CN100488542C - Chinese medicinal lotion - Google Patents

Chinese medicinal lotion Download PDF

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Publication number
CN100488542C
CN100488542C CNB200510060999XA CN200510060999A CN100488542C CN 100488542 C CN100488542 C CN 100488542C CN B200510060999X A CNB200510060999X A CN B200510060999XA CN 200510060999 A CN200510060999 A CN 200510060999A CN 100488542 C CN100488542 C CN 100488542C
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treatment
vaginitis
lotion
chinese medicine
matched group
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CN1765410A (en
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王大冲
郭仲坚
宣铁锋
柯长青
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Echo Qi group Zhejiang Qi Qi Pharmaceutical Co., Ltd.
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ZHEJIANG YADONG PHARMACEUTICAL CO Ltd HUIYINGBI GROUP
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Abstract

The invention relates to a Chinese medicinal lotion wherein each 100ml of the lotion is extracted from the following raw materials: Philippine violet herb 1.2-192g, yellow corktree bark 0.78-124.8g, coptis root 0.63-100.8g, rhizome smilacis glabrae 0.72-115.2g, flavescent sophora root 0.72-115.2g, cnidium fruit 0.63-100.8g, red peony root 0.36-57.6g, and borneol 0.0152-2.4g.

Description

Chinese medicine lotion
Technical field
The present invention relates to a kind of medicinal preparation, specifically is the Chinese medicine lotion of a kind of treatment female vagina (disease).
Background technology
Chinese patent literature CN1415371A discloses " a kind of medicine for the treatment of colpitis mycotica and trichomonal vaginitis and preparation method thereof ", and this pharmaceutical composition is by Herba Violae, Herba Taraxaci, Radix Sophorae Flavescentis, the Fructus Kochiae, Cortex Dictamni, Cortex Phellodendri, Rhizoma Picrorhizae, Fructus Cnidii, Rhizoma Atractylodis, Folium Artemisiae Argyi, Caulis Clematidis Armandii, Margarita powder, 13 flavor Chinese medicines such as Borneolum Syntheticum are formed, and treatment colpitis mycotica and trichomonal vaginitis are had better curative effect.
In the herbal species of existing treatment woman vagina disease disease, JIEERYIN XIYE, Lifukang pleasure etc. exist the circumscribed defective of therapeutic domain, only effective as JIEERYIN XIYE at candidiasis and trichomonal vaginitis, Lifukang is happy only to bacillary effective with colpitis mycotica, all exists certain medication limitation.
Summary of the invention
The technical issues that need to address of the present invention are, overcome the existing deficiency of prior art, provide a kind of not only to colpitis mycotica and trichomonal vaginitis, and bacterial vaginosis are also had the Chinese medicine lotion of better therapeutical effect.
Chinese medicine lotion of the present invention is characterized in that every 100ml lotion obtains from the following bulk drugs extraction:
Herba Violae 1.2~192g, Cortex Phellodendri 0.78~124.8g, Rhizoma Coptidis 0.63~100.8g,
Rhizoma Smilacis Glabrae 0.72~115.2g, Radix Sophorae Flavescentis 0.72~115.2g, Fructus Cnidii 0.63~100.8g,
Radix Paeoniae Rubra 0.36~57.6g, Lignum Dalbergiae Odoriferae 0.36~57.6g, Borneolum Syntheticum 0.015~2.4g.
As preferably, described crude drug:
Herba Violae 2.4~48g, Cortex Phellodendri 1.56~31.2g, Rhizoma Coptidis 1.26~25.2g,
Rhizoma Smilacis Glabrae 1.44~28.8g, Radix Sophorae Flavescentis 1.44~28.8g, Fructus Cnidii 1.26~25.2g,
Radix Paeoniae Rubra 0.72~14.4g, Lignum Dalbergiae Odoriferae 0.72~14.4g, Borneolum Syntheticum 0.03~0.6g.
The present invention is the pale reddish brown washing liquid (Herba Violae, Cortex Phellodendri, Rhizoma Coptidis, Fructus Cnidii, Lignum Dalbergiae Odoriferae) handed down from one's ancestors according to clinical practice Shandong Qiao Shi for many years, carry out rational flavour of a drug plus-minus, press modern Chinese medicine abstract science prescription, Chinese medicine three kind new medicines that the Chinese medicine preparation technology of uses advanced develops.Prescription is a monarch drug with the Herba Violae, and bitter in the mouth is cold in nature, goes into conscience two warps, clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling.Reuse this product in the side, get it and specially go into the conscience warp, kind heat-clearing and toxic substances removing, dampness removing are treated the merit of carbuncle, with the damp and hot evil poison of clear pudendum, treat erosion of vulva detumescence pain.With Rhizoma Coptidis, Cortex Phellodendri heat clearing away, dampness, detoxifcation is ministerial drug, and the product that two bitter in the mouth are cold had both helped the principal agent heat-clearing and toxic substances removing, the dry again part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels wet and be accessory drugs.With Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Lignum Dalbergiae Odoriferae, Fructus Cnidii, Radix Paeoniae Rubra is adjuvant