CN113244339A - Cholestyramine powder for hyperlipidemia and preparation method thereof - Google Patents
Cholestyramine powder for hyperlipidemia and preparation method thereof Download PDFInfo
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- CN113244339A CN113244339A CN202110622281.4A CN202110622281A CN113244339A CN 113244339 A CN113244339 A CN 113244339A CN 202110622281 A CN202110622281 A CN 202110622281A CN 113244339 A CN113244339 A CN 113244339A
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- cholestyramine
- chinese medicine
- traditional chinese
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- 229920001268 Cholestyramine Polymers 0.000 title claims abstract description 96
- 239000000843 powder Substances 0.000 title claims abstract description 47
- 208000031226 Hyperlipidaemia Diseases 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000000463 material Substances 0.000 claims abstract description 155
- 239000000203 mixture Substances 0.000 claims abstract description 79
- 239000003814 drug Substances 0.000 claims abstract description 74
- 239000004094 surface-active agent Substances 0.000 claims abstract description 36
- 239000003381 stabilizer Substances 0.000 claims abstract description 30
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 10
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 10
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229940069328 povidone Drugs 0.000 claims abstract description 9
- KNDHRUPPBXRELB-UHFFFAOYSA-M [4-[3-(4-ethylphenyl)butyl]phenyl]-trimethylazanium;chloride Chemical compound [Cl-].C1=CC(CC)=CC=C1C(C)CCC1=CC=C([N+](C)(C)C)C=C1 KNDHRUPPBXRELB-UHFFFAOYSA-M 0.000 claims abstract description 8
- 229960001678 colestyramine Drugs 0.000 claims abstract description 8
- 238000000034 method Methods 0.000 claims abstract description 7
- 239000002994 raw material Substances 0.000 claims abstract description 7
- 229920000609 methyl cellulose Polymers 0.000 claims abstract description 5
- 239000001923 methylcellulose Substances 0.000 claims abstract description 5
- 235000010981 methylcellulose Nutrition 0.000 claims abstract description 5
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 86
- 238000007873 sieving Methods 0.000 claims description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 32
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 22
- 238000005303 weighing Methods 0.000 claims description 22
- 238000010298 pulverizing process Methods 0.000 claims description 20
- 238000001694 spray drying Methods 0.000 claims description 20
- 238000003756 stirring Methods 0.000 claims description 20
- 238000002156 mixing Methods 0.000 claims description 19
- 238000013268 sustained release Methods 0.000 claims description 19
- 239000012730 sustained-release form Substances 0.000 claims description 19
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 18
- 239000002671 adjuvant Substances 0.000 claims description 13
- 235000009917 Crataegus X brevipes Nutrition 0.000 claims description 12
- 235000013204 Crataegus X haemacarpa Nutrition 0.000 claims description 12
- 235000009685 Crataegus X maligna Nutrition 0.000 claims description 12
- 235000009444 Crataegus X rubrocarnea Nutrition 0.000 claims description 12
- 235000009486 Crataegus bullatus Nutrition 0.000 claims description 12
- 235000017181 Crataegus chrysocarpa Nutrition 0.000 claims description 12
- 235000009682 Crataegus limnophila Nutrition 0.000 claims description 12
- 235000004423 Crataegus monogyna Nutrition 0.000 claims description 12
- 235000002313 Crataegus paludosa Nutrition 0.000 claims description 12
- 235000009840 Crataegus x incaedua Nutrition 0.000 claims description 12
- 241001289529 Fallopia multiflora Species 0.000 claims description 12
- 240000000249 Morus alba Species 0.000 claims description 12
- 235000008708 Morus alba Nutrition 0.000 claims description 12
- 235000007164 Oryza sativa Nutrition 0.000 claims description 12
- 241000304195 Salvia miltiorrhiza Species 0.000 claims description 12
- 235000011135 Salvia miltiorrhiza Nutrition 0.000 claims description 12
- 238000000889 atomisation Methods 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 12
- 239000008187 granular material Substances 0.000 claims description 12
- 235000009566 rice Nutrition 0.000 claims description 12
- 238000005550 wet granulation Methods 0.000 claims description 12
- 229930006000 Sucrose Natural products 0.000 claims description 11
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims description 11
- 239000005720 sucrose Substances 0.000 claims description 11
- -1 sucrose ester Chemical class 0.000 claims description 11
- 239000000706 filtrate Substances 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 10
