, 0.5~2 part of Radix Notoginseng.Can add an amount of Borax and Borneolum Syntheticum in addition.
Each flavour of a drug of the present invention can obtain best clinical efficacy when following weight proportion is arranged:
9 parts of Herba Orostachyos, 9 parts of Fructus Cnidiis, 9 parts of Radix Sophorae Flavescentiss, 6 parts of Cortex Phellodendris, 6 parts of the Radixs Stemonae, 6 parts of Herba Agrimoniaes, 1 part of Radix Notoginseng, 0.1 part of Borax, 0.2 part of Borneolum Syntheticum
The present invention can be obtained by following method, but can not be interpreted as that the present invention only limits to following preparation method:
Technology one: get seven flavor medicine materials such as Herba Orostachyos, Fructus Cnidii, Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae, Herba Agrimoniae, Radix Notoginseng, add 50%~80% alcohol reflux 1~3 time, merge extractive liquid,, reclaim ethanol and be concentrated into thick paste, oven dry gets dry extract, pulverize, cross 80 mesh sieves, as Chinese medicine extract.
Technology two: get seven flavor medicine materials such as Herba Orostachyos, Fructus Cnidii, Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae, Herba Agrimoniae, Radix Notoginseng, decoct with water collecting decoction 1~3 time, filter, be concentrated in right amount, add ethanol, make to contain amount of alcohol 50%~80%, the cold preservation standing over night, draw supernatant, reclaim ethanol and be concentrated into thick paste, oven dry, get dry extract, pulverize, cross 80 mesh sieves, as Chinese medicine extract.
Technology three: get three flavor medical materials such as Herba Orostachyos, Herba Agrimoniae, Fructus Cnidii and decoct with water secondary, each 1 hour, filter, filtrate is concentrated in right amount, adding ethanol makes and contains the alcohol amount to 60%~80%, and the cold preservation standing over night is drawn supernatant, reclaims ethanol and also is concentrated into thick paste, oven dry gets dry extract, and is standby; Other gets three flavor medical materials such as Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae and adds 50%~80% reflux, extract, secondary, and each 2 hours, filter, merging filtrate reclaims ethanol and is concentrated into thick paste, and oven dry gets dry extract, and is standby; Get pseudo-ginseng again, add 50%~80% reflux, extract, secondary, each 3 hours, filter, merging filtrate reclaims ethanol and is concentrated into thick paste, and oven dry gets dry extract, merges with above-mentioned two dry extracts, pulverizes, and crosses 80 mesh sieves, as Chinese medicine extract.
Technology four: get three flavor medical materials such as Herba Orostachyos, Herba Agrimoniae, Fructus Cnidii and add suitable quantity of water, soak after 30 minutes, connect volatile oil extractor, heating extraction volatile oil 3 hours is collected volatile oil, and device is deposited in addition, and is standby; Water liquid filters, and medicinal residues decoct with water secondary again, each 1 hour, filters, merge all filtrates and be concentrated in right amount, adding ethanol makes and contains the alcohol amount to 60%~80%, and the cold preservation standing over night is drawn supernatant, reclaim ethanol and be concentrated into thick paste, oven dry gets dry extract, and is standby; Other gets three flavor medical materials such as Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae and adds 50%~80% reflux, extract, secondary, and each 2 hours, filter, merging filtrate reclaims ethanol and is concentrated into thick paste, and oven dry gets dry extract, and is standby; Get pseudo-ginseng again, add 50%~80% reflux, extract, secondary, each 3 hours, filter, merging filtrate reclaims ethanol and is concentrated into thick paste, and oven dry gets dry extract, merges with above-mentioned two dry extracts, pulverizes, and crosses 80 mesh sieves, as Chinese medicine extract.
The present invention can make following clinical gynecological external use preparation commonly used, but only can not be interpreted as and can make following preparation.
The preparation of spray: get above-mentioned Chinese medicine extract, the water temperature heat that adds ormal weight makes dissolving fully, adds polyoxyethylene sorbitan monoleate, Borax, Borneolum Syntheticum, volatile oil, and an amount of antiseptic, filters, and sterilization, fill, promptly.
The preparation of suppository: get glycerol, gelatin prepares glycerol gelatin matrix, adds Borax then successively, adds above-mentioned Chinese medicine extract again, adds Borneolum Syntheticum, volatile oil at last, injects mold while hot, quenching is taken out, promptly.