drug, clearing away heat-damp and promoting diuresis, killing parasites for relieving itching, separates that stagnation resolvation is swollen wards off evil, eliminating evil in order to toxin expelling, relieving itching and eliminating swelling.Wherein Radix Sophorae Flavescentis heat clearing and damp drying, wind dispelling insecticide are for controlling the product that the leukorrhagia Huang is thick, pudendal pruritus is commonly used; The Fructus Cnidii removing dampness and killing parasites is antipruritic, is the good medicine of external fumigation and washing treatment married woman pudendal pruritus; Rhizoma Smilacis Glabrae detoxifcation dehumidifying is to strengthen the effect of full side's detoxification and promoting urination; Lignum Dalbergiae Odoriferae, Radix Paeoniae Rubra, promoting flow of QI and blood, blood stasis dispelling is antipruritic.The Borneolum Syntheticum aroma looses.Having tonneau a surname soothing the liver merit, is messenger drug to help full side a surname wet dissipation heat.The all medicines in full side are shared, complement each other, and are clearing away heat-damp and promoting diuresis, and removing toxic substances and promoting subsidence of swelling, killing parasites for relieving itching are treatment damp invasion of lower energizer, evil malicious stasis in fact, change worm and the good medicine of the pudendal pruritus card that causes.
Herba Violae except having used background document also to use among the present invention, Radix Sophorae Flavescentis, Cortex Phellodendri, Fructus Cnidii is outside 5 kinds of Chinese medicines such as Borneolum Syntheticum, the ministerial drug that background document is unexistent, play an important role---Rhizoma Coptidis and Rhizoma Smilacis Glabrae have also been used, Radix Paeoniae Rubra, 4 flavor medicines such as Lignum Dalbergiae Odoriferae, they and aforementioned 5 medicines are as an auxiliary medicine agent, evident characteristic is arranged on the property of medicine, on curative effect, be significantly increased and enlarge.At first, Rhizoma Picrorhizae and Rhizoma Coptidis are distinguishing, and Rhizoma Picrorhizae is the dry rhizome of goatweed Rhizoma Picrorhizae, has clearing away damp-heat, remove hectic fever due to YIN-deficiency, and the effect of the infantile malnutrition with fever that disappears is mainly used in damp-heat dysentery, jaundice, haemorrhoids, osteopyrexia and fever, children's's infantile malnutrition with fever.Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis, Coptis deltoidea C.Y.Cheng et Hsiao or Coptis Teeta Wall, has heat clearing and damp drying, and the effect of eliminating fire and detoxication is mainly used in damp and hot feeling of fullness, the vomiting acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, heat in blood is told nosebleed, conjunctival congestion, and the carbuncle furuncle is quenched one's thirst in toothache; External treatment eczema, eczema, auditory meatus is suppurated.Rhizoma Coptidis among the present invention mainly is to utilize its heat clearing and damp drying, and the effect of eliminating fire and detoxication is assisted a ruler in governing a country Herba Violae with the damp and hot evil poison of pudendum, dampness.Secondly, in the side composition Rhizoma Smilacis Glabrae have dehumidifying, the effect of the easing joint movement that detoxifies, strengthen full side's detoxification and promoting urination, be mainly used in limbs rickets, bones and muscles pain due to damp and hot stranguria with turbid discharge, leukorrhagia, carbuncle, scabies and syphilis, the mercurialism; Lignum Dalbergiae Odoriferae promoting flow of QI and blood, pain relieving, hemostasis are used for epigastric pain, hypochondriac pain due to stagnation of liverQI etc.; Radix Paeoniae Rubra clearing away heat and cooling blood, eliminating stasis to stop pain are used for maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, the amenorrhea dysmenorrhea.The Borneolum Syntheticum aroma looses.Having tonneau a surname soothing the liver merit, is messenger drug to help full side a surname wet dissipation heat.
Product of the present invention shows that through II phase clinical research treatment bacterial vaginosis, monilial vaginitis and trichomonal vaginitis total effective rate are respectively 93.33%, 95.08% and 86.67%; Be respectively 92.00%, 94.34% and 89.00% through III phase clinical research proof this product treatment bacterial vaginosis, monilial vaginitis and trichomonal vaginitis total effective rate.Result of study proof this product is evident in efficacy, safe without toxic side effect.
The specific embodiment
Below by embodiment, technical scheme of the present invention is described in further detail.