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 239000001103 potassium chloride Substances 0.000 claims description 9
- 235000011164 potassium chloride Nutrition 0.000 claims description 9
- 240000008397 Ganoderma lucidum Species 0.000 claims description 8
- 235000001637 Ganoderma lucidum Nutrition 0.000 claims description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 6
- 241000222336 Ganoderma Species 0.000 claims description 4
- 201000005577 familial hyperlipidemia Diseases 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 230000006641 stabilisation Effects 0.000 claims description 2
- 238000011105 stabilization Methods 0.000 claims description 2
- 240000000171 Crataegus monogyna Species 0.000 claims 2
- 240000007594 Oryza sativa Species 0.000 claims 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- 229960003943 hypromellose Drugs 0.000 claims 1
- 229960002900 methylcellulose Drugs 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 abstract description 34
- 239000008280 blood Substances 0.000 abstract description 15
- 210000004369 blood Anatomy 0.000 abstract description 15
- 230000009286 beneficial effect Effects 0.000 abstract description 7
- 206010028980 Neoplasm Diseases 0.000 abstract description 4
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- 238000009776 industrial production Methods 0.000 abstract description 4
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- 230000002195 synergetic effect Effects 0.000 abstract description 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract description 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 abstract 1
- 241001092040 Crataegus Species 0.000 description 10
- 241000209094 Oryza Species 0.000 description 10
- 239000007921 spray Substances 0.000 description 8
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- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- 208000026106 cerebrovascular disease Diseases 0.000 description 3
- 238000003304 gavage Methods 0.000 description 3
- 208000024172 Cardiovascular disease Diseases 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- 238000008620 Cholesterol Assay Methods 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 230000002526 effect on cardiovascular system Effects 0.000 description 2
- 125000005456 glyceride group Chemical group 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000002459 sustained effect Effects 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 206010002482 Angiosclerosis Diseases 0.000 description 1
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 108010089254 Cholesterol oxidase Proteins 0.000 description 1
- 102220501443 Cytosolic iron-sulfur assembly component 3_C27N_mutation Human genes 0.000 description 1
- 240000001624 Espostoa lanata Species 0.000 description 1
- 235000009161 Espostoa lanata Nutrition 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 206010045254 Type II hyperlipidaemia Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 239000003957 anion exchange resin Substances 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
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- 201000001883 cholelithiasis Diseases 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- DQYBDCGIPTYXML-UHFFFAOYSA-N ethoxyethane;hydrate Chemical compound O.CCOCC DQYBDCGIPTYXML-UHFFFAOYSA-N 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000010172 mouse model Methods 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
Classifications
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Abstract
The invention discloses cholestyramine powder for hyperlipidemia and a preparation method thereof, relates to the technical field of medicines, and mainly comprises the following raw materials: the colestyramine powder is characterized by comprising colestyramine, a slow release material, auxiliary materials and a traditional Chinese medicine composition, wherein the slow release material is at least one of methyl cellulose, hydroxypropyl methylcellulose and povidone, and the auxiliary materials comprise an auxiliary agent, a stabilizing agent and a surfactant; the traditional Chinese medicine composition has the advantages that the components are synergistic, the immunity of a human body can be improved, the traditional Chinese medicine composition has the effects of resisting tumors, resisting oxidation, reducing blood fat, reducing blood sugar, resisting coagulation and the like, the process is simple, the reproducibility is good, and the industrial production is easy to realize; low cost and is beneficial to reducing the price of the product.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to cholestyramine powder for hyperlipidemia and a preparation method thereof.
