CN106110220B - Preparation process of Chinese patent medicine for treating biliary tract diseases - Google Patents
Preparation process of Chinese patent medicine for treating biliary tract diseases Download PDFInfo
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- CN106110220B CN106110220B CN201610701240.3A CN201610701240A CN106110220B CN 106110220 B CN106110220 B CN 106110220B CN 201610701240 A CN201610701240 A CN 201610701240A CN 106110220 B CN106110220 B CN 106110220B
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- 239000003814 drug Substances 0.000 title claims abstract description 81
- 208000015163 Biliary Tract disease Diseases 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 229940079593 drug Drugs 0.000 claims abstract description 38
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 34
- 239000002994 raw material Substances 0.000 claims abstract description 29
- 239000000341 volatile oil Substances 0.000 claims abstract description 26
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 238000002156 mixing Methods 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 19
- 238000001914 filtration Methods 0.000 claims abstract description 16
- 239000000126 substance Substances 0.000 claims abstract description 15
- 238000001035 drying Methods 0.000 claims abstract description 14
- OMOVVBIIQSXZSZ-UHFFFAOYSA-N [6-(4-acetyloxy-5,9a-dimethyl-2,7-dioxo-4,5a,6,9-tetrahydro-3h-pyrano[3,4-b]oxepin-5-yl)-5-formyloxy-3-(furan-3-yl)-3a-methyl-7-methylidene-1a,2,3,4,5,6-hexahydroindeno[1,7a-b]oxiren-4-yl] 2-hydroxy-3-methylpentanoate Chemical compound CC12C(OC(=O)C(O)C(C)CC)C(OC=O)C(C3(C)C(CC(=O)OC4(C)COC(=O)CC43)OC(C)=O)C(=C)C32OC3CC1C=1C=COC=1 OMOVVBIIQSXZSZ-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000002244 precipitate Substances 0.000 claims abstract description 11
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 9
- 239000001116 FEMA 4028 Substances 0.000 claims abstract description 9
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims abstract description 9
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims abstract description 9
- 229960004853 betadex Drugs 0.000 claims abstract description 9
- 238000004821 distillation Methods 0.000 claims abstract description 9
- 239000012535 impurity Substances 0.000 claims abstract description 8
- 238000001291 vacuum drying Methods 0.000 claims abstract description 8
- 238000000227 grinding Methods 0.000 claims abstract description 7
- 235000009051 Ambrosia paniculata var. peruviana Nutrition 0.000 claims abstract description 6
- 235000003097 Artemisia absinthium Nutrition 0.000 claims abstract description 6
- 240000001851 Artemisia dracunculus Species 0.000 claims abstract description 6
- 235000017731 Artemisia dracunculus ssp. dracunculus Nutrition 0.000 claims abstract description 6
- 235000003261 Artemisia vulgaris Nutrition 0.000 claims abstract description 6
- 241000522190 Desmodium Species 0.000 claims abstract description 6
- 239000001138 artemisia absinthium Substances 0.000 claims abstract description 6
- 239000000084 colloidal system Substances 0.000 claims abstract description 6
- 239000012153 distilled water Substances 0.000 claims abstract description 6
- 238000003756 stirring Methods 0.000 claims abstract description 6
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract description 6
- 238000000967 suction filtration Methods 0.000 claims abstract description 6
- 238000009736 wetting Methods 0.000 claims abstract description 6
- 239000000706 filtrate Substances 0.000 claims description 8
- 244000183685 Citrus aurantium Species 0.000 abstract 1
- 235000007716 Citrus aurantium Nutrition 0.000 abstract 1
- 235000003392 Curcuma domestica Nutrition 0.000 abstract 1
- 244000008991 Curcuma longa Species 0.000 abstract 1
- 235000003373 curcuma longa Nutrition 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 235000013976 turmeric Nutrition 0.000 abstract 1
- 210000000232 gallbladder Anatomy 0.000 description 13
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 12
- 239000002775 capsule Substances 0.000 description 12
- 210000004185 liver Anatomy 0.000 description 8
- 239000008187 granular material Substances 0.000 description 7
- 208000002193 Pain Diseases 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 201000001352 cholecystitis Diseases 0.000 description 4
- 238000002604 ultrasonography Methods 0.000 description 4
- 239000001606 7-[(2S,3R,4S,5S,6R)-4,5-dihydroxy-6-(hydroxymethyl)-3-[(2S,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxyoxan-2-yl]oxy-5-hydroxy-2-(4-hydroxyphenyl)chroman-4-one Substances 0.000 description 3
- 206010000087 Abdominal pain upper Diseases 0.000 description 3
- 210000001015 abdomen Anatomy 0.000 description 3
- 235000013339 cereals Nutrition 0.000 description 3
- DFPMSGMNTNDNHN-ZPHOTFPESA-N naringin Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](OC=2C=C3O[C@@H](CC(=O)C3=C(O)C=2)C=2C=CC(O)=CC=2)O[C@H](CO)[C@@H](O)[C@@H]1O DFPMSGMNTNDNHN-ZPHOTFPESA-N 0.000 description 3
