A pharmaceutical composition and its preparation method and application

Abstract

The present invention discloses a pharmaceutical composition and its preparation method and application, relating to the technical field of traditional Chinese medicine. The pharmaceutical composition includes peach kernel, tangerine peel, hawthorn, wolfberry fruit, gastrodia elata, cassia seed, platycodon grandiflorum, tuckahoe, roasted liquorice root, notoginseng root, notoginseng flower and the like. The present invention designs a formula from the perspective of comprehensive conditioning such as promoting blood circulation and removing blood stasis, clearing the liver and purging fire, strengthening the spleen and removing dampness, nourishing yin and replenishing blood, etc., and has reasonable compatibility, so that the composition can help maintain the function of healthy blood lipid levels, avoid the harm caused by increased blood lipids, and has a significant effect of reducing total cholesterol and triglycerides. In addition, the composition of the present invention is prepared from natural Chinese herbal medicines with the same origin as medicine and food, has no side effects or small side effects on the human body, can nourish the body, can be taken for a long time, is suitable for a wide range of people, and has high practical application value.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a pharmaceutical composition, a preparation method and an application thereof. Background Art

[0002] According to Traditional Chinese Medicine (TCM), the primary causes of hyperlipidemia can be summarized as follows: First, a diet high in rich, sweet foods damages the spleen and stomach. Simultaneously, this impairs the liver and gallbladder's function of dispersing and transporting vital energy, leading to dysfunction of the spleen's digestive and transporting functions, which in turn transforms into phlegm and turbidity. Second, after middle age, kidney qi gradually declines, resulting in both kidney yin and yang deficiency, which in turn leads to excessive activation of the liver's fire, causing liver yang to rise, even transforming into fire. The flourishing of wood overpowers earth, leading to dysfunction of the spleen and stomach's transport and distribution functions, dampness and heat stagnation, and the internal generation of phlegm and turbidity. This internal stagnation of phlegm and turbidity, which infiltrates the blood vessels and obstructs blood flow, can cause chest pain, heart pain, and fainting. This aligns with modern medicine's understanding that impaired fat metabolism is a contributing factor to ischemic heart disease and cerebrovascular disease. Hyperlipidemia falls under the rubric of "phlegm and fluid," "stroke," and "vertigo," with its location in the blood vessels and close association with phlegm and stasis.

[0003] Due to the high incidence of hyperlipidemia and the lack of effective treatments, many patients suffer from chronic illnesses, which in turn causes significant physical and psychological stress and financial burden. Furthermore, most medications are Western medicine or combination drugs, which have certain side effects.

[0004] Therefore, developing products that have no or minimal side effects on the human body, can be used for a long time, and help maintain healthy blood lipid levels has extremely high economic value and social significance. Summary of the Invention

[0005] The present invention aims to address at least one of the technical problems existing in the prior art. To this end, the present invention provides a pharmaceutical composition, a method for preparing the composition, and its use. This invention aims to address the problem that most current drugs for treating hyperlipidemia or maintaining healthy blood lipid levels have side effects on the human body, thereby providing a product that can effectively maintain healthy blood lipid levels with no or minimal side effects.

[0006] The first aspect of the present invention provides a pharmaceutical composition comprising the following components in parts by weight: 5-36 parts of peach kernel, 5-40 parts of dried tangerine peel, 2-30 parts of hawthorn, 2-28 parts of wolfberry, 1-25 parts of gastrodia elata, 1-25 parts of cassia seed, 1-25 parts of platycodon, 1-25 parts of poria, 1-20 parts of roasted licorice, 1-10 parts of Panax notoginseng root, and 1-10 parts of Panax notoginseng flower.

[0007] According to the pharmaceutical composition of the embodiment of the present invention, there are at least the following beneficial effects: the pharmaceutical composition provided by the present invention includes peach kernel, tangerine peel, hawthorn, wolfberry, gastrodia elata, cassia seed, platycodon, tuckahoe, roasted licorice root, Panax notoginseng root, Panax notoginseng flower, etc. The present invention designs the formula from the perspective of comprehensive conditioning such as promoting blood circulation and removing blood stasis, clearing the liver and purging fire, strengthening the spleen and removing dampness, nourishing yin and replenishing blood, etc., and the compatibility is reasonable, so that the composition can help maintain the function of healthy blood lipid levels, avoid the harm caused by increased blood lipids, and has a significant effect on reducing total cholesterol and triglycerides. Not only that, the composition of the present invention is prepared using natural Chinese herbal medicines that are both medicinal and edible, has no side effects or small side effects on the human body, can nourish the body, can be taken for a long time, is suitable for a wide range of people, and has high practical application value.

[0008] The properties, flavors, meridians and effects of the drugs in the composition of the present invention are as follows:

[0009] Peach kernel: Bitter, sweet, neutral. It enters the heart, liver, and large intestine meridians. It promotes blood circulation, removes blood stasis, moistens the intestines and promotes bowel movements, and relieves cough and asthma. It is used to treat amenorrhea, dysmenorrhea, lumps and masses, lung and intestinal abscesses, injuries from falls, constipation caused by dry intestines, and cough and asthma.

[0010] Panax notoginseng root: Sweet, slightly bitter, warm. Enters the Liver and Stomach meridians. It dissipates blood stasis, stops bleeding, and reduces swelling and pain. It is used for hemoptysis, hematemesis, epistaxis, bloody stools, metrorrhagia, bleeding from trauma, stabbing pain in the chest and abdomen, and swelling and pain from falls.

[0011] Hawthorn: Sour, sweet, and slightly warm. It enters the spleen, stomach, and liver meridians. It promotes digestion and stomach function, promotes qi circulation and dissipates blood stasis, and clears turbidity and reduces lipids. It is used to treat meat stagnation, epigastric distension, diarrhea, abdominal pain, blood stasis, amenorrhea, postpartum stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and hyperlipidemia.

