Traditional Chinese medicine composition suitable for lowering lipid and protecting liver as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition suitable for lowering lipid and protecting liver as well as a preparation method and application thereof. The traditional Chinese medicine composition comprises the following raw material components: red kidney beans, red yeast rice, Chinese yams, dendrobium nobile, Chinese wolfberry fruits, haws, lily bulbs, coix seeds, white hyacinth beans, fructus perillae, cassia seeds, fresh ginger, rhizoma polygonati, flaxseeds and black fungi. The composition aims at being simple, convenient and low in cost, has the biological activities of resisting oxidation, reducing lipid, protecting the liver, reducing blood sugar and the like, and can regulate lipid metabolism and sugar metabolism of an organism, inhibit oxidative stress reaction, inflammatory reaction and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition suitable for reducing lipids and protecting the liver, and a preparation method and application thereof. Background Art

[0002] Modern lifestyles have led to an increasing intake of high-protein, high-cholesterol, and high-sugar foods, resulting in a significant increase in the incidence of hyperlipidemia. Hyperlipidemia is a prerequisite for the development of atherosclerosis and is significantly correlated with the incidence of cerebrovascular disease. Hyperlipidemia is also a significant risk factor for coronary heart disease, arteriosclerosis, fatty liver disease, diabetes, and obesity. Furthermore, the number of people with dyslipidemia remains high, and the prevalence is trending towards younger people, leading to serious complications and posing a significant health risk.

[0003] Dyslipidemia in the Chinese population is primarily characterized by high triglycerides and low high-density lipoproteins, unlike Western populations, which are primarily characterized by high total cholesterol. Therefore, it is necessary to find a lipid-lowering drug that targets these dyslipidemias in the Chinese population. Furthermore, preventing and treating hyperlipidemia plays a crucial role in preventing cardiovascular and cerebrovascular diseases, making the research and development of safe and effective lipid-regulating drugs and health foods essential. Summary of the Invention

[0004] In order to overcome the above technical problems, the purpose of the present invention is to provide a traditional Chinese medicine composition suitable for lowering blood lipids and protecting the liver, as well as a preparation method and application thereof.

[0005] To achieve the above-mentioned and other related purposes, the present invention adopts the following technical solutions:

[0006] In a first aspect of the present invention, a traditional Chinese medicine composition suitable for reducing lipids and protecting the liver is provided, wherein the raw material components and their weight proportions in the traditional Chinese medicine composition are as follows:

[0007] 10-50 parts by weight of red kidney beans, 10-40 parts by weight of red yeast rice, 10-50 parts by weight of yam, 3-30 parts by weight of dendrobium, 6-30 parts by weight of wolfberry, 6-30 parts by weight of hawthorn, 1-15 parts by weight of lily, 6-30 parts by weight of coix seed, 3-20 parts by weight of white hyacinth bean; 5-30 parts by weight of perilla seed; 5-30 parts by weight of cassia seed, 1-15 parts by weight of ginger, 5-30 parts by weight of polygonatum, 5-20 parts by weight of flax seed, and 10-30 parts by weight of black fungus.

[0008] Among them, the Latin name of red kidney bean is Phaseolus vulgaris Linn.; the Latin name of red yeast rice is Monascus purpureus Went.; the Latin name of yam is Dioscorea opposita Thunb.; the Latin name of dendrobium is Dendrobium nobile Lindl.; the Latin name of wolfberry is Lycium chinense Mill.; the Latin name of hawthorn is Crataegus pinnatifida Bge.; the Latin name of lily is Lilium lancifolium Thunb.; the Latin name of coix seed is Coix lacryma-jobi var.ma-yuen; the Latin name of white lentil is Dolichos lablab L.; the Latin name of perilla seed is Perilla frutescens; the Latin name of cassia seed is Cassia obtusifolia L.; the Latin name of ginger is Zingiber officinale Roscoe; the Latin name of polygonatum is Polygonatum sibiricum Red. The Latin name of flaxseed is Linum usitatissimum L. The Latin name of black fungus is Auricularia auricula (L.exHook.) Underw.

[0009] Preferably, the components and their weight ratios in the traditional Chinese medicine composition are as follows:

[0010] 25-40 parts by weight of red kidney beans, 15-30 parts by weight of red yeast rice, 25-40 parts by weight of yam, 8-20 parts by weight of dendrobium, 8-20 parts by weight of wolfberry, 10-25 parts by weight of hawthorn, 1-10 parts by weight of lily, 10-25 parts by weight of coix seed, 8-18 parts by weight of white hyacinth bean; 10-25 parts by weight of perilla seed; 8-20 parts by weight of cassia seed, 1-10 parts by weight of ginger, 10-25 parts by weight of polygonatum, 6-15 parts by weight of flax seed, and 15-25 parts by weight of black fungus.

[0011] More preferably, 30-35 parts by weight of red kidney beans, 20-25 parts by weight of red yeast rice, 30-35 parts by weight of yam, 10-15 parts by weight of dendrobium, 10-15 parts by weight of wolfberry, 15-20 parts by weight of hawthorn, 2-5 parts by weight of lily, 15-20 parts by weight of coix seed, 10-15 parts by weight of white hyacinth bean; 15-20 parts by weight of perilla seed; 10-15 parts by weight of cassia seed, 2-5 parts by weight of ginger, 15-20 parts by weight of polygonatum, 8-12 parts by weight of flax seed, and 18-22 parts by weight of black fungus.

