CN1813818A - Soft capsule for reducing blood fat and its preparing method - Google Patents

Soft capsule for reducing blood fat and its preparing method Download PDF

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Publication number
CN1813818A
CN1813818A CN 200510022355 CN200510022355A CN1813818A CN 1813818 A CN1813818 A CN 1813818A CN 200510022355 CN200510022355 CN 200510022355 CN 200510022355 A CN200510022355 A CN 200510022355A CN 1813818 A CN1813818 A CN 1813818A
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soft capsule
blood fat
fat reducing
preparation
gelatin
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CN100431529C (en
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代军平
杨帆
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Wang Miguang
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Wang Miguang
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Abstract

The present invention relates to a blood-lipid-reducing soft capsule and its preparation method. It is characterized by that it uses the raw material containing ang-kak extract and dispersing matrix to prepare soft capsule contents, and utilizes the raw material containing gelatin, glycerin, water and iron oxide red to prepare external shell of said soft capsule, then makes the contents and external shell into the soft capsule with the function of reducing blood-lipid. Besides, said invention also provides the concrete steps of said preparation method.

Description

Blood fat reducing soft capsule and preparation method thereof
(1) technical field:
Blood fat reducing soft capsule and preparation method thereof belongs to pharmaceutical composition and preparation method thereof.
(2) technical background:
Hyperlipoproteinemia (abbreviation hyperlipemia) is to cause one of topmost risk factor of coronary heart disease.When serum total cholesterol was higher than 5.72 mMs/liter (220 milligrams of %), with the rising of cholesterol concentration, Incidence of CHD linearly rose.Domestic existing hypertensive patient people more than 100,000,000 wherein has adult's blood fat of 1/3 higher, and the patient that annual because hypertension, hyperlipidemia cause apoplexy nearly 1,500,000.The oriented rejuvenation trend of hyperlipemic patients.Generally speaking, the sickness rate of hyperlipidemia is along with the increase at age has the trend that increases, the patient is artificial main with 45~60 years old grow up, wherein Zhong Qingnian male is more, middle aged later female patient is quite a few, just present clinical discovery, the trend that youngster also is significantly increased, in addition, Fei Pang people also more easily suffers from hyperlipidemia.
In recent years, along with people's revenue growth and living standard continue to improve, great changes will take place for eating patterns, and the high protein of picked-up, hypercholesterolemia and high sugar content food are more and more, thereby cause hyperlipemia colony sharply to increase.According to Epidemiological study, the prevalence of China's hyperlipemia is more than 7%, and general trend is northern greater than south, and the city is greater than the rural area.China has hyperlipemia 9,000 ten thousand people approximately at present, wherein has 3,600 ten thousand patient using fat-reducing medicament approximately.Also have 460,000 coronary heart disease patients need control the treatment of blood fat.In addition, the patient who suffers from symptoms such as obesity, fatty liver, diabetes also obtains good control because of the higher needs of blood lipid level.Simultaneously high because people's self health consciousness and consumption and payment ability be greatly improved to the demand of blood fat reducing series products, so the blood fat reducing series products be faced with one huge and be the market that increases day by day.
At present, domestic is two classes that have with effect for reducing fat of raw material with Chinese medicine: a class is the blood fat reducing medicine, as Xuezhikang, simvastatin, FUFANG DANSHEN PIAN etc.; Another kind of is the health product with effect for reducing fat, as spirulina, lecithin, fish oil etc.