[0012] Lycium barbarum: Sweet, neutral. Enters the Liver and Kidney meridians. It nourishes the liver and kidneys, improves intelligence, and improves vision. It is used for consumptive disease with spermatorrhea, soreness of the waist and knees, dizziness, tinnitus, impotence, spermatorrhea, internal heat and thirst, blood deficiency, sallow complexion, and blurred vision.

[0013] Gastrodia elata: Sweet, neutral. Enters the Liver meridian. It calms wind and stops spasms, calms liver yang, and dispels wind and dredges the meridians. It is used for infantile convulsions, epilepsy, tetanus, headache, dizziness, paralysis of hands and feet, numbness of limbs, and rheumatic pain.

[0014] Cassia seed: Sweet, bitter, salty, and slightly cold. It enters the liver and large intestine meridians. It clears heat, improves eyesight, and moistens the intestines for a laxative effect. It is used for red and painful eyes, eye pain, excessive tearing, headaches, dizziness, blurred vision, and constipation.

[0015] Tangerine peel: Bitter, pungent, and warm. It enters the lung and spleen meridians. It regulates qi and strengthens the spleen, clears dampness and resolves phlegm. It is used to treat abdominal distension, loss of appetite, vomiting, diarrhea, and cough with excessive phlegm.

[0016] Platycodon grandiflorum: Bitter, pungent, neutral. Enters the Lung Meridian. It has the effects of clearing the lungs, relieving sore throats, removing phlegm, and expelling pus. It is used for cough with excessive phlegm, chest tightness, sore throat, hoarseness, and lung abscess with vomiting pus.

[0017] Poria: Sweet, mild, and neutral. It enters the Heart, Lung, Spleen, and Kidney meridians. It promotes diuresis, dissipates dampness, strengthens the spleen, and calms the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0018] Roasted Licorice: Sweet, neutral. It enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal properties. It is used for spleen and stomach deficiency, fatigue, palpitations, shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncles, sores, and to alleviate drug toxicity and potency.

[0019] Panax notoginseng flower: Sweet, cool. Enters the liver and kidney meridians. Clears heat, promotes fluid production, calms the liver, and lowers blood pressure. Used for thirst caused by loss of fluid, sore throat, hoarseness, and hypertension.

[0020] The Chinese medicine compatibility of the formula is as follows: peach kernel breaks blood stasis and moistens dryness; Panax notoginseng flower clears heat and detoxifies, moistens the intestines and resolves phlegm; Panax notoginseng root promotes blood circulation and dissipates blood stasis to relieve pain, and they are all monarch herbs; hawthorn assists the monarch herbs in promoting qi and dispersing blood stasis, and wolfberry nourishes essence and blood, and they are all minister herbs; Gastrodia elata and cassia seed clear the liver and purge heat; dried tangerine peel, platycodon grandiflorum, and poria promote qi and eliminate dampness, and nourish the spleen and stomach; platycodon grandiflorum guides the herbs upward to the blood vessels, and it is an adjuvant; licorice relieves urgency and harmonizes the herbs, and it is a guiding herb. The raw materials of the composition work together to promote blood circulation and dissipate blood stasis, resolve phlegm and eliminate dampness, and are used for symptoms such as hyperactivity of liver yang, internal blood stasis, and phlegm-dampness obstruction in the middle, thereby helping to maintain a healthy level of blood lipids.

[0021] In some embodiments of the present invention, the pharmaceutical composition includes the following components in parts by weight: 18-36 parts of peach kernel, 18-40 parts of dried tangerine peel, 12-30 parts of hawthorn, 12-28 parts of wolfberry, 9-25 parts of gastrodia elata, 9-25 parts of cassia seed, 9-25 parts of platycodon, 9-25 parts of poria, 6-20 parts of roasted licorice, 5-10 parts of Panax notoginseng root, and 5-10 parts of Panax notoginseng flower.

[0022] In some preferred embodiments of the present invention, the pharmaceutical composition comprises the following components in parts by weight: 18 parts of peach kernel, 18 parts of dried tangerine peel, 12 parts of hawthorn, 12 parts of wolfberry, 9 parts of gastrodia elata, 9 parts of cassia seed, 9 parts of platycodon, 9 parts of poria, 6 parts of roasted licorice, 5 parts of Panax notoginseng root, and 5 parts of Panax notoginseng flower.

[0023] The present invention designs the formula from the perspective of comprehensive conditioning such as promoting blood circulation and removing blood stasis, clearing the liver and purging fire, strengthening the spleen and removing dampness, nourishing yin and replenishing blood, and rationally adjusts the ratio of various Chinese medicines so that their medicinal properties are mutually integrated and the compatibility is reasonable, so that the composition can help maintain healthy blood lipid levels, avoid the harm caused by increased blood lipids, and has a significant effect of lowering total cholesterol and triglycerides.

[0024] In some embodiments of the present invention, the pharmaceutical composition further comprises a pharmaceutically acceptable excipient.

[0025] Preferably, the auxiliary materials include at least one of fillers, lubricants, dispersants, wetting agents, adhesives, antioxidants, and preservatives.

[0026] In some embodiments of the present invention, the pharmaceutical composition can be prepared into any one of decoction, tablet, powder, powder, pill, granule, oral solution, capsule or paste.

[0027] The second aspect of the present invention provides a method for preparing the above-mentioned pharmaceutical composition, comprising the steps of: weighing the medicinal materials of each component according to the weight ratio, soaking them in water for 30-60 minutes, decocting them 2-3 times, combining the medicinal liquids obtained by multiple decoctions, and concentrating the medicinal liquids to obtain a thick paste of the composition.

[0028] The method for preparing a pharmaceutical composition according to an embodiment of the present invention has at least the following beneficial effects: The method is simple and easy to perform, does not require complex equipment, and is more practical for daily life. The resulting thick paste can be used directly or further prepared into a dried form, beverage, or the like. Furthermore, the method is suitable for large-scale production, eliminating the need for time-consuming decoction of medicinal materials each time, and can be applied to the preparation of batch pharmaceutical preparations or health products.

