CN116421650B - Capsule for treating acute gouty arthritis and preparation method thereof - Google Patents
Capsule for treating acute gouty arthritis and preparation method thereof Download PDFInfo
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- CN116421650B CN116421650B CN202310508428.6A CN202310508428A CN116421650B CN 116421650 B CN116421650 B CN 116421650B CN 202310508428 A CN202310508428 A CN 202310508428A CN 116421650 B CN116421650 B CN 116421650B
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- 239000002775 capsule Substances 0.000 title claims abstract description 82
- 238000002360 preparation method Methods 0.000 title claims abstract description 32
- 201000005569 Gout Diseases 0.000 title claims abstract description 27
- 206010018634 Gouty Arthritis Diseases 0.000 title claims abstract description 27
- 230000001154 acute effect Effects 0.000 title claims abstract description 27
- 229920000881 Modified starch Polymers 0.000 claims abstract description 61
- 229920002472 Starch Polymers 0.000 claims abstract description 55
- 235000019698 starch Nutrition 0.000 claims abstract description 55
- 239000008107 starch Substances 0.000 claims abstract description 55
- 238000003756 stirring Methods 0.000 claims abstract description 41
- 239000004368 Modified starch Substances 0.000 claims abstract description 35
- 239000003054 catalyst Substances 0.000 claims abstract description 35
- 235000019426 modified starch Nutrition 0.000 claims abstract description 35
- 238000011049 filling Methods 0.000 claims abstract description 30
- 239000003814 drug Substances 0.000 claims abstract description 29
- 238000001035 drying Methods 0.000 claims abstract description 27
- 239000008367 deionised water Substances 0.000 claims abstract description 22
- 229910021641 deionized water Inorganic materials 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 22
- 239000004014 plasticizer Substances 0.000 claims abstract description 22
- 238000007873 sieving Methods 0.000 claims abstract description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000003607 modifier Substances 0.000 claims abstract description 21
- 108010046377 Whey Proteins Proteins 0.000 claims abstract description 18
- 102000007544 Whey Proteins Human genes 0.000 claims abstract description 18
- 239000007864 aqueous solution Substances 0.000 claims abstract description 18
- 235000021119 whey protein Nutrition 0.000 claims abstract description 18
- 239000002994 raw material Substances 0.000 claims abstract description 17
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 15
- 238000001914 filtration Methods 0.000 claims abstract description 15
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 15
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 15
- 229940079593 drug Drugs 0.000 claims abstract description 8
- 238000005406 washing Methods 0.000 claims abstract description 8
- 239000000243 solution Substances 0.000 claims description 35
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- 239000003292 glue Substances 0.000 claims description 28
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 27
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 26
- 238000002156 mixing Methods 0.000 claims description 18
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 16
- 210000000988 bone and bone Anatomy 0.000 claims description 15
- 241000287828 Gallus gallus Species 0.000 claims description 14
- 241000830535 Ligustrum lucidum Species 0.000 claims description 14
- 235000003805 Musa ABB Group Nutrition 0.000 claims description 14
- 240000008790 Musa x paradisiaca Species 0.000 claims description 14
- 235000015266 Plantago major Nutrition 0.000 claims description 14
- 244000292697 Polygonum aviculare Species 0.000 claims description 14
- 235000006386 Polygonum aviculare Nutrition 0.000 claims description 14
- 244000153955 Reynoutria sachalinensis Species 0.000 claims description 14
- 235000003202 Reynoutria sachalinensis Nutrition 0.000 claims description 14
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 14
- 235000013399 edible fruits Nutrition 0.000 claims description 14
- 239000009910 sargent gloryvine Substances 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 10
- 239000000047 product Substances 0.000 claims description 10
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 9
- 238000001816 cooling Methods 0.000 claims description 9
- 229910052938 sodium sulfate Inorganic materials 0.000 claims description 9
- 235000011152 sodium sulphate Nutrition 0.000 claims description 9
- 244000197580 Poria cocos Species 0.000 claims description 7
- 235000008599 Poria cocos Nutrition 0.000 claims description 7
- 239000000706 filtrate Substances 0.000 claims description 7
- 238000010438 heat treatment Methods 0.000 claims description 7
- 238000010992 reflux Methods 0.000 claims description 7
