CN103417745B - 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 also takes on back radiation to the right with the pain over the hypochondriac region, and nausea and vomiting, under appetite, degradation is main clinical manifestation.For gallbladder infects because of antibacterial or other factors, cause gallbladder wall and neck of gallbladder congestion and edema, even stick together with surrounding tissue, bile excretion is obstructed, and neck of gallbladder and cystic duct shrink simultaneously, and bile is concentrated, not easily discharge, cause antibacterial amount reproduction, increase the weight of gallbladder inflammation.
Acute cholecystitis is the one in cholecystitis, and it is commonly encountered diseases, frequently-occurring disease clinically, often merges cholelithiasis.Clinical symptoms shows as heating, right Upper abdominal pain and tenderness, pain is often radiated to shoulder, scapular region and back, the performances such as companion's Nausea and vomiting, slight jaundice and leukocyte counts increase, often due to cystic duct block, acute cholecystitis disease sexually transmitted disease (STD) caused by chemical irritation and bacteriological infection becomes.
Acute cholecystitis belongs to sick categories such as Chinese medicine " gallbladder-distention " " hypochondriac pain " " stomachache " " jaundice ", and the many and eating and drinking without temperance of its cause of disease, disorder of emotion, the factors such as overstrain are relevant.Middle Jiao is held back in the thick greasy or unclean thing of surfeit delicious food and hungry immoderate, of a specified duration long-pending humidifying expectorant heat-dissipating heap soil or fertilizer over and around the roots of satisfying, so that liver and gall are lost in catharsis, thus gastral cavity side of body feeling of distension and oppression pain, nausea and vomiting; Or disorder of emotion, be worried angry, liver and gall dysfunction of acting as a pivot, bile is logical to fall freely, and stagnated QI transforming into fire, venation is become estranged, and then becomes hypochondriac pain, gallbladder-distention.
Summary of the invention
Technical problem to be solved by this invention is, provides a kind of Chinese medicine preparation for the treatment of acute cholecystitis and preparation method thereof, 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, Physalis minima L., 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: Herba Andrographis 30 ~ 40 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 25 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 30 parts, Radix haleniae ellipticae 10 ~ 20 parts, Herba Pteridis Multifidae 15 ~ 25 parts, Herba Dichodrae 20 ~ 30 parts, Lignum et Radix Naucleae 10 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 30 parts, Herba Stachytarphetae Jamaicensis 10 ~ 20 parts, Herba Solani Lyrati 15 ~ 30 parts, CUIYUNCAO 10 ~ 20 parts, Physalis minima L. 15 ~ 30 parts, Radix Fructus Gardeniae 10 ~ 20 parts, river deer tooth grass 10 ~ 20 parts, Herba Clinacanthi Nutantis 8 ~ 16 parts and Luo Xing grass 15 ~ 25 parts.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can also be preferably as follows: Herba Andrographis 30 ~ 35 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 30 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 25 parts, Radix haleniae ellipticae 10 ~ 15 parts, Herba Pteridis Multifidae 20 ~ 25 parts, Herba Dichodrae 25 ~ 30 parts, Lignum et Radix Naucleae 15 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 25 parts, Herba Stachytarphetae Jamaicensis 10 ~ 15 parts, Herba Solani Lyrati 15 ~ 25 parts, CUIYUNCAO 10 ~ 15 parts, Physalis minima L. 15 ~ 25 parts, Radix Fructus Gardeniae 10 ~ 15 parts, river deer tooth grass 15 ~ 20 parts, Herba Clinacanthi Nutantis 10 ~ 16 parts and Luo Xing grass 15 ~ 20 parts.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows again: Herba Andrographis 33 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 31 parts, Herba Rabdosiae Lophanthoidis 22 parts, Radix haleniae ellipticae 13 parts, Herba Pteridis Multifidae 24 parts, Herba Dichodrae 27 parts, Lignum et Radix Naucleae 15 parts, Herba Clinopodii Polycephali 22 parts, Herba Stachytarphetae Jamaicensis 14 parts, Herba Solani Lyrati 23 parts, CUIYUNCAO 11 parts, Physalis minima L. 17 parts, Radix Fructus Gardeniae 13 parts, river deer tooth grass 16 parts, Herba Clinacanthi Nutantis 12 parts and Luo Xing grass 18 parts.