Embodiment 1.The crude drug of this routine Chinese medicine lotion extracts respectively, and wherein Cortex Phellodendri 26g and Rhizoma Coptidis 21g two flavor medicines obtain medicinal liquid with alcohol reflux extracting process together; Fructus Cnidii 21g and Lignum Dalbergiae Odoriferae 12g two flavor medicines obtain volatile oil with water vapour distillation technology together; Herba Violae 40g, Radix Sophorae Flavescentis 24g, Rhizoma Smilacis Glabrae 24g and Radix Paeoniae Rubra 12g four Chinese medicine obtain extracting solution with water extraction process together; Three extracting section things and at last simply Borneolum Syntheticum 0.5g obtain the 1000ml Chinese medicine lotion through batching, adjust pH, Jia Shui, filtration, last fill, check product.The crude drug that is every 100ml Chinese medicine lotion is: Herba Violae 4.0g, Cortex Phellodendri 2.6g, Rhizoma Coptidis 2.1g, Rhizoma Smilacis Glabrae 2.4g, Radix Sophorae Flavescentis 2.4g, Fructus Cnidii 2.1g, Radix Paeoniae Rubra 1.2g, Lignum Dalbergiae Odoriferae 1.2g, Borneolum Syntheticum 0.05g.
The crude drug that the Chinese medicine lotion of embodiment 2-5 is used sees the following form:
Figure C200510060999D00051
Clinical trial (all using the Chinese medicine lotion of embodiment 1)
This lotion is carried out the therapeutic effect and the safety research of II phase clinical treatment syndrome of dampness-heat diffusing downward vaginitis 362 examples jointly by Second Hospital Attached To Tianjin Chinese Medicine College, Hospital Attached to Shandong Chinese Medical Univ., Jinan City institute of traditional Chinese medicine, four tame units of Weifang Traditional Chinese Medicine Hospital.Wherein (60 examples are organized in treatment to bacterial vaginosis 120 examples, matched group 60 examples), (60 examples are organized in treatment to trichomonal vaginitis 120 examples, matched group 60 examples), candida albicans vaginitis 122 examples (61 examples are organized in treatment, matched group 61 examples) compare with JIEERYIN XIYE, take at random, parallel control, the test of double blinding double-dummy technique, preliminary assessment clinical efficacy, safety and untoward reaction.The group of bacterial vaginosis treatment as a result total effective rate 93.33%, cure-remarkable-effectiveness rate 81.66%; Matched group total effective rate 80.00%, cure-remarkable-effectiveness rate 61.66%.Candida albicans vaginitis treatment group total effective rate 95.08%, cure-remarkable-effectiveness rate 81.97%; Matched group total effective rate 81.97%, cure-remarkable-effectiveness rate 60.66%.Trichomonal vaginitis treatment group total effective rate 86.67%, cure-remarkable-effectiveness rate 71.67%; Matched group total effective rate 73.33%, cure-remarkable-effectiveness rate 51.66%.
Carry out the therapeutic effect and the safety research of III phase clinical treatment syndrome of dampness-heat diffusing downward vaginitis 428 examples jointly by Second Hospital Attached To Tianjin Chinese Medicine College, Hospital Attached to Shandong Chinese Medical Univ., Jinan City institute of traditional Chinese medicine, Weifang Traditional Chinese Medicine Hospital, Hospital Attached to Hubei Chinese Medicine College, Zhejiang Prov. Hospital of Traditional Chinese Medicine six tame units.Wherein (100 examples are organized in treatment to bacterial vaginosis 140 examples, matched group 40 examples), (100 examples are organized in treatment to trichomonal vaginitis 140 examples, matched group 40 examples), candida albicans vaginitis 148 examples (106 examples are organized in treatment, matched group 42 examples) compare with JIEERYIN XIYE, take at random, parallel control, the test of double blinding double-dummy technique, estimate clinical efficacy, safety and untoward reaction.The group of bacterial vaginosis treatment as a result total effective rate 92.00%, cure-remarkable-effectiveness rate 80.00%; Matched group total effective rate 82.50%, cure-remarkable-effectiveness rate 57.50%.Candida albicans vaginitis treatment group total effective rate 94.34%, cure-remarkable-effectiveness rate 79.25%; Matched group total effective rate 83.34%, cure-remarkable-effectiveness rate 57.15%.Trichomonal vaginitis treatment group total effective rate 89.00%, cure-remarkable-effectiveness rate 71.00%; Matched group total effective rate 77.50%, cure-remarkable-effectiveness rate 55.00%.
From its result of study, use this lotion for treatment bacterial vaginosis, candida albicans vaginitis, trichomonal vaginitis (genus syndrome of dampness-heat diffusing downward), adopt at random, parallel control, double blinding double-dummy technique controlled trial, carry out II phase, III phase clinical observation, there are no significant difference, good comparability between group such as age, the state of an illness, sick kind, picture of the tongue, pulse condition, hemogram between treatment group and the matched group.Curative effect compares there was no significant difference between multicenter observation treatment group, treatment group and matched group total effects relatively have significant differences (P<0.01), treatment group three is sick plant between curative effect relatively there are no significant difference (P〉0.05), total mark relatively has the significant difference (P<0.05) except that between two groups of trichomonal vaginitis, all the other all have significant differences, and (P<0.01=, each sick kind total effective rate, all treatment groups of cure-remarkable-effectiveness rate are higher than matched group.
