CN105770001A - Cholestasis caused jaundice complication preventing granules and preparation method thereof - Google Patents
Cholestasis caused jaundice complication preventing granules and preparation method thereof Download PDFInfo
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Abstract
The invention discloses cholestasis caused jaundice complication preventing granules and a preparation method thereof. The granules comprise methylcantharidinimde, ursodesoxycholic acid, apigenin, ursolic acid, genistein, luteolin, limonene, raffinose, baicalin, capillary artemisia extract, hyperoside, centaureidin, betulinic acid, gentiopicrin, Vitamin C, Vitamin E, fillers, binders, disintegrants, lubricants and surfactants. With matching of various active ingredients, the granules have antitumor activity, have efficacy of soothing the liver to dispel depression, treating cancer, regulating choleresis, diminishing inflammation, treating lithiasis and regulating body immunity, are applied to adjuvant therapy of cholestasis caused jaundice and prevention of serious complication of cholestasis caused jaundice to relieve added suffering of patients.
Description
Technical field
The present invention relates to nursing medication field, be particularly used for granule of prevention cholestatic jaundice complication and preparation method thereof.
Background technology
The roles such as liver is the organ in human body based on metabolic function, and plays detoxification element inside health, stores glycogen, secreted protein synthesis, liver also manufactures the bile in digestive system.Bile secretion is the critical function of liver, owing to various harmful factors cause bile secretion and excretion that obstacle occurs, form cholestegnosis; pathological changes person in liver is called hepatic bile stasis; be called that the outer property gallbladder of liver is strongly fragrant in liver epigenesist; cholestatic jaundice is to be its feature with obstructive jaundice without biliary obstruction inside and outside macroscopic liver; can by Different types of etiopathogenises such as medicine; viral hepatitis, alcoholism, gestation, familial etc. cause, allusion quotation subcutaneous ulcer can be presented with clinically, skin disturbs sample and inappetence, the phenomenon such as weak.Obstructive jaundice increases based on conjunction type bilirubin direct, obstructive jaundice serum BIL substantially increases, TBIL is up to 510 μm of more than ol/L, DBIL and TBIL ratio is everlasting more than 60%, the highest up to 90%, urine bilirubin checks the positive, urobilinogen is discharged and is reduced, stercobilinogen significantly reduce or completely lack as, namely serum ALP activity early stage substantially increases, even up to the reference value upper limit 10～15 times, ALP increases than jaundice appearance more earlier, serum GGT activity substantially increases, may be up to the 5～30 of the reference value upper limit times to increase, serum T BA also can dramatically and increases.During obstruction of biliary tract, bile deposits in bile duct, and gallbladder overpressure increases, and reaches to a certain degree to connect bile capillary afterwards and breaks, and bile enters lymph, subsequently into blood circulation, and causes jaundice.
Primary disease hepatic bile stasis has 1/3 etiology unknown; but more than half can find the cause of disease; therefore actively eliminate the cause of disease and coordinate Drug therapy that cholestegnosis is disappeared to have positive role, but primary disease often can cause intrahepatic calculi, cancer embolus; parasitic disease; primary biliary cirrhosis, the severe complication such as choledocholithiasis, tumor, ascarid and inflammation edema, therefore while primary disease is treated; medicaments nursing should be carried out with prevention or the appearance reducing these severe complications, add the misery of heavy patient.
Summary of the invention
Present invention solves the technical problem that granule of being to provide for preventing cholestatic jaundice complication and preparation method thereof.
For solving above-mentioned technical problem, the technical solution adopted in the present invention is as follows:
nullFor preventing the granule of cholestatic jaundice complication，Composition including following weight portion: N-methylcantharidimide 0.6-1.8 part、Apigenin 18-39 part、Ursolic acid 16.4-38.2 part、Genistein 15.1-35.3 part、Luteolin 13.6-32.3 part、Limonene 11.8-29.6 part、Raffinose 10.9-28.7 part、Radix Scutellariae extract 9.7-26.5 part、Herba Artemisiae Scopariae extract 8.8-25.2 part、Centaurcidin 7.5-23.3 part、Betulic acid 6.6-21.4 part、Gentiopicrin 5.4-19.8 part、Filler 53.8-128.4 part、Binding agent 45.7-103.3 part、Disintegrating agent 14-35 part、Lubricant 1-5 part、Surfactant 5.3-10.9 part.