The preparation of gel: get carbomer add the suitable quantity of water swelling fully after, regulate pH value to 7, it is an amount of to add polyoxyethylene sorbitan monoleate etc., make substrate,, slowly add in the substrate above-mentioned Chinese medicine extract and Borax, Borneolum Syntheticum, volatile oil, stirring makes mix homogeneously, makes gel, and packing promptly.
The preparation of effervescent tablet: get sodium bicarbonate and tartaric acid respectively as alkali source and acid source, volatile oil is with beta-cyclodextrin inclusion compound, Chinese medical concrete powder, lactose, Borax, Borneolum Syntheticum separated into two parts, granulate with 3% PVP ethanol solution respectively with alkali source and acid source, add dodecyl sodium sulfate, carbomer, magnesium stearate again, mixing, tabletting, promptly.
For the ease of better understanding the present invention at the medical value aspect the treatment gynecological inflammation, part pharmacology of the present invention and clinical test data are disclosed.
The experimental study of test example 1 antiinflammatory relevant, antipruritic, analgesia, antibacterial, insecticidal action with the present invention
Experimental apparatus and material
Medicine and reagent
We's lotion (every ml contains crude drug 2.4g approximately); FUFANG HUANGSONG XIYE (Yuan An Tang Pharmaceutical Co., Ltd., Guangxi); Histamine phosphate's (Nat'l Pharmaceutical ﹠ Biological Products Control Institute produces, and specification 25mg/ props up); Glacial acetic acid (Tianjin chemical industry all generations company limited); Dimethylbenzene, chemical pure (Tianjin chemical industry all generations company limited).
Strain Escherichia coli, staphylococcus aureus, first type hemolytic hammer, bacillus pyocyaneus and Candida albicans are reference culture.
80 of laboratory animal white mice, male and female half and half, body weight 18~22g; 40 of Wistar kind rat, male and female half and half, body weight 120~180g; 40 of albino guinea-pigs, male and female half and half. body weight 250~300g.
Experimental technique and result
Antiinflammatory action
The scorching experiment of Mice Auricle caused by dimethylbenzene xylene
It is blank group (distilled water group) that 40 mices are divided into four groups of A, B, C, D: A at random; B organizes positive matched group (FUFANG HUANGSONG XIYE group); C is the big concentration group of our lotion (100%); D is an our lotion small concentration group (30%).Every group 10, male and female half and half.Each Mus is coated with two sides, left ear front and back with the dimethylbenzene cotton balls, auris dextra is done contrast, cause scorching preceding 30min and embrocate corresponding medicine respectively, behind the 4h mice is put to death, ears downcut with the position, weigh, and are calculated as follows the swelling rate, swelling rate=((left auricle weight-auris dextra sheet is heavy)/auris dextra sheet is heavy) * 100% the results are shown in Table 1.Difference between comparative drug group and matched group, experimental result shows, originally can obviously suppress mice auricle swelling, effectively the caused mice of antagonism dimethylbenzene ear acute inflammation, and effect strengthens along with concentration and strengthens, and does not have significance with FUFANG HUANGSONG XIYE group contrast difference.
The influence of the our xylol induced mice of table 1 auricle edema
Figure A20071001369600061
The influence of the rat paw edema due to the on Carrageenan
40 rats are divided into four groups of A, B, C, D, the same method of grouping situation, 10 every group, male and female half and half at random.Respectively organize the normal ankle joint girth of rat right hind leg with moccasin chi mensuration before the experiment, 1h before the Yu Zhiyan embrocates corresponding medicine to each group rat right hind leg respectively.Behind the coating, 1% the carrageenin suspension of 0.1ml injected under the right back sufficient aponeurosis (aponeuroses) of rat cause inflammation, mensuration causes the right hind ankle joint girth of scorching back 1,2,4,6h, be calculated as follows the swelling rate, swelling rate=(girth before (cause scorching back girth-cause scorching before girth)/cause is scorching) * 100% the results are shown in Table 2.Experimental result shows, originally can suppress the rat carrageenan pedal swelling, and big concentration group is better than the small concentration group, and the rat acute inflammatory reaction that antagonism carrageenin effectively causes is described originally.
