CN100551404C - Medicament for inducing diuresis to alleviate edema preparation of compositions and detection method and purposes - Google Patents
Medicament for inducing diuresis to alleviate edema preparation of compositions and detection method and purposes Download PDFInfo
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Abstract
The present invention is a kind of edema-alleviating diuretic compositions, it is characterized in that, it is the medicament of being made by following materials of weight proportions, Fructus Solani Nigri 3-6, Herba Scutellariae Barbatae 1-4, Herba Lycopi 1-4, Fructus Broussonetiae 1-4, Semen sojae atricolor 1-4, Fructus Liquidambaris 0.5-2.The invention also discloses its preparation method, method of quality control and purposes.Pharmaceutical composition compatibility of the present invention is rigorous, sends YAOJING and works as, and in diuretic promoting blood circulation and detumescence, detoxicating and fighting cancer eliminating stagnation, is aided with nourishing kidney-YIN and consolidates, and residence is set upright among eliminating evil, reinforcement and elimination in combination, giving consideration to both the incidental and fundamental.
Description
Technical field
The present invention relates to a kind of is the pharmaceutical composition that raw material is made with the Chinese herbal medicine, and particularly a kind of edema-alleviating diuretic compositions the invention still further relates to this preparation of drug combination method, method of quality control and medical usage.
Background technology
Carcinous breast, ascites also are pernicious breast, seroperitoneum, or carcinous breast, peritonitis, are breast, peritoneum transfer or the breast of malignant tumor, breast, the seroperitoneum due to the malignant tumor of peritoneum own.This disease is the common complication of late malignant tumour.Clinically, in a single day breast, seroperitoneum appear in malignant tumor patient, mean that promptly local the or whole body of pathological changes sends out, and have lost the probability of surgical healing.Often more because of the hydrops amount again, and take place often to cause dyspnea, the heart failure of serious patient rapidly, whole body situation rapid deterioration in a short time often fails to adopt the i.e. loss of life of any effective treatment patient.Therefore, this passive situation causes that more and more people pay attention to widely.Over surplus in the of particularly past ten year, the research of carcinous breast, this clinical difficult problem of ascites there has been considerable progress.Many clinical examples and experience have all illustrated and might obtain longer alleviation by suitable positive therapeutic, be further chemotherapy, radiotherapy, even operative treatment win valuable chance and time.Therefore, the carcinous breast of diagnosis and treatment, seroperitoneum energetically have crucial meaning to the life that prolongs patient as early as possible.Modern medicine does not still have ideal medicine to carcinous breast, ascites at present, and general diuretic is invalid to this.Though but the direct cancer inhibitting and killing cell of tradition intracavity chemotherapy high concentration, toxicity is obvious, even has the people to think that effective percentage generally is no more than 60%.And frequent surgical intervention means as draw water, drain etc., the patient has only momentary comfort sense, often makes breast, ascites produce faster, more; Make body lose a large number of nutrients simultaneously,, and easily cause water, metabolic disturbance of electrolyte as albumen etc.Present conventional western medicine therapy often causes the general situation of patient poorer, and sb.'s illness took a turn for the worse, day by day becomes thin, and weight loss, whole body are further depleted.Therefore, control and eliminate carcinous breast, ascites effectively, the life that prolongs, saves the patient is had and important practical sense.Controlled carcinous breast, ascites and just equaled to have controlled growth of tumor and spread, just created chance, also just obtained the condition that " for a long time with tumor existence " has created " life " for the patient for clinical further effective treatment.