Further, for preventing the granule of cholestatic jaundice complication, the composition of following weight portion is also included: ursodesoxycholic acid 0.2-0.8 part, hyperin 16-35 part, vitamin C 0.007-0.015 part, vitamin E 0.004-0.012 part.
nullFurther，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 50-60 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 9-11 times amount，Filter decoction liquor，Add the soak by water 2h of 6-8 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1-2，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72-80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver.
Further, described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer.
Further, described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation.
Further, described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled.
Further, described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective.
Further, described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force.
Further, described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
nullStep one: take Radix Scutellariae dry root，It is placed in dehydrator at 50-60 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 9-11 times amount，Filter decoction liquor，Add the soak by water 2h of 6-8 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1-2，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72-80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
nullStep 2: by the N-methylcantharidimide of described composition by weight、Ursodesoxycholic acid、Apigenin、Ursolic acid、Genistein、Luteolin、Raffinose、Radix Scutellariae extract、Herba Artemisiae Scopariae extract、Hyperin、Centaurcidin、Betulic acid、Gentiopicrin、Vitamin C、Vitamin E、Surfactant mixes，Join in the alcoholic solution that mass concentration is 46% of its 3-5 times amount，It is placed in homogenizer homogenizing and processes，Arranging homogenization pressure is 25-33MPa，Homogenizing temperature is: 24-28 DEG C，Homogenizing time is: 10min，Gained mixture adds filler after reclaiming ethanol、Binding agent、Disintegrating agent、Lubricant，Granule it is ground into after mixing，Take partial particulate powder to rejoin in granule after viscous for limonene wrapping up in，According still further to granulation、Dry、Granulate、The operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Compared with prior art, beneficial effects of the present invention is embodied in: the present invention passes through plurality of active ingredients proportioning, there is the soothing the liver effect dissipating strongly fragrant, anticancer, anti-tumor activity, adjustment bile secretion, also there is the effect of antiinflammatory, calculus, adjustment body immunity, cholestatic jaundice is prevented for auxiliary treatment, prevent it that severe complication occurs, thus alleviating the primary disease additional misery to patient.N-methylcantharidimide, apigenin, ursolic acid, genistein, luteolin, Raffinose, Radix Scutellariae extract, Herba Artemisiae Scopariae extract, centaurcidin, betulic acid, gentiopicrin synergy, the soothing the liver effect dried can be played, it is possible not only to promote the recovery of primary disease, primary disease can also be prevented to be likely to the cancer caused, the complication such as tumor, ursodesoxycholic acid, hyperin, vitamin C, vitamin E synergy have anti-inflammatory, antibacterial, prevent cholelithiasis, improve the effect of Abwehrkraft des Koepers.