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, adding relative to the determining alcohol of mixture quality 5 ~ 8 times is the ethanol of 75% ~ 80%, reflux 4 ~ 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70% ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 ~ 5 times again, reflux 120 ~ 180 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 180 ~ 220 minutes, pulverize and sieve acquisition 200 ~ 400 object micropowders;
3rd step: add the starch relative to the microcrystalline Cellulose of its quality 0.25 ~ 0.45 times, the lactose of 0.25 ~ 0.4 times and 0.2 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.03 ~ 0.05 times, granulate, tabletting, makes.
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 super micron mill and be ground into the mixed powder that the micron particles of 0.1 ~ 10 μm of volume average particle size and particle diameter be less than the nano-scale particle composition of 0.1 μm of volume average particle size, described mixed powder powder rate be at least 90%;
Second step, adding relative to the determining alcohol of the quality 4 ~ 6 times of described mixed powder in the mixed powder that the first step obtains is the ethanol of 90% ~ 95%, stirring and dissolving obtains alcoholic solution, alcoholic solution is left standstill 50 ~ 80 hours under the condition of 5 DEG C ~ 8 DEG C, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, concentrated and dry, and again put into super micron mill pulverizing 150 ~ 180 minutes, the micron particles of acquisition 0.1 ~ 10 μm of volume average particle size and particle diameter are less than the mixed powder of the nano-scale particle composition of 0.1 μm of volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
3rd step, gets mixed powder 100g ~ 200g that second step obtains, adds propylene glycol 350g ~ 550g, add 4000ml water for injection, stir and make it dissolve, inject water to 10000ml further, add 20g ~ 40g needle-use activated carbon again, fully stir 100 ~ 150 minutes; Decarbonization filtering; With 0.22 ~ 0.24 μm of filtering with microporous membrane; Lyophilization obtains sterilized powder, subpackage embedding.
Beneficial effect of the present invention: the theory of Chinese medical science that Chinese medicine preparation provided by the invention utilizes China traditional, heat-clearing and toxic substances removing, depressed liver-energy dispersing and function of gallbladder promoting, has determined curative effect, instant effect, and effective percentage is high, the advantage that side effect is little.
Detailed description of the invention
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, Physalis minima L., 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, removing heat from blood is subsided a swelling.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, controls 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: bitter, 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 " conventional Chinese herbal medicine handbook ": heat clearing away, dampness removing, jaundice eliminating.Control acute icterohepatitis, acute cholecystitis.
Radix haleniae ellipticae: bitter, cold.Clearing away heat-damp and promoting diuresis, suppressing the hyperactive liver function of gallbladder promoting.For acute icterohepatitis, cholecystitis, gastritis, dizziness headache, toothache.
Herba Pteridis Multifidae: light, micro-hardship is 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." classifying herbal ": control all pyretic toxicity, detumescence, relieves inflammation or internal heat.Control carbuncle skin ulcer, acute mastitis, stranguria.
Herba Dichodrae: bitter, pungent, cool.Return lung, Liver Channel.Heat clearing away, dampness removing, removing toxic substances.To harness the Yellow River subcutaneous ulcer, 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.Can treating acute and chronic hepatitis, icterohepatitis, cholecystitis, nephritis, urinary system infection, tonsillitis, stomatitis and carbuncle furuncle treat poison, venom, acute mastitis, dysentery, malaria, pneumorrhagia etc.