Background
Cholestyramine, alternative name: cholestyramine, cholestyramine and cholestyramine ester; english name: colestyramine; the molecular formula is as follows: C27H 47N. The main active ingredients are as follows: chloride of polystyrene quaternary ammonium type strongly basic anion exchange resin. The characteristics are as follows: white to off-white powders, odorless or slightly odoriferous; it has hygroscopicity. Insoluble in water, ethanol, chloroform or diethyl ether. The function is as follows: is used for treating type II hyperlipidemia, atherosclerosis, and pruritus caused by liver cirrhosis and cholelithiasis, and has the defect that 2% of patients generate gastrointestinal tract reaction.
Hyperlipidemia is formed by the increase of fat concentration in blood, can cause diseases such as angiosclerosis, coronary heart disease, cerebral infarction and the like for a long time, and has entered the aging society in China, and is a common disease and frequently encountered disease of middle-aged and elderly people at present, cardiovascular and cerebrovascular diseases caused by hyperlipidemia are one of the diseases with the highest death rate in the world, and the incidence of diseases is on the trend of increasing year by year, the harm to human health is more and more serious, and the hyperlipidemia becomes one of the important factors for the occurrence of cardiovascular and cerebrovascular diseases. Therefore, how to prevent and treat hyperlipidemia is an urgent problem to be solved.
Disclosure of Invention
The invention aims to provide cholestyramine powder for hyperlipidemia and a preparation method thereof, so as to solve the problems in the background technology.
In order to achieve the purpose, the invention provides the following technical scheme:
cholestyramine powder for hyperlipidemia mainly comprises the following raw materials in parts by weight: 20-40 parts of cholestyramine, 8-15 parts of slow release materials, 2-5 parts of auxiliary materials and 7-14 parts of traditional Chinese medicine compositions; wherein, the traditional Chinese medicine composition comprises 8-15 parts of hawthorn, 4-7 parts of rice sprout, 6-9 parts of salvia miltiorrhiza, 5-10 parts of rhizoma alismatis, 2-7 parts of polygonum multiflorum, 3-6 parts of mulberry leaf and 7-10 parts of ganoderma lucidum.
As a further scheme of the invention: the cholestyramine powder for hyperlipemia mainly comprises the following raw materials in parts by weight: 25-35 parts of cholestyramine, 10-14 parts of slow release materials, 3-4 parts of auxiliary materials and 9-12 parts of traditional Chinese medicine compositions.
As a still further scheme of the invention: the cholestyramine powder for hyperlipemia mainly comprises the following raw materials in parts by weight: 30 parts of cholestyramine, 12 parts of slow release materials, 4 parts of auxiliary materials and 10 parts of traditional Chinese medicine compositions.
As a still further scheme of the invention: the slow release material is at least one of methylcellulose, hydroxypropyl methylcellulose and polyvidone.
As a still further scheme of the invention: the auxiliary materials comprise an auxiliary agent, a stabilizing agent and a surfactant, wherein the dosage ratio of the auxiliary agent to the stabilizing agent to the surfactant is 1: (2-5): (4-9).
As a still further scheme of the invention: the auxiliary agent is acetic acid and/or citric acid.
As a still further scheme of the invention: the stabilizer is one or a mixture of sodium chloride and potassium chloride.
As a still further scheme of the invention: the surfactant is at least one of fatty glyceride and sucrose ester.
As a still further scheme of the invention: the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 8-15 parts of hawthorn, 4-7 parts of rice sprout, 6-9 parts of salvia miltiorrhiza, 5-10 parts of rhizoma alismatis, 2-7 parts of polygonum multiflorum, 3-6 parts of mulberry leaf and 7-10 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, mixing decoctions, concentrating until the relative density is 1.20-1.30 at 65 ℃, adding ethanol until the volume percentage of the alcohol content reaches 55-70%, stirring, standing, filtering, concentrating the filtrate under reduced pressure until the relative density is 1.30-1.40 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition.
As a still further scheme of the invention: the decocting conditions are as follows: the first time of adding water is 7-11 times of the weight of the medicinal materials, decocting for 1.5-2.5h, and the second time of adding water is 6-10 times of the weight of the medicinal materials, decocting for 1.5-2.5 h; the spray drying conditions were: the air inlet temperature is 85-110 ℃, the air outlet temperature is 85-90 ℃, the material temperature is 75-85 ℃, the atomization pressure is 0.2-0.4 MPa, and the atomization speed is 6-8 ml/s.