The influence of rat paw edema due to the our on Carrageenan of table 2
Figure A20071001369600062
Compare (F check) with the blank group: * *P<0.001
Itching-relieving action
40 of albino guinea-pigs are divided into four groups at random, the same method of grouping situation, 10 every group.The experiment proxima luce (prox. luc) is shaved hair to each right back instep of group Cavia porcellus, and coating is once tested when daily Coarse Mesh Gauze abrades right back instep and shaved hair place, area 1cm 2, till injuring epidermis, slight oozing of blood arranged.Once more coating once, matched group gives the distilled water of equivalent.10min behind the coating, beginning is only dripped 0.01% 0.05ml/ of histamine phosphate at wound surface, after this comply with 0.01%, 0.02%, 0.03%, 0.04% every 3min ... progressive concentration, only be 0.05ml/ at every turn, when Cavia porcellus occurs that later mouth is licked right foot, write down the total amount of the histamine that every Cavia porcellus gave, be itch-threshold with this total amount, and itch-threshold of relatively respectively organizing, the results are shown in Table 3.Experiment shows that we are big, and the concentration group can obviously improve the Cavia porcellus itch-threshold, compares with blank, and significant difference is arranged; The small concentration group also can improve the Cavia porcellus itch-threshold, and effect is weaker than big concentration group.This description of test we truly have itching-relieving action.
Table 3 we cause the influence of the reaction of itching to histamine phosphate
Group Number of animals (only) Itch-threshold (the total amount μ g of histamine phosphate) (X ± S) P
A 10 79.05±27.56
B 10 196.79±37.91 <0.01
C 10 301.10±38.59 <0.01
D 10 243.46±35.77 <0.01
Analgesic activity
40 of mices are divided into four groups at random, the same method of grouping situation, 10 every group.Except that positive controls lumbar injection 0.2% rotundine, the inherent abdominal part of all the other 3 groups of 30min is embrocated relative medicine 3 times, dosage all calculates by 0.1ml/10g, the equal lumbar injection 0.6% acetum 0.2ml/ of each Mus of 30min only after the administration, observe the interior every Mus of 10min and turn round the body number of times, and calculate the analgesia percentage rate, the results are shown in Table 4.Experimental result shows, the big small concentration of we all obviously antagonism acetic acid cause the pain reaction, the concentration group is stronger than the effect of small concentration group greatly.
The our Dichlorodiphenyl Acetate of table 4 causes the influence of pain reaction
Group Number of animals (only) Turn round body number of times (X ± S) P
A 10 29.23±2.12
B 10 1.09±1.01 <0.01
C 10 1.53±1.25 <0.01
D 10 2.43±1.27 <0.01
Bacteriostasis
Sterility test is got the former medicinal sterile saline dilution of our lotion and with the Nutrient agar mixing, is made culture medium contain our lotion concentration and be respectively 1/10,1/20,1/30,1/40,1/50,1/100 of former medicine.Cultivate after 72 hours for 37 ℃, count the clump count of interior antibacterial of plate and mycete respectively.All there are not antibacterial and fungus growth in result's we's former medicine of lotion and the above-mentioned several diluent culture medium.
Bacteriostatic test depletion Staphylococcus aureus and escherichia coli are coated the bacteriotrophy agar plate surface, group B streptococcus is coated the blood agar plate surface, gonococcus is coated gonococcus separation and Culture planar surface, and Candida albicans is coated the mycotrophy agar plate surface.Respectively at above-mentioned dull and stereotyped punching, the former medicine of our lotion is quantitatively injected in 3 of every dull and stereotyped punchings in the hole with aperture 5mm card punch.Cultivate after 24 hours, measure each dull and stereotyped antibacterial circle diameter for 37 ℃.The former medicine of result we lotion all has in various degree inhibitory action to staphylococcus aureus, escherichia coli, group B streptococcus, gonococcus and Candida albicans.
Minimum inhibitory concentration (MIC) is measured and to be got the former medicinal sterile saline dilution of our lotion and with the Nutrient agar mixing, makes that our lotion final concentration is 1/5,1/10,1/20,1/40,1/80,1/160 in the culture medium, pour plate.Diluting each strain with sterile saline is 300,000,000/ml, respectively gets an inoculating loop and is inoculated in above-mentioned flat board and blank flat board respectively, and every strain is done 3 groups.Cultivate after 24 hours for 37 ℃ and observe, with the high dilution of the our lotion of complete bacteria growing inhibiting as its MIC.Our lotion after the result dilution all has in various degree inhibitory action to staphylococcus aureus, escherichia coli, group B streptococcus, gonococcus and Candida albicans.Above-mentioned 5 kinds of bacterial growths are all suppressed fully after 10 times of the former medicine dilutions, still have staphylococcus aureus, escherichia coli and group B streptococcus to be suppressed fully after diluting 20 times.
