CN1425393A - Vagina cleaning and antiphlogistic suppository and its preparing method - Google Patents

Vagina cleaning and antiphlogistic suppository and its preparing method Download PDF

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Publication number
CN1425393A
CN1425393A CN 01135282 CN01135282A CN1425393A CN 1425393 A CN1425393 A CN 1425393A CN 01135282 CN01135282 CN 01135282 CN 01135282 A CN01135282 A CN 01135282A CN 1425393 A CN1425393 A CN 1425393A
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Prior art keywords
suppository
antiphlogistic
vagina cleaning
medicine
sophorae flavescentis
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CN1193779C (en
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刘玉川
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Liu Yuchuan
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Qilu Petrochemical Co of Sinopec
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Abstract

The vagina cleaning and antiphlogistic suppository is prepared with Chinese medicine materials (in weight portions) including flavescent sophora root 9-30, phellodendron bark 6-30, sessile stemona root 6-30, pricklyas 3-15, cnidium fruit 6-30 and borneol 0.1-6. It has high treating effect on various vaginitis, and is easy to absorb, safe and effective. The preparation process is also provided.

Description

Vagina cleaning and antiphlogistic suppository and preparation method thereof
Technical field
The invention belongs to colpitic Chinese medicine preparation of treatment and preparation method thereof.
Background technology
Modern medicine is divided into trichomonal vaginitis, monilial vaginitis, bacterial vaginitis, senile and infantile vaginitis according to the difference of paathogenic factor with vaginitis.Its Therapeutic Method is:
1, systemic administration: as trichomonal vaginitis, bacterial vaginitis metronidazole; Old age and infantile vaginitis are adjusted estrogen level.
2, local application: fill in intravaginal with metronidazole 200mg as trichomonal vaginitis and bacterial vaginitis; Monilial vaginitis is filled in intravaginal etc. with clotrimazole bolt, miconazole, nystatin bolt or sheet, Nystatin effervescent tablet etc.; Senile obstruction road is scorching puts intravaginal etc. with diethylstilbestrol 0.125-0.25mg.
3, change intravaginal pH value.As controlling infusorian property or bacterial vaginitis with 1% lactic acid or the flushing of 0.5% acetic acid; Colpitis mycotica is controlled in the flushing of 2%-4% sodium bicarbonate.
Modern medicine diagnosis and treatment vaginitis has its advantage that its deficiency is also arranged.Its advantage is:
1, checks that by the modern times measuring means diagnosis index is clear and definite.
2, distinguish the cause of disease, etiological treatment according to diagnosis.
3, used Western medicine classification is clear and definite, and certain pharmacological evaluation basis is arranged.
Its deficiency has:
1, the monistic contradiction of many originality of paathogenic factor and Therapeutic Method.As: it is sour environment and colpitis mycotica should be adjusted the pH alkaline environment that trichomonal vaginitis or bacterial vaginitis should be adjusted vagina pH; Invalid to the effective medicine of antibacterial to fungus, invalid to the effective medicine of fungus to antibacterial; A kind of medicine is difficult to for suitable when cross infection.
2, the contradiction of the hysteresis quality of hastening forward property of pathogenic bacteria and medicine: along with antibiotic extensive use, antibacterial has also produced drug resistance, and specific drug, the relapse rate height of disease are also lacked in the treatment of fungus at present.
3, to a treatment supplementing hormone of estrogen decrease, disease is cured the symptoms, not the disease.
The Chinese traditional treatment vaginitis can play curative effect preferably, and Chinese medicine for external application do not resemble single, the effect limitation of composition the Western medicine, only certain pathogenic microorganism is worked, but multi-flavor medicine prescription, even every flavor medicine just contains plurality of active ingredients.Each medicine composition plays synergism.But multiple pathogenic microorganism can be killed, the active factor that human immunity mechanism is transferred human body can be adjusted again, the vaginitis that the external treatment of tcm of many reports causes mycete, antibacterial infusorian, even non-spy's property led and senile vaginitis have higher cure rate.But the deficiency of these Chinese prescriptions is: select medicine not smart, blindness is arranged.Most prescriptions are to report according to the case observation that tradition and experience composing prescription preparation carry out a usual practice number.Clinical and the pharmacological screening that does not have relevant prescription flavour of a drug can not be accomplished fewer but betterly, so its prescription selects medicine that certain blindness is arranged.Preparation is original, low-level repetition, pharmacology index deficiency.