Modern medicine is breast, abdominal paracentesis extraction hydrops to the main Therapeutic Method of carcinous breast, ascites at present, with respite patient's misery; Secondly be the intracavitary administration chemotherapeutic, promptly give thoracic cavity or intraperitoneal injection cytotoxicity chemotherapeutics, as 5-fluorouracil (5-FU), silk split toxin (MMc), cisplatin (PDD), carboplatin (CBP), sufficient leaf glycoside (VP-16) etc.; Or the intracavitary administration biological product, as coryne bacterium parvum (CP), interleukin II (IL-2), interferon etc.Be only the application of diuretic at last, as two hydrogen gram urea thiophenes, furosemide etc.But above-mentioned conventional therapy means all exist critical limitations and toxic and side effects in various degree.As very easily recurrence (repeatedly) in a short time behind the extraction water that punctures, generally puncture back 3 days breast, ascites begin to increase, and increase to the level before discharging water after the week; And puncture extraction water, the generation of breast, ascites is taken out more and more, and leaching rate is taken out faster and faster; Lose a large amount of albumen in patient's body behind the water of extraction simultaneously, consume greatly, general situation is poorer, and it is more obvious to become thin, and dyscrasia increases the weight of.In addition, patient also is prone to encapsulated effusion behind the repeated multiple times extraction water, and the patient coughs, breathes hard, chest pain further increases the weight of, and respiratory function is poorer.As for breast, intraperitoneal injection drug, can occur feeling sick, untoward reaction such as vomiting, weak, chest pain, heating, shiver with cold, leukopenia.The frequent diuretic that uses, not only curative effect is limited, and can cause electrolyte disturbance, causes vicious cycle, makes above-mentioned symptom more serious.
Summary of the invention
Technical problem to be solved by this invention is at the deficiencies in the prior art, provide a kind of new, compatibility is rigorous, the edema-alleviating diuretic compositions of giving consideration to both the incidental and fundamental.
Another technical problem to be solved by this invention has provided the preparation method of aforementioned pharmaceutical compositions.
Another technical problem to be solved by this invention has provided the method for quality control of aforementioned pharmaceutical compositions.
Another technical problem to be solved by this invention has provided the medical usage of aforementioned pharmaceutical compositions.
Technical problem to be solved by this invention is to realize by following technical scheme.The present invention is a kind of edema-alleviating diuretic compositions, is characterized in, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 3-6 Herba Scutellariae Barbatae 1-4
Herba Lycopi 1-4 Fructus Broussonetiae 1-4
Semen sojae atricolor 1-4 Fructus Liquidambaris 0.5-2.
Technical problem to be solved by this invention can also further realize by following technical scheme.Above-described a kind of edema-alleviating diuretic compositions is characterized in, the weight proportion of each raw material is,
Fructus Solani Nigri 4-5 Herba Scutellariae Barbatae 2-3
Herba Lycopi 2-3 Fructus Broussonetiae 2-3
Semen sojae atricolor 2-3 Fructus Liquidambaris 1-2.
Technical problem to be solved by this invention can also further realize by following technical scheme.Above-described a kind of edema-alleviating diuretic compositions is characterized in, the weight proportion of each raw material is,
Fructus Solani Nigri 4.4 Herba Scutellariae Barbataes 2.2
Herba Lycopi's 2.2 Fructus Broussonetiaes 2.2
Semen sojae atricolor 2.2 Fructus Liquidambaris 1.1.
Technical problem to be solved by this invention can also further realize by following technical scheme.The present invention also provides a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method, be characterized in, its step is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 80-90% Semen sojae atricolor 6 flavor medical material water extraction 2-4 time, adding 4-10 times of water gaging decocted 40-100 minute, filter, filtrate is condensed into that its relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, the Semen sojae atricolor powder that adds remainder 10-20% adds pharmaceutic adjuvant, makes the medicament of acceptable any dosage form on the pharmaceutics.
Technical problem to be solved by this invention can also further realize by following technical scheme.Above-described a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method, be characterized in, its step is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 90% Semen sojae atricolor, 6 flavor medical material water extraction 3 times, adding for the first time 8 times of water gagings decocted 80 minutes, adding for the second time 7 times of water gagings decocted 60 minutes, adding 5 times of water gagings for the third time decocted 50 minutes, filter, filtrate is condensed into that relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, add remainder 10% Semen sojae atricolor powder, add pharmaceutic adjuvant, make concentrated pill.
Technical problem to be solved by this invention can also further realize by following technical scheme.Above-described a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method is characterized in that the every gram of made concentrated pill is with scutellarin C
21H
18O
12Meter is no less than 1.5mg.
