CN103417745A - Chinese herbal preparation for treating acute cholecystitis and preparation method thereof - Google Patents
Chinese herbal preparation for treating acute cholecystitis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese harbal preparation for treating acute cholecystitis and a preparation method thereof. The Chinese herbal preparation comprises the following raw materials: common andrographis herb, armillaria tabescens, linearstripe rabdosia herb, Schnabelia Oligophylla, Chinese brake herb, creeping dichondra herb, Nauclea officinalis, Clinopodium chinense, jamaica vervain, Solanum Vine, uncinata spikemoss herb, Physalis angulata, gardenia jasminoides ellis root, Swertia, nodding clinacanthus and Canscora melastomacea. The invention has the benefits that the Chinese harbal preparation provided by the invention utilizes the traditional Chinese medicine principle to clear away heat and toxic materials and soothe liver-gallbladder and has the advantages of definite curative effect, high efficiency, high effective rate and less side effects.
Description
Technical field
The present invention relates to pharmaceutical technology, particularly a kind of Chinese medicine preparation for the treatment of acute cholecystitis and preparation method thereof.
Background technology
Cholecystitis is with the pain over the hypochondriac region and take on to the right the back radiation, nausea and vomiting, and under appetite, degradation is main clinical manifestation.Because of antibacterial or other factors infection, cause gallbladder wall and neck of gallbladder congestion and edema for gallbladder, even stick together with surrounding tissue, bile excretion is obstructed, and neck of gallbladder and cystic duct shrink simultaneously, makes bile concentrated, be difficult for discharging, cause the antibacterial amount reproduction, increase the weight of the gallbladder inflammation.
Acute cholecystitis is a kind of in cholecystitis, and it is commonly encountered diseases, frequently-occurring disease clinically, often merges cholelithiasis.Clinical symptoms shows as heating, upper right abdomen pain and tenderness, pain often is radiated to shoulder, scapular region and back, the performances such as the companion feels sick, vomiting, slight jaundice and leukocyte counts increase, often because cystic duct blocks, chemical irritation and antibacterial infect caused acute cholecystitis disease sexually transmitted disease (STD) and become.
Acute cholecystitis belongs to the sick categories such as Chinese medicine " gallbladder-distention " " hypochondriac pain " " stomachache " " jaundice ", the many and eating and drinking without temperance of its cause of disease, and disorder of emotion, the factors such as overstrain are relevant.The thick greasy or unclean thing of surfeit delicious food and hungry full immoderate, long-pending humidifying expectorant heat-dissipating of a specified duration is stopped up and is held back middle Jiao, so that liver and gall lose in catharsis, thereby gastral cavity side of body feeling of distension and oppression pain, nausea and vomiting; Or disorder of emotion, be worried angry, the liver and gall dysfunction of acting as a pivot, bile is logical fall not smooth, stagnated QI transforming into fire, venation is become estranged, and satisfies into hypochondriac pain, gallbladder-distention.
Summary of the invention
Technical problem to be solved by this invention is, a kind of Chinese medicine preparation for the treatment of acute cholecystitis and preparation method thereof is provided, the Chinese medicine preparation heat-clearing and toxic substances removing, and depressed liver-energy dispersing and function of gallbladder promoting, determined curative effect, side effect is little
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of acute cholecystitis, wherein, described Chinese medicine preparation comprises following raw medicinal material: Herba Andrographis, Armillaria mella tabescens (Scop.ex Fr.) Sing., Herba Rabdosiae Lophanthoidis, Radix haleniae ellipticae, Herba Pteridis Multifidae, Herba Dichodrae, Lignum et Radix Naucleae, Herba Clinopodii Polycephali, Herba Stachytarphetae Jamaicensis, Herba Solani Lyrati, CUIYUNCAO, lantern bubble, Radix Fructus Gardeniae, Zhang Yacao, Herba Clinacanthi Nutantis and Luo Xingcao.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows: 30～40 parts of Herba Andrographis, 25～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～30 parts of Herba Rabdosiae Lophanthoidiss, 10～20 parts of Radix haleniae ellipticaes, 15～25 parts of Herba Pteridis Multifidaes, 20～30 parts of Herba Dichodraees, 10～20 parts of Lignum et Radix Naucleae, 20～30 parts of Herba Clinopodii Polycephalis, 10～20 parts of Herba Stachytarphetae Jamaicensiss, 15～30 parts of Herba Solani Lyratis, 10～20 parts of CUIYUNCAO, 15～30 parts of lantern bubbles, 10～20 parts of Radix Fructus Gardeniae, 10～20 parts of river deer tooth grass, 15～25 parts of 8～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can also be preferably as follows: 30～35 parts of Herba Andrographis, 