Lignum et Radix Naucleae: bitter, 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, bitter, 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 " conventional Chinese herbal medicine handbook ": 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 " conventional Chinese herbal medicine handbook ": 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, bitter, cold.Heat clearing away, dampness removing, dispels the wind, removing toxic substances.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, spits blood, has blood in stool, rheumatic arthritis.Urticaria is controlled in external, acute mastitis, traumatic hemorrhage and burn and scald.
Physalis minima L.: bitter, 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 is bitter, 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, spits blood, epistaxis, urinary tract infection, oedema due to nephritis, mastitis, acute toothache, sore and toxic, traumatic injury.
River deer tooth grass: bitter, pungent, 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 is flat.Enter liver, spleen, kidney channel.Liver heat removing function of gallbladder promoting, regulating menstruation blood stasis dispelling." register planted by Guangxi medicine ": regulating menstruation, blood stasis removing, detumescence, pain relieving.Control injury and bone fracture, anemia, jaundice, rheumatism." Chinese herbal medicine ": have liver heat removing choleretic effect, treatment jaundice and hepatitis ascites.
Luo Xingcao: bitter, 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: Herba Andrographis 30 ~ 40 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 25 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 30 parts, Radix haleniae ellipticae 10 ~ 20 parts, Herba Pteridis Multifidae 15 ~ 25 parts, Herba Dichodrae 20 ~ 30 parts, Lignum et Radix Naucleae 10 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 30 parts, Herba Stachytarphetae Jamaicensis 10 ~ 20 parts, Herba Solani Lyrati 15 ~ 30 parts, CUIYUNCAO 10 ~ 20 parts, Physalis minima L. 15 ~ 30 parts, Radix Fructus Gardeniae 10 ~ 20 parts, river deer tooth grass 10 ~ 20 parts, Herba Clinacanthi Nutantis 8 ~ 16 parts and Luo Xing grass 15 ~ 25 parts.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can also be preferably as follows: Herba Andrographis 30 ~ 35 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 30 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 25 parts, Radix haleniae ellipticae 10 ~ 15 parts, Herba Pteridis Multifidae 20 ~ 25 parts, Herba Dichodrae 25 ~ 30 parts, Lignum et Radix Naucleae 15 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 25 parts, Herba Stachytarphetae Jamaicensis 10 ~ 15 parts, Herba Solani Lyrati 15 ~ 25 parts, CUIYUNCAO 10 ~ 15 parts, Physalis minima L. 15 ~ 25 parts, Radix Fructus Gardeniae 10 ~ 15 parts, river deer tooth grass 15 ~ 20 parts, Herba Clinacanthi Nutantis 10 ~ 16 parts and Luo Xing grass 15 ~ 20 parts.
Wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably as follows again: Herba Andrographis 33 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 31 parts, Herba Rabdosiae Lophanthoidis 22 parts, Radix haleniae ellipticae 13 parts, Herba Pteridis Multifidae 24 parts, Herba Dichodrae 27 parts, Lignum et Radix Naucleae 15 parts, Herba Clinopodii Polycephali 22 parts, Herba Stachytarphetae Jamaicensis 14 parts, Herba Solani Lyrati 23 parts, CUIYUNCAO 11 parts, Physalis minima L. 17 parts, Radix Fructus Gardeniae 13 parts, river deer tooth grass 16 parts, Herba Clinacanthi Nutantis 12 parts and Luo Xing grass 18 parts.
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, adding relative to the determining alcohol of mixture quality 5 ~ 8 times is the ethanol of 75% ~ 80%, reflux 4 ~ 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70% ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 ~ 5 times again, reflux 120 ~ 180 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 180 ~ 220 minutes, pulverize and sieve acquisition 200 ~ 400 object micropowders;
3rd step: add the starch relative to the microcrystalline Cellulose of its quality 0.25 ~ 0.45 times, the lactose of 0.25 ~ 0.4 times and 0.2 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.03 ~ 0.05 times, granulate, tabletting, makes.