Summary of the invention
Technical problem to be solved by this invention provides the colpitic Chinese medicine preparation of a kind of treatment---vagina cleaning and antiphlogistic suppository, is easy to absorb and safe and effective to various types of vaginitiss are quick-acting.
Vagina cleaning and antiphlogistic suppository of the present invention is characterized in that being made by following parts by weight of traditional Chinese medicines raw material: Radix Sophorae Flavescentis 9~30, Cortex Phellodendri 6~30, Radix Stemonae 6~30, Pericarpium Zanthoxyli 3~15, Fructus Cnidii 6~30, Borneolum Syntheticum 0.1~6.
Best compatibility is: Radix Sophorae Flavescentis 18, Cortex Phellodendri 9, Radix Stemonae 12, Pericarpium Zanthoxyli 6, Fructus Cnidii 12, Borneolum Syntheticum 1.
We are monarch with the Radix Sophorae Flavescentis, and the Radix Sophorae Flavescentis bitter in the mouth is cold in nature, the heat clearing and damp drying parasite killing to be to control primary symptom; Cortex Phellodendri, Fructus Cnidii heat clearing and damp drying, detoxifcation parasite killing, dispelling wind for relieving itching assists Radix Sophorae Flavescentis to think ministerial drug; Assistant is treated pain with Pericarpium Zanthoxyli, Radix Stemonae killing parasites for relieving itching; 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, and the through disease assistant of doing makes it medicine.All medicine contracts hold heat clearing and damp drying altogether, detoxifcation parasite killing, the effect of antipruritic treatment pain.
Modern study Radix Sophorae Flavescentis, Cortex Phellodendri, Fructus Cnidii, Pericarpium Zanthoxyli, Borneolum Syntheticum all have antiinflammatory, resisting pathogenic microbes effect.Radix Sophorae Flavescentis, Cortex Phellodendri, the Radix Stemonae, Fructus Cnidii, all the effect of killing infusorian that presses down arranged.And Radix Sophorae Flavescentis has anti-allergic effects, the generation of Cortex Phellodendri energy enhancing antibody, and the Radix Stemonae has antiviral, and Fructus Cnidii, Pericarpium Zanthoxyli have the local anaesthesia analgesic effect.Pericarpium Zanthoxyli, Fructus Cnidii volatile oil have the fungicidal action of pressing down.Borneolum Syntheticum can be urged the division and the growth of neuroglia archeocyte.All medicines share can reach to press down and kill pathogenic microorganism and infusorian, and human body immunity improving power is treated the pain relieving of itching, quickened metabolism, promotes tissue new life's purpose.
The present invention makes suppository by described raw material of Chinese medicine, uses adjuvant to be polyoxyethylene monostearate (trade name S-40), Tween 80, glycerol.Consumption is for to select for use according to the preparation method of common suppository in right amount.The invention provides following a kind of consumption: polyoxyethylene monostearate is 1/4.5th of a raw material of Chinese medicine gross weight, polyoxyethylene monostearate: Tween 80: glycerol=40: 1: 1.
The present invention can be according to the common preparation method manufacturing of Chinese medicine suppository, and the preferred a kind of processing technology of the present invention is:
1. Pericarpium Zanthoxyli, Fructus Cnidii are put volatile oil extractor (known technology and equipment), carried volatile oil and preserve standby; Medicinal liquid leaches standby; Medicinal residues are preserved standby.
2. after medicinal residues being gone up in Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Stemonae adding, add 8,6,6 times of amounts of water medical material and decoct each 1 hour 3 times.Leach medicinal liquid and above-mentioned medicinal liquid and merge, concentrate and weigh 1: 1, add ethanol and make and contain the alcohol amount and reach 65% as for medical material, cold preservation 72 hours, the filtering precipitation reclaims ethanol, and the medicinal liquid reduced vacuum is condensed into the thick paste shape, and is standby.