[0012] The second aspect of the present invention further provides a Chinese medicine extract, which is prepared by extracting effective ingredients from the above-mentioned lipid-lowering and liver-protecting Chinese medicine composition as a raw material.

[0013] In the present invention, the raw material components and their formulations in the lipid-lowering and liver-protecting Chinese medicine composition are the most critical. After knowing the Chinese medicine formula, those skilled in the art can directly grind or crush the various herbs according to the proportions and then mix them as the active ingredients. In addition, those skilled in the art can also use various conventional Chinese medicine active ingredient extraction methods to extract the active ingredients, such as conventional decoction, water extraction and alcohol precipitation, alcohol extraction and water precipitation, salting out, etc. Since the above extraction methods can obtain the main active ingredients in the aforementioned Chinese medicine formula, they can all have a certain therapeutic effect on lipid lowering.

[0014] After extracting the active ingredients from the lipid-lowering and liver-protecting traditional Chinese medicine composition, the extract can be concentrated using conventional methods to obtain a traditional Chinese medicine extract. Concentration methods include, but are not limited to, atmospheric evaporation, reduced pressure evaporation, thin-film evaporation, and multi-effect evaporation. Different extraction processes can be employed depending on the characteristics of the different active ingredients in the lipid-lowering and liver-protecting traditional Chinese medicine composition.

[0015] Furthermore, the third aspect of the present invention provides a method for preparing a Chinese herbal medicine extract, which comprises the steps of taking various Chinese herbal medicine components according to a ratio, grinding or crushing them evenly, and then mixing them.

[0016] (1) Add appropriate amount of purified water to Chinese yam, dendrobium, wolfberry, hawthorn, lily, coix seed, white hyacinth bean, perilla seed, cassia seed, ginger, polygonatum, flax seed and black fungus according to the proportion, soak, boil, filter and let stand to settle.

[0017] (2) After the filtered juice is concentrated until the concentrated liquid is in a spoonable state, red kidney beans and red yeast rice powder are added according to the proportion.

[0018] Preferably, the soaking time is 35 to 45 minutes, the decoction number is greater than or equal to 1 time, and the decoction time is 50 to 75 minutes.

[0019] Preferably, each Chinese medicinal component is crushed to a particle size D50 of less than 80 mesh.

[0020] A fourth aspect of the present invention provides the use of a Chinese medicine composition or a Chinese medicine extract in the preparation of a medicine having any of the following effects:

[0021] Lowering and / or regulating blood lipids;

[0022] Prevention and / or treatment of dyslipidemia;

[0023] Alleviate and / or eliminate liver tissue damage;

[0024] Assist and / or regulate blood sugar;

[0025] Protect the liver.

[0026] Furthermore, the dyslipidemia is hyperlipidemia, hypercholesterolemia or atherosclerosis.

[0027] Furthermore, the liver tissue damage is fatty liver, alcoholic liver, cirrhosis and liver fibrosis.

[0028] The fifth aspect of the present invention further provides a traditional Chinese medicine preparation comprising a therapeutically effective amount of the aforementioned traditional Chinese medicine extract and one or more conventional pharmaceutically acceptable excipients.

[0029] After the effective ingredients in the lipid-lowering and liver-protecting traditional Chinese medicine composition are extracted, conventional pharmaceutical excipients and additives can be used to prepare the traditional Chinese medicine preparation.

[0030] Pharmaceutically acceptable excipients include (but are not limited to): pharmaceutically acceptable carriers, diluents, fillers, binders and other excipients. Therapeutically inert inorganic or organic carriers known to those skilled in the art include (but are not limited to) lactose, corn starch or its derivatives, talc, vegetable oils, waxes, fats, polyol compounds such as polyethylene glycol, water, sucrose, ethanol, glycerol, and the like, various preservatives, lubricants, dispersants, flavoring agents. Moisturizers, antioxidants, sweeteners, colorants, stabilizers, salts, buffers and the like may also be added thereto. These substances are used as needed to help the stability of the formulation or to help improve its activity or its biological effectiveness or to produce an acceptable taste or smell in the case of oral administration. Traditional Chinese medicine preparations such as granules and ointments can be prepared by conventional methods. The lipid-lowering and liver-protecting traditional Chinese medicine composition of the present invention can also be used in conjunction with other therapeutic agents.

[0031] Preferably, the Chinese medicine preparation is one of clinically acceptable pills, powders, tablets, granules, oral pastes, tea bags, meal replacement powders, capsules or oral liquid preparations.

[0032] The effective therapeutic dose of the Chinese medicine preparation of the present invention is, based on the total weight of the raw medicinal materials, made into tablets (compressed candies), with an effective dose of 600 mg (per tablet) per use for adults, used twice a day (tablets); and based on the total weight of the raw medicinal materials magnified 1000 times and made into ointments, with an effective dose of 10 g (per strip) per use for adults, used twice a day (strips). Of course, the specific dosage should also take into account factors such as the route of administration and the patient's health status, which are all within the skill of a skilled physician.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] The compatibility principle of the lipid-lowering and liver-protecting Chinese medicine composition of the present invention is:

[0035] Red kidney beans can warm the middle and lower the qi, benefit the intestines and stomach, stop hiccups, and nourish the kidneys and replenish vital energy. Red yeast rice has the effects of strengthening the spleen and digestion, promoting blood circulation and removing blood stasis. Red kidney beans and red yeast rice work together to strengthen the spleen and digestion, and regulate blood lipids, and are both the main medicine;

[0036] Chinese yam nourishes qi and yin, consolidates essence and stops leukorrhea; dendrobium nourishes yin, clears heat, promotes fluid production and quenches thirst; wolfberry nourishes the liver and kidneys, improves essence and improves eyesight; hawthorn helps digestion and resolves accumulation, activates blood circulation and removes stasis; lily nourishes yin and moistens the lungs, clears the heart and calms the mind. These five herbs together serve as assistant ingredients, nourishing yin and strengthening the spleen, removing dampness and activating blood circulation. They also work in conjunction with red kidney beans to regulate qi and blood, balancing the warming and drying properties of the entire formula.

