# US 10,307,395 B2 · Pharmaceutical composition containing silybin and L-carnitine > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,395 B2 - Document ID: US10307395B2 - Status: Granted - Kind: B2 - Application number: 15/560,560 - Filed: 2016-03-22 - Published: 2018-04-19 - Granted: 2019-06-04 - Earliest claimed: 2015-03-23 - Assignees: Tasly Pharmaceutical Group Co., Ltd. - Applicants: Tasly Pharmaceutical Group Co., Ltd. - Inventors: He Sun; Xijun Yan; Naifeng Wu; Kaijing Yan; Yonghong Zhu; Shunnan Zhang; Xiaolin Bai; Xiaohui Ma; Yi He; Ting Li; Lei Li - Web page: https://patentgrep.com/patent/US10307395B2 ## CPC - A61K 31/357: having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 9/1617: {Organic compounds, e.g. phospholipids, fats} - A61K 9/1682: {Processes} - A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} - A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine - A61K 31/355: Tocopherols, e.g. vitamin E - A61K 31/683: Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols - A61K 36/488: Pueraria (kudzu) - A61K 36/82: Theaceae (Tea family), e.g. camellia - A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids - A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics - A61K 2236/19: involving fermentation using yeast, bacteria or both; enzymatic treatment - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract A pharmaceutical composition for treating non-alcoholic fatty liver diseases. The pharmaceutical composition is prepared from 8.75-60 parts by weight of silybin, 15-65 parts by weight of phospholipid, 25-150 parts by weight of a Pu'er tea extract, and 10.425-60 parts by weight of L-carnitine. ## Claims ### Claim 1 A pharmaceutical composition comprising active ingredients: 8.75-60 parts by weight of silybin; 15-65 parts by weight of phospholipid; 25-150 parts by weight of Pu'er tea extract; and 5.2-60 parts by weight of L-carnitine. ### Claim 2 (depends on 1) The pharmaceutical composition according to claim 1 comprising 25-40 parts by weight of silybin; 30-50 parts by weight of phospholipid; 80-120 parts by weight of Pu'er tea extract; and 35-50 parts by weight of L-carnitine. ### Claim 3 (depends on 2) The pharmaceutical composition according to claim 2 comprising 35 parts by weight of silybin; 42 parts by weight of phospholipid; 100 parts by weight of Pu'er tea extract; and 41.7 parts by weight of L-carnitine. ### Claim 4 (depends on 1) The pharmaceutical composition according to claim 1, wherein the L-carnitine is L-carnitine tartrate. ### Claim 5 (depends on 1) A pharmaceutical preparation comprising the pharmaceutical composition according to claim 1, further comprising pharmaceutically acceptable carriers; wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total preparation by weight. ### Claim 6 (depends on 5) The pharmaceutical preparation according to claim 5, wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose or a derivate thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal. ### Claim 7 (depends on 5) The pharmaceutical preparation according to claim 5, wherein the pharmaceutical preparation is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, supensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. ### Claim 8 (depends on 2) The pharmaceutical composition according to claim 2, wherein the L-carnitine is L-carnitine tartrate. ### Claim 9 (depends on 3) The pharmaceutical composition according to claim 3, wherein the L-carnitine is L-carnitine tartrate. ### Claim 10 (depends on 2) A pharmaceutical preparation comprising the pharmaceutical composition according to claim 2, further comprising pharmaceutically acceptable carriers; wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total preparation by weight. ### Claim 11 (depends on 10) The pharmaceutical preparation according to claim 10, wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose or a derivate thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal. ### Claim 12 (depends on 10) The pharmaceutical preparation according to claim 10, wherein the pharmaceutical preparation is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, supensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. ### Claim 13 (depends on 3) A pharmaceutical preparation comprising the pharmaceutical composition according to claim 3, further comprising pharmaceutically acceptable carriers; wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total preparation by weight. ### Claim 14 (depends on 13) The pharmaceutical preparation according to claim 13, wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose or a derivate thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal. ### Claim 15 (depends on 13) The pharmaceutical preparation according to claim 13, wherein the pharmaceutical preparation is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, supensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. ### Claim 16 (depends on 5) A method of preparing the pharmaceutical preparation according to claim 5, comprising: (1) taking a prescription amount of raw materials for later use; (2) preparing a silybin complex liquid by weighing a prescription amount of silybin and a phospholipid, and dissolving them in anhydrous ethanol, heating and refluxing to clarify the solution and continuing to heat for a time, then concentrating the clear solution under reduced pressure to a concentrated volume, to obtain the silybin complex liquid for later use; (3) granulating by weighing a prescription amount of Pu'er tea extract as a base material, taking the silybin complex liquid prepared in step (2) as a feed liquid, and preparing granules by a fluidization spray method with a fluidized bed, and drying after the liquid complex is all sprayed in for later use; (4) achieving total blending by mixing the L-carnitine and the granules of step (3) uniformly in an equal incremental manner to obtain the pharmaceutical composition; and (5) combining the pharmaceutical composition and the pharmaceutically acceptable carriers to make a conventional preparation. ### Claim 17 (depends on 16) The method according to claim 16, wherein the heating time in step (2) is 0.5-1.5 hours; the concentrated volume is 5%-20% of the original volume and the temperature of the concentration under reduced pressure is 60-80° C.; the parameters of the fluidized bed in step (3) are that the temperature of the materials is 40-65° C., and parameters including fan frequency, the inlet air temperature and the infusion frequency are adjusted to keep the materials in a good fluidization state during the granulation process; and wherein after the granulation is completed, the granules are dried for 10-60 minutes, and the drying temperature is 55-65° C. ### Claim 18 (depends on 1) A method of treating non-alcoholic fatty liver diseases and/or reducing fat and losing weight and beautifying skin in a human in need of such treatment, comprising administering the pharmaceutical composition according to claim 1. ### Claim 19 (depends on 10) A method of preparing the pharmaceutical preparation according to claim 10, comprising: (1) taking a prescription amount of raw materials for later use; (2) preparing a silybin complex liquid by weighing a prescription amount of silybin and phospholipid, and dissolving them in anhydrous ethanol, heating and refluxing to clarify the solution and continuing to heat for a time, then concentrating the clear solution under reduced pressure to a concentrated volume, to obtain the silybin complex liquid for later use; (3) granulating by weighing a prescription amount of Pu'er tea extract as a base material, taking the silybin complex liquid prepared in step (2) as a feed liquid, and preparing granules by a fluidization spray method with a fluidized bed, and drying after the liquid complex is all sprayed in for later use; (4) achieving total blending by mixing the L-carnitine and the granules of step (3) uniformly in an equal incremental manner to obtain the pharmaceutical composition; and (5) combining the pharmaceutical composition and the pharmaceutically acceptable carriers to make a conventional preparation; wherein the heating time in step (2) is 0.5-1.5 hours; the concentrated volume is 5%-20% of the original volume and the temperature of the concentration under reduced pressure is 60-80° C.; the parameters of the fluidized bed in step (3) are that the temperature of the materials is 40-65° C., and parameters including fan frequency, the inlet air temperature and the infusion frequency are adjusted to keep the materials in a good fluidization state during the granulation process; and wherein after the granulation is completed, the granules are dried for 10-60 minutes, and the drying temperature is 55-65° C. ### Claim 20 (depends on 5) A method of treating non-alcoholic fatty liver diseases and/or reducing fat and losing weight and beautifying skin in a human in need of such treatment, comprising administering the pharmaceutical preparation according to claim 5.