- 229940052490 naringin Drugs 0.000 description 3
- 229930019673 naringin Natural products 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 206010008617 Cholecystitis chronic Diseases 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 208000022531 anorexia Diseases 0.000 description 2
- 230000002279 cholagogic effect Effects 0.000 description 2
- 206010061428 decreased appetite Diseases 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 238000001556 precipitation Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 239000012088 reference solution Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 230000008719 thickening Effects 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- 238000003809 water extraction Methods 0.000 description 2
- 206010028813 Nausea Diseases 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- PBCJIPOGFJYBJE-UHFFFAOYSA-N acetonitrile;hydrate Chemical compound O.CC#N PBCJIPOGFJYBJE-UHFFFAOYSA-N 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000000295 fuel oil Substances 0.000 description 1
- 208000001130 gallstones Diseases 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 239000012982 microporous membrane Substances 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 238000009210 therapy by ultrasound Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention discloses a preparation process of a Chinese patent medicine for treating biliary tract diseases, which comprises the following steps: firstly, crushing and mixing the raw material medicines of oriental wormwood, turmeric root-tuber, desmodium and bitter orange, wetting the mixture by using distilled water, and extracting volatile oil by adopting a distillation method; decocting the raw materials after extracting the volatile oil in water for 3 times, mixing decoctions, filtering, concentrating under reduced pressure to obtain thick paste, adding ethanol into the thick paste, stirring, filtering to remove impurities, and drying to obtain a dried substance A; mixing beta-cyclodextrin, water and volatile oil, grinding by using a colloid mill, refrigerating, carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying to obtain a dried substance B; and fourthly, crushing the dried substance A and the dried substance B, uniformly mixing, and encapsulating to obtain the Chinese patent medicine for treating the biliary tract disease. The invention adopts distillation method to extract the volatile oil in the raw material medicine, reserves the effective components in the raw material medicine, and adopts beta-cyclodextrin to wrap the extracted volatile oil, so that the medicine quality is more stable.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation process of a Chinese patent medicine for treating biliary tract diseases.
Background
The Jinyin gallbladder-benefiting capsule has the effects of clearing heat and promoting diuresis, and soothing liver and benefiting gallbladder, and is suitable for improving symptoms such as hypochondriac pain, stomachache, anorexia and the like caused by liver depression and qi stagnation and liver and gallbladder damp-heat. The existing preparation process of Jinyin Lidan capsules comprises the steps of adding water and decocting for 3 times, adding 6 times of water for the first time and decocting for 3 hours, adding 4 times of water for the second time and the third time respectively, decocting for 2 hours, merging decoction liquids, filtering, decompressing and concentrating filtrate until the relative density is about 1.2(60 ℃), drying at low temperature of 80 ℃, crushing, sieving, mixing uniformly, and encapsulating to obtain the Jinyin Lidan capsules. However, a large amount of volatile oil volatilizes in the process of decocting with water, the volatile oil is just an effective component for treating cholecystitis and gallstone, so that a large amount of effective components in the raw material medicines are lost, and the Jinyin cholagogic capsule prepared by the prior art has the advantages of 0.4 g/capsule, three times a day, 5 capsules which need to be taken each time, large loading amount and larger dosage.
Disclosure of Invention
The invention aims to overcome the defects of the background technology and provide a preparation process of a Chinese patent medicine for treating biliary tract diseases. The process adopts distillation method to extract volatile oil from the raw material medicine, retains effective components in the raw material medicine, and adopts beta-cyclodextrin to wrap the extracted volatile oil, so that the medicine quality is more stable; and then, a water extraction and alcohol precipitation method is adopted to remove impurities, so that the dosage of the medicine is greatly reduced, the loading amount is 0.3 g/granule, the medicine is taken three times a day and 2-3 granules are taken once, and the aims of small dosage, controllable quality and more effective curative effect are fulfilled.
