Ginkgo and spirulina tablet as well as preparation method and application thereof

Abstract

The invention provides a gingko and spirulina tablet and a preparation method and application thereof, and relates to the field of pharmaceutical preparations, and the gingko and spirulina tablet comprises the following raw materials: spirulina powder, a hawthorn extract and a ginkgo leaf extract. The preparation method comprises the following steps: S1, raw materials, auxiliary materials and coating powder are respectively weighed and sieved for later use, the raw materials comprise spirulina powder, a hawthorn extract and a ginkgo leaf extract, the auxiliary materials comprise a filling agent, a disintegrating agent, a flow aid and a lubricant, the filling agent comprises a first filling agent and a second filling agent, and the disintegrating agent comprises a disintegrating agent, a flow aid and a lubricant; the first filling agent and the second filling agent are the same or different; s2, mixing the ginkgo biloba extract, a first filling agent and a disintegrating agent to obtain premixed powder; s3, mixing the premixed powder with spirulina powder, a hawthorn extract, a second filler, a flow aid and a lubricant to obtain total mixed powder; s4, tabletting the total mixed powder to obtain a plain tablet to be coated; and S5, preparing the coating powder into a coating solution, and coating the tablet to obtain the ginkgo and spirulina tablet. The gingko and spirulina tablets obtained by the preparation method have the characteristics of simple raw material components, short disintegration time limit, good friability, proper hardness and the like, have the function of assisting in reducing blood fat, and can improve the symptoms such as headache, dizziness, palpitation, dysphoria, shortness of breath, weakness and the like.

Description

Technical Field

[0001] The invention relates to the field of pharmaceutical preparations, and in particular to a ginkgo spirulina tablet and a preparation method and application thereof. Background Art

[0002] With the aging of the population and changes in people's lifestyles and habits, dyslipidemia has become an increasingly important global health problem and an important cause of death in the global population. Epidemiology shows that the blood lipid level of the Chinese population has increased year by year, and the prevalence of dyslipidemia has increased significantly, becoming a heavy burden on the basic medical insurance of urban residents. The increase in serum cholesterol levels in the population will lead to an increase of approximately 9.2 million cardiovascular disease events in my country between 2010 and 2030. The prevalence of hypercholesterolemia in children and adolescents in my country has increased significantly, indicating that the burden of dyslipidemia and related diseases in Chinese adults will continue to increase in the future.

[0003] Dyslipidemia, also known as hyperlipidemia, refers to one or more of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (ApoB) in plasma that are higher than normal levels, accompanied by decreased high-density lipoprotein cholesterol (HDL-C) and apolipoprotein AI (ApoAI). It can be caused by genetic and environmental factors, especially improper diet, and can also be induced by diabetes, obesity, pancreatitis, and liver, gallbladder, and kidney diseases. Hyperlipidemia is the culprit for atherosclerosis, and atherosclerosis is the culprit for cardiovascular and cerebrovascular diseases (such as coronary heart disease, hypertension, and stroke). Among them, low-density lipoprotein cholesterol (LDL-C), also known as "bad cholesterol", accounts for about 60% of total cholesterol. Elevated low-density lipoprotein cholesterol (LDL-C) has the greatest impact on the occurrence of the disease. Therefore, in clinical practice, controlling the level of low-density lipoprotein cholesterol (LDL-C) is often regarded as the primary goal of hyperlipidemia treatment to reduce the morbidity and mortality of cardiovascular diseases.

[0004] There are many blood lipid lowering drugs on the market now. These drugs can lower blood lipids immediately after taking them, and will not keep the same level if not taken. Moreover, they will reduce human functions, and long-term use may even cause certain harm to the human body. Many scholars have used natural foods to conduct experimental observations on regulating blood lipids, proving that preventing and treating high blood lipids through food is safe and feasible, and has no toxic side effects of drugs.

[0005] Spirulina has existed on Earth for 3.5 billion years, and has been eaten by some local residents in Africa and South America for nearly a thousand years. By the 1970s, spirulina had gradually attracted the attention of many countries and international organizations in the world for its extremely high nutritional value and unique medical and health functions. For example, the World Health Organization (WHO) called spirulina "the most ideal health product in the 21st century". At the first World Spirulina Conference held in Morocco in 1993, spirulina was unanimously recognized as "the best health food for mankind". Spirulina has the characteristics of high protein, low fat and low sugar. It is rich in essential amino acids, vitamins, minerals, trace elements, unsaturated fatty acids and other nutrients. It is rich and balanced in nutrition and is easily digested and absorbed. Spirulina powder contains β-carotene. Studies have found that β-carotene can regulate fat metabolism and reduce the level of lipid peroxides.

[0006] Hawthorn (also known as red fruit) is a fruit tree unique to my country with a long history of cultivation. Hawthorn was recorded in the Er Ya document more than 3,000 years ago. In recent years, studies have found that the active ingredients in hawthorn are mainly flavonoids, triterpenes and organic acids. Pharmacological studies have shown that the triterpenes and flavonoids contained in hawthorn have the effects of softening blood vessels, dilating coronary arteries, improving myocardial function, lowering blood lipids and blood pressure. The wide range of pharmacological activities of hawthorn has attracted more and more attention from researchers.

[0007] Ginkgo biloba L. is a plant of the genus Ginkgo in the Ginkgoaceae family. It is also known as white fruit tree, maidenhair tree and duck-foot tong. It is a relict plant of the ancient Permian period and a rare plant that survived the glacial period. It is known as the "living fossil" of the earth and the "sage of the East". Ginkgo leaf extract comes from the dried leaves of Ginkgo biloba L., a plant of the Ginkgoaceae family. The Chinese Pharmacopoeia records that ginkgo leaves have the effects of promoting blood circulation and removing blood stasis, dredge meridians and relieve pain, astringe the lungs and relieve asthma, and remove turbidity and reduce fat. Ginkgo leaf extract is a type of product that uses ginkgo leaves as raw materials and is extracted with appropriate solvents to enrich the active ingredients.