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- 239000000377 silicon dioxide Substances 0.000 claims description 7
- UGTZMIPZNRIWHX-UHFFFAOYSA-K sodium trimetaphosphate Chemical group [Na+].[Na+].[Na+].[O-]P1(=O)OP([O-])(=O)OP([O-])(=O)O1 UGTZMIPZNRIWHX-UHFFFAOYSA-K 0.000 claims description 7
- 239000006228 supernatant Substances 0.000 claims description 7
- 238000005520 cutting process Methods 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims description 4
- 239000002304 perfume Substances 0.000 claims description 3
- 239000007903 gelatin capsule Substances 0.000 abstract description 5
- 238000004090 dissolution Methods 0.000 abstract description 3
- 239000000499 gel Substances 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 9
- 235000011187 glycerol Nutrition 0.000 description 8
- 229920002261 Corn starch Polymers 0.000 description 5
- 239000008120 corn starch Substances 0.000 description 5
- 229940099112 cornstarch Drugs 0.000 description 5
- NIQCNGHVCWTJSM-UHFFFAOYSA-N Dimethyl phthalate Chemical compound COC(=O)C1=CC=CC=C1C(=O)OC NIQCNGHVCWTJSM-UHFFFAOYSA-N 0.000 description 4
- 241000282414 Homo sapiens Species 0.000 description 4
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 4
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 3
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
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- 239000005482 chemotactic factor Substances 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 230000037213 diet Effects 0.000 description 2
- FBSAITBEAPNWJG-UHFFFAOYSA-N dimethyl phthalate Natural products CC(=O)OC1=CC=CC=C1OC(C)=O FBSAITBEAPNWJG-UHFFFAOYSA-N 0.000 description 2
- 229960001826 dimethylphthalate Drugs 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
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- 235000013305 food Nutrition 0.000 description 2
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- 206010036067 polydipsia Diseases 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 229940116269 uric acid Drugs 0.000 description 2
- 206010003210 Arteriosclerosis Diseases 0.000 description 1
- 208000007212 Foot-and-Mouth Disease Diseases 0.000 description 1
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- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 125000003172 aldehyde group Chemical group 0.000 description 1
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- 239000000427 antigen Substances 0.000 description 1
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- 108091007433 antigens Proteins 0.000 description 1
- 208000011775 arteriosclerosis disease Diseases 0.000 description 1
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- 125000002485 formyl group Chemical class [H]C(*)=O 0.000 description 1
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- 210000004185 liver Anatomy 0.000 description 1
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- 238000007670 refining Methods 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
Classifications
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention provides a capsule for treating acute gouty arthritis, which comprises a capsule shell and filling medicines, wherein the capsule shell comprises the following raw materials in parts by weight: 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water; the preparation method of the modified starch comprises the following steps: firstly, pre-gelatinizing starch, then adding the pre-gelatinized starch into an aqueous solution of a catalyst, then stirring, adding a modifier, stirring, filtering, washing, drying, crushing and sieving to obtain modified starch; the material used for the capsule shell is safe and has good stability, the starch is modified, the gel network structure is enhanced, the stability of the capsule shell is improved, the disintegration time of the capsule shell is short, and the solubility is high; solves the problems of long disintegration time and reduced dissolution of the existing gelatin capsule for treating acute gouty arthritis.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a capsule for treating acute gouty arthritis and a preparation method thereof.
Background
Acute gouty arthritis is one of the common rheumatism caused by food structure change, too abundant diet and excessive drinking, and can cause hypertension, hyperlipidemia, diabetes, arteriosclerosis and the like, which are mostly seen in young and young men. The main inducement is that the food structure is changed, the diet is too abundant, excessive drinking causes increasing blood uric acid and urine uric acid, sodium urate crystals cause inflammation, human leucocytes phagocytose sodium urate crystals to release chemotactic factors, and finally the chemotactic factors are deposited on kidneys, so that renal failure is caused.