Detailed description of the invention
Embodiment 1: for preventing the granule of cholestatic jaundice complication, including the composition of following weight portion: N-methylcantharidimide 0.6 part, apigenin 18 parts, ursolic acid 16.4 parts, genistein 15.1 parts, luteolin 13.6 parts, limonene 11.8 parts, Raffinose 10.9 parts, Radix Scutellariae extract 9.7 parts, Herba Artemisiae Scopariae extract 8.8 parts, centaurcidin 7.5 parts, betulic acid 6.6 parts, gentiopicrin 5.4 parts, filler 53.8 parts, binding agent 45.7 parts, disintegrating agent 14 parts, lubricant 1 part, 5.3 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 50 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 9 times amount，Filter decoction liquor，Add the soak by water 2h of 6 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72-80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 50 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 9 times amount, filter decoction liquor, add the soak by water 2h of 6 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 1, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
Step 2: by the N-methylcantharidimide of described composition by weight, apigenin, ursolic acid, genistein, luteolin, Raffinose, Radix Scutellariae extract, Herba Artemisiae Scopariae extract, centaurcidin, betulic acid, gentiopicrin, surfactant mixes, join in the alcoholic solution that mass concentration is 46% of its 3 times amount, it is placed in homogenizer homogenizing and processes, arranging homogenization pressure is 25MPa, homogenizing temperature is: 24 DEG C, homogenizing time is: 10min, gained mixture adds filler after reclaiming ethanol, binding agent, disintegrating agent, lubricant, granule it is ground into after mixing, take partial particulate powder and rejoin in granule after viscous for limonene wrapping up in, according still further to granulation, dry, granulate, the operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Embodiment 2: for preventing the granule of cholestatic jaundice complication, including the composition of following weight portion: N-methylcantharidimide 1.2 parts, apigenin 28.5 parts, ursolic acid 27.3 parts, genistein 25.2 parts, luteolin 22.95 parts, limonene 20.7 parts, Raffinose 19.8 parts, Radix Scutellariae extract 18.1 parts, Herba Artemisiae Scopariae extract 17 parts, centaurcidin 15.4 parts, betulic acid 13.8 parts, gentiopicrin 12.6 parts, filler 91.1 parts, binding agent 74.5 parts, disintegrating agent 24.5 parts, lubricant 3 parts, 8.1 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 55 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 10 times amount，Filter decoction liquor，Add the soak by water 2h of 7 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1.5，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 76%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 55 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 10 times amount, filter decoction liquor, add the soak by water 2h of 7 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 1.5, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 76%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
Step 2: by the N-methylcantharidimide of described composition by weight, apigenin, ursolic acid, genistein, luteolin, Raffinose, Radix Scutellariae extract, Herba Artemisiae Scopariae extract, centaurcidin, betulic acid, gentiopicrin, surfactant mixes, join in the alcoholic solution that mass concentration is 46% of its 4 times amount, it is placed in homogenizer homogenizing and processes, arranging homogenization pressure is 29MPa, homogenizing temperature is: 26 DEG C, homogenizing time is: 10min, gained mixture adds filler after reclaiming ethanol, binding agent, disintegrating agent, lubricant, granule it is ground into after mixing, take partial particulate powder and rejoin in granule after viscous for limonene wrapping up in, according still further to granulation, dry, granulate, the operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Embodiment 3: for preventing the granule of cholestatic jaundice complication, composition including following weight portion: for preventing the granule of cholestatic jaundice complication, composition including following weight portion: N-methylcantharidimide 1.8 parts, apigenin 39 parts, ursolic acid 38.2 parts, genistein 35.3 parts, luteolin 32.3 parts, limonene 29.6 parts, Raffinose 28.7 parts, Radix Scutellariae extract 26.5 parts, Herba Artemisiae Scopariae extract 25.2 parts, centaurcidin 23.3 parts, betulic acid 21.4 parts, gentiopicrin 19.8 parts, filler 128.4 parts, binding agent 103.3 parts, disintegrating agent 35 parts, lubricant 5 parts, 10.9 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 60 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 11 times amount，Filter decoction liquor，Add the soak by water 2h of 8 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 2，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 60 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 11 times amount, filter decoction liquor, add the soak by water 2h of 8 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 2, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 80%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
