CN1251748C - Lotion for treating gynecological disease and its preparation process - Google Patents

Lotion for treating gynecological disease and its preparation process Download PDF

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CN1251748C
CN1251748C CN 200410040563 CN200410040563A CN1251748C CN 1251748 C CN1251748 C CN 1251748C CN 200410040563 CN200410040563 CN 200410040563 CN 200410040563 A CN200410040563 A CN 200410040563A CN 1251748 C CN1251748 C CN 1251748C
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lotion
water
amounts
herba menthae
fructus cnidii
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CN1628771A (en
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唐秋海
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Abstract

The present invention relates to a lotion for treating gynecological diseases and a preparation method thereof. The lotion of the present invention comprises the following raw materials: 10 to 30 parts by weight of common cnidium fruit, 90 to 110 parts by weight of lightyellow sophora root, 40 to 60 parts by weight of rhizoma and 20 to 30 parts by weight of mint. Because of the prescription and the preparation method of the present invention, functions of effective parts of the medicines and mutual synergistic effect among the medicines can be fully exerted, and the lotion has optimum efficiency of treating diseases. The lotion of the present invention has good treating and itching relieving effect on various kinds of vaginitis and cervicitis of women, and no irritant side effect exists.

Description

Lotion of treatment gynaecopathia and preparation method thereof
Technical field
The present invention relates to treat the medicament of gynaecopathia, specifically is the lotion that raw material is made with the Chinese herbal medicine.The invention still further relates to its preparation method.
Background technology
Gynaecopathia such as vaginitis and cervicitis etc. are women's commonly encountered diseases, can cause leucorrhea abnormal, swelling of external genitals, flushing, fester, increase patient's misery, influence WomanHealth.Though traditional external sterilizing cleaning agent 1/5000 concentration bromo geramine liquid has curative effect preferably to colpitis mycotica and all the other vaginitiss and cervicitis, bromo geramine liquid has two flushings skin irritant performance to take place the back several times, and its antipruritic effect is also undesirable.
Summary of the invention
It is good that order of the present invention provides fruit a kind of better curative effect to various vaginitiss of women and cervicitis, antipruritic, and the lotion of the treatment gynaecopathia of nonirritant side effect and preparation method thereof.
Lotion of the present invention is according to traditional experience of tcm of motherland, and carry out the preparation of scientific formula and science, obtain lotion of the present invention, be used for the treatment of pruritus vulvae, women's damp-heat vaginal discharge, mycotic and trichomonal vaginitis, medicine directly contact lesions position, give full play to antibiotic, anti-trichomonal, antiinflammatory, the itching-relieving action of local application, reach improve curative effect, reduce side effect, purpose easy to use.
The lotion of treatment gynaecopathia of the present invention is the medicament of being made by following weight proportion raw material:
Fructus Cnidii 10~30, Radix Sophorae Flavescentis 90~110, Rhizoma Smilacis Glabrae 40~60, Herba Menthae 20~30.
Its preparation method is to produce according to the following steps:
1) get Fructus Cnidii and soaked 10~15 minutes with 8~9 times of amounts of 60% ethanol, the heating and refluxing extraction secondary, each 1~1.5 hour, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 8~12 times of amounts of water for the first time, decocts embodiment 1:
Choose following raw material (unit of weight: kilogram):
Fructus Cnidii 20, Radix Sophorae Flavescentis 100, Rhizoma Smilacis Glabrae 50, Herba Menthae 25.
Preparation method:
1) Fructus Cnidii was soaked 10 minutes with 8 times of amounts of 60%7 alcohol, the heating and refluxing extraction secondary, each 1 hour, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 10 times of amounts of water for the first time, decocted 2~2.5 hours, second and third time adds 6~10 times of amounts of water respectively, decocts 1~2 hour, collecting decoction filters, and it is 1.10~1.15 that filtrate is concentrated into relative density, add the Fructus Cnidii concentrated solution, put coldly, add Herba Menthae distillate, sodium benzoate 4.5~6 (weight portion), ethyl hydroxybenzoate 0.4~0.6 (weight portion), add water and be adjusted to total amount, mixing filters, promptly.
The physicochemical property of the contained effective ingredient of Chinese crude drug (position) of respectively distinguishing the flavor of in the lotion of the present invention and with function to cure mainly relevant pharmacological action as follows:
Radix Sophorae Flavescentis mainly contains alkaloids compositions such as matrine, oxymatrine, sophoridine, and oxymatrine accounts for more than 90% in the Radix Sophorae Flavescentis total alkaloids.Matrine alkaloid polarity is big, and is soluble in water, has antibiotic, anti-trichomonal, antiinflammatory action, is used for the treatment of vaginitis, cervicitis, pelvic inflammatory disease with matrine and Radix Sophorae Flavescentis decocting liquid vagina administration clinically, safe and effective.Rhizoma Smilacis Glabrae contains water soluble ingredients such as glycoside, organic acid, clinical with its decocting liquid part embrocate, fumigation and wash method is used for the treatment of vaginitis, the condyloma acuminatum effect is remarkable.
Herba Menthae contains volatile oil (main component is a menthol) and phenols component, and its decocting liquid has vitro antibacterial activity; The compound topical application that contains menthol has antiinflammatory, analgesic effect.