The medicine for treating the acute gouty arthritis is prepared into capsules, the capsule part on the market is prepared by taking gelatin as a raw material, and the most common raw material of the gelatin is bones and skins of pigs and cattle, so that the gelatin capsules have the risks of transmitting animal harmful residual substances and animal antigens such as mad cow disease, foot-and-mouth disease and the like to human beings; in terms of processing, the gelatin refining process is complex, and the three wastes generated in the production process have great influence on the surrounding environment; gelatin capsules are easy to react with amino acid and aldehyde group-containing drugs, which causes the problems of long disintegration time, reduced dissolution rate and the like of the capsules.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a capsule for treating acute gouty arthritis and a preparation method thereof, so as to solve the problems in the prior art.
The invention solves the technical problems by adopting the following technical scheme:
the invention provides a capsule for treating acute gouty arthritis, which comprises a capsule shell and filling medicines, wherein the capsule shell comprises the following raw materials in parts by weight: 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 3-5min, adding a modifier, stirring for 3-5h at 30-50 ℃, adjusting the pH value to 6-7, filtering, washing, drying, crushing and sieving to obtain the modified starch.
Preferably, the mass ratio between the capsule shell and the filling medicine is 1:1-1.5.
Preferably, the filling medicine comprises the following raw materials in parts by weight:
78-80 parts of giant knotweed rhizome, 30-34 parts of chicken bone perfume, 63-64 parts of plantain herb, 63-64 parts of glossy privet fruit, 25-27 parts of honeycomb, 20-23 parts of poria cocos, 15-18 parts of common flowery knotweed root, 23-25 parts of sargentgloryvine stem and 0.5-1 part of auxiliary materials.
Preferably, the auxiliary material comprises silicon dioxide.
Preferably, the pre-pasting treatment comprises the following operation steps:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 40-50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 150-160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing and sieving to obtain the pregelatinized starch.
Preferably, the catalyst is a mixture between sodium hydroxide and sodium sulfate.
Preferably, the modifier is sodium trimetaphosphate.
Preferably, the plasticizer is one or more of diethyl phthalate, glycerol, dimethyl phthalate and dibutyl phthalate.
Preferably, the preparation method of the capsule shell comprises the following steps:
mixing 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water under stirring to ensure that the reaction temperature is 70-90 ℃, adjusting the reaction PH to 6.0, reacting for 3-5 hours to obtain a glue solution, cooling the glue solution to 30-50 ℃, pouring the glue solution into a glue groove, cooling, molding, drying and cutting to obtain the capsule shell.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times each time for 1-1.5 hours, filtering, combining filtrate, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.30-1.32, drying under reduced pressure, crushing, sieving, adding auxiliary materials, mixing uniformly, filling into capsule shells, granulating and obtaining the product.
Compared with the prior art, the invention has the following beneficial effects:
the capsule shell is safe in material use, environment-friendly in processing and good in stability, starch is subjected to pregelatinization treatment, so that the starch has good biocompatibility, stability and adhesiveness, the starch and whey protein are mixed, then the modified starch is used for modification, the connection between the starch and the whey protein is further improved, the gel network structure is further enhanced, the stability of the capsule shell is improved, the capsule shell is not easy to generate a crosslinking reaction with an aldehyde-containing drug, the disintegration time of the capsule shell is short, the solubility is high, the drug release effect is good, and the drug effect is absorbed by a human body; the formula of the filling medicine is scientific and reasonable, has the effects of clearing heat, promoting diuresis, removing blood stasis, promoting diuresis, nourishing liver and kidney, and can effectively treat acute gouty arthritis.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The capsule for treating acute gouty arthritis of the embodiment comprises a capsule shell and a filling medicine, wherein the mass ratio of the capsule shell to the filling medicine is 1:1-1.5 parts of raw materials of the capsule shell, which comprises the following components in parts by weight: 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 3-5min, adding a modifier, stirring for 3-5h at 30-50 ℃, adjusting the pH value to 6-7, filtering, washing, drying, crushing, and sieving with a 100-mesh sieve to obtain the modified starch.
In this embodiment, the operation steps of the pregelatinization process are as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 40-50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 150-160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing, and sieving with a 100-mesh sieve to obtain the pregelatinized starch.
In this example, the catalyst is a mixture between sodium hydroxide and sodium sulfate.
In this embodiment, the modifier is sodium trimetaphosphate.
In this embodiment, the plasticizer is one or more of diethyl phthalate, glycerol, dimethyl phthalate, and dibutyl phthalate.