[0008] Patent CN1211107C discloses soft capsules prepared from ginkgo leaf extract, hawthorn extract, garlic oil, jujube seed extract and lily extract, and soft capsules prepared from ginkgo leaf extract, hawthorn extract, garlic oil and rhodiola rosea extract. The two combinations can regulate blood lipids by reducing total cholesterol (TC) and / or triglycerides (TG), but no data on the reduction of low-density lipoprotein cholesterol (LDL-C) are disclosed; Patent CN103622019B discloses a Chinese medicine composition for lowering blood lipids and uric acid containing hawthorn and spirulina, as well as tablets The preparation method comprises 10 components, namely hawthorn, papaya, pit viper, cinnamon bark, hemp seed, gardenia, kudzu root, poria, spirulina and coix seed. The prescription of the composition is large, the raw material components are complex, and only the results of reducing total cholesterol (TC) and triglycerides (TG) are disclosed, and the data of reducing low-density lipoprotein cholesterol (LDL-C) are not disclosed; Patent CN103549437B discloses a health food prepared from spirulina hydrolysate II, hawthorn, Panax notoginseng powder, etc., which can be prepared into capsules, tablets and powders, wherein Panax notoginseng is a precious Chinese herbal medicine, and the preparation method thereof comprises 10 components, namely hawthorn, papaya, pit viper, cinnamon bark, hemp seed, gardenia, kudzu root, poria, spirulina and coix seed. The ... The cost of the prepared health food is high; Patent CN100367876C discloses a lipid-lowering health food containing spirulina, hawthorn, etc., and specifically discloses the preparation process of tablets and capsules, but does not disclose the experimental data of lipid-lowering; Patent CN104687062A discloses that herbivorous food extracts such as hawthorn or ginkgo leaves can be prepared together with honey and / or bee pollen, polyfructose, and spirulina to form a composition for assisting lipid-lowering, but the specific examples do not disclose the experimental data of using hawthorn or ginkgo leaf extracts to form a specific composition, and from the disclosed experimental data It can be seen that in the composition disclosed in the patent application, honey polysaccharides and polyfructose are the main ingredients that exert the function of lowering blood lipids; Patent CN109105893A discloses a blood lipid and blood sugar lowering health food containing components such as spirulina powder, ginkgo leaves, and hawthorn extract. The composition includes 13 raw materials such as buckwheat, yam powder, spirulina powder, ginkgo leaves, ginseng, walnut powder, radish powder, natural plant calcium, angelica, edible seaweed, Sophora japonica extract, American ginseng extract, and hawthorn extract. The prescription of the composition is large, the raw material components are complex, and no specific experimental data on lowering blood lipids are disclosed.

[0009] Therefore, it is very necessary to find a traditional Chinese medicine health food containing three simple raw material components of spirulina, ginkgo leaves and hawthorn, which has low cost and has the function of assisting in lowering blood lipids, and a preparation method thereof. Summary of the invention

[0010] In order to overcome the shortcomings and deficiencies of the prior art, the purpose of the present invention is to provide a Ginkgo Spirulina tablet and a preparation method and application thereof. The tablet prepared by the method not only has the characteristics of simple raw material components, short disintegration time, good friability and appropriate hardness, but also has excellent auxiliary lipid-lowering effect, and has broad application prospects in the field of preventing and treating hyperlipidemia and cardiovascular and cerebrovascular diseases.

[0011] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0012] Preparation method of ginkgo spirulina tablets

[0013] The first aspect of the present invention provides a method for preparing a Ginkgo Spirulina tablet, comprising the following steps:

[0014] S1. Weigh raw materials, auxiliary materials and coating powder according to the formula amount, sieve and set aside, the raw materials include spirulina powder, hawthorn extract and ginkgo leaf extract, the auxiliary materials include fillers, disintegrants, glidants and lubricants, the fillers include a first filler and a second filler, and the first filler and the second filler are the same or different;

[0015] S2, mixing the ginkgo leaf extract, the first filler and the disintegrant to obtain a premixed powder;

[0016] S3, mixing the premixed powder with spirulina powder, hawthorn extract, a second filler, a glidant and a lubricant to obtain a total mixed powder;

[0017] S4, tableting the total mixed powder to obtain plain tablets to be coated;

[0018] S5, preparing the coating powder into a coating solution, coating the plain tablets, and obtaining the Ginkgo Spirulina tablets.

[0019] Furthermore, the filler is selected from one or more of lactose, microcrystalline cellulose, dextrin, starch, pregelatinized starch, D-mannitol, and sorbitol.

[0020] Preferably, the first filler is microcrystalline cellulose and the second filler is lactose.

[0021] Furthermore, the mass ratio of the microcrystalline cellulose to the lactose is 1:(1-3).

[0022] Preferably, the mass ratio of the microcrystalline cellulose to the lactose is 1:3.

[0023] Furthermore, the disintegrant is selected from one or more of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, and cross-linked polyvinyl pyrrolidone.

[0024] Preferably, the disintegrant is a combination of sodium starch glycolate and cross-linked polyvinylpyrrolidone. More preferably, the mass ratio of sodium starch glycolate to cross-linked polyvinylpyrrolidone is 2:1.

[0025] Furthermore, the flow aid is silicon dioxide.

[0026] Furthermore, the lubricant is magnesium stearate.

[0027] Furthermore, the coating powder consists of hydroxypropyl methylcellulose and polyethylene glycol.

[0028] Furthermore, in step S1, the mass proportions of the components in the formula are: 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and the weight gain of the coating powder is 2% of the total mass of the raw materials and excipients.

[0029] Preferably, in step S1, the mass proportions of the components in the formula are: 50% spirulina powder, 15% hawthorn extract, 2.7% ginkgo leaf extract, 18.4% filler, 12% disintegrant, 1.7% glidant, 0.3% lubricant, and the weight gain of the coating powder is 2% of the total mass of the raw materials and excipients.

[0030] Furthermore, in step S1, the raw materials, auxiliary materials and coating powder are sieved with a mesh size of 40 to 80 meshes.

[0031] Preferably, in step S1, the raw materials, auxiliary materials and coating powder are sieved with a mesh size of 80 meshes.

[0032] Furthermore, in step S2, the mixing time is 10 minutes.

[0033] Furthermore, in step S3, the mixing time is 30 to 40 minutes.

[0034] Preferably, in step S3, the mixing time is 30 minutes.

[0035] Furthermore, in step S4, the hardness of the plain sheet is 70-120N.

[0036] Furthermore, in step S4, the weight of the plain tablet is 0.75 g / tablet.

[0037] Furthermore, in step S5, the coating weight gain is 2% of the mass of the plain tablet.

[0038] In some specific embodiments, preparing 1000 Ginkgo Spirulina tablets according to the preparation method comprises the following steps:

[0039] S1. According to the formula, weigh the raw materials: 375g of spirulina powder, 112.5g of hawthorn extract and 20g of ginkgo leaf extract, excipients: filler microcrystalline cellulose 34.5g, filler lactose 103.5g, disintegrant sodium carboxymethyl starch 60g, disintegrant cross-linked polyvinylpyrrolidone 30g, glidant silicon dioxide 12.5g, lubricant magnesium stearate 2g, and coating powder 15g, and pass through 80-mesh sieve for later use;

[0040] S2, mixing the ginkgo leaf extract, microcrystalline cellulose, disintegrant sodium starch glycolate and cross-linked polyvinylpyrrolidone for 10 minutes to obtain a premixed powder;

[0041] S3, mixing the premixed powder with spirulina powder, hawthorn extract, lactose, silicon dioxide and magnesium stearate for 30 minutes to obtain a total mixed powder;

[0042] S4, compressing the total mixed powder into tablets, adjusting the tablet weight to 0.75 g / tablet, and obtaining plain tablets to be coated;

[0043] S5, preparing the coating powder into a coating solution, coating the plain tablets, and obtaining the Ginkgo Spirulina tablets.