Fructus Cnidii contains tonkabean constituents such as volatile oil and Fructus Cnidii, osthole, bergapton, and its decocting liquid treatment eczema scrotum of clinical external, pudendal pruritus, pubic louse, vaginitis, cervicitis, pelvic inflammatory disease etc. are evident in efficacy.Osthole is water insoluble, can be dissolved in alcohol, chloroform, acetone and alkaline solution, has stronger antibacterial action, and trichomonas vaginitis is also had certain inhibitory action, the clinical outer treatment that is used for trichomonal vaginitis and skin fungus, and itching-relieving action is arranged.
Lotion preparation of the present invention is scientifically measured the time of Fructus Cnidii extraction time, number of times and Herba Menthae distillation extraction to obtain best yield.The screening of Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decocting process conditions is to carry out orthogonal test by certain factor, level design, with water solublity total solid leaching rate and oxymatrine leaching rate serves as to investigate index, amount of water, extraction time and number of times have appreciable impact to the total solid leaching rate, the oxymatrine leaching rate is not made significant difference, determine the preparation method of lotion science of the present invention thus.
Prescription of the present invention and preparation method make the above-mentioned medicine of respectively distinguishing the flavor of can give full play to the mutual synergism between its effective site effect and a few flavor medicine, make this medicament have the optimum efficiency of treatment disease.
Below be that lotion of the present invention carries out clinical trial controlled observation result in gynecological of No.1 Hospital Attached to Kunming Medical College:
One, experiment purpose
Observe and estimate lotion of the present invention vaginitis, the therapeutic effect of cervicitis, and investigate its toxic and side effects.
Two, physical data
Observe case 150 examples, test group 100 examples wherein, matched group 50 examples, maximum 52 years old age in the test group, minimal ages 21 years old, 35.9 years old mean age.Maximum 51 years old age in the matched group, minimal ages 22 years old, 34.6 years old mean age.See Table 1, table 2 and table 3:
Table 1 age structure table
Group Age (year)
20-29 30-39 4049 50-59
The test group matched group adds up to 29 11 40 36 25 61 28 11 39 7 3 10
The no significant difference in P>0.05
Table 2 test group and matched group are sick plants
Group Trichomonal vaginitis Mould road vaginitis Nonspecific vaginitis Cervicitis
II° III°
The test group matched group 9 3 36 23 29 12 12 8 8 2 6 2
Table 3 differential diagnosis in tcm table
Group Ascites of liver meridian damp-heat type Liver-kidney yin deficiency
The test group matched group 76 39 24 11
Three, case choice criteria
Vaginitis in the selection female genital disease and chronic cervicitis are for observing.
1, diagnostic criteria
(1) Western medicine diagnose standard
Vaginitis patient leucorrhoea grow in quantity or pruritus discomfort, leucorrhea are purulence or bean curd slag specimen, stench, vaginal mucosa hyperemia, and conventional leucorrhea smear is looked into cleannes.Infusorian, mould road, gonococcus, look into vagina cleanness degree.
Cervicitis patient's leucorrhoea grow in quantity, cervical erosion hyperemia, conventional temporary dwelling palace neck cell learn check with except malignant change.
(2) differential diagnosis in tcm
Dampness-heat of the liver disease:
The pudendum flushing, swelling, the pain of very then itching, uneasy in either sitting or lying, profuse leukorrhea, yellow skin such as pus, or be foam water from washing rice sample, red tongue, yellow and greasy fur wiry and frequent pulse.
Hepatic and renal YIN deficiency disease:
Dry and astringent, the scorching hot pruritus of pudendum, or the few yellow skin of leukorrhagia amount, very then as blood sample, dysphoria with feverish sensation in the chest palms and soles is had a dizzy spell, the time warm sweating, xerostomia is the desire drink not, tinnitus and soreness of loins, red tongue is tongue less, thready and rapid pulse without strength.
2, test case standard
(1) includes the case standard in
Meet trichomonal vaginitis, mould road vaginitis nonspecific vaginitis and chronic cervicitis diagnosis and differential diagnosis in tcm person can include the test case in.
(2) get rid of the case standard
Age is at under-18s or more than 60 years old; Gestation or women breast-feeding their children; To the primary disease allergy sufferers; Be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, the psychotic; Not treatment in accordance with regulations can't be judged not umbra sound curative effect person of curative effect or data.
Four, observation index
1, health giving quality is observed
Clinical manifestation: symptom, sign change;
Gynecologial examination: vagina, cervical secretions inspection.
2, side effect is observed
In the process of the test as toxicity occurs, drug withdrawal immediately, and record faithfully.
Five, clinical observation scheme
1, test method
Single at random blind method is adopted in this test, is in hospital and the outpatient washes treatment by outpatient service gyniatrics chamber special messenger, and strict control variable factor is observed not adding with under other medicine principle.
2, medication, consumption and curative effect
Investigational agent: lotion of the present invention, add warm water and be made into 20% concentration once a day for pudendum, vaginadouche, treating 7 days continuously is a course of treatment.
Contrast medicine: 5% bromo geramine solution, producer: the emerging pharmaceutical factory of traditional Chinese medicine in Kunming, lot number: 991201
1/5000 attempts bromo geramine liquid rinsing vulva, vagina once a day, 7 days one courses of treatment.