30～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～25 parts of Herba Rabdosiae Lophanthoidiss, 10～15 parts of Radix haleniae ellipticaes, 20～25 parts of Herba Pteridis Multifidaes, 25～30 parts of Herba Dichodraees, 15～20 parts of Lignum et Radix Naucleae, 20～25 parts of Herba Clinopodii Polycephalis, 10～15 parts of Herba Stachytarphetae Jamaicensiss, 15～25 parts of Herba Solani Lyratis, 10～15 parts of CUIYUNCAO, 15～25 parts of lantern bubbles, 10～15 parts of Radix Fructus Gardeniae, 15～20 parts of river deer tooth grass, 15～20 parts of 10～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows again: 33 parts of Herba Andrographis, 31 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 22 parts of Herba Rabdosiae Lophanthoidiss, 13 parts of Radix haleniae ellipticaes, 24 parts of Herba Pteridis Multifidaes, 27 parts of Herba Dichodraees, 15 parts of Lignum et Radix Naucleae, 22 parts of Herba Clinopodii Polycephalis, 14 parts of Herba Stachytarphetae Jamaicensiss, 23 parts of Herba Solani Lyratis, 11 parts of CUIYUNCAO, 17 parts of lantern bubbles, 13 parts of Radix Fructus Gardeniae, 16 parts of river deer tooth grass, 18 parts of 12 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adds the ethanol that the determining alcohol with respect to 5～8 times of mixture qualities is 75%～80%, reflux 4～6 hours, extract, and filters and obtain the first extracting solution; The medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 3～5 times of medicinal residues quality is 70%～80% again, and reflux 120～180 minutes, extract, and filters and obtain the second extracting solution; The first extracting solution and the second extracting solution are merged, and concentrating under reduced pressure is removed alcohol solvent, and drying obtains and gets dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill pulverizes 180～220 minutes, pulverizes and sieves and obtains 200～400 purpose micropowders;
The 3rd step: in the micropowders obtained at second step, add the microcrystalline Cellulose with respect to 0.25～0.45 times of its quality, the lactose of 0.25～0.4 times and the starch of 0.2～0.3 times, sieve, mix homogeneously, granulate, drying, add the magnesium stearate with respect to 0.03～0.05 times of micropowders quality, granulate, tabletting, make.
Wherein, when the dosage form of described Chinese medicine preparation is injectable powder, its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 90%;
Second step, add the ethanol that the determining alcohol with respect to 4～6 times of the quality of described mixed powder is 90%～95% in the mixed powder that the first step obtains, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃～8 ℃ standing 50～80 hours, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, concentrated and dry, and again put into super micron mill and pulverize 150～180 minutes, obtain the mixed powder of the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, get mixed powder 100g～200g that second step obtains, and adds propylene glycol 350g～550g, add 4000ml water for injection, stir and make its dissolving, further inject water to 10000ml, add again 20g～40g needle-use activated carbon, fully stir 100～150 minutes; Decarbonization filtering; With 0.22～0.24 μ m filtering with microporous membrane; Lyophilization obtains sterilized powder, the packing embedding.
Beneficial effect of the present invention: Chinese medicine preparation provided by the invention utilizes the traditional theory of Chinese medical science of China, heat-clearing and toxic substances removing, and depressed liver-energy dispersing and function of gallbladder promoting, have determined curative effect, instant effect, effective percentage is high, the advantage that side effect is little.
The specific embodiment
The specific embodiment of the invention provides a kind of Chinese medicine preparation for the treatment of acute cholecystitis, and wherein, described Chinese medicine preparation comprises following raw medicinal material: Herba Andrographis, Armillaria mella tabescens (Scop.ex Fr.) Sing., Herba Rabdosiae Lophanthoidis, Radix haleniae ellipticae, Herba Pteridis Multifidae, Herba Dichodrae, Lignum et Radix Naucleae, Herba Clinopodii Polycephali, Herba Stachytarphetae Jamaicensis, Herba Solani Lyrati, CUIYUNCAO, lantern bubble, Radix Fructus Gardeniae, river deer tooth grass, Herba Clinacanthi Nutantis and Luo Xingcao.
In described Chinese medicine preparation, the pharmacology of each raw medicinal material is as follows:
Herba Andrographis: bitter in the mouth, cold in nature.GUIXIN, lung, large intestine, urinary bladder channel.Heat-clearing and toxic substances removing, the removing heat from blood detumescence.Control acute bacillary dysentery, gastroenteritis, flu, epidemic encephalitis, tracheitis, pneumonia, pertussis, pulmonary tuberculosis, lung abscess, cholecystitis, hypertension, epistaxis, oropharynx swells and ache, furuncle carbuncle, burn due to hot liquid or fire, venom." Jiangxi medical herbs ": clearing away heat and cooling blood, reducing swelling and alleviating pain, control cholecystitis, bronchitis, hypertension, pertussis.