[0029] In some embodiments of the present invention, the medicinal materials of each component are weighed according to the weight ratio, poured into the extraction tank, and then 8-10 times the total weight of the medicinal materials is added with water and soaked for 30-60 minutes, preferably 60 minutes.

[0030] In some embodiments of the present invention, the medicinal material is soaked in water for 30-60 minutes, then decocted 2-3 times, each time for 2-3 hours, and the medicinal liquids obtained from the multiple decoctions are combined. Preferably, the decoction is performed twice, each time for 2 hours.

[0031] In some embodiments of the present invention, the specific steps of concentrating the liquid to obtain a thick paste of the composition are as follows: filtering the liquid, taking the supernatant and transferring it to an evaporation tank, heating and concentrating it to a specific gravity of 1.05-1.20 g / cm 3 , obtaining a concentrated solution; filtering the concentrated solution to remove impurities, and then filtering it through a ceramic membrane to collect the filtrate; concentrating the filtrate again to a specific gravity of 1.25-1.35 g / cm 3 The thick paste of the composition is obtained.

[0032] In a specific embodiment of the present invention, the steps of preparing the thick paste of the pharmaceutical composition are:

[0033] (1) Weigh the medicinal materials according to the weight ratio of each component of the composition, pour them into the extraction tank, add 8-10 times the total weight of the medicinal materials in water, and soak for 30-60 minutes;

[0034] (2) Heat and boil the soaked herbs for 2 hours, filter, and take the supernatant for later use;

[0035] (3) Add 8-10 times the weight of water to the extracted and filtered medicinal materials, heat and boil for 2 hours, filter, and take the supernatant;

[0036] (4) Combine the supernatants from steps (2) and (3) and transfer them to an evaporator. Heat and concentrate to a specific gravity of approximately 1.05-1.20 g / cm 3 ;

[0037] (5) filtering the concentrated solution from step (4) to remove impurities, then filtering it through a ceramic membrane and collecting the filtrate;

[0038] (6) Concentrate the filtrate from step (5) to a specific gravity of 1.25-1.35 g / cm 3 The thick paste, that is, the composition thick paste.

[0039] In some embodiments of the present invention, after obtaining the composition paste, the further step includes: detecting the solid content of the composition paste, adding the same weight of filling auxiliary materials according to the solid content, mixing, and vacuum drying the obtained mixture to obtain a dried composition.

[0040] Specifically, the filling excipient may be starch, sugar, cellulose or any other commonly used pharmaceutically acceptable filling excipient.

[0041] In a specific embodiment of the present invention, after obtaining the thick paste of the composition, it can also be prepared into a dry product by the following steps:

[0042] (7a) detecting the solid content of the thick paste of the composition in step (6);

[0043] (8a) taking a certain weight of the composition paste and mixing it with the same weight of the filling excipients according to its solid content;

[0044] (9a) drying the mixture from step (8a) in a vacuum drying oven at 60°C;

[0045] (10a) The dried material obtained in step (9a) is pulverized and passed through a 100-mesh sieve to obtain a dried composition.

[0046] In some embodiments of the present invention, after obtaining the composition paste, the step of adding food additives and water to the composition paste to prepare a solution is further included, and the solution is packaged according to a predetermined amount, and a composition beverage is obtained after sterilization.

[0047] In a specific embodiment of the present invention, after obtaining the thick paste of the composition, it can also be prepared into a beverage by the following steps:

[0048] (7b) adding food additives and water to the thick paste of the composition of step (6) to prepare a solution;

[0049] (8b) The solution of step (7b) is divided into portions according to a predetermined amount, sterilized at 120° C. for 15 minutes, and cooled to obtain a composition beverage.

[0050] Specifically, the food additives may be sweeteners, flavors, spices and other food additives that comply with regulations.

[0051] In some embodiments of the present invention, the pharmaceutical composition can be prepared into any one of decoctions, tablets, powders, powders, pills, granules, oral liquids, capsules or pastes, or prepared into health-care foods, beverages, etc.

[0052] The present invention can select a suitable preparation method for the above-mentioned pharmaceutical composition according to the actual dosage form required. For example, if it is used as a Chinese medicine decoction, the method of steps (1) to (3) can be adopted, and then the supernatants filtered twice in steps (2) and (3) can be combined and directly consumed; if it is used as a paste dosage form, steps (1) to (6) can be adopted to obtain a thick paste of the composition, and then further processed; if it is used as a tablet, powder, or dust, etc., steps (1) to (10a) can be adopted to obtain a dried composition, and then further processed; if it is used as a beverage, steps (1) to (8b) can be adopted to obtain a composition beverage, and then directly consumed.

[0053] The third aspect of the present invention provides a use of the above-mentioned pharmaceutical composition in the preparation of a drug for treating hyperlipidemia or maintaining healthy blood lipid levels.

[0054] The applications according to embodiments of the present invention have at least the following beneficial effects: the pharmaceutical composition is used in the preparation of a drug for treating hyperlipidemia or maintaining healthy blood lipid levels, thereby helping to maintain healthy blood lipid levels, avoiding the harmful effects of increased blood lipids, and significantly reducing total cholesterol and triglycerides. This application provides a new approach to treating hyperlipidemia or maintaining healthy blood lipid levels.

[0055] In a fourth aspect, the present invention provides a traditional Chinese medicine preparation for treating hyperlipidemia or maintaining healthy blood lipid levels, comprising the pharmaceutical composition described above.

[0056] The Chinese medicine preparation according to the embodiment of the present invention has at least the following beneficial effects: the Chinese medicine preparation provided by the present invention, whose active ingredient is the above-mentioned pharmaceutical composition, is formulated from the perspective of comprehensive conditioning such as promoting blood circulation and removing blood stasis, clearing the liver and purging fire, strengthening the spleen and removing dampness, nourishing yin and replenishing blood, etc., which can help maintain healthy blood lipid levels and avoid the harm caused by increased blood lipids. It has a significant effect of lowering total cholesterol and triglycerides, and is helpful for the treatment of hyperlipidemia with significant effects; and it has a mild effect, good safety, can be taken for a long time, is applicable to a wide range of people, and has high practical application value.