[0037] At the same time, coix seed is used to promote diuresis and eliminate dampness, white lentil nourishes the spleen and eliminates dampness, perilla seed and cassia seed descend qi and resolve phlegm, moisten the intestines and promote bowel movements, ginger warms the middle and stops vomiting, and polygonatum replenishes qi and nourishes yin, improving qi and yin deficiency. It assists the monarch and ministerial herbs to enhance efficacy, while also taking into account bowel movements and removing stagnation, forming a conditioning system that combines tonification and purgation, and takes into account both the symptoms and the root cause.

[0038] Flaxseed and black fungus harmonize the various medicines and help regulate blood lipids. The two are both guiding medicines.

[0039] Red kidney beans have high nutritional value and health benefits. They are rich in protein, vitamins, and trace elements such as calcium, iron, and magnesium. They are also rich in polysaccharides, which can effectively improve lipid metabolism in mice. Red yeast rice, a fermented product with a long history in my country, is made by inoculating rice with Monascus purpurogenum and was known as Danqu in ancient times. Furthermore, red yeast rice, flaxseed, and hawthorn can help regulate dyslipidemia in response to precursors of metabolic syndrome. Polygonatum sibiricum and Dendrobium can lower blood sugar levels, and combined with fiber-rich black fungus and flaxseed, they can slow blood sugar rise.

[0040] Compared to existing medications, this prescription offers unparalleled advantages, including its foundation on the concept of "National Geographic Medicinal and Edible Agricultural Fermented Bacteria" and its resource chain, which facilitates collaboration and drives the further transformation and revitalization of rural resources. Furthermore, this prescription incorporates the concept of "medicine and food have the same origin" and embodies a unique philosophy through its multi-dimensional synergistic conditioning, the integration of dynamic and static medicinal properties, and the combined effects of promoting both circulation and nourishment.

[0041] The dynamic balance between nourishment and purgation is different from simple tonic prescriptions. The present invention uses "purifying" drugs to dissolve the stagnation of tonics, which is suitable for modern people with a "virtual and full" constitution caused by a greasy diet and lack of exercise; it treats qi, blood, body fluids and other body fluids at the same time and regulates multiple systems. It breaks through the conditioning of a single system (such as simple spleen strengthening or yin nourishing) and has a comprehensive intervention effect on "qi, blood, body fluid metabolism disorders" (such as obesity, hyperlipidemia, and constipation); the proportion of medicines with the same origin as food is high, and it has both safety and practicality. Red kidney beans, yam, wolfberry, hawthorn, lily, coix seed, white lentil, ginger, black fungus, flax seeds, etc. are all common ingredients with mild medicinal properties, suitable for long-term conditioning, and the balance of medicinal properties avoids excessive bias. It is milder than bitter and cold prescriptions, and less damaging to yin than warm and dry prescriptions, and is suitable for the characteristics of modern people with a weak constitution and intolerance to attacks.

[0042] The whole prescription of the present invention is mainly based on invigorating the spleen and eliminating dampness, invigorating qi and nourishing yin, and has the effects of promoting blood circulation and removing blood stasis, clearing away heat and improving eyesight, etc., and is suitable for the relevant symptoms of spleen and stomach weakness, yin deficiency and fluid deficiency with phlegm dampness or blood stasis. The monarch drug lays the foundation for invigorating the spleen and promoting blood circulation, the minister drug strengthens the effects of nourishing yin, digesting food and calming the mind, and the adjuvant drug removes dampness and resolves phlegm, relieves constipation and warms the middle, so that the drug guides and harmonizes the other drugs, and the whole prescription has the effect of regulating blood lipids and blood sugar, which embodies the traditional Chinese medicine's compatibility idea of "taking into account both the symptoms and the root cause, and regulating both the positive and the negative". Through the "compatibility wisdom of both promoting and supplementing, the safety of the same origin of medicine and food, and the targeted intervention of modern diseases", an overall advantage is formed, which is in line with the core idea of "differentiation and treatment based on syndrome differentiation" of traditional Chinese medicine, and is close to the physical characteristics of modern people with "mixed deficiency and excess, and metabolic imbalance", and has irreplaceable comprehensive value in preventing and regulating the prodromal symptoms of chronic diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 : Body weight changes during modeling, n=10-50.

[0044] Figure 2 : The weight changes of each group during the experimental period.

[0045] Figure 3 : Changes in food intake of each group during the experimental phase.

[0046] Figure 4 : The body shape changes of mice in each group during the experimental phase, where A: low-fat diet group; B: high-fat model group; C: red kidney bean and red yeast rice compound group; D: metformin group.

[0047] Figure 5 : Effect diagram of lipid accumulation in the liver of mice in each group during the experimental phase, where A: low-fat diet group; B: high-fat model group; C: red kidney bean and red yeast rice compound group; D: metformin group.