Armillaria mella tabescens (Scop.ex Fr.) Sing.: cold in nature, bitter in the mouth.Heat-clearing and toxic substances removing.Main acute and chronic cholecystitis, biliary tract infection, hepatitis, appendicitis, otitis media.
Herba Rabdosiae Lophanthoidis: hardship, cold.Clearing away heat-damp and promoting diuresis, cool the blood dissipate blood stasis.Control acute hepatitis, acute cholecystitis, dysentery, enteritis, the difficulty in urination, traumatic injury congestive edema.Guangzhou army " Chinese herbal medicine handbook commonly used: heat clearing away, dampness removing, jaundice eliminating.Control acute icterohepatitis, acute cholecystitis.
Radix haleniae ellipticae: hardship, cold.Clearing away heat-damp and promoting diuresis, the suppressing the hyperactive liver function of gallbladder promoting.For acute icterohepatitis, cholecystitis, gastritis, dizziness headache, toothache.
Herba Pteridis Multifidae: light, micro-hardship, cool.Clearing away heat-damp and promoting diuresis, removing toxic substances dysentery relieving, cooling blood for hemostasis.For dysentery, gastroenteritis, hepatitis, urinary system infection, cat fever, laryngopharynx swelling and pain, leucorrhea, metrorrhagia, pesticide intoxication; Traumatic hemorrhage is controlled in external, burn and scald." classification medical herbs ": control all pyretic toxicity, detumescence, relieve inflammation or internal heat.Control the carbuncle skin ulcer, acute mastitis, stranguria.
Herba Dichodrae: hardship, suffering, cool.Return lung, Liver Channel.Heat clearing away, dampness removing, removing toxic substances.The subcutaneous ulcer of harnessing the Yellow River, dysentery, sand Stranguria, nebulousurine, edema, furuncle swelling toxin, traumatic injury, venom." Chinese Plants will ": all herbal medicine has the merit of clearing away heat and promoting diuresis, wind-expelling pain-stopping, hemostasia and promoting granulation, eliminating inflammation and expelling toxin, parasite killing.But treating acute and chronic hepatitis, icterohepatitis, cholecystitis, nephritis, urinary system infection, tonsillitis, stomatitis and carbuncle furuncle are treated poison, venom, acute mastitis, dysentery, malaria, pneumorrhagia etc.
Lignum et Radix Naucleae: hardship, cold.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Treating acute tonsillitis, pharyngolaryngitis, mastitis, enteritis, bacillary dysentery, urinary tract infection, cholecystitis, ulcer of the lower limb, tinea pedis infects, furuncle and phyma pus infections, dermatitis and eczema.
Herba Clinopodii Polycephali: acrid in the mouth, hardship, cool in nature.Wind and heat dispersing, removing toxic substances and promoting subsidence of swelling, hemostasis.Main cold, fever, heatstroke, laryngopharynx swelling and pain, diphtheria, acute cholecystitis, hepatitis, enteritis, dysentery, mastitis, furuncle swelling toxin, allergic dermatitis, acute conjunctivitis, hematuria, metrorrhagia, gingival hemorrhage, traumatic hemorrhage.Guangzhou air force " Chinese herbal medicine handbook commonly used: clearing away heat-fire, promoting blood circulation and detumescence.Control acute cholecystitis, hepatitis, dysentery, parotitis, enteritis, hematuria, acute conjunctivitis, venom, innominate toxic swelling, mastitis, knife injury.
Herba Stachytarphetae Jamaicensis: sweet in the mouth, micro-hardship, cold in nature.GUIXIN, liver, kidney channel.Clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling.Main pyretic stranguria, stranguria caused by urinary stone, nebulousurine, leucorrhea, rheumatic ostalgia, acute conjunctivitis, pharyngolaryngitis, gingivitis, cholecystitis, carbuncle furuncle, hemorrhoid, treating swelling and pain by traumatic injury.Guangzhou army " Chinese herbal medicine handbook commonly used: heat-clearing and toxic substances removing, relieving stranguria by diuresis.Control lithangiuria, urinary tract infection, bones and muscles pain due to rheumatism, laryngitis, acute conjunctivitis, carbuncle furuncle and phyma pain.
Herba Solani Lyrati: sweet, hardship, cold.Heat clearing away, dampness removing, dispel the wind, removing toxic substances.The treating malaria disease, jaundice, edema, gonorrhea, rheumatic arthritis, erysipelas, furuncle.
CUIYUNCAO: sweet, light, cool.Heat-clearing and toxic substances removing, dampness removing dredging collateral, hemostasia and promoting granulation, preventing phlegm from forming and stopping coughing.For icterohepatitis, dysentery, hyperpyrexia convulsion, cholecystitis, nephritis, enteritis, spit blood, has blood in stool, rheumatic arthritis.Urticaria is controlled in external, acute mastitis, traumatic hemorrhage and burn and scald.