A preparation method of cholestyramine powder for hyperlipidemia comprises the following steps:
1) sequentially weighing cholestyramine, a slow release material, an auxiliary material and a traditional Chinese medicine composition according to the weight part ratio;
2) pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve;
3) uniformly mixing the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, performing wet granulation by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, and adopting a fluidized bed drying process;
4) sieving the granules prepared in the step 3) with a 15-20 mesh sieve for size stabilization.
Compared with the prior art, the invention has the beneficial effects that:
1) the colestyramine powder realizes sustained and slow release of the medicine in vivo, the blood concentration is stable, the fluctuation is small, so the administration frequency is reduced, the product covers the peculiar smell of the medicine after being prepared into a sustained-release capsule, the medicine is beneficial to patients to take, and the compliance of the patients is improved;
2) the traditional Chinese medicine composition has the advantages that the components are synergistic, the immunity of a human body can be improved, the traditional Chinese medicine composition has the effects of resisting tumors, resisting oxidation, reducing blood fat, reducing blood sugar, resisting coagulation and the like, the process is simple, the reproducibility is good, and the industrial production is easy to realize; low cost and is beneficial to reducing the price of the product.
Detailed Description
The traditional Chinese medicine composition has the advantages that the components are synergistic, the immunity of a human body can be improved, the traditional Chinese medicine composition has the effects of resisting tumors, resisting oxidation, reducing blood fat, reducing blood sugar, resisting coagulation and the like, the process is simple, the reproducibility is good, and the industrial production is easy to realize; low cost and is beneficial to reducing the price of the product.
The technical solution of the present invention will be described in further detail with reference to specific embodiments.
Example 1
Weighing 20 parts of cholestyramine, 8 parts of slow release material, 2 parts of auxiliary material and 7 parts of traditional Chinese medicine composition according to the weight parts, wherein the slow release material is hydroxypropyl methylcellulose, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 2: 4, the auxiliary agent is citric acid, the stabilizing agent is sodium chloride, the surfactant is fatty glyceride, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 8 parts of hawthorn, 4 parts of rice sprout, 6 parts of salvia miltiorrhiza, 5 parts of rhizoma alismatis, 2 parts of polygonum multiflorum, 3 parts of mulberry leaf and 7 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, combining the decoctions, concentrating to the relative density of 1.20 at 65 ℃, adding ethanol to ensure that the volume percentage of the ethanol content reaches 55%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to the relative density of 1.30 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 7 times of the weight of the medicinal materials, decocting for 1.5 hours, and the second time of adding water is 6 times of the weight of the medicinal materials, and decocting for 1.5 hours; the spray drying conditions were: the air inlet temperature is 85 ℃, the air outlet temperature is 85 ℃, the material temperature is 75 ℃, the atomization pressure is 0.2 MPa, and the spray speed is 6 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; uniformly mixing the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, performing wet granulation by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, and adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 2
Weighing 22 parts of cholestyramine, 10 parts of slow release material, 3 parts of auxiliary material and 8 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is methylcellulose, the auxiliary material comprises auxiliary agent, stabilizer and surfactant, and the dosage ratio of the auxiliary agent, the stabilizer and the surfactant is 1: 3: 5, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 10 parts of hawthorn, 5 parts of rice sprout, 7 parts of salvia miltiorrhiza, 6 parts of rhizoma alismatis, 3 parts of polygonum multiflorum, 4 parts of mulberry leaf and 8 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, combining the decoctions, concentrating to the relative density of 1.25 at 65 ℃, adding ethanol to ensure that the volume percentage of the ethanol content reaches 60%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to the relative density of 1.35 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 8 times of the weight of the medicinal materials, decocting for 1.8 hours, the second time of adding water is 7 times of the weight of the medicinal materials, and decocting for 2 hours; the spray drying conditions were: the air inlet temperature is 90 ℃, the air outlet temperature is 90 ℃, the material temperature is 80 ℃, the atomization pressure is 0.3 MPa, and the spray speed is 7 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; uniformly mixing the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, performing wet granulation by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, and adopting a fluidized bed drying process; sieving the obtained granules with 20 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 3