3. respectively the fusion of S-40 heating in water bath, above-mentioned thick paste heating in water bath are dissolved, Borneolum Syntheticum adds that glycerol grinds well, above-mentioned volatile oil adds after Tween 80 grinds well, successively in the water-bath, folk prescription mixed grinding under stirring to even, impouring coats in the Duckbill type suppository mould of lubricant rapidly, put into refrigerator immediately freezing about 10 minutes, and took out, even out, bolt is got in die sinking, and packing gets final product.
Effect of the present invention:
1. pharmaceutics research: studying with the suppository that is easy to absorb by experiment is object, and preferred preparation technology has made the suppository that meets relevant requirements under 2000 editions suppository items of Chinese Pharmacopoeia.
2. toxicologic study: record maximum tolerated dose (MTD)>116.3 times for the rat vagina medication with 1 (quite crude drug 8.17g) by the 60kg day for human beings.Rat is not produced tangible acute toxicity effect, and vaginal mucosa is not seen tangible pathological change.The one or many vagina medicinal does not produce tangible zest to the rat vagina mucosa, and histopathological examination does not see that vaginal mucosa has tangible pathological change.(this experiment is finished by Shandong Province pharmacological room of medicine inspecting institute)
3. the pharmacodynamic study result shows: high and low dose vagina cleaning and antiphlogistic suppository xylol causes mice auricular concha inflammation obvious suppression effect (P<0.001, P<0.001), the mouse skin capillary permeability that causes xylol increases obvious suppression effect (P<0.001, P<0.001), subcutaneous rat granuloma induced by implantation of cotton pellets hypertrophy there is obvious suppression effect (P<0.001, P<0.01), its suppression ratio is respectively 41.0% and 32.3%; The high and low dose vagina cleaning and antiphlogistic suppository is to the effect of being significantly improved of Cavia porcellus itch-threshold (P<0.01, P<0.01); High and low dose vagina cleaning and antiphlogistic suppository Dichlorodiphenyl Acetate causes mouse writhing reaction obvious inhibitory action, makes to turn round body and obviously prolong (P<0.01, P<0.05) incubation period, makes to turn round the body number of times and obviously reduce (P<0.001, P<0.01).Adopt the plate doubling dilution to study the inhibitory action of vagina cleaning and antiphlogistic suppository, adopt the test tube doubling dilution to study medicine clostridium sporogenes, gonococcal inhibitory action to staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans.The result shows, vagina cleaning and antiphlogistic suppository all has in various degree inhibitory action external to staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, clostridium sporogenes, gonococcus, its minimal inhibitory concentration (MIC) is respectively 266.67mg/ml, 533.33mg/ml, 133.33mg/ml, 250mg/ml, 250mg/ml.The prompting of above-mentioned experimental result, this product have antiinflammatory, antipruritic, analgesia, bacteriostasis.(this experiment is finished by Shandong Province pharmacological room of medicine inspecting institute)
4. clinical research: the observation of curative effect by 220 routine patients confirms: (1) vagina cleaning and antiphlogistic suppository has tangible curative effect to polytype vaginitis, and its total effective rate reaches 99.15%, with matched group 92.08% utmost point significant difference (P value<0.01) is arranged.(2) curative effect of vagina cleaning and antiphlogistic suppository treatment trichomonal vaginitis and treatment colpitis mycotica is better than matched group, and there were significant differences (P value<0.05); The curative effect of vagina cleaning and antiphlogistic suppository treatment senile vaginitis and treatment nonspecific vaginitis obviously is better than matched group, and utmost point significant difference (P value<0.01) is arranged.(3) this medicine is safe and effective to polytype colpitic treatment.