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 super micron mill and be ground into the mixed powder that the micron particles of 0.1 ~ 10 μm of volume average particle size and particle diameter be less than the nano-scale particle composition of 0.1 μm of volume average particle size, described mixed powder powder rate be at least 90%;
Second step, adding relative to the determining alcohol of the quality 4 ~ 6 times of described mixed powder in the mixed powder that the first step obtains is the ethanol of 90% ~ 95%, stirring and dissolving obtains alcoholic solution, alcoholic solution is left standstill 50 ~ 80 hours under the condition of 5 DEG C ~ 8 DEG C, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, concentrated and dry, and again put into super micron mill pulverizing 150 ~ 180 minutes, the micron particles of acquisition 0.1 ~ 10 μm of volume average particle size and particle diameter are less than the mixed powder of the nano-scale particle composition of 0.1 μm of volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
3rd step, gets mixed powder 100g ~ 200g that second step obtains, adds propylene glycol 350g ~ 550g, add 4000ml water for injection, stir and make it dissolve, inject water to 10000ml further, add 20g ~ 40g needle-use activated carbon again, fully stir 100 ~ 150 minutes; Decarbonization filtering; With 0.22 ~ 0.24 μm of filtering with microporous membrane; Lyophilization obtains sterilized powder, subpackage embedding.
Below adopt example to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure 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, Physalis minima L. 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, adding relative to the determining alcohol of mixture quality 7 times is the ethanol of 80%, reflux 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 4 times again, reflux 150 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 200 minutes, pulverize and sieve acquisition 400 object micropowders;
3rd step: add the starch relative to the microcrystalline Cellulose of its quality 0.35 times, the lactose of 0.3 times and 0.25 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, dry, add the magnesium stearate relative to micropowders quality 0.03 times, granulate, tabletting, makes.
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, Physalis minima L. 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 super micron mill and be ground into the mixed powder that the micron particles of 4 μm of volume average particle size and particle diameter be less than the nano-scale particle composition of 0.1 μm of volume average particle size, described mixed powder powder rate be at least 90%;
Second step, adding relative to the determining alcohol of the quality 5 times of described mixed powder in the mixed powder that the first step obtains is the ethanol of 95%, stirring and dissolving obtains alcoholic solution, alcoholic solution is left standstill 60 hours under the condition of 8 DEG C, adopt percolation with the speed of 1ml per minute slowly percolation, collect percolate, concentrated and dry, and again put into super micron mill pulverizing 170 minutes, the micron particles of acquisition 1 μm of volume average particle size and particle diameter are less than the mixed powder of the nano-scale particle composition of 0.1 μm of volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
3rd step, gets the mixed powder 180g that second step obtains, adds propylene glycol 450g, add 4000ml water for injection, stirs and makes it dissolve, inject water to 10000ml further, then add 30g needle-use activated carbon, fully stirs 130 minutes; Decarbonization filtering; With 0.22 μm of filtering with microporous membrane; Lyophilization obtains sterilized powder, subpackage embedding.
Toxicity test:
Acute toxicity testing: application mice 60, male and female half and half, body weight 28 ~ 34g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicinal tablet prepared by embodiments of the invention 1, (concentration is 8.34g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 41.7 crude drugs/kg), and matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage tablet of the present invention and LD50 > 41.7 crude drugs/kg, every day, maximum dosage-feeding was 83.4 crude drugs/kg/ day.Chinese medicine preparation clinical application amount of the present invention be 4.8g crude drug/day/people, adult body weight in 60KG, average dosage is 0.04g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 31g) oral administration gavage Chinese medicine preparation of the present invention is 1042 times of quantity.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: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to rat all has no significant effect, and internal organs naked eyes do not find difference change; Histological indications shows, medication 15 weeks and drug withdrawal are after 3 weeks, and each internal organs of rat are all without obviously changing.Illustrate that Chinese medicine preparation of the present invention is little to toxicity after rat long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Clinical data:
Case selection: select acute cholecystitis patient 160 example in year April in May, 2009 to 2012, wherein male 82 example, women 78 example; 15 ~ 73 years old age, average (34 ± 8) year; All there are stomachache, heating, under stomachache is positioned at right upper quadrant of the abdomen or xiphoid-process and with Nausea and vomiting person 134 example, body temperature 37.5 ~ 38.9 DEG C of persons 142 example; There is jaundice person 84 example, neutrophilic leukocyte rising person 126 example.Treatment group and each 80 examples of matched group are divided into by random digits table.The no significant differences (P > 0.05) such as two groups of Genders, age, symptoms, have comparability.