In China, Monascus anka Nakazawa et sato is applied to rare 1000 history on food and medicine.Method for making to Monas cuspurpureus Went in the Ming Dynasty's Compendium of Material Medica and the Exploitation of the Works of Nature has detailed record: " its method is with white Semen oryzae sativae one stone five buckets; water is washed in a pan and soaked one night and make meal; divide and be Shi Wuchu, go into bent female three jin, the rubbing order is even; and do a place; cover so that silks is close, and heat and go silks is spread out; feel that temperature is anxious and piles up ... its red SHENGHUANG of crossing the Mi Xinzhe meaning can be used; If the person of not caring can't bear to use ".About the medical value of Monas cuspurpureus Went, and Ming Dynasty's Li Shizhen (1518-1593 A.D.) Compendium of Material Medica record " Monas cuspurpureus Went temperature sweet in the mouth, nontoxic.Main help digestion, invigorate blood circulation, spleen invigorating, dry stomach, control dysentery with red and white feces, Xia Shuigu ".Contain 19 seed amino acids in the Monas cuspurpureus Went, 10 kinds of medicinal aminoacid (48%~63%) are wherein arranged, 7 kinds of essential amino acids (29%~45%), the content of free amino acid (0.81%~1.14%) are about 15 times~21 times of its fermentation medium Semen oryzae sativae.
The documents and materials of Monas cuspurpureus Went treatment hyperlipidemia, diabetes are more, are that the preparation of raw material has only XUEZHIKANG JIAONANG with the Monas cuspurpureus Went, and XUEZHIKANG JIAONANG is as the basic medical insurance medication, and in clinical practice for many years, its curative effect and safety obtain reliable authentication.But also there is following shortcoming in XUEZHIKANG JIAONANG: 1, its dosage form is single, can not satisfy people to the diversified demand of dosage form; 2, because it is a hard capsule, the inconvenience of swallowing, the clinical different use of incompatibility, the patient is difficult for accepting; 3, since the Monas cuspurpureus Went extract water solublity relatively poor, make hard capsule by human body take the back drug absorption slower, can not bring into play curative effect rapidly.
(3) summary of the invention: the present invention provides a kind of blood fat reducing soft capsule at above deficiency exactly, and its preparation method.This soft capsule is intended to improve the dosage form of Xuezhikang, enriches the kind of Xuezhikang, to satisfy people to the diversified demand of Xuezhikang dosage form.Its technical scheme is as follows:
It is to make soft capsule content with the raw material that contains Monas cuspurpureus Went extract powder and disperse matrix, makes soft capsule rubber with the glue raw material that contains gelatin, glycerol, water, red ferric oxide, and content and rubber are made blood fat reducing soft capsule by pelleting.Disperse matrix is that one or more of salad oil, Oleum Arachidis hypogaeae semen, edible vegetable oil, Cera Flava, oil with hydrogenated soybean, polyethylene glycols are used.The amount ratio of disperse matrix and Monas cuspurpureus Went extract powder is 1.7~1.8: 1.The consumption of Cera Flava, oil with hydrogenated soybean is respectively 1.5% of a soft capsule content weight.The consumption of glue raw material is a gelatin: glycerol: water: red ferric oxide=100: 45~55: 100~120: 2~3.
Its preparation method comprises the steps:
1) preparation of soft capsule content:
Get be equipped with the Monas cuspurpureus Went of Monas cuspurpureus Went weight 87.2%, add the ethanol extraction 1~3 time of 2~4 times of amounts 65%~85%, extracted 1~3 hour at every turn, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25~1.30 (55~60 ℃), will remain Hongqu powder (red colouring agent) is broken into fine powder in addition, mix thoroughly with clear paste, drying is pulverized, and makes extract powder, add disperse matrix, adjust total amount and mixing;
2) preparation of sizing material:
Get gelatin, glycerol, water, red ferric oxide, in the inputization glue jar, 30~40 ℃ of mercerations are warming up to 70~75 ℃ gradually after 30~40 minutes, stir 4~5 hours;
3) pelleting:
The debugging pellet press, 60~65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 40~45 ℃ of sprinkler body temperature controls, rubber thickness 0.7~0.8mm, 18~25 ℃ of indoor temperatures, relative humidity 20%~40%;
4) drying:
1. typing is dry: rotated typing dry 1.5~2 hours in rotating cage;
2. tray dried: contain in charging tray through the soft gelatin capsule of rotating cage inner drying, move in the hothouse of 20~24 ℃ of temperature, relative humidity 20%~40% cool 24~48 hours, and constantly stir, survey capsule moisture be 5%~10% dry suitable;
5) essence is chosen, cleans, is packed.