[0057] In some embodiments of the present invention, the dosage form of the traditional Chinese medicine preparation includes tablets, powders, powders, pills, granules, oral liquids, capsules or pastes.

[0058] Specifically, the preparation method of the traditional Chinese medicine tablets is as follows: after obtaining a dried composition according to the above steps, the dried composition is mixed evenly with fillers (including but not limited to starch, xylitol, maltitol), sweeteners (including but not limited to mogrosides, sucralose, steviol glycosides) and other flavorings, and then granulated, sized, dried and sieved with a wetting agent or a binder to obtain traditional Chinese medicine granules, and the traditional Chinese medicine granules are mixed evenly with a lubricant (including but not limited to magnesium stearate and micro-powdered silica gel) and tableted using a tablet press to obtain traditional Chinese medicine tablets.

[0059] Specifically, the preparation method of the traditional Chinese medicine granules is as follows: after obtaining the dried composition according to the above steps, the dried composition is evenly mixed with fillers (including but not limited to starch, xylitol, maltitol), sweeteners (including but not limited to mogroside, sucralose, steviol glycosides) and other flavorings, and then a wetting agent or a binder is used to granulate, granulate, dry, and sieving to obtain the traditional Chinese medicine granules.

[0060] Specifically, the preparation method of the Chinese medicine pills is as follows: after obtaining the thick paste of the composition according to the above steps, the thick paste of the composition is added with an appropriate amount of auxiliary materials (including but not limited to starch, sugar alcohol, lactose) to mix and form pills of appropriate softness and hardness; then, the strips are extruded mechanically to make pills, and the wet granules are dried, sieved, glazed, and coated to obtain the Chinese medicine pills.

[0061] Specifically, the preparation method for the Chinese herbal oral liquid is as follows: after obtaining a thick paste of the composition according to the aforementioned steps, a predetermined number of portions of the thick paste (calculated based on the amount of the raw herbs) are taken, and an appropriate amount of a sweetener (including but not limited to mogrosides, sucralose, and steviosides), an acidulant (including but not limited to citric acid, malic acid, and tartaric acid), or other food additives are added. The mixture is then diluted with water to a predetermined volume. The mixture is then bottled and sterilized to obtain the Chinese herbal oral liquid. For example, if one bottle of oral liquid contains one portion of the formulated raw herbs, and each bottle of oral liquid has a fixed volume of 20 ml, then 600 portions of the thick paste (calculated based on the amount of the raw herbs) are taken and diluted with water to 2000 ml.

[0062] Specifically, the preparation method of the Chinese herbal ointment is as follows: after obtaining a thick paste of the composition according to the aforementioned steps, a predetermined number of portions of the thick paste of the composition (calculated based on the amount of the crude drug) are taken, and an appropriate amount of a sweetener (including but not limited to honey, fructose syrup, maltitol solution), an acidulant (including but not limited to citric acid, malic acid, tartaric acid), or other food additives are added. The mixture is then diluted with water to a predetermined dosage (e.g., 5000g). The mixture is then filled and sterilized to obtain the Chinese herbal ointment. For example, if one bottle of ointment contains 30 portions of the formulated crude drug, and each bottle contains 250g of the formulated crude drug, then 600 portions of the thick paste of the composition (calculated based on the amount of the crude drug) are taken and diluted with water to 5000g.

[0063] In some embodiments of the present invention, the traditional Chinese medicine preparation further comprises a pharmaceutically acceptable excipient.

[0064] Preferably, the auxiliary materials include at least one of fillers, lubricants, dispersants, wetting agents, adhesives, antioxidants, and preservatives.

[0065] In a fifth aspect, the present invention provides a health food that helps maintain healthy blood lipid levels, comprising the pharmaceutical composition described above.

[0066] The health food according to the embodiments of the present invention has at least the following beneficial effects: the health food provided by the present invention, comprising the above-mentioned pharmaceutical composition, can help maintain healthy blood lipid levels, avoid the harm caused by increased blood lipids, and has a significant effect of lowering total cholesterol and triglycerides; and has a mild effect, good safety, can be taken long-term, and is suitable for a wide range of people. Moreover, its components are all materials that can be used as medicine and food, so it has a better taste and is more convenient to use after being made into food, beverage or granules.

[0067] In some embodiments of the present invention, the health food comprises a beverage or an granule. The present invention does not impose any restrictions on the type of product. For example, the pharmaceutical composition can be ground into a fine powder, mixed with sucrose, and processed into candy; or ground into a fine powder, using yam powder as a carrier, and made into a pastry; or ground into a fine powder, mixed with a carrier, and dried at low temperature, and then formed into an granule for daily drinking; or directly prepared as a beverage as described above and consumed directly.

[0068] Specifically, the beverage preparation method is as follows: after obtaining a thick paste of the composition according to the aforementioned steps, a predetermined number of portions of the thick paste (based on the amount of the crude drug) are taken, and appropriate amounts of food additives (sweeteners, flavors), food nutrient enhancers, and new food ingredients are added. The mixture is then diluted with water to a predetermined volume to prepare a solution. The prepared solution is then packaged, sterilized at 120°C for 15 minutes, and cooled to obtain the beverage. For example, if one bottle of the beverage contains one portion of the formulated crude drug, and each bottle contains 30 ml of the beverage, then 100 portions of the thick paste (based on the amount of the crude drug) are taken, diluted with water to 3000 ml, and the prepared solution is packaged at 30 ml per bottle. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0070] Figure 1 This is a schematic diagram of the triglyceride (TG) levels in the serum of rats in each group after administration provided in an embodiment of the present invention;

[0071] Figure 2 This is a schematic diagram of the serum total cholesterol (TC) levels in the serum of rats in each group after administration provided in an embodiment of the present invention;

[0072] Figure 3 A schematic diagram of the low-density lipoprotein cholesterol (LDL-C) levels in the serum of rats in each group after administration provided in an embodiment of the present invention;

[0073] Figure 4 This is a schematic diagram of the high-density lipoprotein cholesterol (HDL-C) levels in the serum of rats in each group after administration provided by an embodiment of the present invention;

[0074] Among them, compared with the normal group, #P<0.05, ##P<0.01; compared with the model group, *P<0.05, **P<0.01. DETAILED DESCRIPTION

[0075] The following will clearly and completely describe the concept and technical effects of the present invention in conjunction with the embodiments to fully understand the purpose, features and effects of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative work are all within the scope of protection of the present invention.