Diagnostic criteria: formulate 1. symptom with reference to " clinical disease diagnosis is according to curing improvement standard ": upper right abdomen constant pain, paroxysmal increases the weight of, and shoulder radiation to the right, companion's Nausea and vomiting 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 tool touch a tender spot enlargement gallbladder; 3. blood test: total white blood cells and neutrophil count significantly raise, part has liver function change, serum total bilirubin slightly increases; 4. ultrasound diagnosis: gollbladder dilation, cyst wall thickens, visible foreign matters ripple, light group, sound shadow.
Excluded cases standard: 1. have the important organ dysfunction persons such as severe cardiac, liver, kidney; 2. gestation or women breast-feeding their children, allergic constitution person; 3. be associated with severe complication and be badly in need of operative treatment person, as perforation of gallbladder, acute diffuse peritonitis or Acute necrotising pancreatitis etc.; 4. single calculus > 0.5cm person is pointed out in ultrasound diagnosis; 5. ultrasound diagnosis prompting neck of gallbladder does not obviously block person; 6. Subtotal gastrectomy art was done, especially Billra th II formula person.
Therapeutic Method: two groups of equal fasting, water (except medicine), to still need arrangement gastrointestinal decompression with serious vomiter, gives suitable fluid infusion, correct water and rock-soil coupling, maintain acid-base balance.Matched group routine uses antibacterials, based on third-generation cephalosporin and quinolones, adds use spasmolysis and analgesia medicine depending on the state of an illness.The tablet that treatment group adopts the embodiment of the present invention 1 to prepare.Every day 3 times, each 3.
Observation item: observe patient and to suffer from abdominal pain disappearance and abdominal distention remission time and other clinical symptoms and sign.
Curative effect judging standard: clinical cure: in 3d, symptom, sign are alleviated; In 7d, symptom, sign disappear, and lab testing indices is all normal.Effective: in 7d, symptom, sign significantly alleviate, every laboratory normally or only a little higher than normal value.Effective: in 7d, symptom, sign alleviate, every lab testing is significantly improved.Invalid: in 7d, symptom, sign have no obvious improvement, even worsen or turn operative treatment.
Therapeutic outcome: two groups of Clinical efficacy comparisons are in table 1.Result: treatment group curative effect is better than matched group (P < 0.05).
Table 1 liang group Clinical efficacy comparison
| Group | n | Clinical cure | Effective | Effectively | Invalid | Total effective rate |
| Treatment group | 80 | 62 | 8 | 8 | 2 | 78(97.5％) * |
| Matched group | 80 | 38 | 12 | 22 | 8 | 72(90％) |
Compared with matched group,
*p < 0.05.
Two groups of stomachache disappearances and abdominal distention remission time compare in table 2.Result: treatment group is all shorter than matched group (P < 0.01).
Table 2 liang group stomachache disappears and abdominal distention remission time compares
| Group | n | Stomachache extinction time | Abdominal distention remission time |
| Treatment group | 80 | 49±11 ** | 43±12 ** |
| Matched group | 80 | 71±16 | 90±25 |
Compared with matched group,
*p < 0.01.
Body temperature before and after two groups of treatments, numeration of leukocyte compares, and the results are shown in Table 3.
Body temperature before and after table 3 liang group treatment, numeration of leukocyte compares
Be showed no untoward reaction in two groups of patient treatment procedure to occur, before and after treatment, the conventional and electrolyte balance of hematuria, hepatic and renal function inspection, electrocardiogram all do not find obvious exception.