Compared with prior art the present invention has following beneficial effect:
1, lighttight packaging material can make medicine not be subjected to the influence of oxygen, light in dampness and the air, thereby improve medicine stability.
2, the soft capsule Chinese medicine is evenly distributed in the solvent, in human body disintegrate fast, after softgel shell broke, medicine disperseed rapidly, it is fast to discharge stripping, can bring into play curative effect rapidly, the bioavailability height shortens treatment course of treatment;
3, the plasticity of soft capsule is strong, elasticity is big, swallows easily, and the patient is acceptant;
4, the interlock of soft capsule production, intelligent degree improve, and production link reduces, and more meets the requirement of modern pharmaceutical;
5, attractive in appearance, the transportation of overall appearance, storage, easy to carry;
6, enrich this product dosage form, adapted to clinical different use,
(4) description of drawings:
Accompanying drawing is a process chart of the present invention.
(5) specific embodiment:
Embodiment one:
Take by weighing raw material by following proportioning:
Monas cuspurpureus Went 1290g, Cera Flava 9.0g, oil with hydrogenated soybean 9.0g, salad oil 362.1g
Preparation method is as follows:
1) preparation of soft capsule content:
Get Monas cuspurpureus Went 1125g, add 75% ethanol extraction secondary, alcohol adding amount is the triplication of Monas cuspurpureus Went for the first time, extracts 3 hours, adds qdx for the second time and extracts 2 hours, filter, merging filtrate, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25~1.30 (55~60 ℃), the clear paste yield is 4.60%~5.0% of a Monas cuspurpureus Went, gets clear paste 54.9g herein; To remain Monas cuspurpureus Went 165g is ground into fine powder in addition, mixes thoroughly with clear paste, and drying is pulverized, and makes extract powder; In order to guarantee the stability of extract powder and disperse matrix mixture, add Cera Flava and each 9.0g of oil with hydrogenated soybean (shortening), the reuse salad oil be in harmonious proportion to add the total amount of the extract powder behind Cera Flava and the oil with hydrogenated soybean to 600g (weight of soft capsule content) as disperse matrix, here the consumption of salad oil is 362.1g, use the vibrating ball-mill mixing, evacuation removes bubble (vacuum 0.095Mpa), incapsulates in the spice bucket of machine standby;
2) preparation of sizing material:
Get gelatin: glycerol: water: red ferric oxide=100g: 45g: 100g: 2.0g, in the inputization glue jar, 30 ℃ of mercerations are warming up to 70~75 ℃ gradually after 30 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate in the sizing material bucket of machine standby after the filtration.After deliberation: gelatin: glycerol: water: red ferric oxide=100g: 45g: 100g: 2.0g makes soft capsule quality more stable;
3) pelleting:
The sizing material bucket of insulation and the spice bucket of room temperature are delivered to the capsule machine top, be connected debugging pellet press, 65 ℃ of gelatin box temperature controls with machine, 45 ℃ of sprinkler body temperature controls, roll mould rotating speed 2.0, rubber thickness 0.8mm, 18~25 ℃ of indoor temperatures, relative humidity 20%~40%, treat that it is the 600mg/ grain that ball content loading amount is regulated in pellet press debugging back, survey loading amount once every half an hour in the pelleting process, more than make 1000 of soft capsules altogether.
4) drying:
1. typing is dry: in conveyer belt was delivered to rotating cage, rotating cage was blown a cold wind over while rotating, rotates the drying of finalizing the design and is advisable with two hours through the soft capsule of pellet press extrusions, and overlong time is then rough;
2. tray dried: the soft gelatin capsule of cold air drying is contained in clean rustless steel charging tray splendid attire in rotating cage, moved in the hothouse of 20~24 ℃ of temperature, relative humidity 20%~40% airing 48 hours, and constantly stir, survey capsule moisture and be dry suiting 5%~10%.Baking temperature is advisable about investigating with 22 ℃, and it is long that it's low then drying time is past temperature, though increase in temperature can shorten drying time, easily produces Testudinis to capsule surface and splits; Dry relative humidity should be lower than 40% through investigating, otherwise is difficult for dry; Got final product below 10% with control moisture drying time about 24~48 hours.