The lantern bubble: hardship, cool.Clearing away heat-damp and promoting diuresis, expelling phlegm for arresting cough, hard masses softening and resolving.For icterohepatitis, cholecystitis, cold, fever, laryngopharynx swelling and pain, bronchitis, lung abscess, parotitis, orchitis, cystitis, hematuria, the tuberculosis of cervical lymph nodes; Impetigo is controlled in external, eczema, furuncle and phyma.
Radix Fructus Gardeniae: sweet, hardship, cold.Return liver, gallbladder, stomach warp.Clearing away heat-damp and promoting diuresis, cooling blood for hemostasis.Main icterohepatitis, dysentery, cholecystitis, the high heat of flu, spit blood, epistaxis, urinary tract infection, oedema due to nephritis, mastitis, acute toothache, sore and toxic, traumatic injury.
River deer tooth grass: hardship, suffering, cool.Heat-clearing and toxic substances removing, dampness removing, depressed liver-energy dispersing and function of gallbladder promoting.Cure mainly acute hepatitis, chronic hepatitis, cholecystitis, cold, fever, laryngopharynx swelling and pain, gingival swelling and pain, urinary tract infection, gastroenteritis, dysentery, acute catarrhal conjunctivitis.
Herba Clinacanthi Nutantis: sweet, flat.Enter liver, spleen, kidney channel.The liver heat removing function of gallbladder promoting, the regulating menstruation blood stasis dispelling." the Guangxi medicine is planted register ": regulating menstruation, blood stasis removing, detumescence, pain relieving.Control injury and bone fracture, anemia, jaundice, rheumatism." Chinese herbal medicine ": the liver heat removing choleretic effect is arranged, treatment jaundice and hepatitis ascites.
Luo Xingcao: hardship, cold.Heat-clearing and toxic substances removing, eliminating stasis to stop pain.Cure mainly hepatitis, cholecystitis, acute enteritis, dysentery, tonsillitis, injury and bone fracture, arthralgia.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows: 30～40 parts of Herba Andrographis, 25～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～30 parts of Herba Rabdosiae Lophanthoidiss, 10～20 parts of Radix haleniae ellipticaes, 15～25 parts of Herba Pteridis Multifidaes, 20～30 parts of Herba Dichodraees, 10～20 parts of Lignum et Radix Naucleae, 20～30 parts of Herba Clinopodii Polycephalis, 10～20 parts of Herba Stachytarphetae Jamaicensiss, 15～30 parts of Herba Solani Lyratis, 10～20 parts of CUIYUNCAO, 15～30 parts of lantern bubbles, 10～20 parts of Radix Fructus Gardeniae, 10～20 parts of river deer tooth grass, 15～25 parts of 8～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can also be preferably as follows: 30～35 parts of Herba Andrographis, 30～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～25 parts of Herba Rabdosiae Lophanthoidiss, 10～15 parts of Radix haleniae ellipticaes, 20～25 parts of Herba Pteridis Multifidaes, 25～30 parts of Herba Dichodraees, 15～20 parts of Lignum et Radix Naucleae, 20～25 parts of Herba Clinopodii Polycephalis, 10～15 parts of Herba Stachytarphetae Jamaicensiss, 15～25 parts of Herba Solani Lyratis, 10～15 parts of CUIYUNCAO, 15～25 parts of lantern bubbles, 10～15 parts of Radix Fructus Gardeniae, 15～20 parts of river deer tooth grass, 15～20 parts of 10～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows again: 33 parts of Herba Andrographis, 31 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 22 parts of Herba Rabdosiae Lophanthoidiss, 13 parts of Radix haleniae ellipticaes, 24 parts of Herba Pteridis Multifidaes, 27 parts of Herba Dichodraees, 15 parts of Lignum et Radix Naucleae, 22 parts of Herba Clinopodii Polycephalis, 14 parts of Herba Stachytarphetae Jamaicensiss, 23 parts of Herba Solani Lyratis, 11 parts of CUIYUNCAO, 17 parts of lantern bubbles, 13 parts of Radix Fructus Gardeniae, 16 parts of river deer tooth grass, 18 parts of 12 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
Wherein, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adds the ethanol that the determining alcohol with respect to 5～8 times of mixture qualities is 75%～80%, reflux 4～6 hours, extract, and filters and obtain the first extracting solution; The medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 3～5 times of medicinal residues quality is 70%～80% again, and reflux 120～180 minutes, extract, and filters and obtain the second extracting solution; The first extracting solution and the second extracting solution are merged, and concentrating under reduced pressure is removed alcohol solvent, and drying obtains and gets dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill pulverizes 180～220 minutes, pulverizes and sieves and obtains 200～400 purpose micropowders;
The 3rd step: in the micropowders obtained at second step, add the microcrystalline Cellulose with respect to 0.25～0.45 times of its quality, the lactose of 0.25～0.4 times and the starch of 0.2～0.3 times, sieve, mix homogeneously, granulate, drying, add the magnesium stearate with respect to 0.03～0.05 times of micropowders quality, granulate, tabletting, make.