Step 2: by the N-methylcantharidimide of described composition by weight, apigenin, ursolic acid, genistein, luteolin, Raffinose, Radix Scutellariae extract, Herba Artemisiae Scopariae extract, centaurcidin, betulic acid, gentiopicrin, surfactant mixes, join in the alcoholic solution that mass concentration is 46% of its 5 times amount, it is placed in homogenizer homogenizing and processes, arranging homogenization pressure is 33MPa, homogenizing temperature is: 28 DEG C, homogenizing time is: 10min, gained mixture adds filler after reclaiming ethanol, binding agent, disintegrating agent, lubricant, granule it is ground into after mixing, take partial particulate powder and rejoin in granule after viscous for limonene wrapping up in, according still further to granulation, dry, granulate, the operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Embodiment 4: for preventing the granule of cholestatic jaundice complication, composition including following weight portion: N-methylcantharidimide 0.6 part, ursodesoxycholic acid 0.2 part, apigenin 18 parts, hyperin 16 parts, ursolic acid 16.4 parts, genistein 15.1 parts, luteolin 13.6 parts, limonene 11.8 parts, Raffinose 10.9 parts, Radix Scutellariae extract 9.7 parts, Herba Artemisiae Scopariae extract 8.8 parts, centaurcidin 7.5 parts, betulic acid 6.6 parts, gentiopicrin 5.4 parts, vitamin C 0.007 part, vitamin E 0.004 part, filler 53.8 parts, binding agent 45.7 parts, disintegrating agent 14 parts, lubricant 1 part, 5.3 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 50 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 9 times amount，Filter decoction liquor，Add the soak by water 2h of 6 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 50 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 9 times amount, filter decoction liquor, add the soak by water 2h of 6 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 1, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
nullStep 2: by the N-methylcantharidimide of described composition by weight、Ursodesoxycholic acid、Apigenin、Ursolic acid、Genistein、Luteolin、Raffinose、Radix Scutellariae extract、Herba Artemisiae Scopariae extract、Hyperin、Centaurcidin、Betulic acid、Gentiopicrin、Vitamin C、Vitamin E、Surfactant mixes，Join in the alcoholic solution that mass concentration is 46% of its 3 times amount，It is placed in homogenizer homogenizing and processes，Arranging homogenization pressure is 25MPa，Homogenizing temperature is: 24 DEG C，Homogenizing time is: 10min，Gained mixture adds filler after reclaiming ethanol、Binding agent、Disintegrating agent、Lubricant，Granule it is ground into after mixing，Take partial particulate powder to rejoin in granule after viscous for limonene wrapping up in，According still further to granulation、Dry、Granulate、The operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Embodiment 5: for preventing the granule of cholestatic jaundice complication, composition including following weight portion: N-methylcantharidimide 1.2 parts, ursodesoxycholic acid 0.5 part, apigenin 28.5 parts, hyperin 25.5 parts, ursolic acid 27.3 parts, genistein 25.2 parts, luteolin 22.95 parts, limonene 20.7 parts, Raffinose 19.8 parts, Radix Scutellariae extract 18.1 parts, Herba Artemisiae Scopariae extract 17 parts, centaurcidin 15.4 parts, betulic acid 13.8 parts, gentiopicrin 12.6 parts, vitamin C 0.011 part, vitamin E 0.008 part, filler 91.1 parts, binding agent 74.5 parts, disintegrating agent 24.5 parts, lubricant 3 parts, 8.1 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 55 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 10 times amount，Filter decoction liquor，Add the soak by water 2h of 7 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1.5，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 76%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 55 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 10 times amount, filter decoction liquor, add the soak by water 2h of 7 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 1.5, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 76%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
nullStep 2: by the N-methylcantharidimide of described composition by weight、Ursodesoxycholic acid、Apigenin、Ursolic acid、Genistein、Luteolin、Raffinose、Radix Scutellariae extract、Herba Artemisiae Scopariae extract、Hyperin、Centaurcidin、Betulic acid、Gentiopicrin、Vitamin C、Vitamin E、Surfactant mixes，Join in the alcoholic solution that mass concentration is 46% of its 4 times amount，It is placed in homogenizer homogenizing and processes，Arranging homogenization pressure is 29MPa，Homogenizing temperature is: 26 DEG C，Homogenizing time is: 10min，Gained mixture adds filler after reclaiming ethanol、Binding agent、Disintegrating agent、Lubricant，Granule it is ground into after mixing，Take partial particulate powder to rejoin in granule after viscous for limonene wrapping up in，According still further to granulation、Dry、Granulate、The operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Embodiment 6: for preventing the granule of cholestatic jaundice complication, composition including following weight portion: N-methylcantharidimide 1.8 parts, ursodesoxycholic acid 0.8 part, apigenin 39 parts, hyperin 35 parts, ursolic acid 38.2 parts, genistein 35.3 parts, luteolin 32.3 parts, limonene 29.6 parts, Raffinose 28.7 parts, Radix Scutellariae extract 26.5 parts, Herba Artemisiae Scopariae extract 25.2 parts, centaurcidin 23.3 parts, betulic acid 21.4 parts, gentiopicrin 19.8 parts, vitamin C 0.015 part, vitamin E 0.012 part, filler 128.4 parts, binding agent 103.3 parts, disintegrating agent 35 parts, lubricant 5 parts, 10.9 parts of surfactant.