Pharmaceutical composition of the present invention can be made the medicine of acceptable any dosage form on the pharmaceutics, preferred concentrated pill, and its method of quality control is as follows:
[discriminating]
(1) get this product 10 balls, porphyrize adds methanol 10ml, floods 30 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Get Herba Scutellariae Barbatae control medicinal material 1g, shine medical material solution in pairs with legal system.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw above-mentioned need testing solution, each 10ul of control medicinal material solution, put respectively on same silica gel G plate, upper strata with ethyl acetate-formic acid-water (6: 1: 5) is developing solvent, launch, take out, dry.Spray is with 10% aluminum chloride ethanol liquid, and oven dry is put under the ultra-violet lamp (365nm) and inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on the fluorescence speckle of same color is arranged.
(2) get this product 20 balls, porphyrize is put in the 100ml conical flask, add the methanol solution 50ml of 5% formic acid, shake up supersound process 30min, filter, filtrate evaporate to dryness, residue add 5% sodium hydroxide solution dissolving, filter, filtrate is transferred pH to 4 ether shaking out 3 times with hydrochloric acid, and each 15ml merges ether solution, volatilize, residue adds the 1ml ether makes dissolving as need testing solution.Taking by weighing the caffeic acid reference substance adds diethyl ether and makes the reference substance solution that every 1ml contains 0.5mg.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned need testing solution, each 10ul of reference substance solution, put respectively on same silica gel G plate, with toluene-ethyl acetate-formic acid (2: 2: 0.1) is developing solvent, launch 10cm, take out, dry, ammonia is smoked, puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color.
[inspection] should meet relevant every regulation under an appendix I of Chinese Pharmacopoeia version in 2005 the A pill item.
[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Oxolane-acetonitrile-0.1% phosphoric acid (5: 11: 84) is mobile phase; The detection wavelength is 335nm, column temperature: 30 ℃, and flow velocity: 1ml/min.Number of theoretical plate should be not less than 3000 by scutellarin.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the scutellarin reference substance, adds the solution that dissolve with methanol is made 0.02mg/ml, promptly.
The preparation of need testing solution: get this product 5 balls, porphyrize is got about 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 50ml that adds, claim to decide weight, supersound process 30min is put cold, claim to decide weight again, add 50% methanol and supply and subtract weight loss, shake up, filter with microporous filter membrane (0.45um), get subsequent filtrate, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Edema-alleviating diuretic compositions of the present invention possesses the purposes in the medicine of preparation treatment cancerous ascites pleural fluid, and described medicine is the medicine of any dosage form.
Fructus Solani Nigri bitter in the mouth, little sweet, cold in nature in the prescription of the present invention is returned lung, liver, stomach warp, and the length of its existing detoxifcation inducing diuresis to remove edema has the merit of anticancer blood stasis-eliminating and stagnation-dissipating again, have concurrently set upright reach evil wonderful, at one stroke and three, so with being monarch drug.Herba Scutellariae Barbatae acrid in the mouth, hardship, cold in nature, go into lung, liver, kidney channel, heat-clearing and toxic substances removing, inducing diuresis to remove edema, the dissipating blood stasis hemostasis, anticancer; Herba Lycopi's hardship, suffering, tepor is gone into liver, spleen two warps, blood circulation promoting and blood stasis dispelling, line water detumescence, removing toxicity for eliminating carbuncles, the two share with reinforcement Fructus Solani Nigri inducing diuresis to remove edema, blood circulation promoting and dispersing pathogen accumulation, so the power of detoxicating and fighting cancer is with being ministerial drug.Assistant is with the Fructus Broussonetiae sweet in the mouth, and is cold in nature, goes into the liver,kidney,spleen warp, the nourishing kidney tonifying YIN, and liver heat removing and eyesight improving, invigorating spleen for diuresis when nourishing kidney yin, has the merit of inducing diuresis to remove edema concurrently, when helping Fructus Solani Nigri to set upright diuretic, the fraud of anti-its diuretic impairment of YIN of holding concurrently; The Semen sojae atricolor sweet in the mouth, property is flat, and darkish complexion is gone into kidney, doublely goes into spleen channel.Kidney tonifying yin nourishing diuretic, the promoting blood circulation by removing wind detoxifcation, when helping Fructus Solani Nigri detoxifcation activating blood and promoting diuresis, invigorating spleen and kidney, also transfer elder generation's day after tomorrow, the fraud that the anti-Fructus Solani Nigri of holding concurrently, Herba Scutellariae Barbatae bitter cold injure one's stomach.The Fructus Liquidambaris nature and flavor are sweet flat, the acupoints of twelve meridians that can pass through, and supplementary Amplifications of the Compendium of Materia Medica is called it and can be searched by FUSHUI, promoting flow of QI and blood, so the collateral dredging diuretic is with being messenger drug.All medicines share, and play the diuretic promoting blood circulation and detumescence altogether, and detoxicating and resolving stagnation of pathogens is anticancer, the merit that nourishing kidney-YIN consolidates.Reinforce insufficiency and reduce excessiveness, so giving consideration to both the incidental and fundamental is for treating the rare good recipe of carcinous breast, ascites.