[0044] Ginkgo Spirulina Tablets

[0045] The second aspect of the present invention provides a Ginkgo Spirulina tablet obtained by the method according to the first aspect of the present invention.

[0046] Furthermore, the spirulina tablet is composed of raw materials, auxiliary materials and coating powder; the raw materials include spirulina powder, hawthorn extract and ginkgo leaf extract, and the auxiliary materials include fillers, disintegrants, glidants and lubricants.

[0047] Furthermore, the spirulina tablets are composed of the following components in the following mass ratios: 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and coating powder with a weight gain of 2% of the total mass of raw materials and auxiliary materials.

[0048] Preferably, the spirulina tablets are composed of the following components in the following mass ratios: 50% spirulina powder, 15% hawthorn extract, 2.7% ginkgo leaf extract, 18.4% filler, 12% disintegrant, 1.7% glidant, 0.3% lubricant, and coating powder with a weight gain of 2% of the total mass of raw materials and auxiliary materials.

[0049] In some specific embodiments, the formula of every 1000 tablets of the Ginkgo Spirulina tablets is: 375g of spirulina powder, 112.5g of hawthorn extract, 20g of ginkgo leaf extract, 34.5g of microcrystalline cellulose, 103.5g of lactose, 60g of sodium starch glycolate, 30g of cross-linked polyvinylpyrrolidone, 12.5g of silicon dioxide, 2g of magnesium stearate, and 15g of coating powder.

[0050] Furthermore, the plain tablet weight of the Ginkgo Spirulina tablet is 0.75 g / tablet, and the coating weight gain is 2% of the plain tablet weight.

[0051] Pharmaceutical or health product composition

[0052] The third aspect of the present invention provides a composition comprising the Ginkgo Spirulina tablet according to the second aspect of the present invention.

[0053] In some specific embodiments, the composition can be a pharmaceutical composition, including 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and coating powder weight gain of 2% of the total mass of raw materials and auxiliary materials. The pharmaceutical composition is prepared by the method described in the first aspect of the present invention.

[0054] In some specific embodiments, the composition may be a health care product composition, more specifically a health food.

[0055] Furthermore, the health food comprises 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and coating powder with a weight gain of 2% of the total mass of raw materials and auxiliary materials.

[0056] In some specific embodiments, the formula of the health food per 1,000 tablets is: 375g spirulina powder, 112.5g hawthorn extract, 20g ginkgo leaf extract, 34.5g microcrystalline cellulose, 103.5g lactose, 60g sodium starch glycolate, 30g cross-linked polyvinylpyrrolidone, 12.5g silicon dioxide, 2g magnesium stearate, and 15g coating powder.

[0057] Furthermore, the weight of the plain tablet of the health food is 0.75 g / tablet, and the weight gain of the coating is 2% of the mass of the plain tablet.

[0058] The health food is prepared by the method described in the first aspect of the present invention.

[0059] Applications and treatment methods

[0060] The fourth aspect of the present invention provides use of the Ginkgo Spirulina tablets described in the second aspect of the present invention or the composition described in the third aspect.

[0061] In some specific embodiments, provided is a use of the Ginkgo Spirulina tablet described in the second aspect of the present invention or the composition described in the third aspect in the preparation of a drug for preventing and / or treating diseases related to dyslipidemia.

[0062] Furthermore, the dyslipidemia-related disease is selected from hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, mixed hyperlipidemia, low high-density lipoproteinemia, hyperlipoproteinemia, retinopathy, atherosclerotic cardiovascular and cerebrovascular diseases, coronary artery or carotid artery disease, peripheral artery disease, thrombosis, heart attack, stroke, cerebral infarction, hypertension, non-alcoholic fatty hepatitis, non-alcoholic fatty liver disease, pancreatitis, diabetes, insulin resistance and its complications, nephropathy, obesity or xanthomas.

[0063] Furthermore, the hyperlipidemia includes primary hyperlipidemia and secondary hyperlipidemia.

[0064] In some specific embodiments, there is provided a use of the Ginkgo Spirulina tablet of the second aspect of the present invention or the composition of the third aspect in preventing and / or improving and / or treating headache, dizziness, palpitations, irritability, shortness of breath, and fatigue, or in preparing a drug for preventing and / or improving and / or treating headache, dizziness, palpitations, irritability, shortness of breath, and fatigue. The headache, dizziness, palpitations, irritability, shortness of breath, and fatigue are caused by dyslipidemia.

[0065] In some specific embodiments, there is provided a use of the Ginkgo Spirulina tablet described in the second aspect of the present invention or the composition described in the third aspect in the preparation of a health food that assists in lowering blood lipids.

[0066] Furthermore, the auxiliary lipid-lowering specifically includes lowering serum total cholesterol (TC), lowering serum triglycerides (TG) and lowering low-density lipoprotein cholesterol (LDL-C) One or more, while maintaining the high-density lipoprotein cholesterol (HDL-C) level.

[0067] In some specific embodiments, there is provided a use of the Ginkgo Spirulina tablet described in the second aspect of the present invention or the composition described in the third aspect in assisting in lowering blood lipids, wherein the blood lipid lowering function is a non-disease treatment use.

[0068] Furthermore, the lipid-lowering function specifically includes lowering serum total cholesterol (TC), lowering serum triglycerides (TG) and lowering low-density lipoprotein cholesterol (LDL-C) One or more, while maintaining the high-density lipoprotein cholesterol (HDL-C) level.

[0069] The fifth aspect of the present invention provides a method for preventing and / or treating dyslipidemia-related diseases in a subject (e.g., a human), the method comprising administering an effective amount of the Ginkgo Spirulina tablet described in the second aspect of the present invention or the composition described in the third aspect to a subject in need thereof.

[0070] Furthermore, the dyslipidemia-related disease is selected from hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, mixed hyperlipidemia, low high-density lipoproteinemia, hyperlipoproteinemia, retinopathy, atherosclerotic cardiovascular and cerebrovascular diseases, coronary artery or carotid artery disease, peripheral artery disease, thrombosis, heart attack, stroke, cerebral infarction, hypertension, non-alcoholic fatty hepatitis, non-alcoholic fatty liver disease, pancreatitis, diabetes, insulin resistance and its complications, nephropathy, obesity or xanthomas.

[0071] Furthermore, the hyperlipidemia includes primary hyperlipidemia and secondary hyperlipidemia.

[0072] Furthermore, the ginkgo spirulina tablet or composition comprises 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and coating powder with a weight gain of 2% of the total mass of raw materials and auxiliary materials.

[0073] In some specific embodiments, the formula of every 1000 tablets of the Ginkgo Spirulina tablets or composition is: 375g of spirulina powder, 112.5g of hawthorn extract, 20g of ginkgo leaf extract, 34.5g of microcrystalline cellulose, 103.5g of lactose, 60g of sodium starch glycolate, 30g of cross-linked polyvinylpyrrolidone, 12.5g of silicon dioxide, 2g of magnesium stearate, and 15g of coating powder.

[0074] Furthermore, the plain tablet weight of the Ginkgo Spirulina tablet or composition is 0.75 g / tablet, and the coating weight gain is 2% of the plain tablet weight.