Wherein, when the dosage form of described Chinese medicine preparation is injectable powder, its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 90%;
Second step, add the ethanol that the determining alcohol with respect to 4～6 times of the quality of described mixed powder is 90%～95% in the mixed powder that the first step obtains, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃～8 ℃ standing 50～80 hours, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, concentrated and dry, and again put into super micron mill and pulverize 150～180 minutes, obtain the mixed powder of the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, get mixed powder 100g～200g that second step obtains, and adds propylene glycol 350g～550g, add 4000ml water for injection, stir and make its dissolving, further inject water to 10000ml, add again 20g～40g needle-use activated carbon, fully stir 100～150 minutes; Decarbonization filtering; With 0.22～0.24 μ m filtering with microporous membrane; Lyophilization obtains sterilized powder, the packing embedding.
Below adopt example to describe embodiments of the present invention in detail, to the present invention, how the application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Tablet prepared by embodiment 1 the present invention
Get Herba Andrographis 330g, Armillaria mella tabescens (Scop.ex Fr.) Sing. 310g, Herba Rabdosiae Lophanthoidis 220g, Radix haleniae ellipticae 130g, Herba Pteridis Multifidae 240g, Herba Dichodrae 270g, Lignum et Radix Naucleae 150g, Herba Clinopodii Polycephali 220g, Herba Stachytarphetae Jamaicensis 140g, Herba Solani Lyrati 230g, CUIYUNCAO 110g, lantern bubble 170g, Radix Fructus Gardeniae 130g, river deer tooth grass 160g, Herba Clinacanthi Nutantis 120g and Luo Xing grass 180g.
Its preparation method comprises the following steps:
The first step: each raw medicinal material is mixed in proportion, adds the ethanol that the determining alcohol with respect to 7 times of mixture qualities is 80%, reflux 6 hours, extract, and filters and obtain the first extracting solution; The medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 4 times of medicinal residues quality is 75% again, and reflux 150 minutes, extract, and filters and obtain the second extracting solution; The first extracting solution and the second extracting solution are merged, and concentrating under reduced pressure is removed alcohol solvent, and drying obtains and gets dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill and pulverizes 200 minutes, pulverizes and sieves and obtains 400 purpose micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.35 times of its quality, the lactose of 0.3 times and the starch of 0.25 times in the micropowders obtained at second step, sieve, mix homogeneously, granulate, drying, add the magnesium stearate with respect to 0.03 times of micropowders quality, granulate, tabletting, make.
Injectable powder prepared by embodiment 2 the present invention
Get Herba Andrographis 310g, Armillaria mella tabescens (Scop.ex Fr.) Sing. 340g, Herba Rabdosiae Lophanthoidis 240g, Radix haleniae ellipticae 110g, Herba Pteridis Multifidae 220g, Herba Dichodrae 290g, Lignum et Radix Naucleae 180g, Herba Clinopodii Polycephali 230g, Herba Stachytarphetae Jamaicensis 120g, Herba Solani Lyrati 190g, CUIYUNCAO 130g, lantern bubble 210g, Radix Fructus Gardeniae 110g, river deer tooth grass 180g, Herba Clinacanthi Nutantis 140g and Luo Xing grass 160g;
Its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 4 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 90%;
Second step, add the ethanol that the determining alcohol with respect to 5 times of the quality of described mixed powder is 95% in the mixed powder that the first step obtains, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 8 ℃ standing 60 hours, adopt percolation with the speed of 1ml per minute percolation slowly, collect percolate, concentrated and dry, and again put into super micron mill and pulverize 170 minutes, obtain the mixed powder of the micron particles of 1 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, get the mixed powder 180g that second step obtains, and adds propylene glycol 450g, adds 4000ml water for injection, stirs and make its dissolving, further injects water to 10000ml, then add the 30g needle-use activated carbon, fully stirs 130 minutes; Decarbonization filtering; With 0.22 μ m filtering with microporous membrane; Lyophilization obtains sterilized powder, the packing embedding.