Weighing 25 parts of cholestyramine, 12 parts of slow release material, 4 parts of auxiliary material and 9 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is povidone, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 4: 6, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 12 parts of hawthorn, 6 parts of rice sprout, 8 parts of salvia miltiorrhiza, 7 parts of rhizoma alismatis, 4 parts of polygonum multiflorum, 5 parts of mulberry leaf and 9 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, mixing the decoctions, concentrating to a relative density of 1.30 at 65 ℃, adding ethanol to enable the volume percentage of the ethanol content to reach 65%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to a relative density of 1.40 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 9 times of the weight of the medicinal materials, decocting for 2 hours, the second time of adding water is 8 times of the weight of the medicinal materials, and decocting for 2.5 hours; the spray drying conditions were: the air inlet temperature is 95 ℃, the air outlet temperature is 85 ℃, the material temperature is 85 ℃, the atomization pressure is 0.4 MPa, and the spray speed is 8 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 20 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 4
Weighing 30 parts of cholestyramine, 13 parts of slow release material, 5 parts of auxiliary material and 10 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is povidone, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 5: 7, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 13 parts of hawthorn, 7 parts of rice sprout, 9 parts of salvia miltiorrhiza, 9 parts of rhizoma alismatis, 5 parts of polygonum multiflorum, 6 parts of mulberry leaf and 10 parts of lucid ganoderma, mixing and stirring, adding water, decocting twice, combining decoction liquids, concentrating until the relative density is 1.30 at 65 ℃, adding ethanol to enable the volume percentage of the ethanol content to reach 65%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to 1.40 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 10 times of the weight of the medicinal materials, decocting for 2.5 hours, and the second time of adding water is 9 times of the weight of the medicinal materials, and decocting for 2 hours; the spray drying conditions were: the air inlet temperature is 100 ℃, the air outlet temperature is 90 ℃, the material temperature is 75 ℃, the atomization pressure is 0.3 MPa, and the spray speed is 8 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 5
Weighing 35 parts of cholestyramine, 14 parts of slow release material, 3 parts of auxiliary material and 12 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is povidone, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 4: 8, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 14 parts of hawthorn, 5 parts of rice sprout, 7 parts of salvia miltiorrhiza, 10 parts of rhizoma alismatis, 6 parts of polygonum multiflorum, 5 parts of mulberry leaf and 7 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, mixing the decoctions, concentrating to the relative density of 1.20 at 65 ℃, adding ethanol to ensure that the volume percentage of the ethanol content reaches 70%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to the relative density of 1.30 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 11 times of the weight of the medicinal materials, decocting for 2 hours, the second time of adding water is 10 times of the weight of the medicinal materials, and decocting for 1.5 hours; the spray drying conditions were: the air inlet temperature is 110 ℃, the air outlet temperature is 85 ℃, the material temperature is 80 ℃, the atomization pressure is 0.4 MPa, and the spray speed is 7 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 6
Weighing 38 parts of cholestyramine, 12 parts of slow release material, 5 parts of auxiliary material and 14 parts of traditional Chinese medicine composition in sequence according to the parts by weight, wherein the slow release material is povidone, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 5: 9, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 15 parts of hawthorn, 6 parts of rice sprout, 8 parts of salvia miltiorrhiza, 6 parts of rhizoma alismatis, 7 parts of polygonum multiflorum, 6 parts of mulberry leaf and 8 parts of ganoderma lucidum, mixing and stirring, adding water, decocting twice, combining the decoctions, concentrating to the relative density of 1.20 at 65 ℃, adding ethanol to ensure that the volume percentage of the ethanol content reaches 70%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to the relative density of 1.30 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 8 times of the weight of the medicinal materials, decocting for 2.5 hours, and the second time of adding water is 8 times of the weight of the medicinal materials, and decocting for 2 hours; the spray drying conditions were: the air inlet temperature is 110 ℃, the air outlet temperature is 90 ℃, the material temperature is 85 ℃, the atomization pressure is 0.4 MPa, and the spray speed is 7 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 20 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Example 7