Minimum bactericidal concentration (MBC) is measured and is extracted the agar that MIC measures the inoculated bacteria place of each dull and stereotyped asepsis growth, be inoculated in the nutrient agar panel that does not contain our lotion, each strain is done 3 groups, cultivate after 24 hours for 37 ℃ and observe, with the high dilution of the our lotion of asepsis growth as its MBC.Our lotion after result's dilution all has killing action to staphylococcus aureus, escherichia coli, group B streptococcus, gonococcus and Candida albicans.Above-mentioned 5 kinds of bacterial growths all have killing action after 5 times of the former medicine dilutions, staphylococcus aureus, escherichia coli and group B streptococcus are still had killing action after diluting 10 times.
Insecticidal test will pick up from the trichomonas vaginitis of clinical patient and cultivate based on 37 ℃ of cultivations of going down to posterity with 1640, wait it to breed to 20 polypides in the every visual field of microscopically when above, every pipe adds the former medicine of our lotion, makes the interior concentration of its pipe be respectively 1/5,1/10,1/20,1/40,1/80,1/160, each concentration is done 3 groups, shakes up the back and continues to cultivate.After adding our washing liquid 1,2,5,10,20,40,60,80,120min and 12,24h be microscopy infusorian death condition respectively.The result: former medicine of our washing liquid and diluent have killing action to trichomonas vaginitis.
The part clinical trial relevant of test example 2 with the present invention
Diagnostic criteria: nonspecific vaginitis
The tcm diagnosis standard
According to understanding, primary disease can be divided into three kinds of syndrome types and carry out determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs non-specific vulvitis etiology and pathogenesis:
The wet downward flowing type of spleen shows as pudendal pruritus, swells and ache, and is difficult to self-control, and it is many, rare clearly with the leucorrhea amount to scratch back flowing water, anorexia and loose stool, light red tongue, white and moist fur, symptoms such as deep-slow pulse.
Ascites of liver meridian damp-heat type has pudendal pruritus except that seeing, swells and ache, even outside the primary symptom of uneasy in either sitting or lying, pudendum can have hyperemia, scorching hot or due to intestine erosion and ulcer, and profuse leukorrhea, yellow skin matter is thick, have smelly dirty, irritated irritability, dry mouth with bitter taste, constipation, yellow urine, yellowish fur, symptoms such as wiry and frequent pulse.
This type of pattern of syndrome of liver-kidney Yin deficiency type show as pudendal pruritus, skin of vulva thickens, coarse chapping, the companion sees dizziness and tinnitus, feverish sensation in the palms and soles, waist soreness, the few tongue of red tongue, diseases such as stringy,thready and rapid pulse.
The Western medicine diagnose standard:
(1) chronic inflammatory disease: mainly show as pruritus vulvae, pachyderma, coarse, chap, also can be with urodynia or sexual anhedonia.
(2) acute inflammation: the patient feels the pudendum discomfort earlier, pruritus and pain appear then, or burning sensation arranged, pudendum position (comprising big nympha clitoris) skin and mucosa can occur simultaneously in various degree swelling hyperemia is arranged, also can form erosion, ulcer when serious, or large stretch of eczema etc. occurs, and with urodynia, sexual anhedonia.In addition, when folliculitis appears in the pudendum position, also can because of abscess make swelling of pudendum height and pain, and then form furuncle and phyma.
Therapeutic Method: every day 2 times, each 10ml, 7 days was 1 course of treatment, 2 courses of treatment of logotype.
Efficacy assessment standard:
Recovery from illness: symptom and sign disappears, and leucorrhea reduces, leucorrhea lab testing feminine gender
Produce effects: symptom and sign is clearly better, not complete obiteration as yet, leucorrhea lab testing feminine gender
Take a turn for the better: symptom and sign alleviates, the leucorrhea lab testing positive
Invalid: symptom and sign does not have improvement, the leucorrhea lab testing positive
Therapeutic outcome:
Table 5 clinical test results of the present invention
Figure A20071001369600091
By clinical test results of the present invention as can be seen, the total effective rate of a course of treatment of this Chinese medicine compound reaches 90%; The total effective rate of two courses of treatment can reach more than 96%, with positive control drug JIEERYIN XIYE group and normal saline group significant difference is arranged more all, is the rare excellent Chinese medicine composition of clinical effectiveness.