[0076] In the description of the present invention, reference to terms such as "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" means that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the exemplary expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0077] In the description of the present invention, unless otherwise indicated, the numerical range "a to b" is an abbreviation for any combination of real numbers between a and b, where a and b are real numbers. Unless otherwise indicated, the individual reactions or steps may or may not be performed in sequence. Preferably, the reaction methods of the present invention are performed in sequence.

[0078] If no specific techniques or conditions are specified in the following examples, the methods were carried out according to the techniques or conditions described in the literature in the field or according to the product instructions. All reagents or instruments without manufacturer specified are commercially available conventional products.

[0079] Example 1 Preparation of a Chinese medicine composition for maintaining healthy blood lipid levels

[0080] The weight ratio of each component in the composition of this embodiment is: 5 parts of peach kernel, 5 parts of dried tangerine peel, 2 parts of hawthorn, 2 parts of wolfberry, 1 part of gastrodia elata, 1 part of cassia seed, 1 part of platycodon, 1 part of poria, 1 part of roasted licorice, 1 part of Panax notoginseng root, and 1 part of Panax notoginseng flower.

[0081] (1) Weigh the medicinal materials according to the weight ratio of each component of the composition, pour them into the extraction tank, add 8 times the total weight of the medicinal materials in water, and soak for 30 minutes;

[0082] (2) Heat and boil the soaked herbs for 2 hours, filter, and take the supernatant for later use;

[0083] (3) Add 8 times the weight of water to the extracted and filtered medicinal materials, heat and boil for 2 hours, filter, and take the supernatant;

[0084] (4) Combine the supernatants from steps (2) and (3) and transfer them to an evaporator. Heat and concentrate to a specific gravity of approximately 1.10 g / cm 3 ;

[0085] (5) filtering the concentrated solution from step (4) to remove impurities, then filtering it through a ceramic membrane and collecting the filtrate;

[0086] (6) Concentrate the filtrate from step (5) to a specific gravity of 1.25 g / cm 3 The thick paste, that is, the composition thick paste.

[0087] Example 2 Preparation of a Chinese medicine composition for maintaining healthy blood lipid levels

[0088] The weight ratio of each component in the composition of this embodiment is: 36 parts of peach kernel, 40 parts of dried tangerine peel, 30 parts of hawthorn, 28 parts of wolfberry, 25 parts of gastrodia elata, 25 parts of cassia seed, 25 parts of platycodon, 25 parts of poria, 20 parts of roasted licorice, 10 parts of Panax notoginseng root, and 10 parts of Panax notoginseng flower.

[0089] (1) Weigh the medicinal materials according to the weight ratio of each component of the composition, pour them into the extraction tank, add 10 times the total weight of the medicinal materials in water, and soak for 60 minutes;

[0090] (2) Heat and boil the soaked herbs for 2 hours, filter, and take the supernatant for later use;

[0091] (3) Add 10 times the weight of water to the extracted and filtered medicinal materials, heat and boil for 2 hours, filter, and take the supernatant;

[0092] (4) Combine the supernatants from steps (2) and (3), transfer them to an evaporator, and heat and concentrate them to a specific gravity of approximately 1.20 g / cm 3 ;

[0093] (5) filtering the concentrated solution from step (4) to remove impurities, then filtering it through a ceramic membrane and collecting the filtrate;

[0094] (6) Concentrate the filtrate from step (5) to a specific gravity of 1.35 g / cm 3 The thick paste, that is, the composition thick paste.

[0095] Example 3 Preparation of a Chinese medicine composition for maintaining healthy blood lipid levels

[0096] The weight ratio of each component in the composition of this embodiment is: 18 parts of peach kernel, 18 parts of dried tangerine peel, 12 parts of hawthorn, 12 parts of wolfberry, 9 parts of gastrodia elata, 9 parts of cassia seed, 9 parts of platycodon, 9 parts of poria, 6 parts of roasted licorice, 5 parts of Panax notoginseng root, and 5 parts of Panax notoginseng flower.

[0097] (1) Weigh the medicinal materials according to the weight ratio of each component of the composition, pour them into the extraction tank, add 9 times the total weight of the medicinal materials in water, and soak for 50 minutes;

[0098] (2) Heat and boil the soaked herbs for 2 hours, filter, and take the supernatant for later use;

[0099] (3) Add 9 times the weight of water to the extracted and filtered medicinal materials, heat and boil for 2 hours, filter, and take the supernatant;

[0100] (4) Combine the supernatants from steps (2) and (3) and transfer them to an evaporator. Heat and concentrate to a specific gravity of approximately 1.15 g / cm 3 ;

[0101] (5) filtering the concentrated solution from step (4) to remove impurities, then filtering it through a ceramic membrane and collecting the filtrate;

[0102] (6) Concentrate the filtrate from step (5) to a specific gravity of 1.30 g / cm 3 The thick paste, that is, the composition thick paste.