[0048] Figure 6 : Effect diagram of organ indexes of mice in each group during the experimental period, where A: liver index; B: kidney index; C: spleen index; D: epididymal fat index.

[0049] Figure 7 : Graph showing the effects of each group on the blood lipid levels of mice during the experimental phase.

[0050] Figure 8 : Effect diagram of liver lipid levels in mice of each group during the experimental period, where A: TC content; B: TG content.

[0051] Figure 9 : Effect diagram of fecal lipid levels of mice in each group during the experimental period, where A: TC content; B: TG content.

[0052] Figure 10: Effects of ALT and AST levels in serum of mice in each group during the experimental phase.

[0053] Figure 11 : Effects of ALP and TBIL levels in serum of mice in each group during the experimental phase.

[0054] Figure 12 : HE staining results of liver tissues in each group, including A: low-fat diet group; B: high-fat model group; C: red kidney bean and red yeast rice compound group; D: metformin group. DETAILED DESCRIPTION

[0055] Before further describing the specific embodiments of the present invention, it should be understood that the scope of the present invention is not limited to the specific embodiments described below. It should also be understood that the terminology used in the examples is intended to describe specific embodiments and is not intended to limit the scope of the present invention. The experimental procedures in the following examples, where specific conditions are not specified, were generally performed under conventional conditions or according to the conditions recommended by the respective manufacturers.

[0056] When the embodiments provide numerical ranges, it should be understood that, unless otherwise specified in the present invention, both endpoints of each numerical range and any numerical value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by those skilled in the art. In addition to the specific methods, equipment, and materials used in the embodiments, according to the understanding of the prior art by those skilled in the art and the description of the present invention, any methods, equipment, and materials of the prior art similar or equivalent to the methods, equipment, and materials described in the embodiments of the present invention may also be used to implement the present invention.

[0057] Unless otherwise stated, the test methods, detection methods, and preparation methods disclosed in the present invention all adopt conventional techniques in the art.

[0058] The raw materials (or medicinal materials) used in the present invention can be purchased from ordinary pharmacies or Chinese medicinal material sales companies, and their specifications comply with national pharmaceutical standards or relevant regulations such as the Chinese Pharmacopoeia. Unless otherwise specified, the medicinal materials used are all Chinese medicinal material slices, which can also be processed after being obtained.

[0059] The efficacy criteria of the present invention refer to the relevant efficacy criteria in the "Standards for Determining the Efficacy of Traditional Chinese Medicine Diseases". Cured: All clinical symptoms disappear, and laboratory tests are normal. Improved: Clinical symptoms are alleviated, and laboratory tests are improved or normal. Ineffective: Clinical symptoms do not improve significantly or worsen.

[0060] The preparation process of the present invention applies the "Technical Requirements for Research on Preparation Process of New Chinese Medicines" in principle, uses modern preparation technologies to extract the main active ingredients of the medicine for use as medicine, and adds some pharmaceutically acceptable excipients or carriers.

[0061] Toxicological safety evaluation

[0062] ①Acute oral toxicity test.

[0063] Acute oral toxicity tests are conducted using healthy rats. After orally administering Chinese herbal medicine extract samples to the experimental animals once or multiple times within 24 hours, the health damage effects that appear in the animals in the short term are observed, including determining the median lethal dose (concentration), observing the symptoms of acute poisoning, the ability to be absorbed through the skin, and whether there is any local irritation to the skin, mucous membranes and eyes.

[0064] ②Three genetic toxicity tests.

[0065] Conduct microbial reverse mutation tests, chromosome aberration tests in mammalian cultured cells, and in vivo tests to detect direct or indirect induction of genetic damage through different mechanisms.

[0066] ③90d oral toxicity test.

[0067] Conduct a 90-day oral toxicity test to evaluate the toxic effects of the test substance on animals, further determine the safety range of the test substance, and provide a basis for the toxic effects and maximum tolerated dose of animals.

[0068] (6) Clinical observation and data collection

[0069] Clinical trials of a multi-component formula product containing red kidney beans, red yeast rice, and yam were conducted, collecting clinical data from 30 cases each of compressed candies (including capsules and soft capsules), meal replacement powders, tea bags, and bagged oral ointments. The clinical efficacy was evaluated by testing blood lipid indicators, including serum total cholesterol, apolipoprotein A, apolipoprotein B, high-density lipoprotein, low-density lipoprotein, and triglycerides. At the same time, the safety of the medication and the occurrence of adverse reactions were monitored based on the subjects' liver and kidney function indicators. Toxicity testing revealed that the lipid-lowering and liver-protecting Chinese medicine composition of the present invention and the resulting Chinese medicine preparations showed no adverse reactions.

[0070] Example 1

[0071] This Example 1 provides the raw material components and their weight ratios in the traditional Chinese medicine composition suitable for lowering blood lipids and protecting the liver of the present invention.