In this embodiment, the filling medicine includes the following raw materials in parts by weight:
78-80 parts of giant knotweed rhizome, 30-34 parts of chicken bone perfume, 63-64 parts of plantain herb, 63-64 parts of glossy privet fruit, 25-27 parts of honeycomb, 20-23 parts of poria cocos, 15-18 parts of common flowery knotweed root, 23-25 parts of sargentgloryvine stem and 0.5-1 part of auxiliary materials.
In this embodiment, the auxiliary material includes silica.
In this embodiment, the preparation method of the capsule shell is as follows:
mixing 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water under stirring to ensure that the reaction temperature is 70-90 ℃, adjusting the reaction PH to 6.0, reacting for 3-5 hours to obtain a glue solution, cooling the glue solution to 30-50 ℃, pouring the glue solution into a glue groove, cooling, molding, drying and cutting to obtain the capsule shell.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times each time for 1-1.5 hours, filtering, combining filtrate, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.30-1.32, drying under reduced pressure at 70 ℃ and-0.095 Mpa, crushing, sieving with a 40-mesh sieve, adding auxiliary materials, mixing uniformly, filling into capsule shells, granulating and obtaining the product.
Example 1.
A capsule for treating acute gouty arthritis, comprising a capsule shell and a filling medicine, wherein the mass ratio between the capsule shell and the filling medicine is 1:1, the raw materials of the capsule shell comprise the following components in parts by weight: 30 parts of modified starch, 20 parts of whey protein, 1 part of plasticizer, 2 parts of hyaluronic acid and 70 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 3min, adding a modifier, stirring for 3h at 30 ℃, adjusting the pH value to 7, filtering, washing, drying, crushing, and sieving with a 100-mesh sieve to obtain the modified starch.
In this embodiment, the operation steps of the pregelatinization process are as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 40 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 150 ℃, forming a film on the surface of the roller for gelatinization, drying, scraping off the dried starch film, crushing, and sieving with a 100-mesh sieve to obtain the pregelatinized starch.
In this embodiment, the catalyst is a mixture of sodium hydroxide and sodium sulfate, and the mass ratio between sodium hydroxide and sodium sulfate is 1:1, adding the catalyst into an aqueous solution with the weight being 10 times of that of the catalyst, so as to obtain an aqueous solution of the catalyst, wherein the weight of the catalyst is 0.3 time of that of the pregelatinized starch.
In this embodiment, the starch is corn starch.
In this example, the modifier is sodium trimetaphosphate and the amount of modifier added is 0.1 times the weight of pregelatinized starch.
In this embodiment, the plasticizer is glycerol.
In this embodiment, the filling medicine includes the following raw materials in parts by weight:
78 parts of giant knotweed, 30 parts of chicken bone, 63 parts of plantain herb, 63 parts of glossy privet fruit, 25 parts of honeycomb, 20 parts of poria cocos, 15 parts of common flowery knotweed root, 23 parts of sargentgloryvine stem and 0.5 part of auxiliary materials.
In this embodiment, the auxiliary material includes silica.
In this embodiment, the preparation method of the capsule shell is as follows:
mixing 30 parts of modified starch, 20 parts of whey protein, 1 part of plasticizer, 2 parts of hyaluronic acid and 70 parts of deionized water under stirring to ensure that the reaction temperature is 70 ℃, adjusting the reaction pH to 6.0, reacting for 3 hours to obtain a glue solution, cooling the glue solution to 30 ℃, pouring the glue solution into a glue tank, cooling to form, drying and cutting to obtain the capsule shell.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times each time for 1-1.5 hours, filtering, combining filtrate, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.30, drying under reduced pressure at 70 ℃ and minus 0.095Mpa, crushing, sieving with a 40-mesh sieve, adding auxiliary materials, mixing uniformly, filling into capsule shells, and granulating to obtain the product.
Example 2.
A capsule for treating acute gouty arthritis, comprising a capsule shell and a filling medicine, wherein the mass ratio between the capsule shell and the filling medicine is 1:1.5, the raw materials of the capsule shell comprise the following components in parts by weight: 40 parts of modified starch, 30 parts of whey protein, 3 parts of plasticizer, 6 parts of hyaluronic acid and 80 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 5min, adding a modifier, stirring for 5h at 50 ℃, adjusting the pH value to 7, filtering, washing, drying, crushing, and sieving with a 100-mesh sieve to obtain the modified starch.