Compared with prior art, pharmaceutical composition of the present invention is from basic theory of tcm, and compatibility is rigorous, sends YAOJING and works as, and in diuretic promoting blood circulation and detumescence, detoxicating and fighting cancer eliminating stagnation, is aided with nourishing kidney-YIN and consolidates, and residence is set upright among eliminating evil, reinforcement and elimination in combination, giving consideration to both the incidental and fundamental.All have important effect for local symptom and the overall health of patients of improving carcinous breast, patients with ascites, also can remedy the draw water deficiency of treatment of breast, abdominal paracentesis, can strengthen the curative effect of local intracavity chemotherapeutic again; Carcinous breast, patients with ascites are when local conditions takes a turn for the better, and overall health of patients also improves.Pharmaceutical composition economy of the present invention is cheap, taking convenience, and toxic and side effects is little, and its raw material (Chinese crude drug) medicine is rich and easy to get, cheap; Reasonable recipe, long-term clinical practice prove carcinous breast, patients with ascites determined curative effect; Its main medicine is formed on pharmacology, has effects such as inducing diuresis to remove edema, detoxicating and fighting cancer, blood circulation promoting and dispersing pathogen accumulation, matches with the main pathological change of carcinous breast, ascites.By Study on extraction to preparation, can be made into the medicine of any dosage form, particularly concentrated pill, by Preliminary Clinical Observation and study of pharmacy, think preparation stabilization, can reach the prescription of treatment fully.
The specific embodiment
Embodiment 1.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 3 Herba Scutellariae Barbataes 1
Herba Lycopi's 1 Fructus Broussonetiae 1
Semen sojae atricolor 1 Fructus Liquidambaris 0.5;
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes pill.
Embodiment 2.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 3.5 Herba Scutellariae Barbataes 3.5
Herba Lycopi's 3.5 Fructus Broussonetiaes 3.5
Semen sojae atricolor 3.5 Fructus Liquidambaris 0.8;
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes oral liquid.
Embodiment 3.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 6 Herba Scutellariae Barbataes 4
Herba Lycopi's 4 Fructus Broussonetiaes 4
Semen sojae atricolor 4 Fructus Liquidambaris 2
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes tablet.
Embodiment 4.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 5.5 Herba Scutellariae Barbataes 1.5
Herba Lycopi's 1.5 Fructus Broussonetiaes 1.5
Semen sojae atricolor 1.5 Fructus Liquidambaris 1.5
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes lyophilized injectable powder.
Embodiment 5.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 4 Herba Scutellariae Barbataes 2
Herba Lycopi's 2 Fructus Broussonetiaes 2
Semen sojae atricolor 2 Fructus Liquidambaris 1;
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes capsule.
Embodiment 6.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 5 Herba Scutellariae Barbataes 3
Herba Lycopi's 3 Fructus Broussonetiaes 3
Semen sojae atricolor 3 Fructus Liquidambaris 2;
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes injection.