Six, curative effect determinate standard
1, recovery from illness: symptom, sign disappear, and check and recover I ° of normal leucorrhea cleannes.
2, produce effects: symptom, sign obviously alleviates, leucorrhea microscopy feminine gender, vagina cleanness degree I ° or II °.
3, effective: symptom, sign alleviates, and leucorrhea microscopy positive or negative, vagina cleanness degree are II °, III °.
4, invalid: symptom, sign no change, the leucorrhea microscopy positive.
Following table 4, table 5 are observation of curative effect results
Table 4 vaginitis curative effect table
Group The example number Infusorian property Mould road Non-specific
Pool more The amount number Effectively Invalid Effective percentage % Cure The amount number Effectively Invalid Effective percentage % Cure The amount number Effectively Invalid Effective percentage %
The experimental group matched group 74 38 9 1 2 2 1 0 0 0 100 100 23 11 9 7 3 4 1 1 99 97 21 6 3 2 2 2 0 0 100 100
The no significant difference in P>0.05.
Table 5 cervicitis curative effect table
Group The example number II° III°
Recovery from illness Produce effects Effectively Invalid Effective percentage % Recovery from illness Produce effects Effectively Invalid Effective percentage % Recovery from illness Produce effects Effectively Invalid Effective percentage %
The experimental group matched group adds up to 26 12 38 6 4 10 3 2 5 3 2 5 0 0 0 100 100 1 0 1 4 2 6 3 0 3 0 0 0 100 100 0 0 0 3 1 4 3 1 4 0 0 0 100 100
Seven, untoward reaction is observed
Lotion rinsing vulva of the present invention, vaginal treatment 100 examples have no adverse reaction and anaphylaxis.
Have 2 people to feel skin of vulva twinge, pruritus after the 1/5000 bromo geramine rinsing vulva, vaginadouche 4 times, after take a turn for the better after treatment.
Eight, conclusion
According to this clinical observation experiment result lotion of the present invention perineum and vagina, cervix uteri, skin, mucosa there are cleaning, sterilization and antiinflammatory, itching-relieving action.Be used for vaginitis 74 examples in this group case, effective percentage 100%, wherein cure rate reaches 75.7%.Treatment cervicitis 26 examples, effective percentage reaches 100%, and wherein cure rate reaches 26.9%, and better to slight cervicitis therapeutic effect, cure rate reaches 50%.Cervicitis treatment back leucorrhea obviously reduces, and laser and the cold therapy healing of going again after the flushing is fast, promotes epithelial repair, and prevention naturopathy postoperative infection takes place.
Lotion of the present invention has heat-clearing and toxic substances removing, damp eliminating, the function of the wind that looses, be used for damp-heat vaginal discharge, its effects of vaginitis treatment such as the red and swollen pruritus of pudendum significantly, be used for pudendum, vaginadouche, reach the effect of antibacterial parasite killing easing pain and diminishing inflammation, and fine antipruritic effect is arranged, do not find untoward reaction in the therapeutic process, the medicinal liquid of dilution 20% is to skin, mucosa nonirritant, and is safe in utilization.
The specific embodiment
Embodiment 1:
Choose following raw material (unit of weight: kilogram):
Fructus Cnidii 20, Radix Sophorae Flavescentis 100, Rhizoma Smilacis Glabrae 50, Herba Menthae 25.
Preparation method:
1) Fructus Cnidii was soaked 10 minutes with 8 times of amounts of 60% ethanol, the heating and refluxing extraction secondary, each 1 hour, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 10 times of amounts of water for the first time, decocted 2 hours, second and third time adds 8 times of amounts of water respectively, decocts 1.5 hours, collecting decoction filters, and it is 1.10~1.15 (98 ℃) that filtrate is concentrated into relative density, add the Fructus Cnidii concentrated solution, put coldly, add Herba Menthae distillate, 5 kilograms of sodium benzoate, 0.5 kilogram of ethyl hydroxybenzoate, add water and be adjusted to 1000 liters of total amounts, mixing filters, promptly.
This product be yellowish-brown to dark-brown liquid, feeble QI perfume (or spice).
Embodiment 2:
Choose following raw material (unit of weight: kilogram):
Fructus Cnidii 10, Radix Sophorae Flavescentis 90, Rhizoma Smilacis Glabrae 40, Herba Menthae 20.
Preparation method:
1) Fructus Cnidii was soaked 10 minutes with 8 times of amounts of 60% ethanol, the heating and refluxing extraction secondary, each 1 hour, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 10 times of amounts of water for the first time, decocted 2 hours, second and third time adds 8 times of amounts of water respectively, decocts 1.5 hours, collecting decoction filters, and it is 1.10~1.15 (98 ℃) that filtrate is concentrated into relative density, add the Fructus Cnidii concentrated solution, put coldly, add Herba Menthae distillate, 4.5 kilograms of sodium benzoate, 0.4 kilogram of ethyl hydroxybenzoate, add water and be adjusted to 1000 liters of total amounts, mixing filters, promptly.
Embodiment 3:
Choose following raw material (unit of weight: kilogram):
Fructus Cnidii 30, Radix Sophorae Flavescentis 110, Rhizoma Smilacis Glabrae 60, Herba Menthae 30.
Preparation method:
1) Fructus Cnidii was soaked 15 minutes with 9 times of amounts of 60% ethanol, the heating and refluxing extraction secondary, each 1.5 hours, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 12 times of amounts of water for the first time, decocted 2.5 hours, second and third time adds 10 times of amounts of water respectively, decocts 2 hours, collecting decoction filters, and it is 1.10~1.15 (98 ℃) that filtrate is concentrated into relative density, add the Fructus Cnidii concentrated solution, put coldly, add Herba Menthae distillate, 6 kilograms of sodium benzoate, 0.6 kilogram of ethyl hydroxybenzoate, add water and be adjusted to 1000 liters of total amounts, mixing filters, promptly.