In order to achieve the purpose, the invention adopts the technical scheme that: a preparation process of a Chinese patent medicine for treating biliary tract diseases comprises the following raw material medicines in parts by weight: 1200 parts of oriental wormwood, 600 parts of radix curcumae, 600 parts of desmodium and 300 parts of fructus aurantii; the preparation method is characterized by comprising the following steps:
firstly, crushing and mixing the raw material medicines, then wetting the mixed raw material medicines by using distilled water, and extracting volatile oil of the wetted raw material medicines by adopting a distillation method;
step two, adding water into the crude drug after extracting the volatile oil, decocting for 3 times, wherein the water adding amount for the first time is 6 times of the total mass of the crude drug, the decocting time is 3 hours, the water adding amount for the second time and the water adding amount for the third time are both 4 times of the total mass of the crude drug, the decocting time is 2 hours, merging decoction, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.20 measured at 60 ℃, then adding ethanol into the thick paste, stirring uniformly, filtering impurities, and drying to obtain a dried substance A;
step three, mixing beta-cyclodextrin, water and the volatile oil extracted in the step one according to the mass ratio of (4-8): 150-200): 1, grinding by using a colloid mill, refrigerating, carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying on the white precipitate to obtain a dried substance B;
and step four, crushing the dried substance A in the step two and the dried substance B in the step three, uniformly mixing, and encapsulating to obtain the Chinese patent medicine for treating the biliary tract diseases.
The preparation process of the Chinese patent medicine for treating biliary tract diseases is characterized in that the mass of the ethanol in the second step is 8 times of that of the thick paste.
The preparation process of the Chinese patent medicine for treating biliary tract diseases is characterized in that the drying temperature in the step two is 70-80 ℃, and the drying time is 6-12 hours.
The preparation process of the Chinese patent medicine for treating biliary tract diseases is characterized in that the temperature of vacuum drying in the step three is 70-80 ℃, and the time is 10-15 hours.
The weight portion can be measured in units of weight such as gram, two, jin, kg and ton.
The Chinese patent medicine prepared by the invention has the effects of clearing heat and promoting diuresis, soothing liver and benefiting gallbladder, and is suitable for improving symptoms such as hypochondriac pain, stomachache, anorexia and the like caused by liver depression and qi stagnation and liver and gallbladder damp-heat.
Compared with the prior art, the invention has the following advantages:
1. the invention adopts distillation method to extract the volatile oil in the raw material medicine, reserves the effective components in the raw material medicine, and adopts beta-cyclodextrin to wrap the extracted volatile oil, so that the medicine quality is more stable.
2. The invention adopts a water extraction and alcohol precipitation method to remove impurities, greatly reduces the dosage of the medicine, is taken three times a day, and is taken 2-3 grains (0.3 g/grain) once, thereby achieving the purposes of small dosage, controllable quality and more effective curative effect.
The technical solution of the present invention is further described in detail by the following examples.
Detailed Description
Example 1
The Chinese patent medicine for treating biliary tract diseases is prepared from the following raw material medicines: 1200g of oriental wormwood, 600g of radix curcumae, 600g of desmodium and 300g of fructus aurantii.
The preparation process comprises the following steps:
firstly, crushing and mixing the raw material medicines, then wetting the mixed raw material medicines by using distilled water, and extracting volatile oil of the wetted raw material medicines by adopting a distillation method;
step two, decocting the crude drug with the extracted volatile oil for 3 times, wherein the water adding amount for the first time is 6 times of the total mass of the crude drug, the decocting time is 3 hours, the water adding amount for the second time and the water adding amount for the third time are 4 times of the total mass of the crude drug, the decocting time is 2 hours, merging decoction, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.20 at 60 ℃, then adding ethanol into the thick paste, uniformly stirring, filtering impurities, drying at the drying temperature of 80 ℃ for 6 hours to obtain a dried substance A; the mass of the ethanol is 8 times of that of the thick paste;
step three, mixing beta-cyclodextrin, water and the volatile oil extracted in the step one according to the mass ratio of 6:200:1, grinding by using a colloid mill, refrigerating, and carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying on the white precipitate at the temperature of 80 ℃ for 10 hours to obtain a dried substance B;
and step four, crushing the dried substance A in the step two and the dried substance B in the step three, uniformly mixing, and encapsulating, wherein each capsule contains 0.3g of the dried substance A, so as to obtain the Chinese patent medicine for treating the biliary tract disease.