[0103] Example 4 Preparation of a Chinese medicine composition for maintaining healthy blood lipid levels

[0104] The weight ratio of each component in the composition of this embodiment is: 16 parts of peach kernel, 28 parts of dried tangerine peel, 10 parts of hawthorn, 10 parts of wolfberry, 5 parts of gastrodia elata, 6 parts of cassia seed, 6 parts of platycodon, 5 parts of poria, 7 parts of roasted licorice, 4 parts of Panax notoginseng root, and 4 parts of Panax notoginseng flower.

[0105] The preparation method of the composition paste is the same as that in Example 3.

[0106] Example 5 Preparation of a Chinese medicine composition for maintaining healthy blood lipid levels

[0107] The weight ratio of each component in the composition of this embodiment is: 22 parts of peach kernel, 20 parts of dried tangerine peel, 15 parts of hawthorn, 15 parts of wolfberry, 12 parts of gastrodia elata, 10 parts of cassia seed, 10 parts of platycodon, 12 parts of poria, 8 parts of roasted licorice, 6 parts of Panax notoginseng root, and 6 parts of Panax notoginseng flower.

[0108] The preparation method of the composition paste is the same as that in Example 3.

[0109] Example 6 Preparation of Chinese medicine composition tablets for maintaining healthy blood lipid levels

[0110] (1) Take the thick paste of the composition prepared in Example 1, add the filling auxiliary material maltodextrin in a ratio of solid content: filling auxiliary material = 1:1, mix and place in a vacuum drying oven at 60°C to dry;

[0111] (2) Grinding the dried product and passing it through a 100-mesh sieve to obtain a dried composite product;

[0112] (3) The dried composition is mixed evenly with a filler (starch) and a sweetener (mogroside), and then granulated, sized, dried, and sieved using a wetting agent or adhesive to obtain Chinese medicine granules. The Chinese medicine granules are mixed evenly with a lubricant (magnesium stearate) and compressed using a tablet press to obtain Chinese medicine tablets.

[0113] Example 7 Preparation of Chinese medicine composition granules for maintaining healthy blood lipid levels

[0114] (1) Take the thick paste of the composition prepared in Example 2, add the filling excipients in a ratio of solid content to filling excipients = 1:1, mix, and place in a vacuum drying oven at 60°C to dry;

[0115] (2) Grinding the dried product and passing it through a 100-mesh sieve to obtain a dried composite product;

[0116] (3) The dried composition is mixed evenly with a filler (starch) and a sweetener (sucralose), and then a wetting agent or a binder is used to carry out granulation, granulation, drying, and screening to obtain a Chinese medicine granule.

[0117] Example 8 Preparation of Chinese medicine pills for maintaining healthy blood lipid levels

[0118] (1) Take the thick paste of the composition prepared in Example 3, add an appropriate amount of starch and mix to form balls of appropriate hardness;

[0119] (2) Use mechanical extrusion to make pills, dry the wet granules, sieve, polish and coat them to obtain Chinese medicine pills.

[0120] Example 9 Preparation of a Chinese herbal oral solution for maintaining healthy blood lipid levels

[0121] Assuming one bottle of oral liquid contains one portion of the formulated crude drug, each bottle of oral liquid is quantitatively 20 ml. Take 100 portions of the thick paste of the composition prepared in Example 4 (calculated based on the crude drug amount), add appropriate amounts of a sweetener (sucralose) and an acidulant (citric acid, malic acid) (the added amounts meet national standards), and dilute with water to 2000 ml. After filling and sterilization, a Chinese medicine oral liquid is obtained.

[0122] Example 10 Preparation of a Traditional Chinese Medicine Ointment for Maintaining Healthy Blood Lipid Levels

[0123] Assuming that one bottle of paste contains 30 parts of the formulated crude drugs, each bottle of paste is 250 g. Take 600 parts of the thick paste of the composition prepared in Example 5 (calculated based on the crude drugs), add appropriate amounts of sweeteners (honey, fructose syrup) and acidulants (citric acid, malic acid) (the added amounts meet national standards), and then add water to dilute to 5000 g. After filling and sterilization, a traditional Chinese medicine paste is obtained.

[0124] Example 11 Preparation of a Chinese medicine composition beverage for maintaining healthy blood lipid levels

[0125] (1) Based on the assumption that one bottle of beverage contains one portion of the formulated herbal medicine, the quantitative amount of each bottle of beverage is 30 ml. Take 100 portions of the thick paste of the composition prepared in Example 3 (calculated based on the amount of the herbal medicine), add appropriate amounts of sweeteners, flavors, food nutrient enhancers, and new food raw materials (the amount of additives must comply with national standards), and then add water to dilute to 3000 ml to prepare a solution;

[0126] (2) The prepared solution was divided into 30 ml / bottles, sterilized at 120°C for 15 minutes, and cooled to obtain the composite beverage.

[0127] Example 12 Preparation of a Chinese medicine composition beverage for maintaining healthy blood lipid levels

[0128] (1) Based on the assumption that one bottle of beverage contains 0.5 parts of the formulated herbal medicine, the quantitative amount of each bottle of beverage is 30 ml. Take 50 parts of the thick paste of the composition prepared in Example 3 (calculated by the amount of herbal medicine), add the same amount of food additives, food nutrient enhancers, and new food raw materials as in Example 11, and then add water to dilute to 3000 ml to prepare a solution;

[0129] (2) The prepared solution was divided into 30 ml / bottles, sterilized at 120°C for 15 minutes, and cooled to obtain the composite beverage.

[0130] Example 13 Preparation of a Chinese medicine composition beverage for maintaining healthy blood lipid levels

[0131] (1) Based on the assumption that one bottle of beverage contains two parts of the formulated herbal medicine, the quantitative amount of each bottle of beverage is 30 ml. Take 200 parts of the thick paste of the composition prepared in Example 3 (calculated by the amount of herbal medicine), add the same amount of food additives, food nutrient enhancers, and new food raw materials as in Example 11, and then add water to dilute to 3000 ml to prepare a solution;

[0132] (2) The prepared solution was divided into 30 ml / bottles, sterilized at 120°C for 15 minutes, and cooled to obtain the composite beverage.