5) essence is chosen: the soft capsule that drying is good is selected through testing with the lamp inspection of 75% ethanol disinfection, and the outward appearance eligible is packed in the rustless steel charging basket.
6) clean: will select qualified capsule in rustless steel container, the silk with clean uses 95% an amount of ethanol that its surface clean is clean.
7) packing: cleaned soft gelatin capsule is several excessively, pack with solid medication aluminium-plastic panel.
Embodiment two:
Take by weighing raw material by following proportioning:
Monas cuspurpureus Went 1290g, salad oil 380.1g
Preparation method is as follows:
1) preparation of soft capsule content:
Get Monas cuspurpureus Went 1125g, add 75% ethanol extraction secondary, alcohol adding amount is the triplication of Monas cuspurpureus Went for the first time, extracts 3 hours, add for the second time qdx and extracted 2 hours, filter merging filtrate, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25~1.30 (55~60 ℃), gets clear paste 54.9g; To remain Monas cuspurpureus Went 165g is ground into fine powder in addition, mixes thoroughly with clear paste, and drying is pulverized, and makes extract powder.Be in harmonious proportion the total amount of extract powder to 600g with salad oil as disperse matrix, and the consumption of salad oil is 380.1g here, use the vibrating ball-mill mixing, and evacuation is except that bubble (vacuum 0.095Mpa), incapsulates in the spice bucket of machine standby.Other method of present embodiment is identical with the method for embodiment one, repeats no more here.
Disperse matrix of the present invention also can be selected Oleum Arachidis hypogaeae semen, edible vegetable oil or polyethylene glycols such as PEG400 for use.But one or more are used disperse matrix, in order to guarantee the stability of extract powder and disperse matrix mixture, generally use Cera Flava and oil with hydrogenated soybean (shortening) and other disperse matrix to be used.
Product of the present invention is a soft capsule; Content is the aubergine glop; Feeble QI acid, lightly seasoned.Specification is every soft capsule content 0.6 gram.Usage and dosage: oral, one time 2,2 times on the one, one after each meal sooner or later; Gently, 2 of moderate patients one day, take after the supper, or follow the doctor's advice.
This preparation semi-finished product have reached the sterilization purpose, gelatin and glycerol drug of choice rank, meet the sanitary standard requirement, change glue, pelleting, drying, selected, cleaning purifies rank with packing shop and is 300000 grades, preparation can reach the sanitary standard requirement than capsule is generally equal with this understanding.Packing is after by the sanitary standard check, the internal control sanitary standard is: bacterial population, fungi count, escherichia coli and the demodicid mite that lives are all up to specification.
Indication Monas cuspurpureus Went of the present invention is that Aspergillaceae fungus monascus parpureus Went Monascus purpureus Went colonizes in the Monas cuspurpureus Went that forms on the kernel of grass rice Oryza sativa L..Get crude drug, sieve dedust bits, remove impurity, standby.The Monas cuspurpureus Went raw material has special manufacturer to produce, and its raw material sources are wider.
Cera Flava is Apidae insecticide China Apis cerana Fabricius or the excretory wax of apis mellifera Linnaeus Apismellifera Linnaeus.To heat in the Nidus Vespae water, filter, condensation is got wax or is re-refined and forms.
Oil with hydrogenated soybean (shortening) should meet " People's Republic of China's industry standard " SB/T10073-92 and record the pertinent regulations under the shortening item.
Salad oil be the Semen Allii Tuberosi crude oil through deacidification decolouring deodorize, etc. the refining senior edible vegetable oil that now forms of working procedure processing.It should meet in " the rape salad oil national standard " that the Ministry of Commerce of the People's Republic of China (PRC) proposes " rape salad oil " down pertinent regulations.
Glycerol is 1,2, the 3-glycerol.Contain C 3H 8O 3Must not be less than 95.0%.It should meet, and " two " glycerol " items of Chinese pharmacopoeia version in 2000 are (P down 86) pertinent regulations.