nullWherein，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 60 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Subsequent extracted effective ingredient can be made more abundant，Add the soak by water 3h of 11 times amount，Filter decoction liquor，Add the soak by water 2h of 8 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 2，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract，Have anticancer，Antiinflammatory、Antiallergic action、Antiviral、Heat clearing and damp drying，Eliminating fire and detoxication、The effect protected the liver；Described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited, it is mainly composed of 6,7-Dimethylesculetin and volatile oil, volatile oil is mainly a-pinene, capillin, capillen block, capillanol, capillarisin, chlorogenic acid etc., there is clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer；Described filler is: lactose, the dissolubility having had and mobility, for the molding of preparation；Described binding agent is: pregelatinized Starch, good fluidity, and cohesive is strong, it is simple to material powders is assembled；Described disintegrating agent is: carboxymethyl starch sodium, and after water suction, dilatancy is good, and medicine can be made to dissolve rapidly, and disintegrate is effective；Described lubricant is: micropowder silica gel, has strong hygroscopic effect, it is possible to decrease intergranular frictional force；Described surfactant is: polyoxyethylene sorbitan monoleate, can play solubilising and scattered effect, makes to mix better between drug molecule, so that preparation is more uniform.
For preventing the preparation method of the granule of cholestatic jaundice complication to be:
Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 60 DEG C and dries 5min, coarse powder it is ground into after taking-up, subsequent extracted effective ingredient can be made more abundant, add the soak by water 3h of 11 times amount, filter decoction liquor, add the soak by water 2h of 8 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 2, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 80%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract.Have anticancer, antiinflammatory, antiallergic action, antiviral, heat clearing and damp drying, eliminating fire and detoxication, the effect protected the liver, standby；
nullStep 2: by the N-methylcantharidimide of described composition by weight、Ursodesoxycholic acid、Apigenin、Ursolic acid、Genistein、Luteolin、Raffinose、Radix Scutellariae extract、Herba Artemisiae Scopariae extract、Hyperin、Centaurcidin、Betulic acid、Gentiopicrin、Vitamin C、Vitamin E、Surfactant mixes，Join in the alcoholic solution that mass concentration is 46% of its 5 times amount，It is placed in homogenizer homogenizing and processes，Arranging homogenization pressure is 33MPa，Homogenizing temperature is: 28 DEG C，Homogenizing time is: 10min，Gained mixture adds filler after reclaiming ethanol、Binding agent、Disintegrating agent、Lubricant，Granule it is ground into after mixing，Take partial particulate powder to rejoin in granule after viscous for limonene wrapping up in，According still further to granulation、Dry、Granulate、The operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
Present invention application in prevention cholestatic jaundice complication:
One, animal toxicity test:
1, animal selects and administration: choose 60 healthy rats, it is randomly divided into 1 group, 2 groups, 3 groups, often group 20,1 group is blank group, 2 groups, 3 groups is experimental group, the embodiment of the present invention 2 and the granule of embodiment 5 preparation is gavaged respectively every day to 2 groups, 3 groups rats, observe two weeks, observe every change of rat, after two weeks, gavaging the embodiment of the present invention 2 of 4 times amount and the granule of embodiment 5 preparation to the distribution in continuous 5 days of 2 groups, 3 groups rats, observe heavy dose of toxic reaction, blank group rat gives normal saline every day.