[0075] Furthermore, the Ginkgo Spirulina tablets or composition are orally administered to a subject in need thereof twice a day, with 4 tablets being orally administered each time.

[0076] Further, about 6.00 g of the Ginkgo Spirulina tablet or composition is orally administered to a subject in need thereof daily.

[0077] Further, the Ginkgo Spirulina tablet or composition is orally administered to a subject in need thereof for at least 90 days.

[0078] It is worth noting that the theoretical basis for the compatibility of the three raw material formulas involved in the present invention is as follows:

[0079] From the perspective of modern pharmacological research, spirulina contains β-carotene. Studies have found that β-carotene can regulate fat metabolism and reduce the level of lipid peroxidation. It also contains rich unsaturated fatty acids, of which linoleic acid and linolenic acid account for 45%. Both are important components of mitochondrial phospholipids that constitute the cell membrane, and can prevent total cholesterol (TC) and triglycerides (TG) from accumulating in the liver and blood vessels. Hawthorn increases the expression level of cholesterol 7α-hydroxylase, inhibits the activity of 3-hydroxy-3-methylglutaryl coenzyme A reductase and acyl coenzyme A-cholesterol acyltransferase, increases the level of low-density lipoprotein receptors, and regulates blood lipids through the mechanism of regulating multiple fat metabolism enzymes. Ginkgo leaf extract can significantly reduce the levels of TC, TG and LDL-C in hyperlipidemia rats, and increase the content of HDL-C. It may increase the cholesterol transport process from peripheral tissue cells of hyperlipidemia rats to the liver, thereby reducing the aggregation of cholesterol in peripheral tissue cells and extensive damage to vascular endothelial cells, and preventing the formation of atherosclerosis.

[0080] From the perspective of traditional Chinese medicine, hawthorn tastes sour and sweet, and is slightly warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion and strengthening the stomach, promoting qi and dispersing blood stasis, and removing turbidity and reducing lipids. Ginkgo biloba tastes sweet, bitter, and astringent, and is neutral in nature. It enters the heart and lung meridians. It has the effects of promoting blood circulation and removing blood stasis, dredge meridians and relieve pain, astringe the lungs and relieve asthma, and remove turbidity and reduce lipids. Hawthorn promotes digestion and strengthening the stomach, and the spleen is restored to its normal function, raising the clear and lowering the turbid in an orderly manner, and plays the role of transferring and distributing the essence of water and grain; in addition, hawthorn promotes qi and dispersing blood stasis, and ginkgo biloba promotes blood circulation and removes blood stasis. The combination of the two can promote the smooth flow of qi and blood, and phlegm and dampness will not gather, which can effectively prevent and treat hyperlipidemia. The three raw materials are used in combination to fully and effectively regulate blood lipid metabolism while reducing serum total cholesterol, triglycerides, and low-density lipoprotein levels, increasing high-density lipoprotein levels, maintaining lipid balance, and achieving the effect of assisting in lowering blood lipids.

[0081] Compared with the prior art, the present invention has the following beneficial effects:

[0082] (1) The raw material components of the Ginkgo Spirulina tablets obtained by the preparation method of the present invention are simple and low in cost;

[0083] (2) The Ginkgo Spirulina tablets obtained by the preparation method of the present invention have a short disintegration time, good friability and appropriate hardness;

[0084] (3) The Ginkgo Spirulina tablets obtained by the preparation method of the present invention can not only reduce serum total cholesterol (TC) and serum triglycerides (TG), but also reduce low-density lipoprotein cholesterol (LDL-C) without affecting high-density lipoprotein cholesterol (HDL-C), and have excellent auxiliary lipid-lowering effects, and have broad application prospects in the fields of preventing and treating hyperlipidemia and cardiovascular and cerebrovascular diseases;

[0085] (4) The Ginkgo Spirulina tablets obtained by the preparation method of the present invention not only have the function of assisting in lowering blood lipids, but also can improve symptoms such as headache, dizziness, palpitations, irritability, shortness of breath, fatigue, etc.;

[0086] (5) The Ginkgo Spirulina tablets obtained by the preparation method of the present invention have stable quality, accurate dosage, small content difference, and are convenient to carry, transport and take;

[0087] (6) The preparation method of the Ginkgo Spirulina tablet of the present invention is easy to mechanize and produce, has a large output, and is also easy to control sanitary standards;

[0088] (7) The film coating used in the Ginkgo Spirulina tablets obtained by the preparation method of the present invention can cover up the bad smell of the drug itself, prevent moisture and light, isolate air to increase stability, and the tablets have beautiful appearance and are easily accepted by the appropriate population. DETAILED DESCRIPTION

[0089] In order to facilitate the understanding of the present invention, the technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0090] In the embodiments of the present invention, microcrystalline cellulose, lactose, sodium starch glycolate, cross-linked polyvinylpyrrolidone, dioxide, magnesium stearate, and coating powder are all common commercially available products, and their sources are not specifically limited.

[0091] Example 1 Investigation of the basic physical and chemical properties of the raw material mixed powder

[0092] 1. Sample preparation: Spirulina powder (purchased from Etuoke Banner Derong Algae Industry Co., Ltd.), hawthorn extract and ginkgo leaf extract (both provided by Xi'an Tianyi Biotechnology Co., Ltd.) that passed through an 80-mesh sieve were weighed according to the proportions in Table 1 and mixed evenly to obtain a raw material mixed powder for use in the following experiments.

[0093] Table 1 Composition of raw material mixed powder

[0094] Raw material name Sample preparation amount (g) Spirulina Powder 375 Hawthorn Extract 112.5 Ginkgo Biloba Extract 20

[0095] 2. Determination of repose angle: Take the raw material mixed powder, use the fixed diameter method, fix the iron ring on the iron frame at an appropriate height, place the watch glass directly below the funnel, adjust the watch glass so that its center is perpendicular to the funnel, slowly add the material from the funnel until the edge of the watch glass can no longer hold the material and it becomes a regular cone, then stop adding material, use a ruler to measure the material height H, then measure the outer diameter 2R of the watch glass, calculate the repose angle α, formula: tanα=H / R, perform the operation 5 times in parallel, and calculate the average value. The results are shown in Table 2.

[0096] Table 2 Repose angle measurement results

[0097] serial number 1 2 3 4 5 average value Angle of repose(°) 44.71 45.00 44.13 45.00 45.00 44.77

[0098] 3. Bulk density determination: Take a certain amount of raw material mixed powder and accurately weigh the weight (m), then carefully put it into a dry measuring cylinder, record the volume (V1), tap it lightly and then record the volume (V2), the light bulk density ρ1 = m / V1, the tapped bulk density ρ2 = m / V2. Measure 3 times respectively and calculate the average value. The results are shown in Table 3.