Toxicity test:
Acute toxicity testing: 60 of application mices, male and female half and half, body weight 28～34g, carry out acute toxicity test.Mice is divided into two groups at random, be matched group and administration group, before experiment, fasting is 12 hours, and the Chinese medicinal tablet of embodiments of the invention 1 preparation is dissolved in water, (concentration is 8.34g crude drug/ml, maximum concentration) gavage, the gavage volume is 5ml/kg (being that single-dose dosage is 41.7 crude drugs/kg), matched group gives the equivalent normal saline, administration in one day 2 times, delivery time 6 hours, after administration, Continuous Observation is 14 days, and record mice toxic reaction and death toll.Experimental result shows: with matched group, compare, after administration, mice has no notable difference, experiment Continuous Observation 14 days, and mice overall health of patients, diet, drinking-water, body weight gain are all normal.Mice oral administration gavage tablet of the present invention is LD50>41.7 crude drugs/kg, and every day, maximum dosage-feeding was 83.4 crude drugs/kg/ day.Chinese medicine preparation clinical application amount of the present invention is 4.8g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.04g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight take 31g) oral administration gavage Chinese medicine preparation of the present invention is quantity 1042 times.Therefore Chinese medicine preparation acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: the tablet of embodiment 1 prepared by the present invention to 3 groups of rats by 15.45,22.68 and 43.12g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and drug withdrawal after 3 weeks, result shows: Chinese medicine preparation of the present invention all has no significant effect indexs such as the hair of rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, and the internal organs naked eyes do not find that difference changes; The histological examination result shows, medication 15 weeks and drug withdrawal are after 3 weeks, and each internal organs of rat are all without obviously changing.Illustrate that toxicity is little after Chinese medicine preparation of the present invention is to the rat long-term prescription, also there is no the difference reaction after drug withdrawal, application safety.
Clinical data:
Case is selected: select acute cholecystitis patient 160 examples in year April in May, 2009 to 2012, male's 82 examples wherein, women's 78 examples; 15～73 years old age, average (34 ± 8) year; Stomachache, heating are all arranged, stomachache be positioned under right upper quadrant of the abdomen or xiphoid-process and with feeling sick, vomiter's 134 examples, 37.5～38.9 ℃ of person's 142 examples of body temperature; Jaundice person's 84 examples appear, neutrophilic leukocyte rising person 126 examples.Be divided into treatment group and each 80 examples of matched group by the table of random number method.The no significant differences (P>0.05) such as two groups of Genders, age, symptom, have comparability.
Diagnostic criteria: 1. symptom is formulated in reference " clinical disease diagnosis is according to curing the improvement standard ": upper right abdomen constant pain, and paroxysmal increases the weight of, and shoulder radiation to the right, and the companion feels sick, vomits and heating; 2. sign: upper right abdominal pressure pain, muscle tonus, Fei Shi does not levy the positive, sometimes can lay one's hand on and enlargement gallbladder that tool is touched a tender spot; 3. blood test: total white blood cells and neutrophil count significantly raise, and part has liver function change, serum total bilirubin slightly to increase; 4. ultrasound diagnosis: the gallbladder enlargement, cyst wall thickens, visible foreign matters ripple, light group, sound shadow.
Excluded cases standard: 1. the important organ dysfunction persons such as severe cardiac, liver, kidney are arranged; 2. gestation or women breast-feeding their children, allergic constitution person; 3. be associated with severe complication and be badly in need of the operative treatment person, as perforation of gallbladder, acute diffuse peritonitis or the pancreatitis of acute necrosis type etc.; 4. single calculus>0.5cm person is pointed out in ultrasound diagnosis; 5. ultrasound diagnosis prompting neck of gallbladder does not obviously block the person; 6. did the Subtotal gastrectomy art, especially Billra th II formula person.
Therapeutic Method: two groups of equal fasting, water (except medicine), with the serious vomiter arrangement gastrointestinal decompression of still needing, give suitable fluid infusion, correct water, electrolyte disturbance, maintain acid-base balance.The conventional antibacterials of using of matched group, take the 3rd generation cephalosporin and quinolones as main, add and use the spasmolysis and analgesia medicine depending on the state of an illness.Treatment group adopts the tablet of the embodiment of the present invention 1 preparation.Every day 3 times, each 3.
Observation item: the observation patient suffers from abdominal pain and disappears and abdominal distention remission time and other clinical symptoms and sign.
In curative effect judging standard: clinical cure: 3d, symptom, sign are alleviated; In 7d, symptom, sign disappear, and the lab testing indices is all normal.Symptom, sign significantly alleviate in produce effects: 7d, and every laboratory is an a little higher than normal value normally or only.Effectively: in 7d, symptom, sign alleviate, and every lab testing is significantly improved.Invalid: in 7d, symptom, sign have no obvious improvement, even worsen or change hands art and treat.
Therapeutic outcome: two groups of Clinical efficacy comparisons are in Table 1.Result: the treatment group curative effect is better than matched group (P<0.05).