Below be pharmacology and clinical data:
1, toxicity data
The rat body weight growth pattern of table 1 vagina cleaning and antiphlogistic suppository acute toxicity testing (x ± s, n=10)
Body weight (g) experiment body weight (g) experiment forebody-afterbody anharmonic ratio (P) after 7 days before the group experiment
Medicine 215.4 ± 7.90 231.0 ± 13.4<0.01
Substrate 216.2 ± 7.91 230.2 ± 10.4<0.01
2. pharmacological datum
Table 2 medicine xylol cause the mice ear degree influence (x ± s, n=10)
Group ear swelling degree (mg) P
Blank 12.5 ± 3.69
Fluocinonide 4.0 ± 2.16<0.001
Vagina cleaning and antiphlogistic suppository low dosage 7.1 ± 4.20<0.01
Vagina cleaning and antiphlogistic suppository high dose 6.5 ± 4.12<0.01
Table 3 medicine xylol causes the influence that the mouse skin capillary permeability increases
( x±s,n=10)
Group trap value P
Blank 0.3893 ± 0.08606
Fluocinonide 0.1621 ± 0.05278<0.001
Vagina cleaning and antiphlogistic suppository low dosage 0.2022 ± 0.05581<0.001
Vagina cleaning and antiphlogistic suppository high dose 0.1841 ± 0.03300<0.001 table 4 medicine to the swollen outgrowth influence of rat granuloma (x ± s, n=10)
Granuloma/100g body weight
Group P suppression ratio (%)
(mg)
Blank group 54.24 ± 12.96
Fluocinonide 28.21 ± 14.85<0.001 48.0
Vagina cleaning and antiphlogistic suppository low dosage 37.53 ± 10.01<0.01 30.8
Vagina cleaning and antiphlogistic suppository high dose 23.42 ± 6.37<0.001 56.8
Table 5 medicine to Cavia porcellus itch-threshold influence (x ± s, n=10)
Group itch-threshold (the total amount ug of histamine phosphate) P
Blank 209.0 ± 110.3
JIEERYIN 1153.0 ± 317.8<0.001
Vagina cleaning and antiphlogistic suppository low dosage 720.5 ± 456.5<0.01
Vagina cleaning and antiphlogistic suppository high dose 815.5 ± 489.0<0.01
Table 6 medicine Dichlorodiphenyl Acetate cause mouse writhing reaction influence (x ± s, n=10)
Group is turned round body incubation period (min) and is turned round body number of times (inferior)
Blank 3.24 ± 0.822 38.9 ± 9.65
Aspirin 10.46 ± 2.619 * *6.2 ± 5.34 * *
Vagina cleaning and antiphlogistic suppository low dosage 4.13 ± 1.139 *24.5 ± 11.20 *
Vagina cleaning and antiphlogistic suppository high dose 4.89 ± 1.744 *18.6 ± 11.36 * *
Annotate: *P<0.05, *P<0.01, * *Compare with blank group P<0.001
Table 7. contains vagina cleaning and antiphlogistic suppository plate preparation method
Liquor strength (mg/ml) Add amount of liquid medicine (ml) Add and cultivate base unit weight (ml) Medicine final concentration (mg/ml)
4000 ????4 ????11 ????1066.67
????2 ????13 ????533.33
????1 ????14 ????266.67
2000 ????1 ????14 ????133.33
1000 ????1 ????14 ????66.67
500 ????1 ????14 ????33.33
250 ????1 ????14 ????16.67
125 ????1 ????14 ????8.33
62.5 ????1 ????14 ????4.17
31.25 ????1 ????14 ????2.08
Table 8. contains JIEERYIN (matched group) plate preparation method
Medicinal liquid dilution factor (V/V) Add amount of liquid medicine (ml) Add and cultivate base unit weight (ml) The whole dilution factor (V/V) of medicinal liquid
Stock solution ?2 ?11 ?1∶7.5
?1 ?13 ?1∶15
?1∶2 ?1 ?14 ?1∶30
?1∶4 ?1 ?14 ?1∶60
?1∶8 ?1 ?14 ?1∶120
?1∶16 ?1 ?14 ?1∶240
?1∶32 ?1 ?14 ?1∶480
?1∶64 ?1 ?14 ?1∶960
?1∶128 ?1 ?14 ?1∶1920
?1∶256 ?1 ?14 ?1∶3840
3. clinical data
Table 9 vagina cleaning and antiphlogistic suppository treatment group observation of curative effect table
Vaginitis recovery from illness produce effects enabledisable total effective rate
The example number