Claims (2)

1. lotion for the treatment of gynaecopathia is characterized in that it is the medicament of being made by following weight proportion raw material:
Fructus Cnidii 10~30, Radix Sophorae Flavescentis 90~110, Rhizoma Smilacis Glabrae 40~60, Herba Menthae 20~30.
2. press the preparation method of the lotion of the described treatment gynaecopathia of claim 1, it is characterized in that producing according to the following steps:
1) get Fructus Cnidii and soaked 10~15 minutes with 8~9 times of amounts of 60% ethanol, the heating and refluxing extraction secondary, each 1~1.5 hour, merging filtrate filtered, and decompression recycling ethanol is standby;
2) Herba Menthae is used steam distillation, and medicinal residues and Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae decoct with water three times, adds 8~12 times of amounts of water for the first time, decocted 2~2.5 hours, second and third time adds 6~10 times of amounts of water respectively, decocts 1~2 hour, collecting decoction filters, and it is 1.10~1.15 that filtrate is concentrated into relative density, add the Fructus Cnidii concentrated solution, put coldly, add Herba Menthae distillate, sodium benzoate 4.5~6 (weight portion), ethyl hydroxybenzoate 0.4~0.6 (weight portion), add water and be adjusted to total amount, mixing filters, promptly.
CN 200410040563 2004-08-26 2004-08-26 Lotion for treating gynecological disease and its preparation process Expired - Fee Related CN1251748C (en)

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Application Number Priority Date Filing Date Title
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CN1251748C true CN1251748C (en) 2006-04-19

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Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105125870A (en) * 2015-09-28 2015-12-09 高辉花 Traditional Chinese medicine for treating chronic cervicitis
CN106908542A (en) * 2017-03-16 2017-06-30 云南优克制药公司 The quality determining method of antipyretic and itching-stopping lotion
WO2020010919A1 (en) * 2018-07-12 2020-01-16 江苏正阳药业有限公司 Traditional chinese medicine composition, traditional chinese medicine compound preparation and preparation method and use thereof
CN108671178A (en) * 2018-07-26 2018-10-19 贵州东仪医疗器械有限公司 A kind of private parts is antibacterial, antipruritic, anti-inflammatory preparation and its preparation method and application
CN111012859A (en) * 2019-12-30 2020-04-17 重庆宫妙生物科技有限公司 Bacteriostatic external pill of composite biological preparation
CN111888408A (en) * 2020-08-11 2020-11-06 西安浩然药业有限责任公司 Preparation method of antibacterial gel
CN112316012A (en) * 2020-11-19 2021-02-05 陕西康乐实业有限公司 Moisturizing antibacterial gel and preparation method thereof
CN112999128B (en) * 2021-03-19 2022-07-08 陕西倍康健生物科技有限公司 Natural galenical composition with mosquito repelling and itching relieving functions

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