From Syndrome in TCM marquis curative effect relatively, learn result by statistics and show, do not have significance (P〉0.05) though processing difference is learned in the comparison of trichomonal vaginitis Syndrome in TCM marquis curative effect by statistics, the treatment group is better than matched group; More all there were significant differences (P<0.05) for bacterial vaginosis, candida albicans vaginitis Syndrome in TCM marquis curative effect, points out this medicine treatment bacterial vaginosis and candida albicans vaginitis Syndrome in TCM marquis curative effect to improve and be better than matched group.
From local sign curative effect relatively, removing two groups of local sign curative effects of bacterial vaginosis relatively has significant differences (P<0.01), points out this medicine treatment bacterial vaginosis Syndrome in TCM marquis curative effect to improve and is better than matched group; Do not have significance (P〉0.05) though processing difference is learned in the comparison of two groups of local sign curative effects of Candida albicans, trichomonal vaginitis by statistics, the treatment group is better than matched group; The former two groups of situations of turning out cloudy of causing a disease are removed trichomonal vaginitis there was no significant difference (P〉0.05), and all the other all have significant difference (P<0.05); PH value (bacillary) situation of change has significant differences (P<0.01); Two groups of comparisons of cleannes there was no significant difference (P〉0.05).
Come comparison from traditional Chinese medical science primary symptom improvement situation: two groups of bacterial vaginosis profuse leukorrheas improve situation relatively has significant differences (P<0.01) treatment group to be better than matched group, leukorrhagia flavor improvement situation relatively has significant difference (P<0.05), and the treatment group is better than matched group; Two groups of candida albicans vaginitis pudendal pruritus improve situation relatively significant differences (P<0.01), and the treatment group is better than matched group, and profuse leukorrhea improves situation relatively significant difference (P<0.05), and the treatment group is better than matched group; Two groups of trichomonal vaginitis profuse leukorrheas and leukorrhagia flavor improvement situation relatively have significant differences (P<0.01), and the treatment group is better than matched group.
From local sign improvement situation relatively: two groups of bacterial vaginosis leukorrhagia improve situation unusually relatively significant difference (P<0.05), and the treatment group is better than matched group; Two groups of candida albicans vaginitis vaginal mucosa improvement situations relatively have significant difference, and (P<0.05=, the treatment group is better than matched group.
Carry out the relevance factors analysis relatively: age and curative effect be there was no significant difference relatively, and prompting age size is irrelevant with the state of an illness; The state of an illness and curative effect are relatively, remove bacterial vaginitis moderate and severe significant difference (P<0.05 is relatively arranged, the light patient's curative effect of the prompting state of an illness is better than state of an illness weight, all the other infusorian vaginosis, candida albicans vaginitis state of an illness weight and curative effect relatively there are no significant difference (P〉0.05), prompting state of an illness weight has nothing to do with curative effect.The course of disease and curative effect be relatively: remove bacterial vaginitis<7 day with 15 days-significant difference (P<0.05=relatively arranged, significant difference (P<0.05=was relatively arranged in<7 days and 7-14 days, all the other bacterial vaginosis, the candida albicans vaginitis course of disease and curative effect relatively there are no significant difference (P〉0.05), prompting course of disease length and curative effect do not have obvious relation.
Do not find untoward reaction in the clinical trial, relevant new unusual case with test is not found in safety detection, curative effect check.
In a word, lotion of the present invention is as three kind new medicines of treatment female vagina (disease), be pure Chinese medicinal preparation, effect with heat-clearing and toxic substances removing, killing parasites for relieving itching, be applicable to damp heat downward flowing type bacterial vaginosis and Candida albicans, trichomonal vaginitis, through II phase and III phase clinical observation determined curative effect, do not find toxicity, be treatment a kind of more satisfactory, new Chinese medicine of being worthy to be popularized in the vaginitis.