[0072] Table 1 Formula components (unit: g)

[0073] Recipe 1 Recipe 2 Recipe 3 Recipe 4 Recipe 5 Recipe 6 Recipe 7 Comparison 1 Red Kidney Beans 32 30 35 25 40 10 50 32 Red Yeast Rice 22 25 20 30 15 40 10 22 yam 32 35 30 25 40 10 50 32 Dendrobium 12 10 15 8 20 30 3 12 wolfberry 12 15 10 20 8 6 30 12 hawthorn 18 20 15 10 25 30 6 18 lily 3 2 5 10 1 15 1 3 Job's tears 18 15 20 25 10 6 30 0 White lentils 12 15 10 8 18 20 3 0 Perilla seeds 17 15 20 25 10 5 30 0 Cassia seeds 12 10 15 8 20 30 5 0 ginger 3 5 2 10 1 1 15 0 Polygonatum sibiricum 17 15 20 10 25 30 5 0 flaxseed 10 12 8 6 15 20 5 10 black fungus 20 18 22 15 25 10 30 20

[0074] Preparation method: Prepare the raw materials according to Formulas 1-7 and Comparative Formula 1 in Table 1. Grind the raw materials into powder and pass through a 200-mesh sieve. Soak Chinese yam, dendrobium, hawthorn, lily, coix seed, white lentil, perilla seed, ginger, polygonatum, linseed, and black fungus in appropriate amounts of water for 40 minutes, then high-pressure decoction for 60 minutes or repeat the decoction twice, and filter the juice (which can be allowed to settle after filtration); concentrate the filtered juice over low heat while stirring continuously until the concentrate is sticky. Add red kidney bean and red yeast rice powder in the above proportions, stir evenly, and cool for later use. Formulas 1-7 and Comparative Formula 1 can be replaced with auxiliary materials, and after cooling, divide them into portions for later use.

[0075] Example 2

[0076] This Example 2 is used to verify the therapeutic effect of Formula 1 prepared in Example 1.

[0077] 1. Animals

[0078] Sixty healthy SPF-grade C57BL / 6J males, 4-5 weeks old and weighing 16-18 g, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd. Mice were housed and experiments were conducted in an SPF-grade environment at the Shanghai University of Traditional Chinese Medicine Laboratory Animal Research Center. The room temperature was maintained at 24-26°C, the humidity at 40-60%, and the lighting was cycled 12 h on and off.

[0079] 2. Construction of a Diet-Induced Obese Mouse Model

[0080] After 3 days of adaptive feeding, 60 C57BL / 6J mice weighed 20 ± 2 g. They were randomly assigned to a low-fat diet group (10 weeks), and the remaining 50 mice were placed in the modeling group and fed a high-fat diet for 10 weeks.

[0081] At week 10, the body weights of mice in the low-fat and high-fat diet groups were measured respectively. A body weight exceeding 120% of the average body weight of mice in the low-fat diet group was used as the inclusion criteria for the diet-induced obesity (DIO) mouse model, and high-fat obese mice that met the modeling conditions were screened.

[0082] 3. Animal Grouping and Dosing

[0083] Ten mice fed a low-fat diet were randomly assigned to the low-fat diet group. Meanwhile, 30 mice from the DIO modeling group that met the inclusion criteria were randomly divided into three groups: a high-fat model group, a red kidney bean and red yeast rice compound group (i.e., Formula 1 in Example 1), and a metformin group, with 10 mice in each group. Drugs were administered by gavage daily at 9:00 AM, with dosing information shown in Table 2, for 5 weeks, at a gavage coefficient of 0.1 mL / 10 g.

[0084] Table 2 Animal grouping and drug administration

[0085] Group Modeling method drug Dosage (mg / kg) Low-fat diet group low-fat feed water / High-fat model group high-fat feed water / Red kidney bean and red yeast rice compound group high-fat feed Red kidney bean and red yeast rice compound group 180 Metformin group high-fat feed Metformin 250

[0086] Note: Red yeast rice is a combination of red yeast rice fermentation products and their secondary metabolites.

[0087] 4. Serum index detection

[0088] After standing at room temperature for 4 hours, whole blood was centrifuged at 5000 rpm at 4°C, and the supernatant was aliquoted into 0.5 mL EP tubes. Serum levels of TG, TC, LDL-c, HDL-c, ALT, AST, ALP, and TBIL were measured in each group using an automated biochemical analyzer, strictly following the manufacturer's instructions and instrument SOPs.

[0089] 5. Test results

[0090] 5.1 Construction of diet-induced obesity animal model

[0091] Depend on Figure 1 As can be seen, the average weight of mice fed a high-fat diet gradually widened after 30 days compared to mice fed a low-fat diet, and this gap continued to widen until week 10. The average weight of the high-fat mice reached over 125% of that of the low-fat mice, indicating that the high-fat diet-induced obese mouse model can be used for subsequent lipid-lowering drug efficacy evaluation.

[0092] 5.2 Effect of Red Kidney Bean and Red Yeast Rice Compound on Body Weight in DIO Mice

[0093] from Figure 2 As shown, after the DIO mice were divided into groups based on body weight data, their initial weights before dosing were similar, with no significant differences between groups (p>0.05). The mean weight of the mice in the low-fat diet group varied by more than 6g. Over the five-week dosing period, the average weight of the mice in the low-fat diet group fluctuated between 28g and 30g, while the average weight of the animals in the high-fat diet group increased by nearly 5g. The weight of mice receiving 250mg / kg metformin by gavage began to decrease from day 10. Compared with the high-fat diet group, the weight of mice receiving metformin by gavage showed a significant difference, which was maintained until the end of the study. The weight of mice receiving the red kidney bean compound by gavage continued to increase slowly, remaining slightly higher than that of the metformin group throughout the study. After 28 days of feeding, the weight of the mice in the red kidney bean and red yeast rice compound group was significantly lower than that of the high-fat diet group until the end of the study. The results showed that long-term administration of red kidney bean and red yeast rice compound can effectively reduce the trend of continuous weight increase in DIO mice caused by high-fat diet, showing an intervention effect on the weight of obese mice.