Embodiment 7.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 4.5 Herba Scutellariae Barbataes 2.5
Herba Lycopi's 2.5 Fructus Broussonetiaes 2.5
Semen sojae atricolor 2.5 Fructus Liquidambaris 1.5;
Its preparation method is that technology is extracted its active ingredient routinely, adds conventional pharmaceutic adjuvant, makes granule.
Embodiment 8.A kind of edema-alleviating diuretic compositions, it is the medicament of being made by following materials of weight proportions,
Fructus Solani Nigri 4.4 Herba Scutellariae Barbataes 2.2
Herba Lycopi's 2.2 Fructus Broussonetiaes 2.2
Semen sojae atricolor 2.2 Fructus Liquidambaris 1.1;
Its preparation methods steps is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 80% Semen sojae atricolor, 6 flavor medical material water extraction 2 times, adding 10,8 times of water gagings respectively decocted 100,80 minutes, filter, filtrate is condensed into that its relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, the Semen sojae atricolor powder that adds remainder 20% adds pharmaceutic adjuvant, makes medicinal preparation for oral administration.
Embodiment 9.A kind of edema-alleviating diuretic compositions, it is the pill of being made by following materials of weight proportions, (unit: gram)
Fructus Solani Nigri 400 Herba Scutellariae Barbataes 200
Herba Lycopi's 200 Fructus Broussonetiaes 200
Semen sojae atricolor 200 Fructus Liquidambaris 100;
Its preparation methods steps is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 85% Semen sojae atricolor, 6 flavor medical material water extraction 4 times, adding for the first time 8 times of water gagings decocted 80 minutes, adding for the second time 7 times of water gagings decocted 60 minutes, adding 5 times of water gagings for the third time decocted 50 minutes, adding 4 times of water gagings for the 4th time decocted 40 minutes, filter, filtrate is condensed into that relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening adds remainder 15% Semen sojae atricolor powder, add pharmaceutic adjuvant, make concentrated pill 1000 balls.Be used for the treatment of cancerous ascites pleural fluid.
Embodiment 10.A kind of edema-alleviating diuretic compositions, it is the pill of being made by following materials of weight proportions, (unit: gram)
Fructus Solani Nigri 440 Herba Scutellariae Barbataes 220
Herba Lycopi's 220 Fructus Broussonetiaes 220
Semen sojae atricolor 220 Fructus Liquidambaris 110;
Its preparation methods steps is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 90% Semen sojae atricolor, 6 flavor medical material water extraction 3 times, add 8 times of water gagings for the first time and decocted 80 minutes, add 7 times of water gagings for the second time and decocted 60 minutes, adding 5 times of water gagings for the third time decocted 50 minutes, filter, filtrate is condensed into that relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, add remainder 10% Semen sojae atricolor powder, add pharmaceutic adjuvant, make concentrated pill 1000 balls.Be used for the treatment of cancerous ascites pleural fluid.
Embodiment 11.The every gram of embodiment 8 prepared concentrated pills is with scutellarin C
21H
18O
12Meter is 1.5mg.
Embodiment 12.The every gram of embodiment 9 prepared concentrated pills is with scutellarin C
21H
18O
12Meter is 1.8mg.
Embodiment 13.The every gram of embodiment 10 prepared concentrated pills is with scutellarin C
21H
18O
12Meter is 2.0mg.
Embodiment 14.The method of quality control of the concentrated pill that embodiment 8 is prepared.
[character] this product is the black concentrated pill; Feeble QI perfume (or spice), mildly bitter flavor.
[discriminating]
(1) get this product 10 balls, porphyrize adds methanol 10ml, floods 30 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Get Herba Scutellariae Barbatae control medicinal material 1g, shine medical material solution in pairs with legal system.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw above-mentioned need testing solution, each 10ul of control medicinal material solution, put respectively on same silica gel G plate, upper strata with ethyl acetate-formic acid-water (6: 1: 5) is developing solvent, launch, take out, dry.Spray is with 10% aluminum chloride ethanol liquid, and oven dry is put under the ultra-violet lamp (365nm) and inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on the fluorescence speckle of same color is arranged.