2, test data statistics and result: blank group rat all goes well, experimental group rat through observation after there are no any untoward reaction, body weight increases in two weeks, finds not occur over administration and every organ injury of causing, illustrate that toxic and side effects of the present invention is little after solving plane heavy dose test rat.
Two, clinical data:
1, inventor chooses 140 example cholestatic jaundice patient clinically, nursing for treating is carried out with granule of the present invention after treatment, it is randomly divided into 7 groups, first 6 groups is treatment group, 7th group of matched group, all patient profiles there are no significant difference, the care drug being commonly used for primary disease is taken to matched group patient, 6 groups for the treatment of group patients take the granule of the embodiment of the present invention 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5, embodiment 6 preparation respectively, each one bag sooner or later.
2. criterion of therapeutical effect and therapeutic outcome
2.1 criterions of therapeutical effect
(1) effective: patient has not only promoted primary disease stagnant the disappearing of the bile stasis of blood after taking medicine, it is observed that there is not any severe complication；
(2) effective: severe complication does not occur in patient, but has slight malaise symptoms, also needs continual cure；
(3) invalid: patient is had no any effect by the present invention.
2.2 treatment statistical results
1 liang of table group comparitive study
| Group | Case number | Effective | Effectively | Invalid | Total effective rate % |
| Treat 1 group | 20 | 12 | 6 | 2 | 90.0 |
| Treat 2 groups | 20 | 14 | 5 | 1 | 95 |
| Treat 3 groups | 20 | 12 | 5 | 3 | 85 |
| Treat 4 groups | 20 | 13 | 6 | 1 | 95 |
| Treat 5 groups | 20 | 14 | 5 | 1 | 95 |
| Treat 6 groups | 20 | 12 | 6 | 2 | 90 |
| Matched group | 20 | 7 | 5 | 8 | 60 |
3. conclusion: as can be seen from the above table, the present invention is used for preventing cholestatic jaundice complication effective percentage up to more than 85%, and safety is treated effectively, can be used for clinical expansion.
Although describing with reference to its specific embodiments and illustrating the present invention, but it will be appreciated by those skilled in the art that and it can be variously modified, revise and replace when without departing substantially from the spirit and scope of the present invention.Such as, owing to being treated the change of the responding ability of the people of particular condition, the effective dose beyond preferred dose as explained above is likely to be suitable for.Similarly, the pharmacology observed responds possible basis and relies on selected particular active compounds or whether there is pharmaceutical carrier and preparation type and mode of administration used and become, and is contemplated to this kind of expection change in result or difference according to the purpose of the present invention and practice.Therefore, scope restriction and these claim of the invention is intended to be limited only by following claims should be explained as broadly as possible in rational degree.
Claims (10)
- null1. for preventing the granule of cholestatic jaundice complication，It is characterized in that，Described granule mainly includes the composition of following weight portion: N-methylcantharidimide 0.6-1.8 part、Apigenin 18-39 part、Ursolic acid 16.4-38.2 part、Genistein 15.1-35.3 part、Luteolin 13.6-32.3 part、Limonene 11.8-29.6 part、Raffinose 10.9-28.7 part、Radix Scutellariae extract 9.7-26.5 part、Herba Artemisiae Scopariae extract 8.8-25.2 part、Centaurcidin 7.5-23.3 part、Betulic acid 6.6-21.4 part、Gentiopicrin 5.4-19.8 part、Filler 53.8-128.4 part、Binding agent 45.7-103.3 part、Disintegrating agent 14-35 part、Lubricant 1-5 part、Surfactant 5.3-10.9 part.
- 2. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterized in that, also include the composition of following weight portion: ursodesoxycholic acid 0.2-0.8 part, hyperin 16-35 part, vitamin C 0.007-0.015 part, vitamin E 0.004-0.012 part.