4. the specific embodiment
Embodiment 1
Prescription: Herba Orostachyos 900g Fructus Cnidii 900g Radix Sophorae Flavescentis 900g Cortex Phellodendri 600g
Radix Stemonae 600g Herba Agrimoniae 600g Radix Notoginseng 100g Borax 10g
Borneolum Syntheticum 20g
Method for making:
1) measures three flavor medical materials such as Herba Orostachyos, Herba Agrimoniae, Fructus Cnidii by prescription, add 10 times of amounts of water, decocted 1 hour, filter filtrate for later use;
2) medicinal residues add 8 times of amounts of water again, decoct 1 hour, filter, and filtrate and first is fried in shallow oil filtrate merging, is evaporated to relative density 1.15~1.20, put coldly, add ethanol and make and contain alcohol and measure to 70% the cold preservation standing over night;
3) draw supernatant, reclaim ethanol and be concentrated into thick paste, vacuum drying gets dry extract, and is standby;
4) measure three flavor medical materials such as Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae by prescription, add 8 times of amounts of 60% ethanol reflux, extract, 2 hours, filter filtrate for later use;
5) medicinal residues added 8 times of amounts of 60% ethanol reflux, extract, 2 hours again, filtered, and with the extracting solution merging first time, reclaimed ethanol and also were concentrated into thick paste, and vacuum drying gets dry extract, and is standby;
6) take by weighing pseudo-ginseng by recipe quantity, add 8 times of amounts of 70% ethanol reflux, extract, 3 hours, filter filtrate for later use;
7) medicinal residues added 6 times of amounts of 70% ethanol reflux, extract, 3 hours again, filtered, and with the extracting solution merging first time, reclaimed ethanol and also were concentrated into thick paste, and vacuum drying gets dry extract, and is standby;
8) three kinds of dry extracts of above-mentioned gained are merged, pulverize, cross 80 mesh sieves, as the Chinese medical concrete powder, standby.The result altogether the about 550g of dry extract
Preparation process:
The preparation of suppository:
Prescription: Chinese medical concrete powder 50g
Borax 1g
Borneolum Syntheticum 2g
Glycerol 110
Gelatin 30
Glucose 10g
Water is an amount of
Make 100 altogether
Preparation technology:
1) gelatin that takes by weighing recipe quantity adds suitable quantity of water, and fully swelling is 24 hours, and inclining excessive moisture, and heating makes dissolves, and adds glycerol 80g and makes the glycerin cement gel matrix;
2) take by weighing extract powder, Borax, Borneolum Syntheticum, the glucose of recipe quantity, add low amounts of water and make pasty state, add glycerol, stir evenly;
3) under tepid state with the substrate mixing that prepared, the limit edged stirs, and injects the bolt mould rapidly, cooling cuts redundance, promptly.
The spray preparation:
Prescription: Chinese medical concrete powder 50g
Borax 1g
Borneolum Syntheticum 2g
Polyoxyethylene sorbitan monoleate 20g
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) takes by weighing the polyoxyethylene sorbitan monoleate of recipe quantity, add the suitable quantity of water dilution, mixing;
2) Chinese medical concrete powder, Borax, the Borneolum Syntheticum that takes by weighing recipe quantity adds and makes dissolving fully in the above-mentioned solution, filters;
3) adjust pH to 5~6, thin up are to ormal weight, packing, promptly.
The preparation of gel:
Prescription: Chinese medical concrete powder 100g
Borax 2g
Borneolum Syntheticum 4g
Polyoxyethylene sorbitan monoleate 20g
Card pool nurse P934 15g
Glycerol 30g
Triethanolamine is an amount of
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) card taking pool nurse P934 adds suitable quantity of water, makes abundant swelling;
2) get 5% triethanolamine solution and regulate above-mentioned solution pH value to 6, stir;
3) Borax, the Borneolum Syntheticum of getting recipe quantity adds in an amount of glycerol and makes dissolving;
4) get Chinese medical concrete powder and the above-mentioned solution and the substrate mixing of recipe quantity, cross colloid mill to fully grinding well, packing, promptly.
The preparation of effervescent tablet:
Prescription: Chinese medical concrete powder 100g
Borax 2g
Borneolum Syntheticum 4g
Sodium bicarbonate 150g
Tartaric acid 140g
Dodecyl sodium sulfate 20g
Lactose 400g
Carbomer 40g
Magnesium stearate 8g
Make 1000 altogether
Preparation technology:
1) take by weighing the Chinese medical concrete powder of above-mentioned 1/2 recipe quantity, the lactose of 1/2 recipe quantity and the sodium bicarbonate mixing of recipe quantity, the PVP ethanol solution with 3% is granulated, and 50 ℃ of oven dry get granule A;
2) Borax, Borneolum Syntheticum add a small amount of lactose and are ground into fine powder altogether, with tartaric acid and remaining Chinese medical concrete powder, lactose, mixing, and the PVP ethanol solution granulation with 3%; 50 ℃ of oven dry get granule B;
3) granule A and granule B mixing add dodecyl sodium sulfate, carbomer, magnesium stearate, mixing, and tabletting, promptly.