(2) get this product 20 balls, porphyrize is put in the 100ml conical flask, add the methanol solution 50ml of 5% formic acid, shake up supersound process 30min, filter, filtrate evaporate to dryness, residue add 5% sodium hydroxide solution dissolving, filter, filtrate is transferred pH to 4 ether shaking out 3 times with hydrochloric acid, and each 15ml merges ether solution, volatilize, residue adds the 1ml ether makes dissolving as need testing solution.Taking by weighing the caffeic acid reference substance adds diethyl ether and makes the reference substance solution that every 1ml contains 0.5mg.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned need testing solution, each 10ul of reference substance solution, put respectively on same silica gel G plate, with toluene-ethyl acetate-formic acid (2: 2: 0.1) is developing solvent, launch 10cm, take out, dry, ammonia is smoked, puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color.
[inspection] should meet relevant every regulation under an appendix I of Chinese Pharmacopoeia version in 2005 the A pill item.
[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Oxolane-acetonitrile-0.1% phosphoric acid (5: 11: 84) is mobile phase; The detection wavelength is 335nm, column temperature: 30 ℃, and flow velocity: 1ml/min.Number of theoretical plate should be not less than 3000 by scutellarin.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the scutellarin reference substance, adds the solution that dissolve with methanol is made 0.02mg/ml, promptly.
This product 5 balls are got in the preparation of need testing solution, and porphyrize is got about 0.5g, and accurate the title decides, and puts the taper of tool plug
In the bottle, the accurate 50% methanol 50ml that adds claims decide weight, and supersound process 30min is put coldly, claims decide weight again, adds 50% methanol and supplies and subtract weight loss, shakes up, and uses microporous filter membrane (0.45um) filtration, gets subsequent filtrate, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
This product contains Herba Scutellariae Barbatae with scutellarin (C
21H
18O
12) meter, every 1g must not be less than 1.5mg.
[function with cure mainly] inducing diuresis to remove edema, detoxicating and fighting cancer, blood circulation promoting and dispersing pathogen accumulation, strengthening vital QI to eliminate pathogenic factors effect are used for cancerous ascites pleural fluid.
[usage and consumption] is oral.One time 15 ball, 3 times on the one.
The heavy 0.2g of [specification] every ball
[storage] sealing.
Experimental example 1.By the pharmaceutical composition concentrated pill of the present invention of embodiment 10 preparation (hereinafter to be referred as the Long Lian water concentrated pill that disappears) to Hep and the inhibiting experiment of EAC ehrlich ascites carcinoma.
One, experiment material
(1) medicine and reagent
The Long Lian water concentrated pill that disappears, Jiangsu Zhongkang Medicine Science ﹠ Technology Co., Ltd provides; Fluorouracil Injection, 0.25g/10ml, Tianjin gold credit aminoacid company limited, lot number: 0505231; 0.9% sodium chloride injection, Nanjing Xiaoying Pharmaceutical Factory, lot number: 2005052505.
(2) laboratory animal
The KM mice is provided production licence by Nanjing Medical University's Experimental Animal Center: SCXK (Soviet Union) 2002-0031; Jiangsu Zhongkang Medicine Science ﹠ Technology Co., Ltd, occupancy permit: SYXK (Soviet Union) 2003-0029
(3) instrument
The MP12001 electronic balance, the permanent flat scientific instrument company limited in Shanghai City;
Two, experiment condition and statistics side.
(1) experiment condition
Before and after the administration, the laboratory animal male and female are divided cage, feed with full-valence pellet feed; 20～22 ℃ of room temperatures, humidity 40～70%.The laboratory animal feedstuff is provided by Nanjing An Limo Science and Technology Ltd..
(2) statistical method.This experimental amount reaction data adopts the Student-T method of inspection, the statistical software Excel of Microsoft software.