Gelatin is the collagen that contains in skin, bone, tendon and the ligament of animal, a kind of goods that obtain after partial hydrolysis.It should meet " the pertinent regulations under two 385 pages of gelatin items of Chinese pharmacopoeia version in 2000.
Water should meet " the pertinent regulations of purified water in 186 pages of appendix XVI of Chinese pharmacopoeia two appendix of version in 2000 preparation water item.
Red ferric oxide should meet " pertinent regulations under two 261~262 pages " red ferric oxide " items of Chinese pharmacopoeia version in 2000.
By preparation technology, carried out the engineer testing of pilot-scale, feed intake 3 batches altogether, three batches of pilot products detect data and see the following form:
Lot number 200401 20 200401 22 200401 24
Clear cream yield (%) Red Yeast Rice P.E of the amount (kg) of red colouring agent for food, also used as a Chinese medicine inventory (kg) Red Yeast Rice P.E and red colouring agent for food, also used as a Chinese medicine powder mixture weight (kg) add the actual finished product number of the theoretical finished product number of mixture weight (kg) soft capsule content gross weight (Kg) (grain) (grain) yield rates (%) such as salad oil-beeswax 11.25 0.549 4.88 2.199 3.801 6.000 10000 9022 90.22 11.25 0.528 4.69 2.178 3.822 6.000 10000 8798 87.98 11.25 0.539 4.79 2.189 3.811 6.000 10000 8863 88.63
The result of study of middle trial production shows: the technology of blood fat reducing soft capsule is rational, feasible.

Claims (9)

1, a kind of blood fat reducing soft capsule, it is characterized in that it is to make soft capsule content with the raw material that contains Monas cuspurpureus Went extract powder and disperse matrix, make soft capsule rubber with the glue raw material that contains gelatin, glycerol, water, red ferric oxide, content and rubber are made blood fat reducing soft capsule by pelleting.
2, blood fat reducing soft capsule according to claim 1 is characterized in that disperse matrix is that one or more of salad oil, Oleum Arachidis hypogaeae semen, edible vegetable oil, Cera Flava, oil with hydrogenated soybean, polyethylene glycols are used.
3, blood fat reducing soft capsule according to claim 1 and 2 is characterized in that the amount ratio of disperse matrix and Monas cuspurpureus Went extract powder is 1.7~1.8: 1.
4, blood fat reducing soft capsule according to claim 3, the consumption that it is characterized in that Cera Flava, oil with hydrogenated soybean is respectively 1.5% of a soft capsule content weight.
5, blood fat reducing soft capsule according to claim 1, the consumption that it is characterized in that the glue raw material is a gelatin: glycerol: water: red ferric oxide=100: 45~55: 100~120: 2~3.
6, blood fat reducing soft capsule according to claim 1 is characterized in that making the raw material of soft capsule content and the preferred version of weight proportion is:
Monas cuspurpureus Went 1290
Salad oil is transferred total amount to 600
7, blood fat reducing soft capsule according to claim 1 is characterized in that making the raw material of soft capsule content and the preferred plan of weight proportion is:
Monas cuspurpureus Went 1290
Cera Flava 9.0
Oil with hydrogenated soybean 9.0
Salad oil is transferred total amount to 600
8, a kind of preparation method of blood fat reducing soft capsule is characterized in that comprising the steps:
1) preparation of soft capsule content:
Get be equipped with the Monas cuspurpureus Went of Monas cuspurpureus Went 87.2%, add the ethanol extraction 1~3 time of 2~4 times of amounts 65%~85%, extracted 1~3 hour at every turn, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25~1.30 (55~60 ℃), will remain Hongqu powder (red colouring agent) is broken into fine powder in addition, mix thoroughly with clear paste, drying is pulverized, and makes extract powder, add disperse matrix, adjust total amount and mixing;
2) preparation of sizing material:
Get gelatin, glycerol, water, red ferric oxide, in the inputization glue jar, 30~40 ℃ of mercerations are warming up to 70~75 ℃ gradually after 30~40 minutes, stir 4~5 hours;
3) pelleting:
The debugging pellet press, 60~65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 40~45 ℃ of sprinkler body temperature controls, rubber thickness 0.7~0.8mm, 18~25 ℃ of indoor temperatures, relative humidity 20%~40%;
4) drying:
1. typing is dry: rotated typing dry 1.5~2 hours in rotating cage;
2. tray dried: contain in charging tray through the soft gelatin capsule of rotating cage inner drying, move in the hothouse of 20~24 ℃ of temperature, relative humidity 20%~40% cool 24~48 hours, and constantly stir, survey capsule moisture be 5%~10% dry suitable;
5) essence is chosen, cleans, is packed.