In this embodiment, the operation steps of the pregelatinization process are as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing, and sieving with a 100-mesh sieve to obtain the pregelatinized starch.
In this example, the catalyst is a mixture of sodium hydroxide and sodium sulfate, and the catalyst is added to an aqueous solution of 10 times the weight of the catalyst to obtain an aqueous solution of the catalyst, wherein the weight of the catalyst is 0.3 times the weight of the pregelatinized starch.
In this embodiment, the starch is corn starch.
In this example, the modifier is sodium trimetaphosphate and the amount of modifier added is 0.1 times the weight of pregelatinized starch.
In this embodiment, the plasticizer is a mixture of diethyl phthalate and glycerin, and the mass ratio of diethyl phthalate to glycerin is 1:1.
in this embodiment, the filling medicine includes the following raw materials in parts by weight:
80 parts of giant knotweed, 34 parts of chicken bone, 64 parts of plantain herb, 64 parts of glossy privet fruit, 27 parts of honeycomb, 23 parts of poria cocos, 18 parts of common flowery knotweed root, 25 parts of sargentgloryvine stem and 1 part of auxiliary material.
In this embodiment, the auxiliary material includes silica.
In this embodiment, the preparation method of the capsule shell is as follows:
40 parts of modified starch, 30 parts of whey protein, 3 parts of plasticizer, 6 parts of hyaluronic acid and 80 parts of deionized water are stirred and mixed, so that the reaction temperature is 90 ℃, the reaction pH is regulated to 6.0, the reaction is carried out for 5 hours, a glue solution is obtained, the glue solution is cooled to 50 ℃, the glue solution is poured into a glue tank, and the capsule shell is obtained after cooling, molding, drying and cutting.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times, 1.5 hours each time, filtering, combining filtrates, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.32, drying under reduced pressure at 70 ℃ and minus 0.095Mpa, crushing, sieving with a 40-mesh sieve, adding auxiliary materials, mixing uniformly, filling into capsule shells, and granulating to obtain the product.
Example 3.
A capsule for treating acute gouty arthritis, comprising a capsule shell and a filling medicine, wherein the mass ratio between the capsule shell and the filling medicine is 1:1.3, the raw materials of the capsule shell comprise the following components in parts by weight: 38 parts of modified starch, 22 parts of whey protein, 1.5 parts of plasticizer, 3 parts of hyaluronic acid and 78 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 5min, adding a modifier, stirring for 5h at 50 ℃, adjusting the pH value to 7, filtering, washing, drying, crushing, and sieving with a 100-mesh sieve to obtain the modified starch.
In this embodiment, the operation steps of the pregelatinization process are as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing, and sieving with a 100-mesh sieve to obtain the pregelatinized starch.
In this example, the catalyst is a mixture of sodium hydroxide and sodium sulfate, and the catalyst is added to an aqueous solution of 10 times the weight of the catalyst to obtain an aqueous solution of the catalyst, wherein the weight of the catalyst is 0.3 times the weight of the pregelatinized starch.
In this embodiment, the starch is corn starch.
In this example, the modifier is sodium trimetaphosphate and the amount of modifier added is 0.1 times the weight of pregelatinized starch.
In this embodiment, the plasticizer is a mixture of diethyl phthalate and glycerin, and the mass ratio of diethyl phthalate to glycerin is 1:1.
in this embodiment, the filling medicine includes the following raw materials in parts by weight:
79.6 parts of giant knotweed rhizome, 33 parts of chicken bone, 63.6 parts of plantain herb, 63.6 parts of glossy privet fruit, 26.5 parts of honeycomb, 21 parts of poria cocos, 16 parts of common flowery knotweed root, 23 parts of sargentgloryvine stem and 0.5 part of auxiliary materials.
In this embodiment, the auxiliary material includes silica.