[0133] Example 14: Evaluation of the Function of a Chinese Medicine Composition in Maintaining Healthy Blood Lipid Levels

[0134] 1. Principle: Feeding animals with a mixed high-fat feed containing cholesterol, sugar, lard, sodium cholate, etc. can form an animal model of lipid metabolism disorder (mixed hyperlipidemia animal model). Then, giving the animals test samples can detect the effects of the test samples on hyperlipidemia and determine the effects of the test samples on lipid absorption, lipoprotein formation, lipid degradation or excretion.

[0135] 2. Instruments and reagents: Triglyceride (TG) test kit, total cholesterol (T-CHO) test kit, low-density lipoprotein cholesterol (LDL-C) test kit, high-density lipoprotein cholesterol (HDL-C) test kit were purchased from Nanjing Jiancheng Bioengineering Research Institute.

[0136] The BPX-52 electric constant-temperature incubator was manufactured by Shanghai Boxun Medical Biological Instrument Co., Ltd.; the 5424R high-speed refrigerated centrifuge was manufactured by Eppendorf; the Multiskan GO Thermo continuous wavelength microplate reader was manufactured by Thermo Fisher Scientific; the JJ2000 electronic balance was purchased from Shuangjie Testing Instrument Factory in Changshu, Jiangsu Province; and the ELGA LA613 ultrapure water machine was purchased from ELGALab Water / VWS (UK) Ltd. in the United Kingdom.

[0137] 3. Animal selection: SPF-grade SD rats, weighing 180.0-220.0 g, were purchased from Beijing Huafukang Biotechnology Co., Ltd.

[0138] 4. Model feed: 20.0% sucrose, 15.0% lard, 1.2% cholesterol, 0.2% sodium cholate, and appropriate amounts of casein, calcium hydrogen phosphate, and stone powder were added to the maintenance feed. Except for crude fat, the model feed's moisture, crude protein, crude fiber, crude ash, calcium, and phosphorus content all met national standards for maintenance feed. The feed was purchased from Keao Xieli (Tianjin) Feed Co., Ltd.

[0139] 5. Construction of mixed hyperlipidemia animal model

[0140] (1) Modeling period: 80 male SPF SD rats were randomly divided into a normal group and a modeling group, with 12 and 68 rats respectively. The normal group was fed with a basic diet, and the modeling group was fed with a mixed high-fat diet to establish a mixed hyperlipidemia model rat model. After 14 days of feeding, blood was collected from the inner canthus without fasting, and the serum was separated. The serum total cholesterol (TC) concentration in the serum of the modeling group rats was detected. Rats with TC concentrations that were too high or too low were eliminated, and the remaining 60 rats were randomly divided into 5 groups, with 12 rats in each group, for the next step of the experiment. The groups were model group, Chinese medicine combination group (low-dose Chinese medicine combination group, medium-dose Chinese medicine combination group, high-dose Chinese medicine combination group), and atorvastatin calcium tablet group.

[0141] (2) Experimental period: After grouping, the normal group without modeling was used as a blank control and continued to be fed with basic feed. The modeling group (including the model group, the Chinese medicine composition groups of various doses, and the atorvastatin calcium tablet group) continued to be fed with mixed high-fat feed. At the same time, each group was gavaged with the corresponding test sample: the atorvastatin calcium tablet group was gavaged with atorvastatin calcium tablets (purchased from a commercial source) at a dose of 20.0 mg / kg as a positive control; the Chinese medicine composition group was gavaged with the Chinese medicine composition obtained in Example 3 (the Chinese medicine composition was recorded as Sanqi Tianma Bazhen Yin), among which the low-dose Chinese medicine composition group was gavaged with the Chinese medicine composition obtained in Example 3 at a dose of 1.43 g / kg, the medium-dose Chinese medicine composition group was gavaged with the Chinese medicine composition obtained in Example 3 at a dose of 2.86 g / kg, and the high-dose Chinese medicine composition group was gavaged with the Chinese medicine composition obtained in Example 3 at a dose of 5.72 g / kg; the normal group and the model group were gavaged with pure water, with a volume of 10.0 mL / kg. Each group was gavage-fed once a day for 30 consecutive days.

[0142] (3) Observation indicators: After the end of the experiment, all rats were not fasted and blood was collected from the abdominal aorta. The serum was separated and the levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in the serum of each group were detected.

[0143] (4) Effects on mixed hyperlipidemia model rats

[0144] SPSS 20.0 statistical software was used for processing, and the measurement data were expressed as mean ± standard deviation ( ± s). Multiple group comparisons were performed with analysis of variance, and pairwise comparisons were performed with the LSD test. P < 0.05 was considered statistically significant.

[0145] The results are shown in Table 1 and Figure 1-4 As shown, among them, "Sanqi Tianma Bazhen Drink" is each group of the Chinese medicine composition obtained in Example 3 administered by gavage.

[0146]

[0147] Note: Compared with the normal group, #P<0.05, ##P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0148] The results showed that compared with the normal group, the TC concentration of SPF male SD rats fed a mixed high-fat diet was significantly increased and suitable for the experiment (P < 0.01). After the experiment, compared with the normal group, the TC, TG, LDL-C, and HDL-C concentrations of the model group were significantly changed (P < 0.05 or 0.01). Compared with the model group, the TG concentration of each dose group administered with the Chinese medicine composition in Example 3 of the present invention was significantly decreased, and the HDL-C concentration was significantly increased (P < 0.05 or 0.01), and this was dose-dependent. There was no significant change in TC and LDL-C concentrations (P > 0.05).

[0149] In summary, the composition of the present invention has the effect of improving the blood lipid level of the mixed hyperlipidemia animal model rats, indicating that the composition of the present invention is helpful in maintaining healthy blood lipid (cholesterol / triglyceride) levels.