Concrete case: Zheng, female, 40 years old, right Upper abdominal pain 2 days, took antibiotic medicine without alleviation.Upper right angina abdominis, and take on back radiation to the right, belching and acid regurgitation, bitter taste is vexed, defecates not well.Have a medical check-up warm 38.4 DEG C, spirit is withered, and obviously, murphy sign is positive, red tongue yellow and greasy fur, stringy and rolling pulse for upper right abdominal pressure pain.B ultrasonic prompting gallbladder 6.4cm × 4.6cm, wall thickness 0.6cm, crude.Be diagnosed as acute cholecystitis.Take the embodiment of the present invention 1 prepare tablet, 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 shoulder back pain, stomach receive can, two just adjust, white and thin fur soft pulse.B ultrasonic prompting gallbladder 5cm × 3cm, wall thickness 0.3cm are smooth.Recovery from illness.Follow up a case by regular visits to and do not recur for 1 year.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (7)
1. treat the Chinese medicine preparation of acute cholecystitis for one kind, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: Herba Andrographis 30 ~ 40 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 25 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 30 parts, Radix haleniae ellipticae 10 ~ 20 parts, Herba Pteridis Multifidae 15 ~ 25 parts, Herba Dichodrae 20 ~ 30 parts, Lignum et Radix Naucleae 10 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 30 parts, Herba Stachytarphetae Jamaicensis 10 ~ 20 parts, Herba Solani Lyrati 15 ~ 30 parts, CUIYUNCAO 10 ~ 20 parts, Physalis minima L. 15 ~ 30 parts, Radix Fructus Gardeniae 10 ~ 20 parts, river deer tooth grass 10 ~ 20 parts, Herba Clinacanthi Nutantis 8 ~ 16 parts and Luo Xing grass 15 ~ 25 parts.
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: Herba Andrographis 30 ~ 35 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 30 ~ 35 parts, Herba Rabdosiae Lophanthoidis 20 ~ 25 parts, Radix haleniae ellipticae 10 ~ 15 parts, Herba Pteridis Multifidae 20 ~ 25 parts, Herba Dichodrae 25 ~ 30 parts, Lignum et Radix Naucleae 15 ~ 20 parts, Herba Clinopodii Polycephali 20 ~ 25 parts, Herba Stachytarphetae Jamaicensis 10 ~ 15 parts, Herba Solani Lyrati 15 ~ 25 parts, CUIYUNCAO 10 ~ 15 parts, Physalis minima L. 15 ~ 25 parts, Radix Fructus Gardeniae 10 ~ 15 parts, river deer tooth grass 15 ~ 20 parts, Herba Clinacanthi Nutantis 10 ~ 16 parts and Luo Xing grass 15 ~ 20 parts.
3. 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: Herba Andrographis 33 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 31 parts, Herba Rabdosiae Lophanthoidis 22 parts, Radix haleniae ellipticae 13 parts, Herba Pteridis Multifidae 24 parts, Herba Dichodrae 27 parts, Lignum et Radix Naucleae 15 parts, Herba Clinopodii Polycephali 22 parts, Herba Stachytarphetae Jamaicensis 14 parts, Herba Solani Lyrati 23 parts, CUIYUNCAO 11 parts, Physalis minima L. 17 parts, Radix Fructus Gardeniae 13 parts, river deer tooth grass 16 parts, Herba Clinacanthi Nutantis 12 parts and Luo Xing grass 18 parts.
4. the Chinese medicine preparation as described in as arbitrary in claims 1 to 3, it 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, adding relative to the determining alcohol of mixture quality 5 ~ 8 times is the ethanol of 75% ~ 80%, reflux 4 ~ 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70% ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 ~ 5 times again, reflux 120 ~ 180 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 180 ~ 220 minutes, pulverize and sieve acquisition 200 ~ 400 object micropowders;
3rd step: add the starch relative to the microcrystalline Cellulose of its quality 0.25 ~ 0.45 times, the lactose of 0.25 ~ 0.4 times and 0.2 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.03 ~ 0.05 times, granulate, tabletting, makes.