Embodiment 2
Prescription: Herba Orostachyos 9kg Fructus Cnidii 9kg Radix Sophorae Flavescentis 9kg Cortex Phellodendri 6kg
Radix Stemonae 6kg Herba Agrimoniae 6kg Radix Notoginseng 1kg Borax 100g
Borneolum Syntheticum 200g
Method for making:
1) measure three flavor medical materials such as Herba Orostachyos, Herba Agrimoniae, Fructus Cnidii by prescription, add 5 times of amounts of water, soaked 30 minutes, connect volatile oil extractor, heating and refluxing extraction 3 hours is collected volatile oil, and device is deposited in addition, and is standby;
2) water liquid filters, filtrate for later use; Medicinal residues add 10 times of amounts of water again, decoct 1 hour, filter filtrate for later use;
3) medicinal residues add 8 times of amounts of water again, decoct 1 hour, filter, and merge all above-mentioned filtrates, are evaporated to relative density 1.15~1.20, put coldly, add ethanol and make and contain the alcohol amount to 70%, the cold preservation standing over night;
4) draw supernatant, reclaim ethanol and be concentrated into thick paste, vacuum drying gets dry extract, and is standby;
5) measure three flavor medical materials such as Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae by prescription, add 8 times of amounts of 60% ethanol reflux, extract, 2 hours, filter filtrate for later use;
6) medicinal residues added 8 times of amounts of 60% ethanol reflux, extract, 2 hours again, filtered, and with the extracting solution merging first time, reclaimed ethanol and also were concentrated into thick paste, and vacuum drying gets dry extract, and is standby;
7) take by weighing pseudo-ginseng by recipe quantity, add 8 times of amounts of 70% ethanol reflux, extract, 3 hours, filter filtrate for later use;
8) medicinal residues added 6 times of amounts of 70% ethanol reflux, extract, 3 hours again, filtered, and with the extracting solution merging first time, reclaimed ethanol and also were concentrated into thick paste, and vacuum drying gets dry extract, and is standby;
9) three kinds of dry extracts of above-mentioned gained are merged, pulverize, cross 80 mesh sieves, as the Chinese medical concrete powder, standby.The result altogether the about 5.30kg of dry extract; The about 1100ml of volatile oil
Preparation process:
The preparation of suppository:
Prescription: Chinese medical concrete powder 50g
Volatile oil 10ml
Borax 1g
Borneolum Syntheticum 2g
Glycerol 110
Gelatin 30
Glucose 10g
Polyoxyethylene sorbitan monoleate 15g
Water is an amount of
Make 100 altogether
Preparation technology:
1) gelatin that takes by weighing recipe quantity adds suitable quantity of water, and fully swelling is 24 hours, and inclining excessive moisture, and heating makes dissolves, and adds glycerol 80g and makes the glycerin cement gel matrix;
2) take by weighing extract powder, Borax, Borneolum Syntheticum, the glucose of recipe quantity, add low amounts of water and make pasty state;
3) get residue glycerol and add polyoxyethylene sorbitan monoleate, grind well, add volatile oil, make dissolving and above-mentioned pastel mixing fully;
4) under tepid state with the substrate mixing that prepared, the limit edged stirs, and injects the bolt mould rapidly, cooling cuts redundance, promptly.
The spray preparation:
Prescription: Chinese medical concrete powder 50g
Volatile oil 10ml
Borax 1g
Borneolum Syntheticum 2g
Polyoxyethylene sorbitan monoleate 20g
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) gets the polyoxyethylene sorbitan monoleate of recipe quantity, add the suitable quantity of water dilution, mixing;
2) Chinese medical concrete powder, Borax, Borneolum Syntheticum, the volatile oil that takes by weighing recipe quantity adds and makes dissolving fully in the above-mentioned solution, filters;
3) adjust pH to 5~6, thin up are to ormal weight, packing, promptly.
The preparation of gel:
Prescription: Chinese medical concrete powder 100g
Volatile oil 20ml
Borax 2g
Borneolum Syntheticum 4g
Polyoxyethylene sorbitan monoleate 20g
Card pool nurse P934 15g
Glycerol 30g
Triethanolamine is an amount of
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) card taking pool nurse P934 adds suitable quantity of water, makes abundant swelling;
2) get 5% triethanolamine solution and regulate above-mentioned solution pH value to 6, stir;
3) get an amount of glycerol and add polyoxyethylene sorbitan monoleate, mixing, adding Borax, Borneolum Syntheticum, volatile oil stir and make dissolving;
4) get Chinese medical concrete powder and the above-mentioned solution and the substrate mixing of recipe quantity, cross colloid mill to fully grinding well, packing, promptly.