Type N % n % n % n % %
Infusorian property 60 50 83.33 6 10 351 1.67 98.3
Mycotic 60 53 88.33 4 6.67 2 3.33 1 1.67 98.3
Senile 60 56 93.33 4 6.67 0000 100
Non-specific 40 35 87.5 3 7.5 2500 100
Table 10 JIEERYIN lotion matched group observation of curative effect table
Vaginitis recovery from illness produce effects enabledisable total effective rate
The example number
Type n % n % n % n % %
Infusorian property 30 17 56.67 6 20 4 13.33 3 10 90
Mycotic 30 19 63.33 5 16.67 3 10 3 10 90
Senile 30 18 60 6 20 4 13.33 2 6.67 93.3
Non-specific 20 11 55 3 15 5 25 15 95
Table 11 vagina cleaning and antiphlogistic suppository and JIEERYIN lotion for treatment trichomonal vaginitis efficacy analysis table
Example number recovery from illness produce effects enabledisable P value
Matched group 30 17 643
<0.05
Treatment organizes 60 50 631
Table 12 vagina cleaning and antiphlogistic suppository and JIEERYIN lotion for treatment colpitis mycotica efficacy analysis table
Example number recovery from illness produce effects enabledisable P value
Matched group 30 19 533
<0.05
Treatment organizes 60 53 421
Table 13 vagina cleaning and antiphlogistic suppository and JIEERYIN lotion for treatment senile vaginitis efficacy analysis table
Example number recovery from illness produce effects enabledisable P value
Matched group 30 18 642
<0.01
Treatment organizes 60 56 400
Table 14 vagina cleaning and antiphlogistic suppository and JIEERYIN lotion for treatment nonspecific vaginitis efficacy analysis table
Example number recovery from illness produce effects enabledisable P value
Matched group 20 11 351
<0.05
Treatment organizes 40 35 320
Table 15 vagina cleaning and antiphlogistic suppository and JIEERYIN lotion for treatment vaginitis efficacy analysis table
Example number recovery from illness produce effects enabledisable total effective rate % P value
Matched group 110 65 20 16 9 92.08
<0.01
Treatment organizes 220 194 17 72 99.15
The specific embodiment
Following examples are made suppository according to preparation method of the present invention, and the parts by weight of used raw material of Chinese medicine are as follows respectively:
Embodiment 1:
Radix Sophorae Flavescentis 18, Cortex Phellodendri 9, Radix Stemonae 12, Pericarpium Zanthoxyli 6, Fructus Cnidii 12, Borneolum Syntheticum 1.
Embodiment 2:
Radix Sophorae Flavescentis 9, Cortex Phellodendri 6, Radix Stemonae 10, Pericarpium Zanthoxyli 11, Fructus Cnidii 6, Borneolum Syntheticum 0.5.
Embodiment 3:
Radix Sophorae Flavescentis 20, Cortex Phellodendri 18, Radix Stemonae 22, Pericarpium Zanthoxyli 3, Fructus Cnidii 20, Borneolum Syntheticum 4.
Embodiment 4:
Radix Sophorae Flavescentis 30, Cortex Phellodendri 30, Radix Stemonae 6, Pericarpium Zanthoxyli 15, Fructus Cnidii 30, Borneolum Syntheticum 6.
Embodiment 5:
Radix Sophorae Flavescentis 10, Cortex Phellodendri 8, Radix Stemonae 30, Pericarpium Zanthoxyli 8, Fructus Cnidii 10, Borneolum Syntheticum 2.
Embodiment 6:
Radix Sophorae Flavescentis 9, Cortex Phellodendri 13, Radix Stemonae 6, Pericarpium Zanthoxyli 3, Fructus Cnidii 7, Borneolum Syntheticum 0.1.

Claims (4)

1, vagina cleaning and antiphlogistic suppository is characterized in that being made by following parts by weight of traditional Chinese medicines raw material: Radix Sophorae Flavescentis 9~30, Cortex Phellodendri 6~30, Radix Stemonae 6~30, Pericarpium Zanthoxyli 3~15, Fructus Cnidii 6~30, Borneolum Syntheticum 0.1~6.