[0094] 5.3 Effect of Red Kidney Bean and Red Yeast Rice Compound on Food Intake in Mice

[0095] Depend on Figure 3 It can be seen that mice fed a low-fat diet consumed an average of over 3g of feed per day, consistent with normal feed consumption for C57BL / 6 mice. However, the average daily feed intake of all three groups of DIO mice fed a high-fat diet was less than 3g, lower than that of the low-fat group, consistent with the observed decrease in food intake seen in animals fed a long-term high-fat diet. Furthermore, the food intake of mice in the red kidney bean and red yeast rice compound group was slightly higher than that in the high-fat model group, suggesting that oral administration of the red kidney bean and red yeast rice compound had no effect on the food intake of DIO mice, and its ability to inhibit rapid weight gain in animals was unrelated to suppressing food intake.

[0096] 5.4 Effect of Red Kidney Bean and Red Yeast Rice Compound on Body Shape in DIO Mice

[0097] Depend on Figure 4 It can be seen that compared with normal mice fed a low-fat diet, the body size of the high-fat model group mice that received a high-fat diet for a long time was significantly larger. However, the body size of the mice that received the red kidney bean and red yeast rice compound intervention was relatively small, comparable to that of the metformin group. 5.5 Effect of the red kidney bean and red yeast rice compound on organ indexes and organ morphology of DIO mice

[0098] Depend on Figure 5 It can be seen that the livers of mice in the low-fat diet group were of moderate size (approximately 2.2×2 cm) and had a healthy reddish-brown color. The livers of mice in the high-fat model group were enlarged (approximately 3×2.2 cm) compared to those in the low-fat diet group, and their color was relatively sallow. The liver tissue volume of mice in the red kidney bean and red yeast rice compound group was between the low-fat and high-fat diet groups, at approximately 2.2×2.5 cm, and its color was also redder than that of the high-fat diet group. The liver tissue volume of the metformin group was 2.5×2 cm, which was lower than that of the red kidney bean compound group, and its color was closer to that of the low-fat diet group. The above results indicate that the administration of the red kidney bean and red yeast rice compound can effectively reduce the lipid accumulation and enlargement of the liver tissue of mice induced by a high-fat diet.

[0099] from Figure 6 As shown in Figure A, a high-fat diet significantly increases the liver index in mice, suggesting that a large amount of fat accumulates in the liver tissue, causing overall liver enlargement and weight gain. Simultaneously consuming a red kidney bean and red yeast rice compound and metformin on a high-fat diet effectively reduces the liver index in DIO mice, demonstrating an interventional effect on abnormal lipid metabolism. Figure 6 B shows that high-fat diet and drug intervention had no effect on the renal index of mice.

[0100] from Figure 6 C showed that the high-fat diet model caused the spleen index of DIO mice to be lower than that of the low-fat group, and the intake of red kidney bean and red yeast rice compound and metformin intervention had no significant effect on this. Figure 6D shows that a high-fat diet causes a significant increase in the ratio of epididymal fat pad to body weight in animals, and the administration of a red kidney bean and red yeast rice compound can reduce the value of epididymal fat to a certain extent (but after statistics, there is no significant difference).

[0101] 5.6 Effects of Red Kidney Bean and Red Yeast Rice Compound on Blood Lipid Levels in DIO Mice

[0102] from Figure 7 A shows that compared with the low-fat diet group, the TC, LDL-c and TG levels in the serum of mice in the high-fat model group were significantly increased (p < 0.01), but there was no significant change in the HDL-c level. This shows that in addition to a significant increase in body weight compared with low-fat mice, the DIO model constructed using a high-fat diet also has significant differences in blood lipid levels, which can be used to evaluate the efficacy of lipid-lowering drugs.

[0103] from Figure 7 A shows that in terms of TC level, the administration of red kidney bean and red yeast rice compound can significantly reduce the TC content, which is better than the group given 250 mg / kg metformin during the same period, indicating that the red kidney bean and red yeast rice compound can effectively reduce the total cholesterol level of DIO mice.

[0104] like Figure 7 As shown in Figure B, the overall trend of the effect of the red kidney bean and red yeast rice compound on LDL-c levels was similar to that of TC. Under high-fat diet conditions, both showed a trend toward lowering serum LDL-c levels, but there was no significant difference compared to the high-fat model group (p>0.05). Combined with the data presented for TC and HDL-c, long-term use of the red kidney bean and red yeast rice compound can lower DIO hour total cholesterol levels.

[0105] like Figure 7 As shown in B, in terms of serum TG levels, both red kidney bean compound and metformin can effectively reduce the serum triglyceride levels of obese mice, indicating that long-term use of red kidney bean and red yeast rice compound can effectively reduce the abnormal serum lipid metabolism caused by a high-fat diet and maintain a lower blood lipid level.

[0106] 5.7 Effect of Red Kidney Bean and Red Yeast Rice Compound on Liver Lipid Content in DIO Mice

[0107] from Figure 8 It can be seen that the data of each group in liver tissue TC ( Figure 8 A), TG( Figure 8 The content of B) in the model group was consistent, showing a significant increase compared with the low-fat group, and a significant decrease after the intervention of red kidney bean and red yeast rice compound and metformin, indicating that both can effectively intervene in lipid accumulation in the liver of obese high-fat mice.