- null3. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication，It is characterized in that，The extracting method of described Radix Scutellariae extract is: take Radix Scutellariae dry root，It is placed in dehydrator at 50-60 DEG C and dries 5min，Coarse powder it is ground into after taking-up，Add the soak by water 3h of 9-11 times amount，Filter decoction liquor，Add the soak by water 2h of 6-8 times amount，Filter decoction liquor，Merge twice gained decoction liquor，After being concentrated to half volume，Add HCl solution and regulate pH to 1-2，83 DEG C of constant temperature water bath 25min，Stand 15h，Gained precipitate adds the distilled water of 1 times amount，Stir，Adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7，Supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72-80%，After gained extracting solution reclaims ethanol，Filter，Concentrating under reduced pressure through vacuum drying，It is gained Radix Scutellariae extract.
- 4. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterised in that described Herba Artemisiae Scopariae extract is purchased from Xi'an Jin Lv biotechnology company limited.
- 5. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterised in that described filler is: lactose.
- 6. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterised in that described binding agent is: pregelatinized Starch.
- 7. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterised in that described disintegrating agent is: carboxymethyl starch sodium.
- 8. as claimed in claim 1 for preventing the granule of cholestatic jaundice complication, it is characterised in that described lubricant is: micropowder silica gel.
- 9. the granule being used for preventing cholestatic jaundice complication as claimed in claim 1, is characterised by, described surfactant is: polyoxyethylene sorbitan monoleate.
- 10. the granule for preventing cholestatic jaundice complication as described in claim 1-9 any one, its preparation method is:Step one: take Radix Scutellariae dry root, it is placed in dehydrator at 50-60 DEG C and dries 5min, coarse powder it is ground into after taking-up, add the soak by water 3h of 9-11 times amount, filter decoction liquor, add the soak by water 2h of 6-8 times amount, filter decoction liquor, merge twice gained decoction liquor, after being concentrated to half volume, add HCl solution and regulate pH to 1-2, 83 DEG C of constant temperature water bath 25min, stand 15h, gained precipitate adds the distilled water of 1 times amount, stir, adding mass concentration is that 40% sodium hydroxide solution is adjusted to pH to 7, supersound extraction 30min is carried out with the solid-liquid ratio of 1:20 again with the alcoholic solution that mass concentration is 72-80%, after gained extracting solution reclaims ethanol, filter, concentrating under reduced pressure through vacuum drying, it is gained Radix Scutellariae extract, standby；nullStep 2: by the N-methylcantharidimide of described composition by weight、Ursodesoxycholic acid、Apigenin、Ursolic acid、Genistein、Luteolin、Raffinose、Radix Scutellariae extract、Herba Artemisiae Scopariae extract、Hyperin、Centaurcidin、Betulic acid、Gentiopicrin、Vitamin C、Vitamin E、Surfactant mixes，Join in the alcoholic solution that mass concentration is 46% of its 3-5 times amount，It is placed in homogenizer homogenizing and processes，Arranging homogenization pressure is 25-33MPa，Homogenizing temperature is: 24-28 DEG C，Homogenizing time is: 10min，Gained mixture adds filler after reclaiming ethanol、Binding agent、Disintegrating agent、Lubricant，Granule it is ground into after mixing，Take partial particulate powder to rejoin in granule after viscous for limonene wrapping up in，According still further to granulation、Dry、Granulate、The operations such as subpackage are made described for preventing the granule of cholestatic jaundice complication.
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| CN1795901A (en) * | 2004-12-27 | 2006-07-05 | 李文军 | Medication for removing toxic heat, eliminating wetness and treating jaundice |
| CN102138966A (en) * | 2010-01-29 | 2011-08-03 | 天津药物研究院 | Tibetan capillaris extract and preparation method, pharmaceutical composition and use thereof |
| CN105412295A (en) * | 2015-12-21 | 2016-03-23 | 贵州瑞和制药有限公司龙里药厂 | Production process of Shuganning Preparation |
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| CN106177899A (en) * | 2016-08-11 | 2016-12-07 | 张晓莉 | Radiation-resistant granule is assisted when tumor intervention therapeutic |
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