CN100335084C - Compound Chinese medicine for treating leukoplakia vulvae and its preparation method - Google Patents

Compound Chinese medicine for treating leukoplakia vulvae and its preparation method Download PDF

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Publication number
CN100335084C
CN100335084C CNB031175848A CN03117584A CN100335084C CN 100335084 C CN100335084 C CN 100335084C CN B031175848 A CNB031175848 A CN B031175848A CN 03117584 A CN03117584 A CN 03117584A CN 100335084 C CN100335084 C CN 100335084C
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compound chinese
raw material
preparation
portions
chinese medicinal
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CN1442189A (en
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余定国
邓世明
朱绪民
李存勇
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Beida'er New Tech Dev Co Ltd Sichuan
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Beida'er New Tech Dev Co Ltd Sichuan
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Abstract

The present invention provides a compound Chinese medicine for treating leukoplakia vulvae and a preparation method thereof. The compound Chinese medicine for treating leukoplakia vulvae is mainly prepared from 0.5 to 2.0 portions of prepared fleece flower roots, 0.5 to 1.5 portions of herba pyrolae, 0.5 to 2.0 portions of lucid ligustrum fruit, 0.5 to 1.5 portions of glossy privet fruit and 0.5 to 1.0 portions of dittany bark as raw materials according weight proportion. The compound Chinese medicine for treating leukoplakia vulvae has the advantages of high active component content, obvious and exact therapeutic effect on clinical symptoms, high therapeutic effective rate (up to 95%), macroporous resin adoption, high enriched active component, advanced preparation process and stable and controllable quality and can be made into various oral or injection dosage forms.