[0108] 5.8 Effect of Red Kidney Bean and Red Yeast Rice Compound on Fecal Lipid Content in DIO Mice

[0109] Long-term high-calorie food intake can lead to weight gain, increased blood lipids, and accumulation of lipids in liver tissue. At the same time, normal lipid metabolism in the body also includes excretion through feces.

[0110] from Figure 9 As shown in Figure A, metformin administration effectively increased total cholesterol levels in the feces of DIO mice, thereby metabolizing and excreting excess TC in the diet that the body cannot utilize, effectively maintaining cholesterol homeostasis. This experiment also demonstrated that long-term administration of the red kidney bean and red yeast rice compound also demonstrated the efficacy of utilizing feces to encapsulate and excrete more cholesterol.

[0111] from Figure 9 As shown in B, the administration of red kidney bean compound red yeast rice can also effectively increase the TG content in feces, thereby excreting more triglycerides from the body and effectively resisting the symptoms of lipid metabolism disorders caused by a high-fat diet.

[0112] 5.9 Effects of Red Kidney Bean and Red Yeast Rice Compound on Liver Damage Indicators in DIO Mice

[0113] ALT and AST are the most common clinical indicators used to detect the degree of liver tissue damage. Long-term exposure to a high-fat diet environment puts the body in a state of overall chronic inflammation, which in turn damages liver cells. Figure 10 In this study, after 15 weeks of high-fat diet, the high-fat model group mice showed significantly increased serum ALT and AST levels compared to the low-fat group, accompanied by obesity and lipid accumulation, indicating some liver cell damage. Five weeks after administration of the red kidney bean and red yeast rice compound significantly reduced these liver damage indicators, surpassing the effects observed with 250mg / kg metformin administration during the same period, suggesting that long-term administration of the red kidney bean and red yeast rice compound may have a protective effect against liver cell damage induced by a high-fat diet.

[0114] like Figure 11 As shown in A, under high-fat conditions, the adipocytes of obese animals secrete a variety of cytokines and hormones, which lead to increased synthesis and release of ALP in liver cells. After metformin administration, the ALP content in the serum of DIO mice was significantly reduced, showing a protective effect against liver lipid metabolism disorders. The administration of red kidney bean and red yeast rice compound was also observed to reduce the ALP content in the serum of obese mice, but there was no significant difference compared with the model group. Finally, Figure 11 B indicates that the high-fat diet and drug intervention used in this experiment had no effect on the total bilirubin index of DIO mice.

[0115] 5.10 Effects of Red Kidney Bean and Red Yeast Rice Compound on Liver Histomorphology in DIO Mice

[0116] like Figure 12H&E staining of liver tissue visually demonstrates the extent of liver cell damage in animals exposed to high-fat diets. The results showed that the liver tissue of mice fed a low-fat diet had intact hepatic lobule structures, clear cytoplasm and nuclei, and hepatocytes arranged radially from the central vein.

[0117] like Figure 12 As shown in Figure B, the liver tissue cells of mice in the high-fat model group were extremely swollen, and the cytoplasm of the liver cells contained fat vacuoles of varying sizes. The cell nucleus had deviated from the center of the cell and was squeezed to one side of the cell. This is a typical fatty degeneration of liver cells, showing symptoms of fatty liver.

[0118] Compared with the high-fat diet model group, the hepatocytes of mice in the red kidney bean and red yeast rice compound group showed reduced swelling, with relatively clear and intact cytoplasmic and nuclear morphology. At 100x magnification, the degree of fat vacuolation within different regions of the field of view was significantly reduced. Compared with the model group, the overall condition was closer to that of the low-fat diet group. Furthermore, pathological section results showed that the overall condition of the metformin group was comparable to that of the red kidney bean and red yeast rice compound group. Long-term administration of the red kidney bean and red yeast rice compound has a moderate effect on improving hepatocyte swelling and vacuolation induced by a high-fat diet.

[0119] 6. Summary

[0120] A high-fat diet was used to establish a dietary-induced obese mouse model to evaluate the intervention effect of red kidney bean and red yeast rice compound on obesity and lipid metabolism disorders in DIO mice.

[0121] The study found that under high-fat conditions, continuous gavage of a red kidney bean and red yeast rice compound for five weeks, without affecting food intake, inhibited the rapid weight gain of DIO mice and significantly reduced excessive lipid accumulation in abdominal organs. Blood biochemistry tests indicated that administration of the red kidney bean and red yeast rice compound significantly reduced serum levels of TG, TC, LDL-c, as well as ALT and AST in DIO mice, demonstrating lipid-lowering and liver-protective effects. Histopathological morphological analysis also revealed that the degree of liver cell vacuolation was reduced in mice treated with the red kidney bean and red yeast rice compound. In summary, long-term administration of the red kidney bean and red yeast rice compound has a protective effect against lipid metabolism disorders such as weight gain, lipogenesis, organ lipid accumulation, and elevated blood lipids under high-calorie conditions.

[0122] However, relevant studies have shown that long-term use of metformin may pose certain risks to patients' gastrointestinal tract, liver and kidney function, and hypoglycemia. Furthermore, long-term use of metformin may cause gastrointestinal adverse side effects such as nausea, vomiting, diarrhea, abdominal pain, and bloating, with an incidence rate of approximately 15-25%. Controlling the dosage is an effective measure to alleviate these symptoms, so patient compliance with daily medication is a relatively important medical requirement.

[0123] At the same time, the risk of hypoglycemia when taking metformin alone is generally low, but the risk of hypoglycemia will increase when it is taken in combination with insulin or other sulfonylurea drugs.