Three, experimental technique and result
(1) the Long Lian influence of water concentrated pill that disappear to EAC ehrlich ascites carcinoma life-delaying rate
1. experimental technique
Aseptic condition extracts 8 days ascites cells suspension of growth in the KM mouse peritoneal down, and cancerous cell suspension and sterile saline are got 50 of KM mices by dilution in 1: 3, and the cancerous cell suspension 0.2ml after the inoculation dilution is in the abdominal cavity.Be divided into 5 groups behind the 24h at random, it is model group, 5-Fu group (0.025g/kg) He Longlian basic, normal, high dosage group of water concentrated pill (1.17g/kg, 2.34g/kg, 4.68g/kg) that disappears, every group 10, irritate stomach respectively and give relative medicine (model group is irritated stomach and given the isometric(al) distilled water), 2 weeks of successive administration.Behind inoculation tumor liquid, begin to observe, observe each treated animal death condition every day, calculate the mean survival time (MST) in 30 days, calculate and respectively organize life-delaying rate.This experiment repeats 3 times.
2. experimental result
After the mouse inoculation EAC ehrlich ascites carcinoma, 5 days visible obviously ascites, Long Lian three dosage groups of water concentrated pill survival time of mice that disappears obviously is longer than model group, and wherein Long Lian disappears the life-delaying rate of the middle and high dosage group of water concentrated pill mice greater than 50%.The results are shown in Table 1.
Table 1 Long Lian disappear the water concentrated pill to the influence of EAC ehrlich ascites carcinoma life-delaying rate (X ± S, n=10)
Annotate: compare with model group,
*P＜0.05,
*P＜0.01.
(2) the Long Lian influence of water concentrated pill that disappear to Hep hepatic ascites cancer life-delaying rate
1. experimental technique
Aseptic condition extracts 8 days ascites cells suspension of growth in the KM mouse peritoneal down, and cancerous cell suspension and sterile saline are got 50 of KM mices by dilution in 1: 3, and the cancerous cell suspension 0.2ml after the inoculation dilution is in the abdominal cavity.Be divided into 5 groups behind the 24h at random, it is model group, 5-Fu group (0.025g/kg) He Longlian basic, normal, high dosage group of water concentrated pill (1.17g/kg, 2.34g/kg, 4.68g/kg) that disappears, every group 10, irritate stomach respectively and give relative medicine (model group is irritated stomach and given the isometric(al) distilled water), 2 weeks of successive administration.Behind inoculation tumor liquid, begin to observe, observe each treated animal death condition every day, calculate the mean survival time (MST) in 30 days, calculate and respectively organize life-delaying rate.
2. experimental result
After the mouse inoculation Hep ehrlich ascites carcinoma, 5 days visible obviously ascites, Long Lian three dosage groups of water concentrated pill survival time of mice that disappears obviously is longer than model group, and wherein Long Lian disappears the life-delaying rate of the middle and high dosage group of water concentrated pill mice greater than 50%.The results are shown in Table 2.
Table 2 Long Lian disappears the water concentrated pill to the influence of Hep ehrlich ascites carcinoma life-delaying rate (X ± S)
Annotate: compare with model group,
*P＜0.05,
*P＜0.01.
Four, conclusion
Pass through S
180With Hep ehrlich ascites carcinoma experiment, the prompting Long Lian water concentrated pill that disappears all has certain anti-S
180Effect with the Hep ehrlich ascites carcinoma.
Claims (8)
1, a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method is characterized in that it is made by following materials of weight proportions,
Fructus Solani Nigri 3-6 Herba Scutellariae Barbatae 1-4
Herba Lycopi 1-4 Fructus Broussonetiae 1-4
Semen sojae atricolor 1-4 Fructus Liquidambaris 0.5-2;
Its step is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 80-90% Semen sojae atricolor 6 flavor medical material water extraction 2-4 time, adding 4-10 times of water gaging decocted 40-100 minute, filter, filtrate is condensed into that its relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, the Semen sojae atricolor powder that adds remainder 10-20% adds pharmaceutic adjuvant, makes the medicament of acceptable any dosage form on the pharmaceutics.
2, a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method according to claim 1 is characterized in that, the weight proportion of each raw material is,
Fructus Solani Nigri 4-5 Herba Scutellariae Barbatae 2-3
Herba Lycopi 2-3 Fructus Broussonetiae 2-3
Semen sojae atricolor 2-3 Fructus Liquidambaris 1-2.