Table 1 liang group Clinical efficacy comparison
| Group | n | Clinical cure | Produce effects | Effectively | Invalid | Total effective rate |
| Treatment group | 80 | 62 | 8 | 8 | 2 | 78(97.5％) * |
| Matched group | 80 | 38 | 12 | 22 | 8 | 72(90％) |
With matched group, compare,
*P<0.05.
Two groups of stomachache disappear and the abdominal distention remission time relatively in Table 2.Result: treatment group all is shorter than matched group (P<0.01).
Table 2 liang group stomachache disappears and the abdominal distention remission time compares
| Group | n | The stomachache extinction time | The abdominal distention remission time |
| Treatment group | 80 | 49±11 ** | 43±12 ** |
| Matched group | 80 | 71±16 | 90±25 |
With matched group, compare,
*P<0.01.
Body temperature before and after two groups of treatments, numeration of leukocyte relatively, the results are shown in Table 3.
Body temperature before and after table 3 liang group treatment, numeration of leukocyte relatively
Be showed no untoward reaction in two groups of patient treatment processes and occur, before and after treatment, hematuria routine and electrolyte balance, hepatic and renal function inspection, electrocardiogram are not all found obviously abnormal.
Concrete case: Zheng, the female, 40 years old, upper right abdomen pain 2 days, took antibiotic medicine without alleviation.The upper right angina abdominis, and take on the back radiation to the right, belching and acid regurgitation, bitter taste is vexed, defecates not well.38.4 ℃ of the temperature of having a medical check-up, spirit is withered, and abdominal pressure pain in upper right is obvious, the murphy sign positive, red tongue yellow and greasy fur, stringy and rolling pulse.B ultrasonic prompting gallbladder 6.4cm * 4.6cm, wall thickness 0.6cm, crude.Be diagnosed as acute cholecystitis.Take the tablet of the embodiment of the present invention 1 preparation, every day 3 times, each 3, treat 4 days rear right Upper abdominal paines and obviously alleviate, without belching and acid regurgitation, stomach receive can, two just adjust.7 days rear right Upper abdominal paines disappear, without the shoulder back pain, stomach receive can, two just adjust, the white and thin fur soft pulse.B ultrasonic prompting gallbladder 5cm * 3cm, wall thickness 0.3cm is smooth.Recovery from illness.Follow up a case by regular visits to not recurrence in 1 year.
The above, be only preferred embodiment of the present invention, is not the present invention to be done to the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (8)
1. a Chinese medicine preparation for the treatment of acute cholecystitis, is characterized in that, described Chinese medicine preparation comprises following raw medicinal material: Herba Andrographis, Armillaria mella tabescens (Scop.ex Fr.) Sing., Herba Rabdosiae Lophanthoidis, Radix haleniae ellipticae, Herba Pteridis Multifidae, Herba Dichodrae, Lignum et Radix Naucleae, Herba Clinopodii Polycephali, Herba Stachytarphetae Jamaicensis, Herba Solani Lyrati, CUIYUNCAO, lantern bubble, Radix Fructus Gardeniae, river deer tooth grass, Herba Clinacanthi Nutantis and Luo Xingcao.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: 30～40 parts of Herba Andrographis, 25～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～30 parts of Herba Rabdosiae Lophanthoidiss, 10～20 parts of Radix haleniae ellipticaes, 15～25 parts of Herba Pteridis Multifidaes, 20～30 parts of Herba Dichodraees, 10～20 parts of Lignum et Radix Naucleae, 20～30 parts of Herba Clinopodii Polycephalis, 10～20 parts of Herba Stachytarphetae Jamaicensiss, 15～30 parts of Herba Solani Lyratis, 10～20 parts of CUIYUNCAO, 15～30 parts of lantern bubbles, 10～20 parts of Radix Fructus Gardeniae, 10～20 parts of river deer tooth grass, 15～25 parts of 8～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
3. Chinese medicine preparation as claimed in claim 1 or 2, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: 30～35 parts of Herba Andrographis, 30～35 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 20～25 parts of Herba Rabdosiae Lophanthoidiss, 10～15 parts of Radix haleniae ellipticaes, 20～25 parts of Herba Pteridis Multifidaes, 25～30 parts of Herba Dichodraees, 15～20 parts of Lignum et Radix Naucleae, 20～25 parts of Herba Clinopodii Polycephalis, 10～15 parts of Herba Stachytarphetae Jamaicensiss, 15～25 parts of Herba Solani Lyratis, 10～15 parts of CUIYUNCAO, 15～25 parts of lantern bubbles, 10～15 parts of Radix Fructus Gardeniae, 15～20 parts of river deer tooth grass, 15～20 parts of 10～16 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
4. Chinese medicine preparation as described as claims 1 to 3, is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: 33 parts of Herba Andrographis, 31 parts of Armillaria mella tabescens (Scop.ex Fr.) Sing.s, 22 parts of Herba Rabdosiae Lophanthoidiss, 13 parts of Radix haleniae ellipticaes, 24 parts of Herba Pteridis Multifidaes, 27 parts of Herba Dichodraees, 15 parts of Lignum et Radix Naucleae, 22 parts of Herba Clinopodii Polycephalis, 14 parts of Herba Stachytarphetae Jamaicensiss, 23 parts of Herba Solani Lyratis, 11 parts of CUIYUNCAO, 17 parts of lantern bubbles, 13 parts of Radix Fructus Gardeniae, 16 parts of river deer tooth grass, 18 parts of 12 parts of Herba Clinacanthi Nutantis and Luo Xing grass.