Weighing 40 parts of cholestyramine, 15 parts of slow release material, 5 parts of auxiliary material and 14 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is methyl cellulose, the auxiliary material comprises auxiliary agent, stabilizing agent and surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 2: 4, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 15 parts of hawthorn, 7 parts of rice sprout, 9 parts of salvia miltiorrhiza, 7 parts of rhizoma alismatis, 7 parts of polygonum multiflorum, 6 parts of mulberry leaf and 10 parts of lucid ganoderma, mixing and stirring, adding water, decocting twice, mixing the decoctions, concentrating to the relative density of 1.30 at 65 ℃, adding ethanol to ensure that the volume percentage of the ethanol content reaches 70%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to the relative density of 1.40 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 11 times of the weight of the medicinal materials, decocting for 2.5 hours, and the second time of adding water is 10 times of the weight of the medicinal materials, and decocting for 2.5 hours; the spray drying conditions were: the air inlet temperature is 110 ℃, the air outlet temperature is 90 ℃, the material temperature is 85 ℃, the atomization pressure is 0.4 MPa, and the spray speed is 8 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 20 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Comparative example 1
Weighing 30 parts of cholestyramine, 13 parts of slow release material and 5 parts of auxiliary material in sequence according to the weight parts, wherein the slow release material is povidone, the auxiliary material comprises an auxiliary agent, a stabilizing agent and a surfactant, and the dosage ratio of the auxiliary agent, the stabilizing agent and the surfactant is 1: 5: 7, the auxiliary agent is acetic acid, the stabilizer is potassium chloride, and the surfactant is sucrose ester; the cholestyramine is crushed and sieved by a 100-mesh sieve, and the sustained-release material and the auxiliary material are respectively crushed and sieved by a 80-mesh sieve; the cholestyramine, the sustained-release material and the auxiliary material are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the sustained-release material and the auxiliary material. Adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Comparative example 2
Weighing 30 parts of cholestyramine, 13 parts of slow release material, 5 parts of auxiliary material and 10 parts of traditional Chinese medicine composition in sequence according to the weight parts, wherein the slow release material is povidone, the auxiliary material comprises auxiliary agent and surfactant, and the dosage ratio of the auxiliary agent to the surfactant is 1: 7, the auxiliary agent is acetic acid, the surfactant is sucrose ester, and the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing 13 parts of hawthorn, 7 parts of rice sprout, 9 parts of salvia miltiorrhiza, 9 parts of rhizoma alismatis, 5 parts of polygonum multiflorum, 6 parts of mulberry leaf and 10 parts of lucid ganoderma, mixing and stirring, adding water, decocting twice, combining decoction liquids, concentrating until the relative density is 1.30 at 65 ℃, adding ethanol to enable the volume percentage of the ethanol content to reach 65%, stirring, standing, filtering, concentrating the filtrate under reduced pressure to 1.40 at 60 ℃, recovering the ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the first time of adding water is 10 times of the weight of the medicinal materials, decocting for 2.5 hours, and the second time of adding water is 9 times of the weight of the medicinal materials, and decocting for 2 hours; the spray drying conditions were: the air inlet temperature is 100 ℃, the air outlet temperature is 90 ℃, the material temperature is 75 ℃, the atomization pressure is 0.3 MPa, and the spray speed is 8 ml/s; pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve; the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition. Adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Comparative example 3
Weighing 30 parts of cholestyramine, 13 parts of slow release material and 5 parts of auxiliary material in sequence according to the weight part ratio, wherein the slow release material is povidone, the auxiliary material comprises an auxiliary agent and a surfactant, and the dosage ratio of the auxiliary agent to the surfactant is 1: 7, the auxiliary agent is acetic acid, and the surfactant is sucrose ester; the cholestyramine is crushed and sieved by a 100-mesh sieve, and the sustained-release material and the auxiliary material are respectively crushed and sieved by a 80-mesh sieve; the cholestyramine, the sustained-release material and the auxiliary material are uniformly mixed, and wet granulation is carried out by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the sustained-release material and the auxiliary material. Adopting a fluidized bed drying process; sieving the obtained granules with 15 mesh sieve, and grading to obtain cholestyramine powder for treating hyperlipidemia.