[0099] Table 3 Bulk density measurement results

[0100] serial number 1 2 3 average value Light bulk density ρ1(g / ml) 0.50 0.50 0.49 0.50 Tapped bulk density ρ2 (g / ml) 0.73 0.77 0.77 0.75

[0101] 4. Hygroscopicity determination: The determination was carried out according to the specific test method under the Guiding Principles of the Hygroscopicity Test of Drugs in 9103 of the Chinese Pharmacopoeia. The results are shown in Table 4.

[0102] Table 4 Hygroscopicity measurement results

[0103] serial number 1 2 3 4 5 average value Hygroscopicity (%) 11.22 11.07 10.89 10.94 11.61 11.15

[0104] Conclusion: It has been determined that the raw materials of this product can pass through an 80-mesh sieve and the particle size can meet production needs; the angle of repose of the raw material mixed powder is relatively large, the fluidity is slightly poor, and it is hygroscopic. Auxiliary materials need to be added to improve the material's fluidity, hygroscopicity, and compressibility to meet production needs.

[0105] Example 2 Screening of auxiliary materials and fillers

[0106] Since the tablets require materials to have certain fluidity, compressibility and lubricity during tablet compression, a certain amount of auxiliary materials should be added in addition to the main raw materials in Example 1 to play the role of filling, disintegration, flow aid, lubrication, etc. The preliminary proposed tablet specification is 0.75g / tablet, the total daily amount of raw materials is 507.5mg / tablet, and the total daily amount of auxiliary materials is 242.5mg / tablet.

[0107] According to the specification requirements, the tablets need to be appropriately added with some filling auxiliary materials to improve the compressibility of the tablets and ensure the hardness and friability of the tablets. Lactose with good compressibility was initially selected as the filler, and another filler, microcrystalline cellulose, was appropriately added. The dosage of the two fillers was adjusted, and three groups of formulas were set up respectively, (1) Formula 1: only 92g of lactose was added; (2) Formula 2: 92g of lactose and microcrystalline cellulose, wherein the mass ratio of microcrystalline cellulose to lactose was 1:3; (3) Formula 3: 92g of lactose and microcrystalline cellulose, wherein the mass ratio of microcrystalline cellulose to lactose was 1:1. The dosage of fillers, microcrystalline cellulose and lactose, was screened based on the compressibility, appearance, tablet weight difference, hardness, friability and disintegration time of the product, as shown in Table 5 for the screening of fillers and the results. In addition, based on the basic physical and chemical properties of the raw materials in Example 1 and the production experience, the more commonly used disintegrant sodium carboxymethyl starch was initially selected as the disintegrant of this product, and the initial dosage was 6%. Silicon dioxide is used as a glidant, and the initial dosage is 1.5%. Magnesium stearate is used as a lubricant, and the initial dosage is about 0.3%.

[0108] Conclusion: The above formula screening and results show that Formula 2 has good compressibility, the tableting process is smooth, and the friability and tablet weight differences meet the requirements, but the disintegration time is relatively long. Therefore, it is preliminarily determined to screen the disintegrant based on Formula 2.

[0109] Table 5 Screening of fillers and results

[0110]

[0111]

[0112] Example 3 Screening of auxiliary disintegrants

[0113] In Example 2, although the tablet hardness and friability of Formula 2 are qualified, the disintegration time is long and it is difficult to meet the quality requirements. Therefore, based on Formula 2, by increasing the type of disintegrant and adjusting the dosage of the disintegrant, a formula that can shorten the disintegration time of the plain tablet is screened. Three groups of formulas are set up, (1) Formula 4: only sodium carboxymethyl starch is added as a disintegrant, the usage amount is 33.75g, and the mass proportion is increased from 6% in Example 2 to 9%; (2) Formula 5: Add cross-linked polyvinylpyrrolidone, use two disintegrants, sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone, the usage amount is 33.75g, the mass proportion is also 9%, and the mass ratio of sodium carboxymethyl starch: cross-linked polyvinylpyrrolidone is 2:1; (3) Formula 6: Two disintegrants, sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone, are used, the usage amount is 45g, the mass proportion is increased to 12%, and the mass ratio of sodium carboxymethyl starch: cross-linked polyvinylpyrrolidone is also 2:1. The specific screening formulas and results are shown in Table 6. In addition, according to the process literature data consulted, increasing the amount of silicon dioxide is beneficial to improving the friability of the tablets, so the amount of silicon dioxide was adjusted to 1.7%.

[0114] Conclusion: The above formula screening and results show that the disintegration time of Formula 4 and Formula 5 are 51min and 54min respectively. As plain tablets, the disintegration time is too long. The disintegration time of Formula 6 is 42min, which is more appropriate. Therefore, Formula 6 was preliminarily selected in this screening result.

[0115] In addition, the friability and disintegration time of the tablets of Formula 6 were qualified, and the angle of repose was measured to be 37.31° (see Table 7), which met the requirements. In addition, the total mixed powder had good fluidity, so there was no need to adjust the amount of glidant and lubricant, and Formula 6 was determined to be the final formula.

[0116] Table 6 Screening of disintegrants and results

[0117]

[0118]

[0119] Table 7 Repose angle measurement results

[0120] serial number 1 2 3 4 5 average value Angle of repose(°) 37.92 37.92 36.38 37.16 37.16 37.31

[0121] Example 4 Screening of mixing time of raw materials and auxiliary materials

[0122] According to the formula determined in Example 3 above, the raw materials and auxiliary materials were weighed. Since the amount of ginkgo leaf extract was small, the ginkgo leaf extract was mixed with microcrystalline cellulose, sodium carboxymethyl starch, and cross-linked polyvinylpyrrolidone by a step-by-step mixing method, and then mixed with spirulina powder, hawthorn extract, lactose, silicon dioxide, and magnesium stearate. When the total mixing time was 20, 30, and 40 minutes, samples were taken from five different positions to detect the content of total flavonoids, one of the index components at each sampling point, and the RSD value was calculated. The determination method was determined according to the detection method of "total flavonoids" in the "Technical Specifications for Inspection and Evaluation of Health Foods" (2003 Edition). The test results are shown in Table 8.

[0123] Conclusion: From the data in Table 8, it can be seen that when the materials are mixed for 30 minutes, the color of the mixed powder is uniform, and the content of the index components of the mixed powder is uniform (RSD < 5%), indicating that the materials have been mixed evenly, so the total mixing time of the mixed powder can reach 30 minutes.

[0124] Table 8 Mixing uniformity test results

[0125]

[0126] Example 5 Determination of tableting process

[0127] The pressure in the tableting process has a direct relationship with the hardness and friability of the tablets, which affects the quality of the product and the coating process. Therefore, the tablet hardness is taken as a key parameter, and the tableting process, tablet friability, and tablet disintegration time are used as indicators to investigate the tablet hardness during the tableting process. Four hardness ranges are set, namely 40-60N, 70-90N, 100-120N, and 130-150N. The specific experimental results are shown in Table 9.

[0128] Conclusion: From the data in Table 9, it can be seen that the hardness of the plain tablets is too small, resulting in unqualified friability, and the hardness of the plain tablets is too large, resulting in excessive load on the equipment and easy damage to the equipment. It is finally determined that the hardness is most suitable in the range of 70-120N, which can meet the smooth progress of the tableting process and meet the requirements of the coating process.