Description

A kind of compound Chinese medicinal preparation for the treatment of the pudendum leukoplakia and preparation method thereof
Affiliated technical field
The present invention relates to compound Chinese medicinal preparation and preparation method, especially treat the compound Chinese medicinal preparation and the preparation method of pudendum leukoplakia.
Background technology
The pudendum leukoplakia, claim vulvar dystrophy again, be meant that female vulva skin and mucosal tissue cause epidermal tissue's growth disorderly and dermal tissue degeneration and discolored chronic disease because of malnutrition, with pudendum very itch, ulceration, severe pain and skin is changed to feature, be that a kind of cause of disease is unclear, refractory easily recurs and do not have the common gynaecopathia of the Therapeutic Method of suiting the medicine to the illness at present.Its sickness rate of foreign statistic is 1/300-1/1000, accounts for 50% of vulva, can fall ill every year until old from childhood, and the peak age, the course of disease was different in size before and after 50 years old, and the elder can reach many decades.In recent years domestic and foreign literature is reported, the pudendum leukoplakia has malignant potential, and canceration rate is up to 0.7-5.0%.
The treatment of at present relevant pudendum leukoplakia, the method for still not having specially good effect and curing fully, Western medicine adopts hormones and chemotherapy class Drug therapy more, and side effect is bigger, and the patient is difficult to long-term acceptance; Operative treatment has inconvenience more and 50% relapse rate is arranged, and doctor and patient is not all advocated; Treatment by Chinese herbs mostly is hospital's proved recipe or hospital preparation.The patent documentation relevant with the pudendum leukoplakia has " vulvar dystrophy spirit compound method " (number of patent application: 88103434) select 8 flavor oral medicinal herbs such as Radix Angelicae Sinensis, Radix Paeoniae Rubra, Radix Bupleuri, Poria for use, make external-use lotion with 8 flavor Chinese medicines such as Radix Angelicae Sinensis, Radix Paeoniae Rubra, Herba Epimedii, Rhizoma Acori Graminei in addition; " high efficiency sterilizing ointment for women " (number of patent application: 94103619) provide a kind of externally applied anti-inflammation medicine, mainly be applicable to all kinds of vaginitiss; " a kind of oral medicine for the treatment of white diseases of vulva " of temperature duckweed application (number of patent application: 97111371) select 9 flavor Chinese prescriptions such as Fructus Ligustri Lucidi, Semen Sesami Nigrum, Semen sojae atricolor for use, focus on from interior accent and mend, not obvious to the clinical symptoms curative effect.
Summary of the invention
The purpose of this invention is to provide a kind of compound Chinese medicinal preparation for the treatment of the pudendum leukoplakia, this compound Chinese medicinal preparation active component content height, to pudendum leukoplakia clinical symptoms curative effect obviously, definitely, treatment effective percentage height.
The technical scheme that the present invention solves its technical problem employing is: a kind of compound Chinese medicinal preparation for the treatment of the pudendum leukoplakia, its characteristics are: it mainly is the preparation of being made by the following weight proportion raw material: Radix Polygoni Multiflori Preparata 0.5-2.0 part, Herba Pyrolae 0.5-1.5 part, Semen Astragali Complanati 0.5-2.0 part, Fructus Ligustri Lucidi 0.5-1.5 part and Cortex Dictamni 0.5-1.0 part.
Compound Chinese medicinal preparation of the present invention also can be added with at least a following weight proportion raw material: Radix Paeoniae Rubra 0.5-1.0 part, Radix Gentianae 0.5-1.0 part, Rhizoma Osmundae 0.5-1.0 part, Flos Lonicerae 0.5-1.0 part.
Compound Chinese medicinal preparation of the present invention, the optimum weight proportioning of each raw material is: 0.9 part of Radix Polygoni Multiflori Preparata, 0.8 part of Herba Pyrolae, 0.6 part of Semen Astragali Complanati, 0.6 part of Fructus Ligustri Lucidi, 0.5 part of Cortex Dictamni, 0.5 part of Radix Paeoniae Rubra, 0.5 part of Radix Gentianae, 0.5 part of Rhizoma Osmundae, 0.5 part of Flos Lonicerae.
Compound Chinese medicinal preparation of the present invention, its dosage form can be any dosage form on the pharmaceuticss such as tablet, capsule, soft capsule, granule, pill, water preparation, syrup, freeze-dried powder, liquid drugs injection.
With can received disintegrating agent in the oral formulations, after auxiliary adding ingredient that excipient, lubricant, binding agent, filler etc. are commonly used mixes, promptly may be made in solid pharmaceutical preparations such as tablet, capsule, soft capsule, granule and pill according to a conventional method; With commonly used surfactants such as solubilizing agent, emulsifying agent, wetting agent, foaming or defoamer, diluent, antiseptic, stabilizing agent, distinguish the flavor of agent, thickening agent etc. mix, and by corresponding conventional method, promptly may be made in liquid pharmaceutical formulations such as water preparation, syrup; Cooperate with appropriate solvent commonly used in the injection and additives and operate, can also be prepared into intramuscular injection pharmaceutical preparatioies such as corresponding freeze-dried powder, liquid drugs injection.
Another object of the present invention provides a kind of compound Chinese medicinal preparation preparation method for the treatment of the pudendum leukoplakia.
The preparation method of compound Chinese medicinal preparation of the present invention the steps include:
A. get raw material pulverizing, mix, add the water that raw material total amount 10-20 doubly measures, decoct 2-4 time, each 0.5-1.5 hour, filter stand for standby use;
B. press the weight of 0.2 to 1 times of raw material total amount, get macroporous adsorbent resin, the dress post; Then with the decocting liquid of step a by this macroporous adsorptive resins, the abundant eluting resin column of water treats in the eluent that behind the sugar-free, reuse 40-85% ethanol-eluting resin column is collected ethanol elution, concentrates, and concentrated solution vacuum drying or spray drying are got pressed powder;
C. with step b gained pressed powder, add auxiliary element, promptly can be made into any dosage form on the pharmaceutics.
The present invention compared with prior art, its beneficial effect is:
The cysthus leukoplakia is the disease that the hepatic and renal YIN deficiency, dampness-heat of the liver are made a bet at Chinese medical discrimination.Monarch drug Radix Polygoni Multiflori Preparata strengthening bone and muscle, the gas of enriching blood in the side are controlled all diseases of women's puerperal and leukorrhagia; Semen Astragali Complanati tonifying the kidney to consolidate the essence, liver-benefiting eye-brightening; Herba Pyrolae returns liver, kidney channel, and energy the kidney invigorating bone strengthening, expelling wind and removing dampness are all ministerial drug with Semen Astragali Complanati; Dampness-heat of the liver is made a bet, and causes pudendal pruritus acutely unbearably, and assistant is with Fructus Ligustri Lucidi, Cortex Dictamni, with heat clearing and damp drying, the detoxifcation, antipruritic of dispeling the wind; All medicines share, and play the merit of nourishing the kidney and liver, removing damp-heat, warm cloudy QI invigorating altogether.
Compound Chinese medicinal preparation of the present invention, be collect, on comprehensive, the research distinguished veteran doctors of TCM proved recipe basis, the modern Chinese medicine compound preparation that filters out.Determined curative effect has clinical basis in good early stage; The flavour of a drug number is few, helps to formulate the higher quality standard, satisfies the requirement of modern Chinese medicine compound recipe " quality controllable "; Technology advanced person adopts macroporous resin to remove most impurity, highly enriched active component.
This compound Chinese medicinal preparation active component content height, to pudendum leukoplakia clinical symptoms curative effect obviously, definitely, treatment effective percentage height reaches 95%.
Curative effect of the present invention is proved by following experiment and clinical use:
According to " study of tcm new drug specification requirement " and " new Chinese medicine clinical research guideline ",, estimate the itching-relieving action and the estrogen activity of this compound Chinese medicinal preparation respectively by antipruritic experiment of white mice and immaturity white mice uterus weight method.
The itching-relieving action experiment
Group The pruritus number of times Incubation period
Model group positive controls compound preparation group 25.2±12.53 10.1±6.35 11.0±5.65 7.03±2.79 11.1±5.25 12.0±5.36
The estrogen activity experiment
Group Organ index
Normal group positive controls compound preparation group 0.78±0.12 3.5±0.50 1.9±0.25
Experimental result shows: this compound Chinese medicinal preparation has tangible itching-relieving action and estrogen activity.
Choose accepting the multiple patient who fails to respond to any medical treatment 24 examples such as Western medicine, laser, freezing, sealing, carried out preliminary clinical treatment research, the patient all makes a definite diagnosis through pathologic finding.The clinical symptoms that treatment back 24 routine patients all very itch at month inner control pudendum, leukoplakia decreases that the district is basic to disappear in four months, and it is normal that skin of vulva recovers, and the treatment effective percentage reaches 95%, and is no abnormal through liver, renal function, Electrocardioscopy.Check once more after four months that symptom is further improved, no case was recurrence.
The specific embodiment
Embodiment 1
Get Radix Polygoni Multiflori Preparata 900 grams, Herba Pyrolae 800 grams, Semen Astragali Complanati 600 grams, Fructus Ligustri Lucidi 600 grams, Cortex Dictamni 500 grams, Radix Paeoniae Rubra 500 grams, Radix Gentianae 500 grams, Rhizoma Osmundae 500 grams, Flos Lonicerae 500 grams are suitably pulverized, and mix, and add 80 liters in water for the first time, decoct 1.5 hours, filter; For the second time add 55 liters in water, decocted 1.0 hours, filter, twice filtrate merges stand for standby use;
Get D101 type macroporous adsorbent resin 2500 gram dress posts, above-mentioned decocting liquid is passed through this macroporous adsorptive resins, the abundant eluting resin column of elder generation's water, 70% ethanol-eluting resin column is collected ethanol elution and is concentrated again, the concentrated solution spray drying gets pressed powder 160 grams, it is an amount of to add pharmaceutic adjuvant, mixes, and granulates, tabletting gets 500 tablet finished products.
Embodiment 2
Get Radix Polygoni Multiflori Preparata 500 grams, Herba Pyrolae 500 grams, Semen Astragali Complanati 500 grams, Fructus Ligustri Lucidi 1500 grams and Cortex Dictamni 1000 grams are pulverized, and mix, and add 40 liters in water, decoct 3 times, each 0.5 hour, filter stand for standby use;
Get D101 type macroporous adsorbent resin 800 gram dress posts, above-mentioned decocting liquid is passed through this macroporous adsorptive resins, the abundant eluting resin column of elder generation's water, 40% ethanol-eluting resin column again, the collection ethanol elution concentrates, and the concentrated solution spray drying gets pressed powder 120 grams, and it is an amount of to add pharmaceutic adjuvant, dress up capsule, get 400 seed lac wafer finished products.
Embodiment 3
Get Radix Polygoni Multiflori Preparata 2000 grams, Herba Pyrolae 1500 grams, Semen Astragali Complanati 2000 grams, Fructus Ligustri Lucidi 500 grams, Cortex Dictamni 500 grams, Radix Paeoniae Rubra 1000 grams, Radix Gentianae 1000 grams, Rhizoma Osmundae 1000 grams, Flos Lonicerae 1000 grams are pulverized, and mix, and add 210 liters in water, decoct 4 times, each 1.5 hours, filter stand for standby use;
Get D101 type macroporous adsorbent resin 10500 gram dress posts, above-mentioned decocting liquid is passed through this macroporous adsorptive resins, the abundant eluting resin column of elder generation's water, 85% ethanol-eluting resin column again, the collection ethanol elution concentrates, and it is an amount of that concentrated solution adds pharmaceutic adjuvant, and spray drying gets pressed powder 320 grams, dress up capsule, get 1000 seed lac wafer finished products.
Embodiment 4
Get Radix Polygoni Multiflori Preparata 1000 grams, Herba Pyrolae 1000 grams, Semen Astragali Complanati 1200 grams, Fructus Ligustri Lucidi 1000 grams, Cortex Dictamni 600 grams, Radix Gentianae 1000 grams, Flos Lonicerae 500 grams are suitably pulverized, and mix, and add 85 liters in water for the first time, decoct 2.0 hours, filter; For the second time add 65 liters in water, decocted 1.5 hours, filter stand for standby use;
Get D101 type macroporous adsorbent resin 2000 gram dress posts, above-mentioned decocting liquid is passed through this macroporous adsorptive resins, the abundant eluting resin column of elder generation's water, 50% ethanol-eluting resin column is collected ethanol elution and is concentrated again, the concentrated solution spray drying gets pressed powder 200 grams, it is an amount of to add pharmaceutic adjuvant, mixes, and granulates, packing gets 400 bags of granule finished products.