Example 2
The Chinese patent medicine for treating biliary tract diseases is prepared from the following raw material medicines: 1200g of oriental wormwood, 600g of radix curcumae, 600g of desmodium and 300g of fructus aurantii.
The preparation process comprises the following steps:
firstly, crushing and mixing the raw material medicines, then wetting the mixed raw material medicines by using distilled water, and extracting volatile oil of the wetted raw material medicines by adopting a distillation method;
step two, decocting the crude drug with the extracted volatile oil for 3 times, wherein the water adding amount for the first time is 6 times of the total mass of the crude drug, the decocting time is 3 hours, the water adding amount for the second time and the water adding amount for the third time are 4 times of the total mass of the crude drug, the decocting time is 2 hours, merging decoction, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.20 at 60 ℃, then adding ethanol into the thick paste, uniformly stirring, filtering impurities, drying at the drying temperature of 70 ℃ for 12 hours to obtain a dried substance A; the mass of the ethanol is 8 times of that of the thick paste;
step three, mixing beta-cyclodextrin, water and the volatile oil extracted in the step one according to the mass ratio of 4:180:1, grinding by using a colloid mill, refrigerating, and carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying on the white precipitate at the temperature of 70 ℃ for 15 hours to obtain a dried substance B;
and step four, crushing the dried substance A in the step two and the dried substance B in the step three, uniformly mixing, and encapsulating, wherein each capsule contains 0.3g of the dried substance A, so as to obtain the Chinese patent medicine for treating the biliary tract disease.
Example 3
The Chinese patent medicine for treating biliary tract diseases is prepared from the following raw material medicines: 1200g of oriental wormwood, 600g of radix curcumae, 600g of desmodium and 300g of fructus aurantii.
The preparation process comprises the following steps:
firstly, crushing and mixing the raw material medicines, then wetting the mixed raw material medicines by using distilled water, and extracting volatile oil of the wetted raw material medicines by adopting a distillation method;
step two, decocting the crude drug with the extracted volatile oil for 3 times, wherein the water adding amount for the first time is 6 times of the total mass of the crude drug, the decocting time is 3 hours, the water adding amount for the second time and the water adding amount for the third time are 4 times of the total mass of the crude drug, the decocting time is 2 hours, merging decoction, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.20 at 60 ℃, then adding ethanol into the thick paste, uniformly stirring, filtering impurities, drying at the drying temperature of 75 ℃ for 10 hours to obtain a dried substance A; the mass of the ethanol is 8 times of that of the thick paste;
step three, mixing beta-cyclodextrin, water and the volatile oil extracted in the step one according to the mass ratio of 8:150:1, grinding by using a colloid mill, refrigerating, and carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying on the white precipitate at the temperature of 75 ℃ for 12 hours to obtain a dried substance B;
and step four, crushing the dried substance A in the step two and the dried substance B in the step three, uniformly mixing, and encapsulating, wherein each capsule contains 0.3g of the dried substance A, so as to obtain the Chinese patent medicine for treating the biliary tract disease.
The Chinese patent medicine of the invention has the following usage and dosage: the preparation is orally taken 2-3 granules at a time, 3 times a day.
Measured according to high performance liquid chromatography (appendix VI D of the first part of the Chinese pharmacopoeia 2000 edition).
Octadecylsilane chemically bonded silica is used as a filler for chromatographic conditions and systematic applicability tests; acetonitrile-water (20:80) as a mobile phase; the detection wavelength is 283 nm. The number of theoretical plates is not less than 2000 calculated according to naringin peak.
Preparation of reference solution A proper amount of naringin reference dried at 110 deg.C to constant weight is precisely weighed, and methanol is added to obtain a solution containing 60 μ g per 1 mL.
Preparing test solution by mixing the contents of the product with different contents, grinding, collecting about 1g, precisely weighing, adding 30mL of methanol, performing ultrasonic treatment for 30 min (power 250W), filtering, placing the filtrate in a 50mL measuring flask, washing the residue and container with methanol in small amount for several times, filtering the washing solution in the same measuring flask, adding methanol to scale, shaking, filtering with microporous membrane (0.45 μm), and collecting the filtrate.
The determination method comprises precisely sucking 10 μ L of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.