The preparation of effervescent tablet:
Prescription: Chinese medical concrete powder 100g
Volatile oil 20ml
Borax 2g
Borneolum Syntheticum 4g
Sodium bicarbonate 150g
Tartaric acid 140g
Dodecyl sodium sulfate 20g
Lactose 400g
Carbomer 40g
Magnesium stearate 8g
Beta-schardinger dextrin-80g
Make 1000 altogether
Preparation technology:
1) get the Chinese medical concrete powder of above-mentioned 1/2 recipe quantity, the lactose of 1/2 recipe quantity and the sodium bicarbonate mixing of recipe quantity, the PVP ethanol solution with 3% is granulated, and 50 ℃ of oven dry get granule A;
2) Borax, Borneolum Syntheticum add a small amount of lactose and are ground into fine powder altogether, with tartaric acid and remaining Chinese medical concrete powder, lactose, mixing, and the PVP ethanol solution granulation with 3%; 50 ℃ of oven dry get granule B;
3) beta-schardinger dextrin-adds water furnishing pasty state, adds volatile oil, fully grinds, and lyophilization is pulverized, and is standby;
4) granule A and granule B mixing add Benexate Hydrochloride, dodecyl sodium sulfate, carbomer, magnesium stearate, mixing, and tabletting, promptly.

Claims (10)

1. a Chinese medicine composition and preparation thereof for the treatment of gynecological inflammation is characterized in that it mainly is made up of following parts by weight of traditional Chinese medicines raw material: 3~15 parts of Herba Orostachyos, 3~15 parts of Fructus Cnidiis, 3~15 parts of Radix Sophorae Flavescentiss, 2~10 parts of Cortex Phellodendris, 2~10 parts of the Radixs Stemonae, 2~10 parts of Herba Agrimoniaes, 0.2~2 part of Radix Notoginseng.
2. medicine according to claim 1 is characterized in that the proportioning of each raw material of Chinese medicine is: 8~10 parts of Herba Orostachyos, 8~10 parts of Fructus Cnidiis, 8~10 parts of Radix Sophorae Flavescentiss, 5~7 parts of Cortex Phellodendris, 5~7 parts of the Radixs Stemonae, 5~7 parts of Herba Agrimoniaes, 0.5~2 part of Radix Notoginseng.
3. medicine according to claim 1 is characterized in that the best proportioning of each raw material of Chinese medicine is: 9 parts of Herba Orostachyos, 9 parts of Fructus Cnidiis, 9 parts of Radix Sophorae Flavescentiss, 6 parts of Cortex Phellodendris, 6 parts of the Radixs Stemonae, 6 parts of Herba Agrimoniaes, 1 part of Radix Notoginseng.
4. medicine as claimed in claim 1, can also contain Borax and Borneolum Syntheticum, its raw materials in part by weight ratio is: 3~15 parts of Herba Orostachyos, 3~15 parts of Fructus Cnidiis, 3~15 parts of Radix Sophorae Flavescentiss, 2~10 parts of Cortex Phellodendris, 2~10 parts of the Radixs Stemonae, 2~10 parts of Herba Agrimoniaes, 0.2~2 part of Radix Notoginseng, 0.03~0.3 part of Borax, 0.06~0.6 part of Borneolum Syntheticum.
5. medicine as claimed in claim 4, the best proportioning of its raw material is: 9 parts of Herba Orostachyos, 9 parts of Fructus Cnidiis, 9 parts of Radix Sophorae Flavescentiss, 6 parts of Cortex Phellodendris, 6 parts of the Radixs Stemonae, 6 parts of Herba Agrimoniaes, 1 part of Radix Notoginseng, 0.1 part of Borax, 0.2 part of Borneolum Syntheticum.
6. the preparation that medicine as claimed in claim 1 is made is characterized in that said preparation can be clinically or pharmaceutically acceptable any external preparation.
7. external preparation as claimed in claim 6 is characterized in that it can be suppository, gel, spray, effervescent tablet, membrane etc.
8. as the preparation technology of the described Chinese medicine composition of claim 1~5, it is characterized in that: take by weighing the Chinese medicine of respectively distinguishing the flavor of through cleaning processing by the described weight ratio of claim 1~5, solubilizer extracts, and is refining, concentrated, adds the corresponding medicinal adjuvant respectively according to the difference for preparing dosage form and is prepared from.