2, vagina cleaning and antiphlogistic suppository according to claim 1 is characterized in that described raw material of Chinese medicine is: Radix Sophorae Flavescentis 18, Cortex Phellodendri 9, Radix Stemonae 12, Pericarpium Zanthoxyli 6, Fructus Cnidii 12, Borneolum Syntheticum 1.
3, vagina cleaning and antiphlogistic suppository according to claim 1 and 2 is characterized in that making suppository by described raw material of Chinese medicine, and using adjuvant is an amount of polyoxyethylene monostearate, Tween 80, glycerol.
4, a kind of method for preparing the described vagina cleaning and antiphlogistic suppository of claim 1 is characterized in that comprising the steps:
(1) Pericarpium Zanthoxyli, Fructus Cnidii are put volatile oil extractor, carry volatile oil and preserve standby; Medicinal liquid leaches standby; Medicinal residues are preserved standby.
(2) Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Stemonae are added above-mentioned medicinal residues after, add water and be respectively 8,6,6 times of weight decoctions of medical material 3 times, each 1 hour, leach medicinal liquid and above-mentioned medicinal liquid and merge, be concentrated into medical material and weigh 1: 1, adding ethanol makes and contains alcohol amount and reach 65%, cold preservation 72 hours, the filtering precipitation reclaims ethanol, the medicinal liquid reduced vacuum is condensed into the thick paste shape, and is standby.
(3) after the volatile oil adding Tween 80 that the thick paste heating in water bath that respectively fusion of polyoxyethylene monostearate heating in water bath, above-mentioned (2) is prepared dissolves, Borneolum Syntheticum adding glycerol grinds well, extract above-mentioned (1) grinds well, successively in the water-bath, folk prescription mixed grinding under stirring to even, impouring coats in the Duckbill type suppository mould of lubricant rapidly, freezing about 10 minutes, take out, even out, bolt is got in die sinking, and packing gets final product.
CNB011352825A 2001-12-13 2001-12-13 Vagina cleaning and antiphlogistic suppository and its preparing method Expired - Fee Related CN1193779C (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100525797C (en) * 2005-04-22 2009-08-12 姜惠民 Vagina external-use medicine composition and its preparing method and use
CN102755577A (en) * 2012-07-24 2012-10-31 周堃 Traditional Chinese medicine lotion for treating pruritus vulvae
CN105012326A (en) * 2015-08-13 2015-11-04 云南与诺生物工程有限责任公司 Application of ginsenoside CK and Rh1 and composition thereof in preparation of medicine for improving non-alcoholic fatty hepatic fibrosis and insulin resistance
CN105435033A (en) * 2015-12-04 2016-03-30 管遵信 Itching-relieving liniment
CN110123903A (en) * 2018-02-02 2019-08-16 刘光毕 A kind of volatility Chinese medicine suppository and preparation method thereof for treating vaginitis

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100525797C (en) * 2005-04-22 2009-08-12 姜惠民 Vagina external-use medicine composition and its preparing method and use
CN102755577A (en) * 2012-07-24 2012-10-31 周堃 Traditional Chinese medicine lotion for treating pruritus vulvae
CN102755577B (en) * 2012-07-24 2014-01-08 周堃 Traditional Chinese medicine lotion for treating pruritus vulvae
CN105012326A (en) * 2015-08-13 2015-11-04 云南与诺生物工程有限责任公司 Application of ginsenoside CK and Rh1 and composition thereof in preparation of medicine for improving non-alcoholic fatty hepatic fibrosis and insulin resistance
CN105012326B (en) * 2015-08-13 2018-02-27 云南与诺生物工程有限责任公司 Ginsenoside compound K, Rh1 and combinations thereof are preparing the application in improving nonalcoholic fatty liver fibrosis and insulin resistance medicine
CN105435033A (en) * 2015-12-04 2016-03-30 管遵信 Itching-relieving liniment
CN110123903A (en) * 2018-02-02 2019-08-16 刘光毕 A kind of volatility Chinese medicine suppository and preparation method thereof for treating vaginitis

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