5. the Chinese medicine preparation as described in as arbitrary in claims 1 to 3, it 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 super micron mill and be ground into the mixed powder that the micron particles of 0.1 ~ 10 μm of volume average particle size and particle diameter be less than the nano-scale particle composition of 0.1 μm of volume average particle size, described mixed powder powder rate be at least 90%;
Second step, adding relative to the determining alcohol of the quality 4 ~ 6 times of described mixed powder in the mixed powder that the first step obtains is the ethanol of 90% ~ 95%, stirring and dissolving obtains alcoholic solution, alcoholic solution is left standstill 50 ~ 80 hours under the condition of 5 DEG C ~ 8 DEG C, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, concentrated and dry, and again put into super micron mill pulverizing 150 ~ 180 minutes, the micron particles of acquisition 0.1 ~ 10 μm of volume average particle size and particle diameter are less than the mixed powder of the nano-scale particle composition of 0.1 μm of volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
3rd step, gets mixed powder 100g ~ 200g that second step obtains, adds propylene glycol 350g ~ 550g, add 4000ml water for injection, stir and make it dissolve, inject water to 10000ml further, add 20g ~ 40g needle-use activated carbon again, fully stir 100 ~ 150 minutes; Decarbonization filtering; With 0.22 ~ 0.24 μm of filtering with microporous membrane; Lyophilization obtains sterilized powder, subpackage embedding.
6. the preparation method of the arbitrary described Chinese medicine preparation of claims 1 to 3, 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, adding relative to the determining alcohol of mixture quality 5 ~ 8 times is the ethanol of 75% ~ 80%, reflux 4 ~ 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 70% ~ 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 ~ 5 times again, reflux 120 ~ 180 minutes, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 180 ~ 220 minutes, pulverize and sieve acquisition 200 ~ 400 object micropowders;
3rd step: add the starch relative to the microcrystalline Cellulose of its quality 0.25 ~ 0.45 times, the lactose of 0.25 ~ 0.4 times and 0.2 ~ 0.3 times in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds the magnesium stearate relative to micropowders quality 0.03 ~ 0.05 times, granulate, tabletting, makes.
7. the preparation method of the arbitrary described Chinese medicine preparation of claims 1 to 3, 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 super micron mill and be ground into the mixed powder that the micron particles of 0.1 ~ 10 μm of volume average particle size and particle diameter be less than the nano-scale particle composition of 0.1 μm of volume average particle size, described mixed powder powder rate be at least 90%;
Second step, adding relative to the determining alcohol of the quality 4 ~ 6 times of described mixed powder in the mixed powder that the first step obtains is the ethanol of 90% ~ 95%, stirring and dissolving obtains alcoholic solution, alcoholic solution is left standstill 50 ~ 80 hours under the condition of 5 DEG C ~ 8 DEG C, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, concentrated and dry, and again put into super micron mill pulverizing 150 ~ 180 minutes, the micron particles of acquisition 0.1 ~ 10 μm of volume average particle size and particle diameter are less than the mixed powder of the nano-scale particle composition of 0.1 μm of volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
3rd step, gets mixed powder 100g ~ 200g that second step obtains, adds propylene glycol 350g ~ 550g, add 4000ml water for injection, stir and make it dissolve, inject water to 10000ml further, add 20g ~ 40g needle-use activated carbon again, fully stir 100 ~ 150 minutes; Decarbonization filtering; With 0.22 ~ 0.24 μm of filtering with microporous membrane; Lyophilization obtains sterilized powder, subpackage embedding.
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| CN104758620A (en) * | 2015-04-22 | 2015-07-08 | 王玉玲 | Liver-soothing and bladder-relieving agent for patients with cholecystitis and preparation method of liver-soothing and bladder-relieving agent |
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