5. Chinese medicine preparation as described as claim 1 to 4, is characterized in that, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adds the ethanol that the determining alcohol with respect to 5～8 times of mixture qualities is 75%～80%, reflux 4～6 hours, extract, and filters and obtain the first extracting solution; The medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 3～5 times of medicinal residues quality is 70%～80% again, and reflux 120～180 minutes, extract, and filters and obtain the second extracting solution; The first extracting solution and the second extracting solution are merged, and concentrating under reduced pressure is removed alcohol solvent, and drying obtains and gets dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill pulverizes 180～220 minutes, pulverizes and sieves and obtains 200～400 purpose micropowders;
The 3rd step: in the micropowders obtained at second step, add the microcrystalline Cellulose with respect to 0.25～0.45 times of its quality, the lactose of 0.25～0.4 times and the starch of 0.2～0.3 times, sieve, mix homogeneously, granulate, drying, add the magnesium stearate with respect to 0.03～0.05 times of micropowders quality, granulate, tabletting, make.
6. Chinese medicine preparation as described as claim 1 to 4, is characterized in that, when the dosage form of described Chinese medicine preparation is injectable powder, its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 90%;
Second step, add the ethanol that the determining alcohol with respect to 4～6 times of the quality of described mixed powder is 90%～95% in the mixed powder that the first step obtains, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃～8 ℃ standing 50～80 hours, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, concentrated and dry, and again put into super micron mill and pulverize 150～180 minutes, obtain the mixed powder of the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, get mixed powder 100g～200g that second step obtains, and adds propylene glycol 350g～550g, add 4000ml water for injection, stir and make its dissolving, further inject water to 10000ml, add again 20g～40g needle-use activated carbon, fully stir 100～150 minutes; Decarbonization filtering; With 0.22～0.24 μ m filtering with microporous membrane; Lyophilization obtains sterilized powder, the packing embedding.
7. the preparation method of the described Chinese medicine preparation of claim 1 to 4, is characterized in that, the dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adds the ethanol that the determining alcohol with respect to 5～8 times of mixture qualities is 75%～80%, reflux 4～6 hours, extract, and filters and obtain the first extracting solution; The medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 3～5 times of medicinal residues quality is 70%～80% again, and reflux 120～180 minutes, extract, and filters and obtain the second extracting solution; The first extracting solution and the second extracting solution are merged, and concentrating under reduced pressure is removed alcohol solvent, and drying obtains and gets dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill pulverizes 180～220 minutes, pulverizes and sieves and obtains 200～400 purpose micropowders;
The 3rd step: in the micropowders obtained at second step, add the microcrystalline Cellulose with respect to 0.25～0.45 times of its quality, the lactose of 0.25～0.4 times and the starch of 0.2～0.3 times, sieve, mix homogeneously, granulate, drying, add the magnesium stearate with respect to 0.03～0.05 times of micropowders quality, granulate, tabletting, make.
8. the preparation method of the described Chinese medicine preparation of claim 1 to 4, is characterized in that, the dosage form of described Chinese medicine preparation is injectable powder, and its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 90%;
Second step, add the ethanol that the determining alcohol with respect to 4～6 times of the quality of described mixed powder is 90%～95% in the mixed powder that the first step obtains, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃～8 ℃ standing 50～80 hours, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, concentrated and dry, and again put into super micron mill and pulverize 150～180 minutes, obtain the mixed powder of the micron particles of 0.1～10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, get mixed powder 100g～200g that second step obtains, and adds propylene glycol 350g～550g, add 4000ml water for injection, stir and make its dissolving, further inject water to 10000ml, add again 20g～40g needle-use activated carbon, fully stir 100～150 minutes; Decarbonization filtering; With 0.22～0.24 μ m filtering with microporous membrane; Lyophilization obtains sterilized powder, the packing embedding.
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| CN104984181A (en) * | 2015-07-14 | 2015-10-21 | 王彦刚 | Traditional Chinese medicine for treating toxic-heat internal stagnation type acute cholecystitis and preparing method of traditional Chinese medicine |
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