3, a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method according to claim 1 is characterized in that, the weight proportion of each raw material is,
Fructus Solani Nigri 4.4 Herba Scutellariae Barbataes 2.2
Herba Lycopi's 2.2 Fructus Broussonetiaes 2.2
Semen sojae atricolor 2.2 Fructus Liquidambaris 1.1.
4, a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method according to claim 1, it is characterized in that, its step is, get Fructus Solani Nigri, Herba Scutellariae Barbatae, Herba Lycopi, Fructus Broussonetiae, Fructus Liquidambaris, 90% Semen sojae atricolor, 6 flavor medical material water extraction 3 times, adding for the first time 8 times of water gagings decocted 80 minutes, adding for the second time 7 times of water gagings decocted 60 minutes, adding 5 times of water gagings for the third time decocted 50 minutes, filter, filtrate is condensed into that relative density is the clear paste of 1.05-1.10 in the time of 80 ℃, spray drying, crushing screening, add remainder 10% Semen sojae atricolor powder, add pharmaceutic adjuvant, make concentrated pill.
5, a kind of medicament for inducing diuresis to alleviate edema preparation of compositions method according to claim 1 is characterized in that the every gram of made concentrated pill is with scutellarin C
21H
18O
12Meter is no less than 1.5mg.
6, the discrimination method of the edema-alleviating diuretic compositions concentrated pill that makes of a kind of method according to claim 1 is characterized in that its step is as follows:
(1) get this product 10 balls, porphyrize adds methanol 10ml, floods 30 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Get Herba Scutellariae Barbatae control medicinal material 1g, shine medical material solution in pairs with legal system; According to thin layer chromatography test, draw above-mentioned need testing solution, each 10ul of control medicinal material solution, put respectively on same silica gel G plate, be developing solvent with the upper strata of ethyl acetate-formic acid of 6: 1: 5-water, launch, take out, dry; Spray is with 10% aluminum chloride ethanol liquid, and oven dry is put under the 365nm ultra-violet lamp and inspected, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on the fluorescence speckle of same color is arranged;
(2) get this product 20 balls, porphyrize is put in the 100ml conical flask, add the methanol solution 50ml of 5% formic acid, shake up supersound process 30min, filter, filtrate evaporate to dryness, residue add 5% sodium hydroxide solution dissolving, filter, filtrate is transferred pH to 4 ether shaking out 3 times with hydrochloric acid, and each 15ml merges ether solution, volatilize, residue adds the 1ml ether makes dissolving as need testing solution; Taking by weighing the caffeic acid reference substance adds diethyl ether and makes the reference substance solution that every 1ml contains 0.5mg; According to the thin layer chromatography test, draw above-mentioned need testing solution, each 10ul of reference substance solution, put respectively on same silica gel G plate, with toluene-ethyl acetate of 2: 2: 0.1-formic acid is developing solvent, launches 10cm, takes out, dry, ammonia is smoked, puts under the 365nm ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color.
7, the content assaying method of the edema-alleviating diuretic compositions concentrated pill that makes of a kind of method according to claim 1 is characterized in that its step is as follows:
(1) chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Oxolane-acetonitrile of 5: 11: 84-0.1% phosphoric acid is mobile phase; The detection wavelength is 335nm, column temperature: 30 ℃, and flow velocity: 1ml/min; Number of theoretical plate should be not less than 3000 by scutellarin;
(2) preparation of reference substance solution: it is an amount of that precision takes by weighing the scutellarin reference substance, adds the solution that dissolve with methanol is made 0.02mg/ml, promptly;
(3) preparation of need testing solution: get this product 5 balls, porphyrize is got about 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 50ml that adds, claim to decide weight, supersound process 30min is put cold, claim to decide weight again, add 50% methanol and supply and subtract weight loss, shake up, filter with the 0.45um microporous filter membrane, get subsequent filtrate, promptly;
(4) algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
8, the purposes of the edema-alleviating diuretic compositions that any one described method makes among the claim 1-3 in the medicine of preparation treatment cancerous ascites pleural fluid, described medicine is the medicine of any dosage form.
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