9, the preparation method of described blood fat reducing soft capsule according to Claim 8 is characterized in that the preferred plan of preparation method is:
1) preparation of soft capsule content:
Get 1125 parts in Monas cuspurpureus Went, add 75% ethanol extraction secondary, adding for the first time triplication extracted 3 hours, add for the second time qdx and extracted 2 hours, filter merging filtrate, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25~1.30 (55~60 ℃), in addition Monas cuspurpureus Went is ground into fine powder for 165 parts, mixes thoroughly with clear paste, dry, pulverize, make extract powder, add each 9.0 parts of Cera Flava and oil with hydrogenated soybean, transfer total amount to 600 part with salad oil, mixing, evacuation remove bubble, incapsulate in the spice bucket of machine standby;
2) preparation of sizing material:
Get gelatin: glycerol: water: red ferric oxide=100: 45: 100: 2.0, in the inputization glue jar, 30 ℃ of mercerations are warming up to 70~75 ℃ gradually after 30 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate in the sizing material bucket of machine standby after the filtration;
3) pelleting:
The sizing material bucket of insulation and the spice bucket of room temperature are delivered to the capsule machine top, be connected with machine, the debugging pellet press, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18~25 ℃ of indoor temperatures, relative humidity 20%~40%;
4) drying:
1. typing is dry: rotated typing dry 2 hours in rotating cage;
2. tray dried: contain in charging tray through the soft gelatin capsule of rotating cage inner drying, move in the hothouse of 20~24 ℃ of temperature, relative humidity 20%~40% cool 48 hours, and constantly stir, survey capsule moisture be 5%~10% dry suitable.
CNB2005100223551A 2005-12-22 2005-12-22 Soft capsule for reducing blood fat and its preparing method Expired - Fee Related CN100431529C (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102726734A (en) * 2012-07-12 2012-10-17 邓群洲 Soft capsule rich in xanthophylls and multiple vitamins and preparation method of soft capsule
WO2013155995A1 (en) * 2012-04-20 2013-10-24 北京北大维信生物科技有限公司 Red yeast and kudzu root pharmaceutical composition for regulating blood lipids and preparation method therefor
CN104172167A (en) * 2014-08-20 2014-12-03 陕西华州医药生物工程有限公司 Cholesterol-lowering functional food and preparation method thereof
CN111053821A (en) * 2019-12-24 2020-04-24 贵州贵安精准医学研究院股份有限公司 Development and application of natural sterilizing soft capsule

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1061537C (en) * 1996-09-26 2001-02-07 张茂良 Monascus preparation for hyperlipemia and relevant cardiac and cerebral diseases
CN1246014C (en) * 2004-06-25 2006-03-22 浙江省医学科学院 Blood fat lowering capsule or tablet and its preparation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013155995A1 (en) * 2012-04-20 2013-10-24 北京北大维信生物科技有限公司 Red yeast and kudzu root pharmaceutical composition for regulating blood lipids and preparation method therefor
CN102726734A (en) * 2012-07-12 2012-10-17 邓群洲 Soft capsule rich in xanthophylls and multiple vitamins and preparation method of soft capsule
CN104172167A (en) * 2014-08-20 2014-12-03 陕西华州医药生物工程有限公司 Cholesterol-lowering functional food and preparation method thereof
CN111053821A (en) * 2019-12-24 2020-04-24 贵州贵安精准医学研究院股份有限公司 Development and application of natural sterilizing soft capsule

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