Experimental example 1
The method is characterized in that 110 wistar hyperlipoidemia mouse models are randomly and averagely divided into ten groups, wherein the 1 st group to the 7 th group are experimental groups, the 8 th group to the 10 th group are control groups, and the 11 th group is a blank group. Group 1-7 cholestyramine powder prepared in the gavage examples 1-7, the specification of which is 0.4mg/kg, 3 times a day; 8-10 groups were administered by gavage the colestyramine powder prepared in comparative examples 1-3, the specification was 0.5mg/kg, 1 time per day, and the blank group was not subjected to gavage. Blood was collected before administration, on days 1, 3, 5, 10, 15 and 20 after administration to detect the cholesterol level.
Blood lipid cholesterol assay
Anesthesia: the mice are anesthetized by ether until the breath is uniform and the limbs are relaxed, and the tail is soaked in warm water at the temperature of 40-45 ℃ for 20-30 seconds. Blood collection: wiping dry rat tail with dry cotton ball, cutting off 2-4mm tail tip with scissors, collecting blood, and separating serum.
And (3) detection: and (3) detecting by adopting a cholesterol oxidase method. Results of cholesterol assay (mmol/l) for each group of mice
| Group of | Before administration | 1 day | 3 days | 5 days | 10 days | 15 days | 20 days |
| First group | 6.48 | 5.31 | 3.87 | 2.94 | 2.61 | 1.39 | 1.28 |
| Second group | 6.51 | 5.46 | 4.21 | 3.12 | 2.54 | 1.48 | 1.33 |
| Third group | 6.44 | 5.64 | 4.41 | 3.65 | 2.70 | 1.46 | 1.39 |
| Fourth group | 6.53 | 4.58 | 3.27 | 2.08 | 1.65 | 1.32 | 1.21 |
| Fifth group | 6.67 | 5.26 | 4.69 | 3.54 | 2.83 | 1.95 | 1.42 |
| Sixth group | 6.58 | 5.61 | 4.26 | 3.64 | 2.39 | 1.57 | 1.35 |
| Seventh group | 6.61 | 5.93 | 4.61 | 3.75 | 2.96 | 1.65 | 1.52 |
| Eighth group | 6.56 | 6.31 | 6.28 | 5.94 | 5.31 | 5.08 | 4.92 |
| Ninth group | 6.49 | 6.27 | 6.05 | 5.73 | 5.36 | 5.21 | 4.94 |
| Tenth group | 6.62 | 6.59 | 6.45 | 6.39 | 6.25 | 6.21 | 6.18 |
| Eleventh group | 6.47 | 6.56 | 6.49 | 6.62 | 6.59 | 6.64 | 6.70 |
In conclusion, the cholestyramine powder realizes the sustained and slow release of the medicine in vivo, the blood concentration is stable, the fluctuation is small, so the administration frequency is reduced, the product is prepared into the sustained-release capsule, the peculiar smell of the medicine is covered, the medicine is beneficial to patients to take, and the compliance of the patients is improved; the traditional Chinese medicine composition has the advantages that the components are synergistic, the immunity of a human body can be improved, the traditional Chinese medicine composition has the effects of resisting tumors, resisting oxidation, reducing blood fat, reducing blood sugar, resisting coagulation and the like, the process is simple, the reproducibility is good, and the industrial production is easy to realize; low cost and is beneficial to reducing the price of the product.
While the preferred embodiments of the present invention have been described in detail, the present invention is not limited to the above embodiments, and various changes can be made without departing from the spirit of the present invention within the knowledge of those skilled in the art.
Claims (10)
1. The cholestyramine powder for hyperlipemia is characterized by mainly comprising the following raw materials in parts by weight: 20-40 parts of cholestyramine, 8-15 parts of slow release materials, 2-5 parts of auxiliary materials and 7-14 parts of traditional Chinese medicine compositions; wherein, the traditional Chinese medicine composition comprises 8-15 parts of hawthorn, 4-7 parts of rice sprout, 6-9 parts of salvia miltiorrhiza, 5-10 parts of rhizoma alismatis, 2-7 parts of polygonum multiflorum, 3-6 parts of mulberry leaf and 7-10 parts of ganoderma lucidum.