[0129] Table 9 Hardness of different plain tablets

[0130]

[0131] Example 6 Preparation of Ginkgo Spirulina Tablets

[0132] According to the production process determined by the screening process of Examples 1-5, Ginkgo Spirulina tablets were prepared. The specific preparation process is as follows:

[0133] 1. Weighing and sieving: Weigh spirulina powder, hawthorn extract, ginkgo leaf extract, lactose, microcrystalline cellulose, sodium starch glycolate, cross-linked polyvinylpyrrolidone, silicon dioxide, magnesium stearate, and coating powder according to the formula amounts in Table 10 below, pass through an 80-mesh sieve, and set aside;

[0134] 2. Mixing: first mix the ginkgo leaf extract, microcrystalline cellulose, sodium starch glycolate and cross-linked polyvinylpyrrolidone for 10 minutes to obtain a premixed powder, and then mix the premixed powder, spirulina powder, hawthorn extract, lactose, silicon dioxide and magnesium stearate together for 30 minutes to obtain a total mixed powder;

[0135] 3. Tableting: Tablet the total mixed powder and adjust the tablet weight to 0.75g / tablet. The weight difference should be controlled within ±5%.

[0136] 4. Coating: (1) Prepare coating solution: Take an appropriate amount of 95% edible alcohol and add purified water to prepare a 70% ethanol solution for use. Slowly add the sieved coating powder weighed in step 1 to the above 70% ethanol solution and stir evenly to obtain an 8% coating solution. (2) Film coating: Sieve the plain tablets to remove dust. Preheat the coating machine and control the tablet bed temperature to 35°C. Put the plain tablets in, start the coating machine, and evenly spray the coating solution on the rotating plain tablet surface. After the coating is completed, continue to dry and air the tablets. Pick out the damaged and defective coated tablets to obtain qualified coated tablets. The final coating weight gain is about 2% of the mass of the plain tablets.

[0137] Table 10 Ginkgo Spirulina Tablets Formula (1000 tablets, 0.75 g / tablet)

[0138]

[0139] Example 7 Animal Experiment on Assisting Blood Lipid Lowering Function

[0140] 1. Model building

[0141] Sixty healthy SPF male SD rats (purchased from Beijing Huafukang Biotechnology Co., Ltd.) were selected, 12 rats were given maintenance feed (purchased from Beijing Ke'ao Xieli Feed Co., Ltd.) as the blank control group, and 48 rats were given high-fat feed (20% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate were added to the maintenance feed, purchased from Beijing Huafukang Biotechnology Co., Ltd.) as the model group. After the model group was given high-fat feed for 14 days, the body weight of the rats in the blank control group and the model group are shown in Table 11. In addition, venous blood was collected from rats in the blank control group and the model group without fasting. After blood collection, the blood was centrifuged at 3000r / min for 10min to separate the serum. The serum total cholesterol (see Table 12), triglycerides (see Table 13), high-density lipoprotein cholesterol (see Table 14) and low-density lipoprotein cholesterol (see Table 15) were measured using an automatic biochemical analyzer (BECKMAN AU80 biochemical analyzer), a total cholesterol (TC) kit, a triglyceride (TG) kit, a high-density lipoprotein cholesterol (HDL-C) kit and a low-density lipoprotein cholesterol (LDL-C) kit (all four kits were purchased from Sinopharm Biotechnology Co., Ltd.). SPSS software was used for data processing. ANOVA was used, but the variance homogeneity test must be performed first according to the ANOVA procedure. If the variance is homogeneous, the F value is calculated. If the F value is < F 0.05 , the conclusion is that there is no significant difference between the means of each group; F value ≥ F 0.05 , P≤0.05, using the pairwise comparison method between the means of multiple experimental groups and a control group for statistics; for non-normal or unequal variance data, appropriate variable transformation is performed, and after meeting the normality or variance requirements, the transformed data is used for statistics; if the variable transformation still fails to achieve the purpose of normality or variance equality, the rank sum test is used for statistics. Before and after the test substance is given, the model control group is compared with the blank control group using the t test. As can be seen from the table, compared with the blank control group, the model control group: (1) There is no significant difference in rat body weight; (2) Serum total cholesterol is increased, with a significant difference; (3) Serum triglycerides are increased, with a significant difference; (4) Serum high-density lipoprotein cholesterol is reduced, with a significant difference; (5) Serum low-density lipoprotein cholesterol is increased, with a significant difference. This shows that the model was successfully established.

[0142] 2. Group test

[0143] The model group was randomly divided into four groups according to the total cholesterol level: model control group, low-dose group, medium-dose group and high-dose group. The preparation method of Example 6 was enlarged, and the feed amount was 110 times the formula amount in Table 10. The obtained Ginkgo Spirulina tablets (produced by Beijing Haiderun Pharmaceutical Group Co., Ltd., the sample specification was 0.75g / tablet × 80 tablets / bottle, batch number: 20180802) were fully ground into powder, hereinafter referred to as samples, and different doses of test substances were prepared with sterile water. High-dose test substance: take 15.00g of sample, add sterile water to 50.0mL; medium-dose test substance: take 5.00g of sample, add sterile water to 50.0mL; low-dose test substance: take 2.50g of sample, add sterile water to 50.0mL. The mixed hyperlipidemia animal model experimental method was adopted. The low, medium and high dose groups were gavaged with 0.25g / kgBW, 0.50g / kgBW and 1.50g / kgBW of the test substance (equivalent to 2.5, 5 and 15 times the recommended human intake of 6g / kgBW) while being given a high-fat diet; the model control group was gavaged with a corresponding volume of sterile water while being given a high-fat diet; the blank control group was gavaged with a corresponding volume of sterile water while being given a maintenance diet, once a day orally. After 31 consecutive days of gavage, the body weights of rats in the model control group, blank control group and each dose group are shown in Table 11. In addition, venous blood was collected from rats in the model control group, blank control group and each dose group without fasting. After blood collection, the blood was centrifuged at 3000r / min for 10min to separate the serum. The total cholesterol (see Table 12), triglyceride (see Table 13), high-density lipoprotein cholesterol (see Table 14) and low-density lipoprotein cholesterol (see Table 15) of each group of rats were measured using an automatic biochemical analyzer (BECKMAN AU80 biochemical analyzer), a total cholesterol (TC) kit, a triglyceride (TG) kit, a high-density lipoprotein cholesterol (HDL-C) kit and a low-density lipoprotein cholesterol (LDL-C) kit (all four kits were purchased from Sinopharm Biotechnology Co., Ltd.). SPSS software was used for data processing. ANOVA was used, but the variance homogeneity test must be performed first according to the procedure of ANOVA. If the variance is homogeneous, the F value is calculated. If the F value is less than F 0.05 , the conclusion is that there is no significant difference between the means of each group; F value ≥ F 0.05 , P≤0.05, using the pairwise comparison method between the means of multiple experimental groups and a control group for statistics; for non-normal or unequal variance data, appropriate variable transformation was performed, and after meeting the normality or variance requirements, the transformed data were used for statistics; if the variable transformation still did not meet the purpose of normality or variance equality, the rank sum test was used for statistics. Before and after the test substance was administered, the model control group was compared with the blank control group using the t test.