Each granule of the product contains naringin (C)27H32O14) Not less than 0.8 mg.
The therapeutic effect judgment standard is as follows: chronic cholecystitis is usually caused by liver depression, qi stagnation and damp-heat in the liver and gallbladder.
The method has the following advantages: pain in the right upper abdomen was reduced and ultrasound B showed an improvement in the wall of the gallbladder.
Improvement: the right upper abdominal pain disappeared and ultrasound B showed an improvement in the wall of the gallbladder.
And (3) curing: gallbladder fat meal test (-), the gallbladder wall returns to normal.
And (4) invalidation: there was no improvement.
General clinical data: the invention clinically observes 100 cases (18 cases of silt-type stones), wherein 50 cases are in a treatment group, and 50 cases are in a control group. The treatment group adopts the Chinese patent medicine prepared in the embodiment 1 of the invention, and is orally taken 3 times a day, 2 granules each time; the control group is treated by using a conventional medicament Jinyin cholagogic capsule, and the administration is carried out according to the conventional dosage shown in the instruction. The overall efficacy of the treatment groups was compared to the control group and the results are shown in the table below.
TABLE 1 comparison of the therapeutic effects of the treatment groups with those of the control group
As can be seen from Table 1, the Chinese patent medicine prepared by the process of the invention has a cure rate of 96 percent for treating biliary tract diseases, which is obviously higher than that of the conventional medicine Jinyinldan capsule, and the curative effect of the Chinese patent medicine prepared by the process of the invention is obviously better than that of the conventional medicine Jinyinldan capsule.
Typical cases
Case 1
Zhangzhi, male, 52 years old, dull pain in the right upper abdomen, nausea for more than 2 years with heavy oil, B-ultrasound showed thickening and rough gallbladder wall, and several stones with rice grain size, and was diagnosed as chronic cholecystitis with stones. The Chinese patent medicine prepared by the process of the invention is taken 2 granules each time, 3 times a day, and after 28 days of continuous use, the gall bladder is recovered to be normal, and the calculus disappears.
Case 2
In Zhouji, women aged 45 years old, dull pain in the right upper abdomen for more than 3 years, type B ultrasound showed thickening of the gallbladder wall with 2 stones 1.5X 1.6cm in size, and was diagnosed as calculous cholecystitis. The Chinese patent medicine prepared by the process of the invention is taken 2 granules each time, 3 times a day, and after being used for 3 months, the Chinese patent medicine is rechecked, the calculus disappears, and the gallbladder is recovered to be normal.
Claims (2)
1. A preparation process of a Chinese patent medicine for treating biliary tract diseases comprises the following raw material medicines in parts by weight: 1200 parts of oriental wormwood, 600 parts of radix curcumae, 600 parts of desmodium and 300 parts of fructus aurantii; the preparation method is characterized by comprising the following steps:
firstly, crushing and mixing the raw material medicines, then wetting the mixed raw material medicines by using distilled water, and extracting volatile oil of the wetted raw material medicines by adopting a distillation method;
step two, adding water into the crude drug after extracting the volatile oil, decocting for 3 times, wherein the water adding amount for the first time is 6 times of the total mass of the crude drug, the decocting time is 3 hours, the water adding amount for the second time and the water adding amount for the third time are both 4 times of the total mass of the crude drug, the decocting time is 2 hours, merging decoction, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.20 measured at 60 ℃, then adding ethanol into the thick paste, stirring uniformly, filtering impurities, and drying to obtain a dried substance A; the mass of the ethanol is 8 times of that of the thick paste, the drying temperature is 70-80 ℃, and the drying time is 6-12 hours;
step three, mixing beta-cyclodextrin, water and the volatile oil extracted in the step one according to the mass ratio of (4-8): 150-200): 1, grinding by using a colloid mill, refrigerating, carrying out suction filtration to obtain a white precipitate, and carrying out vacuum drying on the white precipitate to obtain a dried substance B;
and step four, crushing the dried substance A in the step two and the dried substance B in the step three, uniformly mixing, and encapsulating to obtain the Chinese patent medicine for treating the biliary tract diseases.
2. The preparation process of a Chinese patent medicine for treating biliary tract diseases according to claim 1, wherein the vacuum drying temperature in step three is 70-80 ℃ for 10-15 h.
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| CN101062299A (en) * | 2006-04-28 | 2007-10-31 | 通化盛和药业股份有限公司 | Medicine for treating cholecystitis and its preparation |
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