[0150] Example 15: Human food test on the function of the composition beverage in maintaining healthy blood lipid levels

[0151] This example conducts human consumption of the composition beverage, and the test process has been subject to informed consent from the subjects and complies with relevant regulations. The test method is as follows:

[0152] 1. Subject selection: 10 subjects with simple dyslipidemia were selected regardless of gender and maintained a normal diet.

[0153] 2. Experimental Method: The test group took the composition beverage obtained in Example 11 of the present invention, twice a day, one bottle each time, for two consecutive stages (28 days, each stage lasting 14 days). Blood biochemical indicators were measured on the last day of each stage. During the experimental period, the original living and eating habits were not changed and the diet was normal.

[0154] 3. Observation indicators

[0155] (1) General inquiry: The participants were asked about their mental state, sleep, and diet before and after the tasting. It was found that the participants were in good general condition before and after the tasting, with no obvious abnormalities in their mental state, sleep, and diet.

[0156] (2) Biochemical index determination: On the last day of each stage, the levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were tested. The results are shown in Table 2.

[0157]

[0158] Among them, the normal reference values ​​of the four blood lipid indicators are: TC: 0-5.60 mmol / L; TG: 0-2.30mmol / L; LDL-C: 0-4.11 mmol / L; HDL-C, male > 0.9 mmol / L, female > 1.15 mmol / L.

[0159] As shown in Table 2, the serum total cholesterol (TC) was abnormal in 9 subjects before the trial, 5 subjects after the first stage of the trial, and 3 subjects after the second stage of the trial.

[0160] Triglyceride (TG): 6 subjects had abnormal levels before the trial, 0 subjects had abnormal levels after the first stage of the trial, and 0 subjects had abnormal levels after the second stage of the trial.

[0161] Low-density lipoprotein cholesterol (LDL-C): 2 people had abnormal results before the trial, 3 people had abnormal results after the first stage of the trial, and 1 person had abnormal results after the second stage of the trial.

[0162] High-density lipoprotein cholesterol (HDL-C): 2 subjects had abnormal results before the trial, 3 subjects had abnormal results after the first stage of the trial, and 2 subjects had abnormal results after the second stage of the trial.

[0163] As shown above, the subjects showed no significant changes in their mental state, sleep, or diet during continuous consumption of the beverage composition of the present invention, and no other adverse reactions were observed. This indicates that the product had no adverse effects on the subjects' health. After four weeks of consumption, the number of volunteers with abnormal total cholesterol (TC) levels dropped from 9 to 3, all 6 with abnormal triglyceride (TG) levels returned to normal, and the number of volunteers with abnormal low-density lipoprotein cholesterol (LDL-C) levels dropped from 2 to 1.

[0164] In summary, the beverage composition of the present invention helps maintain healthy blood lipid (total cholesterol / triglyceride) levels, and the beverage composition of the present invention has reasonable compatibility, is a raw material of medicinal and edible origin, has no adverse reactions, and can be used for a long time.

[0165] The above-described embodiments merely illustrate several implementations of the present invention. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, and all such variations and improvements fall within the scope of protection of the present invention.

Claims

1. A pharmaceutical composition for treating hyperlipidemia, characterized in that: The invention is composed of the following components in parts by weight: 5-36 parts of peach kernel, 5-40 parts of dried tangerine peel, 2-30 parts of hawthorn, 2-28 parts of wolfberry, 1-25 parts of gastrodia elata, 1-25 parts of cassia seed, 1-25 parts of platycodon, 1-25 parts of poria, 1-20 parts of roasted licorice root, 1-10 parts of Panax notoginseng root and 1-10 parts of Panax notoginseng flower.

2. The pharmaceutical composition according to claim 1, characterized in that The pharmaceutical composition is composed of the following components in parts by weight: 18-36 parts of peach kernel, 18-40 parts of dried tangerine peel, 12-30 parts of hawthorn, 12-28 parts of wolfberry, 9-25 parts of gastrodia elata, 9-25 parts of cassia seed, 9-25 parts of platycodon, 9-25 parts of poria, 6-20 parts of roasted licorice root, 5-10 parts of Panax notoginseng root, and 5-10 parts of Panax notoginseng flower.

3. The pharmaceutical composition according to claim 2, characterized in that The pharmaceutical composition is composed of the following components in parts by weight: 18 parts of peach kernel, 18 parts of dried tangerine peel, 12 parts of hawthorn, 12 parts of wolfberry, 9 parts of gastrodia elata, 9 parts of cassia seed, 9 parts of platycodon, 9 parts of poria, 6 parts of roasted licorice, 5 parts of Panax notoginseng root, and 5 parts of Panax notoginseng flower.

4. A method for preparing the pharmaceutical composition according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: weighing medicinal materials of various components according to weight ratio, soaking in water for 30-60 minutes, decocting for 2-3 times, combining the medicinal liquids obtained by multiple decoctions, and concentrating the medicinal liquids to obtain a thick paste of the composition.

5. The preparation method according to claim 4, characterized in that After obtaining the composition paste, the method further comprises the steps of detecting the solid content of the composition paste, adding the same weight of filling auxiliary materials according to the solid content, mixing the mixture, and vacuum drying the obtained mixture to obtain a dried composition.

6. Use of the pharmaceutical composition according to any one of claims 1 to 3 in the preparation of a medicament for treating hyperlipidemia.

7. A Chinese medicine preparation for treating hyperlipidemia, characterized in that: The traditional Chinese medicine preparation comprises the pharmaceutical composition according to any one of claims 1 to 3.

8. The Chinese medicine preparation according to claim 7, characterized in that The dosage form of the Chinese medicine preparation is decoction, tablet, powder, powder, pill, granule, oral liquid, capsule or paste.

9. A health food that helps maintain healthy blood lipid levels, characterized in that: The health food comprises the pharmaceutical composition according to any one of claims 1 to 3.

10. The health food according to claim 9, characterized in that The health food is a beverage or an granule.

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