[0144] As shown in the table, compared with the model control group, the low-dose 0.25g / kgBW group and the medium-dose 0.50g / kgBW group can significantly reduce the total cholesterol (P<0.001) and serum low-density lipoprotein cholesterol (P<0.001) in the serum of hyperlipidemia model rats; the high-dose 1.50g / kgBW group can significantly reduce the total cholesterol (P<0.001), serum triglycerides (P<0.001) and serum low-density lipoprotein cholesterol (P<0.001) in the serum of hyperlipidemia model rats. The test substance had no effect on the serum high-density lipoprotein cholesterol of rats in each dose group. In addition, the test substance had no adverse effect on the weight gain of rats. According to the criteria for judging the results of the auxiliary blood lipid lowering function, "Compared with the model control group, the serum total cholesterol or low-density lipoprotein cholesterol in each dose group was reduced, and the serum triglycerides in each dose group were reduced, and the differences were significant. At the same time, the serum high-density lipoprotein cholesterol in each dose group was not significantly lower than that in the model control group. It can be judged that the animal test results of the auxiliary blood lipid lowering function of the test sample are positive." It can be concluded that the animal test results of the auxiliary blood lipid lowering function of the Ginkgo Spirulina tablets obtained according to the preparation method of the present invention are positive.

[0145] Table 11 Effects on body weight of hyperlipidemia model rats

[0146]

[0147] Table 12 Effects on serum total cholesterol (TC) in hyperlipidemia model rats

[0148]

[0149] Note: # indicates significant difference compared with blank control group, * indicates significant difference compared with model control group.

[0150] Table 13 Effects on serum triglycerides (TG) in hyperlipidemia model rats

[0151]

[0152] Note: # indicates significant difference compared with blank control group, * indicates significant difference compared with model control group.

[0153] Table 14 Effects on serum high-density lipoprotein cholesterol (HDL-C) in hyperlipidemia model rats

[0154]

[0155]

[0156] Note: # indicates significant difference compared with the blank control group.

[0157] Table 15 Effects on serum low-density lipoprotein cholesterol (LDL-C) in hyperlipidemia model rats

[0158]

[0159] Note: # indicates significant difference compared with blank control group, * indicates significant difference compared with model control group.

[0160] Example 8 Human Food Trial Experiment on Assisting Blood Lipid Lowering Function

[0161] 1. Test sample: According to the preparation method of Example 6, the scaled-up process was performed, and the feed amount was 110 times the formula amount in Table 10. The obtained Ginkgo Spirulina tablets were produced by Beijing Haiderun Pharmaceutical Group Co., Ltd. Sample properties: gray-green tablets; sample specifications: 0.75g / tablet × 80 tablets / bottle; sample quantity: 1080 bottles; production batch number: 20180802; storage conditions: sealed, placed in a ventilated, cool and dry place; shelf life: 24 months. The recommended dosage for humans is 2 times a day, 4 tablets each time, oral, and the dosage is 6.00g / d.

[0162] 2. Subjects:

[0163] 2.1 Subject inclusion criteria:

[0164] (1) Under normal dietary conditions, blood lipid levels were tested after fasting for 12-14 hours. Blood lipid tests were performed at least twice within six months. If serum total cholesterol was 5.18-6.21 mmol / L and serum triglycerides were 1.70-2.25 mmol / L, the subjects could be selected as candidates for the auxiliary lipid-lowering function; if serum triglycerides were 1.70-2.25 mmol / L and serum total cholesterol ≤6.21 mmol / L, the subjects could be selected as candidates for the auxiliary triglyceride-lowering function; if serum total cholesterol was 5.18-6.21 mmol / L and serum triglycerides ≤2.25 mmol / L, the subjects could be selected as candidates for the auxiliary cholesterol-lowering function. Based on the animal experimental results of Reference Example 7, subjects with corresponding indicators were selected as subjects;

[0165] (2) Primary hyperlipidemia;

[0166] (3) Obtain informed consent from participants who voluntarily participate in the trial.

[0167] 2.2 Subject Exclusion Criteria:

[0168] (1) Those under 18 years of age or over 65 years of age;

[0169] (2) Pregnant or lactating women, those with allergic constitution or those who are allergic to the test sample;

[0170] (3) Patients with serious diseases of the heart, liver, kidney and hematopoietic system, or mental illness;

[0171] (4) Those who have taken lipid-lowering drugs in the past two weeks, which may affect their judgment of the results;

[0172] (5) hospitalized patients with hyperlipidemia;

[0173] (6) Failure to consume the test samples in accordance with regulations or incomplete information, which affects the judgment of efficacy or safety.

[0174] 3. Experimental design and grouping

[0175] Two control designs, self-control and between-group control, were used. 104 effective hyperlipidemia subjects who met the requirements, 52 in the trial group and 52 in the control group, all of whom had abnormal serum total cholesterol and triglycerides. The balance between the trial group and the control group was compared, as shown in Table 16. As can be seen from Table 16, there was no significant difference in blood lipid levels (serum total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol), age, and gender between the two groups before the trial (P>0.05), indicating that the two groups were balanced and comparable.

[0176] Table 16 Comparison of blood lipid, age and gender balance between the two groups before the trial

[0177]

[0178] The test group took the above test sample, i.e., Ginkgo Spirulina Tablets, orally, twice a day, 4 tablets each time, as required, and the control group used a blank control. During the test period, they maintained their usual living and eating habits, and took the medicine for 90 consecutive days. The test group compared themselves before and after the test, and analyzed the effects of the test on serum total cholesterol (TC), serum triglycerides (TG), serum low-density lipoprotein cholesterol (LDL-C) and serum high-density lipoprotein cholesterol (HDL-C), as well as the total effective rate. The specific experimental results are shown in Tables 17-21.

[0179] As can be seen from the table, (1) after the trial, compared with before the trial, serum cholesterol (TC) was significantly reduced (P < 0.01), serum triglyceride (TG) was significantly reduced (P < 0.001), serum low-density lipoprotein cholesterol (LDL-C) was significantly reduced (P < 0.001), and serum high-density lipoprotein cholesterol (HDL-C) content had no significant difference (P > 0.05); (2) after the trial, compared with the control group, serum cholesterol (TC) was significantly reduced (P < 0.05), serum triglyceride (TG) was significantly reduced (P < 0.01), serum low-density lipoprotein cholesterol (LDL-C) was significantly reduced (P < 0.01), and serum high-density lipoprotein cholesterol (HDL-C) content had no significant difference (P > 0.05); (3) the total effective rate of the trial group was 30.8%, and the total effective rate of the control group was 3.8%, and the total effective rate of the two groups was significantly different (P < 0.001).