9. as the described Chinese medicine composition of claim 1~5, it is characterized in that the application in the treatment gynecological inflammation.
10. Chinese medicine composition as claimed in claim 9 is in the application of treatment in the gynecological inflammation, it is characterized in that the medicine of vaginitis that this Chinese medicine composition can be used for preparing the treatment a variety of causes and cause, pelvic inflammatory disease, cervical erosion.
CNA2007100136961A 2007-03-20 2007-03-20 Chinese medicinal composition for treating gynaecologic inflammation and preparation thereof Pending CN101269192A (en)

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102178814A (en) * 2011-04-13 2011-09-14 王连芝 Chinese medicinal composition for treating trichomonas vaginitis and preparation method thereof
CN102552503A (en) * 2012-01-18 2012-07-11 陈玉生 Traditional Chinese medicine powder used for treating cervical erosion
CN102727768A (en) * 2012-06-17 2012-10-17 赵青 Preparation method for Chinese herbal lotion used for treating hemorrhagic senile vaginitis
CN102743556A (en) * 2012-06-17 2012-10-24 马红 Preparation method of Chinese medicine irrigation solution for treating hemorrhagic mycotic vaginitis
CN103385926A (en) * 2013-07-09 2013-11-13 武汉烺祺生物科技有限公司 Antibiosis gel for curing cervical and vaginal diseases of gynaecology
CN103705824A (en) * 2013-12-22 2014-04-09 王东荣 Traditional Chinese medicine preparation for treating cervical erosion
CN105853629A (en) * 2016-06-03 2016-08-17 王秀芬 Pharmaceutical composition for treating cervicitis and preparing method thereof
CN105998974A (en) * 2016-06-28 2016-10-12 深圳市纯原上品文化传播有限公司 Traditional Chinese medicine composition and gels for treating gynecologic inflammation and preparation method thereof
CN108310047A (en) * 2018-03-13 2018-07-24 傅伯良 It is a kind of to treat the rotten preparations and preparation method thereof of Fu sections Gong Jing Porridge
CN109432353A (en) * 2018-11-26 2019-03-08 西安百世惠众生物工程有限公司 A kind of contraception cleaning pure Chinese medicinal preparation and preparation method
CN110433206A (en) * 2019-09-11 2019-11-12 翡林谷生物科技(上海)有限公司 Compound Radix et Rhizoma Gynurae divaricatae medicated roll and its preparation method and application for treating female vagina

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102178814B (en) * 2011-04-13 2012-11-07 王连芝 Chinese medicinal composition for treating trichomonas vaginitis and preparation method thereof
CN102178814A (en) * 2011-04-13 2011-09-14 王连芝 Chinese medicinal composition for treating trichomonas vaginitis and preparation method thereof
CN102552503A (en) * 2012-01-18 2012-07-11 陈玉生 Traditional Chinese medicine powder used for treating cervical erosion
CN102552503B (en) * 2012-01-18 2013-12-25 陈玉生 Traditional Chinese medicine powder used for treating cervical erosion
CN102743556A (en) * 2012-06-17 2012-10-24 马红 Preparation method of Chinese medicine irrigation solution for treating hemorrhagic mycotic vaginitis
CN102727768A (en) * 2012-06-17 2012-10-17 赵青 Preparation method for Chinese herbal lotion used for treating hemorrhagic senile vaginitis
CN103385926A (en) * 2013-07-09 2013-11-13 武汉烺祺生物科技有限公司 Antibiosis gel for curing cervical and vaginal diseases of gynaecology
CN103705824A (en) * 2013-12-22 2014-04-09 王东荣 Traditional Chinese medicine preparation for treating cervical erosion
CN105853629A (en) * 2016-06-03 2016-08-17 王秀芬 Pharmaceutical composition for treating cervicitis and preparing method thereof
CN105998974A (en) * 2016-06-28 2016-10-12 深圳市纯原上品文化传播有限公司 Traditional Chinese medicine composition and gels for treating gynecologic inflammation and preparation method thereof
CN108310047A (en) * 2018-03-13 2018-07-24 傅伯良 It is a kind of to treat the rotten preparations and preparation method thereof of Fu sections Gong Jing Porridge
CN109432353A (en) * 2018-11-26 2019-03-08 西安百世惠众生物工程有限公司 A kind of contraception cleaning pure Chinese medicinal preparation and preparation method
CN110433206A (en) * 2019-09-11 2019-11-12 翡林谷生物科技(上海)有限公司 Compound Radix et Rhizoma Gynurae divaricatae medicated roll and its preparation method and application for treating female vagina

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