2. The cholestyramine powder for hyperlipidemia according to claim 1, wherein the cholestyramine powder for hyperlipidemia is mainly composed of the following raw materials in parts by weight: 25-35 parts of cholestyramine, 10-14 parts of slow release materials, 3-4 parts of auxiliary materials and 9-12 parts of traditional Chinese medicine compositions.
3. The cholestyramine powder for hyperlipidemia according to claim 2, wherein the cholestyramine powder for hyperlipidemia is mainly composed of the following raw materials in parts by weight: 30 parts of cholestyramine, 12 parts of slow release materials, 4 parts of auxiliary materials and 10 parts of traditional Chinese medicine compositions.
4. The colestyramine powder for hyperlipidemia as claimed in claim 3, wherein the sustained release material is at least one of methylcellulose, hypromellose, povidone.
5. The cholestyramine powder for hyperlipidemia as claimed in claim 4, wherein the adjuvant comprises adjuvant, stabilizer and surfactant at a ratio of 1: (2-5): (4-9).
6. The colestyramine powder for hyperlipidemia as claimed in claim 5, wherein the adjuvant is acetic acid and/or citric acid.
7. The cholestyramine powder for hyperlipidemia according to claim 6, wherein the stabilizer is one or a mixture of two of sodium chloride and potassium chloride.
8. The colestyramine powder for hyperlipidemia according to claim 7, wherein the surfactant is at least one of fatty acid glyceride and sucrose ester.
9. The cholestyramine powder for hyperlipidemia according to claim 1, wherein the preparation method of the Chinese medicinal composition is as follows: weighing 8-15 parts of hawthorn, 4-7 parts of rice sprout, 6-9 parts of salvia miltiorrhiza, 5-10 parts of rhizoma alismatis, 2-7 parts of polygonum multiflorum, 3-6 parts of mulberry leaf and 7-10 parts of lucid ganoderma, mixing and stirring, adding water, decocting twice, mixing decoctions, concentrating until the relative density is 1.20-1.30 at 65 ℃, adding ethanol until the volume percentage of the alcohol content reaches 55-70%, stirring, standing, filtering, concentrating the filtrate under reduced pressure until the relative density is 1.30-1.40 at 60 ℃, recovering ethanol, spray-drying the concentrated solution, and crushing into dry extract powder to obtain the traditional Chinese medicine composition, wherein the decocting conditions are as follows: the first time of adding water is 7-11 times of the weight of the medicinal materials, decocting for 1.5-2.5h, and the second time of adding water is 6-10 times of the weight of the medicinal materials, decocting for 1.5-2.5 h; the spray drying conditions were: the air inlet temperature is 85-110 ℃, the air outlet temperature is 85-90 ℃, the material temperature is 75-85 ℃, the atomization pressure is 0.2-0.4 MPa, and the atomization speed is 6-8 ml/s.
10. A method for preparing cholestyramine powder for hyperlipidemia according to any one of claims 1 to 9, comprising the steps of:
1) sequentially weighing cholestyramine, a slow release material, an auxiliary material and a traditional Chinese medicine composition according to the weight part ratio;
2) pulverizing cholestyramine and sieving with 100 mesh sieve, respectively pulverizing sustained-release material, adjuvant and Chinese medicinal composition and sieving with 80 mesh sieve;
3) uniformly mixing the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, performing wet granulation by using 65% of alcohol by mass concentration, wherein the amount of the alcohol is 25% of the total weight of the cholestyramine, the slow release material, the auxiliary material and the traditional Chinese medicine composition, and adopting a fluidized bed drying process;
4) sieving the granules prepared in the step 3) with a 15-20 mesh sieve for size stabilization.
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| CN202110622281.4A CN113244339B (en) | 2021-06-04 | 2021-06-04 | Cholestyramine powder for hyperlipidemia and preparation method thereof |
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