[0180] Table 17 Effects of the test substances on serum total cholesterol (TC) mmol / L)

[0181]

[0182] Note: # indicates significant difference between groups (P<0.05), ** indicates significant difference between groups (P<0.01).

[0183] Table 18 Effects of the test substances on serum triglycerides (TG) mmol / L)

[0184]

[0185] Note: ## indicates significant difference between groups (P<0.01), *** indicates significant difference within group (P<0.001).

[0186] Table 19 Effects of the test substances on serum low-density lipoprotein cholesterol (LDL-C) mmol / L)

[0187]

[0188] Note: ## indicates significant difference between groups (P<0.01), *** indicates significant difference within group (P<0.001).

[0189] Table 20 Effects of the test substances on serum high-density lipoprotein cholesterol (HDL-C) mmol / L)

[0190]

[0191] Table 21 Comparison of total effective rate

[0192]

[0193] In addition, the subjects' mental state, sleep, diet, defecation and urination were compared before and after the tasting, and blood pressure and heart rate were measured. The chest X-ray, electrocardiogram, abdominal B-ultrasound, blood routine, urine routine, stool routine and blood biochemistry (except blood lipids) indicators were all within the normal range, and no allergies or other adverse reactions were observed. The improvement of the main clinical symptoms such as headache, dizziness, palpitations, irritability, shortness of breath, and fatigue in the tasting group before and after the tasting was also statistically analyzed (see Table 22). It can be seen from the table that after the subjects tried the Ginkgo Spirulina tablets prepared according to the method of the present invention, headache, dizziness, palpitations, irritability, shortness of breath, and fatigue were improved.

[0194] Based on the above observations and test analysis results of the testers before and after the test, it is shown that the Ginkgo Spirulina tablets prepared according to the method of the present invention have no adverse effects on the health of the testers. According to the criteria for the auxiliary blood lipid lowering function result judgment "the comparison between the test group itself and the test group and the control group, the subjects' serum total cholesterol, triglycerides, and low-density lipoprotein cholesterol decreased, and the differences were significant. At the same time, the serum high-density lipoprotein cholesterol was not significantly lower than that of the control group, and the total effective rate of the test group was significantly higher than that of the control group. It can be determined that the human body test result of the test sample's auxiliary blood lipid lowering function is positive." It can be concluded that the Ginkgo Spirulina tablets prepared according to the method of the present invention have the auxiliary blood lipid lowering function.

[0195] Table 22 Improvement of main clinical symptoms

[0196]

[0197] Note: The data in () represent the control group data.

[0198] The above contents are only used to illustrate the technical solution of the present invention, rather than to limit the protection scope of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing a Ginkgo Spirulina tablet, characterized in that: The preparation method comprises the following steps: S1. Weigh raw materials, auxiliary materials and coating powder according to the formula amount, sieve and set aside, the raw materials include spirulina powder, hawthorn extract and ginkgo leaf extract, the auxiliary materials include fillers, disintegrants, glidants and lubricants, the fillers include a first filler and a second filler, and the first filler and the second filler are the same or different; S2, mixing the ginkgo leaf extract, the first filler and the disintegrant to obtain a premixed powder; S3, mixing the premixed powder with spirulina powder, hawthorn extract, a second filler, a glidant and a lubricant to obtain a total mixed powder; S4, tableting the total mixed powder to obtain plain tablets; S5, preparing the coating powder into a coating solution, coating the plain tablets, and obtaining the Ginkgo Spirulina tablets.

2. The method for preparing the Ginkgo Spirulina tablet according to claim 1, characterized in that: The filler is selected from one or more of lactose, microcrystalline cellulose, dextrin, starch, pregelatinized starch, D-mannitol, and sorbitol.

3. The method for preparing the Ginkgo Spirulina tablet according to claim 1 or 2, characterized in that: The first filler is microcrystalline cellulose, and the second filler is lactose.

4. The method for preparing the Ginkgo Spirulina tablet according to claim 3, characterized in that: The mass ratio of the microcrystalline cellulose to the lactose is 1:(1-3).

5. The method for preparing the Ginkgo Spirulina tablet according to any one of claims 1 to 4, characterized in that: The disintegrant is selected from one or more of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, and cross-linked polyvinyl pyrrolidone.

6. The method for preparing the Ginkgo Spirulina tablet according to claim 5, characterized in that: The disintegrant is a combination of sodium starch glycolate and cross-linked polyvinylpyrrolidone.

7. The method for preparing the Ginkgo Spirulina tablet according to any one of claims 1 to 6, characterized in that: In step S1, the mass proportions of the components in the formula are: 45-55% spirulina powder, 10-20% hawthorn extract, 1-3% ginkgo leaf extract, 10-20% filler, 10-15% disintegrant, 1-2% glidant, 0.2-1% lubricant, and the weight gain of the coating powder is 2% of the total mass of the raw materials and auxiliary materials.

8. The method for preparing the Ginkgo Spirulina tablet according to any one of claims 1 to 7, characterized in that: In step S3, the mixing time is 30 to 40 minutes.

9. The method for preparing the Ginkgo Spirulina tablet according to any one of claims 1 to 8, characterized in that: In step S4, the hardness of the plain sheet is 70-120N.

10. A Ginkgo Spirulina tablet obtained according to the method of any one of claims 1 to 9.

11. The Ginkgo Spirulina tablet according to claim 10, characterized in that: The spirulina tablet is composed of the following components in mass ratio: 45-55% of spirulina powder, 10-20% of hawthorn extract, 1-3% of ginkgo leaf extract, 10-20% of filler, 10-15% of disintegrant, 1-2% of glidant, 0.2-1% of lubricant, and coating powder with a weight gain of 2% of the total mass of raw materials and auxiliary materials.

12. A composition, characterized in that The composition comprises the Ginkgo Spirulina tablet according to claim 10 or 11.

13. The composition according to claim 12, characterized in that The composition is a pharmaceutical composition or a health care product composition.

14. Use of the Ginkgo Spirulina tablet according to claim 10 or 11, or the composition according to claim 12 or 13, in the preparation of a drug for preventing and / or treating diseases related to dyslipidemia, or in the preparation of a drug for preventing and / or improving and / or treating headache, dizziness, palpitations, irritability, shortness of breath, and fatigue.

15. The use according to claim 14, characterized in that: The dyslipidemia-related disease is selected from hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, mixed hyperlipidemia, low high-density lipoproteinemia, hyperlipoproteinemia, retinitis, atherosclerotic cardiovascular and cerebrovascular diseases, coronary artery or carotid artery disease, peripheral artery disease, thrombosis, heart attack, stroke, cerebral infarction, hypertension, non-alcoholic fatty hepatitis, non-alcoholic fatty liver disease, pancreatitis, diabetes, insulin resistance and its complications, nephropathy, obesity or xanthomas.

16. Use of the Ginkgo Spirulina tablet according to claim 10 or 11, or the composition according to claim 12 or 13 in the preparation of a health food for assisting in lowering blood lipids.

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