In this embodiment, the preparation method of the capsule shell is as follows:
40 parts of modified starch, 21 parts of whey protein, 1 part of plasticizer, 3 parts of hyaluronic acid and 80 parts of deionized water are stirred and mixed, so that the reaction temperature is 90 ℃, the reaction pH is regulated to 6.0, the reaction is carried out for 5 hours, a glue solution is obtained, the glue solution is cooled to 35 ℃, the glue solution is poured into a glue tank, cooled to be molded, dried and cut, and then the capsule shell is obtained.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times, 1.5 hours each time, filtering, combining filtrates, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.32, drying under reduced pressure at 70 ℃ and minus 0.095Mpa, crushing, sieving with a 40-mesh sieve, adding auxiliary materials, mixing uniformly, filling into capsule shells, and granulating to obtain the product.
Example 4.
A capsule for treating acute gouty arthritis, comprising a capsule shell and a filling medicine, wherein the mass ratio between the capsule shell and the filling medicine is 1:1.3, the raw materials of the capsule shell comprise the following components in parts by weight: 38 parts of modified starch, 22 parts of whey protein, 1.5 parts of plasticizer, 3 parts of hyaluronic acid and 78 parts of deionized water;
the preparation method of the modified starch comprises the following steps: the preparation method comprises the steps of pre-gelatinizing starch, adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, stirring for 5min, adding a modifier, stirring for 5h at 50 ℃, adjusting the pH value to 7, filtering, washing, drying, crushing, and sieving with a 100-mesh sieve to obtain the modified starch.
In this embodiment, the operation steps of the pregelatinization process are as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing, and sieving with a 100-mesh sieve to obtain the pregelatinized starch.
In this example, the catalyst is a mixture of sodium hydroxide and sodium sulfate, and the catalyst is added to an aqueous solution of 10 times the weight of the catalyst to obtain an aqueous solution of the catalyst, wherein the weight of the catalyst is 0.3 times the weight of the pregelatinized starch.
In this embodiment, the starch is corn starch.
In this example, the modifier is sodium trimetaphosphate and the amount of modifier added is 0.1 times the weight of pregelatinized starch.
In this embodiment, the plasticizer is glycerol.
In this embodiment, the filling medicine includes the following raw materials in parts by weight:
79.6 parts of giant knotweed rhizome, 33 parts of chicken bone, 63.6 parts of plantain herb, 63.6 parts of glossy privet fruit, 26.5 parts of honeycomb, 21 parts of poria cocos, 16 parts of common flowery knotweed root, 23 parts of sargentgloryvine stem and 0.5 part of auxiliary materials.
In this embodiment, the auxiliary material includes silica.
In this embodiment, the preparation method of the capsule shell is as follows:
40 parts of modified starch, 21 parts of whey protein, 1 part of plasticizer, 3 parts of hyaluronic acid and 80 parts of deionized water are stirred and mixed, so that the reaction temperature is 90 ℃, the reaction pH is regulated to 6.0, the reaction is carried out for 5 hours, a glue solution is obtained, the glue solution is cooled to 35 ℃, the glue solution is poured into a glue tank, cooled to be molded, dried and cut, and then the capsule shell is obtained.
The invention also provides a preparation method of the capsule for treating acute gouty arthritis, which comprises the following steps:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times, 1.5 hours each time, filtering, combining filtrates, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.32, drying under reduced pressure at 70 ℃ and minus 0.095Mpa, crushing, sieving with a 40-mesh sieve, adding auxiliary materials, mixing uniformly, filling into capsule shells, and granulating to obtain the product.
Comparative example 1.
Unlike example 4, the modified starch was prepared without pregelatinizing the starch.
Comparative example 2.
Unlike example 3, the modified starch was prepared without modifying the starch with a modifier.
Comparative example 3.
In contrast to example 3, cornstarch was directly used instead of modified starch in the preparation of the capsule shell.
Comparative example 4.
Unlike example 3, no whey protein was added in the preparation of the capsule shell.
The results of the measurements of the products prepared in example 4, comparative examples 1-4 and the products of gelatin capsules currently available on the market were carried out according to the corresponding method of the chinese pharmacopoeia 2020 edition, as shown in table 1 below.