Claims (1)

1, a kind of Chinese medicine lotion for the treatment of female vagina is characterized in that every 100ml lotion obtains from the following bulk drugs extraction:
Herba Violae 4.0g, Cortex Phellodendri 2.6g, Rhizoma Coptidis 2.1g,
Rhizoma Smilacis Glabrae 2.4g, Radix Sophorae Flavescentis 2.4g, Fructus Cnidii 2.1g,
Radix Paeoniae Rubra 1.2g, Lignum Dalbergiae Odoriferae 1.2g, Borneolum Syntheticum 0.05g.
CNB200510060999XA 2005-10-09 2005-10-09 Chinese medicinal lotion Active CN100488542C (en)

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Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102743678B (en) * 2012-06-17 2013-10-02 朱秀红 Preparation method of Chinese medicine irrigation solution for treating overfeeding greasy food type trichomonas vaginitis
CN102743662B (en) * 2012-07-18 2015-03-11 广西中医药大学 Zhuang medicine preparation for treating gynecological inflammation and preparation method thereof
CN103585576A (en) * 2013-10-24 2014-02-19 青岛华仁技术孵化器有限公司 Traditional Chinese medicine for treating monilial vaginitis

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
霉菌性阴道炎外用方. 胡达坤.江苏中医,第10卷第8期. 1989
霉菌性阴道炎外用方. 胡达坤.江苏中医,第10卷第8期. 1989 *

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