Claims (4)

1. compound Chinese medicinal preparation for the treatment of the pudendum leukoplakia, it is characterized in that: it is the preparation of being made by the following weight proportion raw material: Radix Polygoni Multiflori Preparata 0.5-2.0 part, Herba Pyrolae 0.5-1.5 part, Semen Astragali Complanati 0.5-2.0 part, Fructus Ligustri Lucidi 0.5-1.5 part and Cortex Dictamni 0.5-1.0 part.
2. compound Chinese medicinal preparation according to claim 1 is characterized in that: it also is added with a kind of in the following weight proportion raw material: Radix Paeoniae Rubra 0.5-1.0 part, Radix Gentianae 0.5-1.0 part, Rhizoma Osmundae 0.5-1.0 part, Flos Lonicerae 0.5-1.0 part.
3. compound Chinese medicinal preparation according to claim 2, the weight proportion that it is characterized in that described each raw material is: 0.9 part of Radix Polygoni Multiflori Preparata, 0.8 part of Herba Pyrolae, 0.6 part of Semen Astragali Complanati, 0.6 part of Fructus Ligustri Lucidi, 0.5 part of Cortex Dictamni, 0.5 part of Radix Paeoniae Rubra, 0.5 part of Radix Gentianae, 0.5 part of Rhizoma Osmundae, 0.5 part of Flos Lonicerae.
4. the preparation method of claim 1 or 2 or 3 described compound Chinese medicinal preparation the steps include:
A. get raw material pulverizing, mix, add the water that raw material total amount 10-20 doubly measures, decoct 2-4 time, each 0.5-1.5 hour, filter stand for standby use;
B. press the weight of 0.2 to 1 times of raw material total amount, get macroporous adsorbent resin, the dress post; Then with the decocting liquid of step a by this macroporous adsorptive resins, the abundant eluting resin column of water treats in the eluent that behind the sugar-free, reuse 40-85% ethanol-eluting resin column is collected ethanol elution, concentrates, and concentrated solution vacuum drying or spray drying are got pressed powder;
C. with step b gained pressed powder, add auxiliary element, promptly can be made into any dosage form on the pharmaceutics.
CNB031175848A 2003-04-01 2003-04-01 Compound Chinese medicine for treating leukoplakia vulvae and its preparation method Expired - Fee Related CN100335084C (en)

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CN102895507B (en) * 2012-10-19 2014-02-26 高峰 Chinese medicine for treating leukoplakia vulvae and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1085785A (en) * 1993-05-04 1994-04-27 宝鸡民族医药保健品厂 Ginseng deer YIYUAN GAO and preparation method thereof
CN1174081A (en) * 1997-09-09 1998-02-25 沈静波 'Longteng' medicinal wine

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1085785A (en) * 1993-05-04 1994-04-27 宝鸡民族医药保健品厂 Ginseng deer YIYUAN GAO and preparation method thereof
CN1174081A (en) * 1997-09-09 1998-02-25 沈静波 'Longteng' medicinal wine

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