TABLE 1
| Group of | Dissolution (%) | Time limit of disintegration |
| Example 4 | 91.6 | 6 minutes 33 seconds |
| Comparative example 1 | 91.3 | 7 minutes 42 seconds |
| Comparative example 2 | 90.5 | 7 minutes 35 seconds |
| Comparative example 3 | 89.1 | 8 minutes 58 seconds |
| Comparative example 4 | 86.6 | 9 minutes 27 seconds |
| Commercial gelatin capsule products | 76.8 | 10 minutes |
As can be seen from Table 1, the capsule shell of the present invention has good stability, and the stability of the starch capsule shell can be further improved by pregelatinizing the starch and modifying the pregelatinized starch by using the modifying agent, so that the disintegration time of the capsule shell is shortened, the solubility is improved, the drug release effect is good, and the drug effect is easily absorbed by human body.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.
Claims (6)
1. The capsule for treating the acute gouty arthritis is characterized by comprising a capsule shell and a filling medicine, wherein the capsule shell comprises the following raw materials in parts by weight: 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water;
the preparation method of the modified starch comprises the following steps: firstly, pre-gelatinizing starch, then adding the pre-gelatinized starch into an aqueous solution of a catalyst under a stirring state, then stirring for 3-5min, adding a modifier, stirring for 3-5h at 30-50 ℃, adjusting the pH value to 6-7, and then filtering, washing, drying, crushing and sieving to obtain modified starch;
the catalyst is a mixture between sodium hydroxide and sodium sulfate; the modifier is sodium trimetaphosphate;
the mass ratio between the sodium hydroxide and the sodium sulfate is 1:1, adding the catalyst into an aqueous solution with the weight being 10 times of that of the catalyst to obtain an aqueous solution of the catalyst, wherein the weight of the catalyst is 0.3 time of that of pregelatinized starch; the addition amount of the modifier is 0.1 time of the weight of the pregelatinized starch;
the plasticizer is a mixture of diethyl phthalate and glycerol, and the mass ratio of the diethyl phthalate to the glycerol is 1:1, a step of;
the filling medicine comprises the following raw materials in parts by weight:
78-80 parts of giant knotweed rhizome, 30-34 parts of chicken bone perfume, 63-64 parts of plantain herb, 63-64 parts of glossy privet fruit, 25-27 parts of honeycomb, 20-23 parts of poria cocos, 15-18 parts of common flowery knotweed root, 23-25 parts of sargentgloryvine stem and 0.5-1 part of auxiliary materials.
2. A capsule for the treatment of acute gouty arthritis according to claim 1, wherein the mass ratio between the capsule shell and the filling drug is 1:1-1.5.
3. A capsule for the treatment of acute gouty arthritis according to claim 1, wherein the adjunct comprises silica.
4. Capsule for the treatment of acute gouty arthritis according to claim 1, characterized in that the pre-pasting process is operated as follows:
stirring and mixing starch and deionized water to make the concentration of the starch solution 40%, stirring and preheating to 40-50 ℃, conveying the preheated starch solution to the surface of a roller in a single-shaft roller dryer to make the temperature in the roller 150-160 ℃, forming a film on the surface of the roller to gelatinize the starch, drying, scraping off the dried starch film, crushing and sieving to obtain the pregelatinized starch.
5. The capsule for treating acute gouty arthritis according to claim 1, wherein the capsule shell is prepared by the following method:
mixing 30-40 parts of modified starch, 20-30 parts of whey protein, 1-3 parts of plasticizer, 2-6 parts of hyaluronic acid and 70-80 parts of deionized water under stirring to ensure that the reaction temperature is 70-90 ℃, adjusting the reaction PH to 6.0, reacting for 3-5 hours to obtain a glue solution, cooling the glue solution to 30-50 ℃, pouring the glue solution into a glue groove, cooling, molding, drying and cutting to obtain the capsule shell.
6. A method of preparing a capsule for treating acute gouty arthritis according to any one of claims 1 to 5, comprising the steps of:
respectively adding 8 times of ethanol with the mass fraction of 70% into giant knotweed rhizome, chicken bone, plantain herb, glossy privet fruit, honeycomb, indian buead, common flowery knotweed root and sargentgloryvine stem, heating and refluxing for two times each time for 1-1.5 hours, filtering, combining filtrate, standing for 8 hours, taking supernatant, recovering ethanol under reduced pressure, concentrating to extract with the relative density of 1.30-1.32, drying under reduced pressure, crushing, sieving, adding auxiliary materials, mixing uniformly, filling into capsule shells, granulating and obtaining the product.
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