[0124] Regarding the burden on liver and kidney function, approximately 90% of metformin is excreted unchanged through renal tubular secretion and glomerular filtration, with only a small amount broken down into inactive metabolites by enzymes in the gut flora or blood. Renal impairment may affect drug clearance, so the dosage should be adjusted based on renal function.

[0125] The red kidney bean and red yeast rice formula, as a combination of medicine and food, does not show any related risks and influencing factors in the above issues, and is more suitable for patients to take for a long time. In addition, the results in Example 2 show that the effects of the metformin group are basically equivalent in terms of body shape maintenance, organ morphology and index, and food intake. The red kidney bean and red yeast rice group is better than the metformin group in alleviating liver damage and resisting the symptoms of lipid metabolism disorders caused by a high-fat diet, making it more suitable for patients to take for a long time.

[0126] Example 3

[0127] Animal models were constructed and dosed using the same methods as in Example 2, and the therapeutic effects of Formulas 1-7, Comparative Formula 1, and a blank control (high-fat model group) prepared in Example 1 were investigated. Formulas 1-7, Comparative Formula 1, and the high-fat model group were all fed the high-fat diet described in Example 2, and were gavaged with Formulas 1-7 and Comparative Formula 1 according to the method of Example 2. The blank control group was fed the high-fat diet described in Example 2, and this group of mice served as the high-fat model group.

[0128] Treatment results:

[0129] Formula 1 group in Example 1: Compared with the blank control, the lipid-lowering and liver-protecting effects of Formula 1 are particularly prominent. In terms of body weight, the trend of continuous increase in body weight of mice in Formula 1 group was significantly reduced, and the average body weight was maintained at 37.79g, showing a good intervention effect. In terms of body shape, the mice in Formula 1 group were significantly smaller than those in the high-fat model group. In terms of organ morphology, the volume of liver tissue in Formula 1 group was approximately 2.2×2.5cm, which was significantly lower than that in the high-fat model group (approximately 3×2.2cm). In terms of the impact of liver damage indicators, ALT in Formula 1 group was 105.4IU / L, AST was 127.1IU / L, and ALP was 122.5IU / L. Compared with ALT of 170.1IU / L, AST of 189.9IU / L, and ALP of 157.1IU / L in the high-fat model group, the indicators were greatly reduced, which played a significant protective role. Regarding blood lipid levels, Formula 1 showed TC at 5.57 mmol / L and TG at 1.14 mmol / L, effectively lowering total cholesterol levels, a significant decrease compared to the high-fat model group (TC at 6.78 mmol / L and TG at 1.59 mmol / L). Regarding fecal lipid levels, Formula 1 effectively increased fecal TG levels, increasing by 39.42% compared to the blank control group. This increased triglyceride excretion, effectively counteracting the lipid metabolism disorders caused by a high-fat diet.

[0130] Formula 2 and Formula 3: The lipid-lowering and liver-protecting effects of Formula 2 and Formula 3 are slightly inferior to those of Formula 1. In terms of body weight, the trend of continuous increase in body weight of mice in Formula 2 and Formula 3 groups was significantly reduced, and the average body weight was maintained at 38.91g, showing a better weight intervention effect relative to the high-fat model group. In terms of body shape, the mice in Formula 2 and Formula 3 groups were relatively small. Compared with the high-fat model group, the mice in Formula 2 and Formula 3 groups were significantly smaller. In terms of organ morphology, the liver tissue volume in Formula 2 and Formula 3 groups was approximately 2.2×2.7cm, which was significantly lower than that in the high-fat model group (approximately 3×2.2cm). In terms of the impact on liver damage indicators, the average ALT in Group 2 and Group 3 was 124.5 IU / L, AST was 147.7 IU / L, and ALP was 135 IU / L. These indicators were significantly lower than those in the high-fat model group (170.1 IU / L, AST was 189.9 IU / L, and ALP was 157.1 IU / L), but slightly higher than those in Group 1. In terms of the impact on blood lipid levels, the average TC in Group 2 and Group 3 was 6.01 mmol / L and TG was 1.24 mmol / L, effectively lowering total cholesterol levels. These were significantly lower than those in the high-fat model group (TC was 6.78 mmol / L and TG was 1.59 mmol / L), but slightly higher than those in Group 1. In terms of the effect on fecal fat content, Formula 2 and Formula 3 groups were also able to effectively increase the TG content in feces, which increased by 30.93% compared with the blank control group and decreased by 8.49% compared with Formula 1, thereby excreting more triglycerides from the body and effectively resisting the symptoms of lipid metabolism disorders caused by a high-fat diet.

[0131] Formula 4 and Formula 5: The lipid-lowering and liver-protective effects of Formula 4 and Formula 5 were slightly inferior to those of Formula 2 and Formula 3. In terms of body weight, the continuously increasing weight trend of mice in Formula 4 and Formula 5 groups was reduced to a certain extent, with the average weight maintained at 39.26g, indicating a certain intervention effect. In terms of body size, the mice in Formula 4 and Formula 5 groups were relatively small, slightly different from the high-fat model group. In terms of organ morphology, the liver tissue volume in Formula 4 and Formula 5 groups was approximately 2.2×2.8cm, slightly lower than that of the high-fat model group (approximately 3×2.2cm). In terms of liver damage indicators, blood lipid levels, and fecal fat content, Formula 4 and Formula 5 showed a certain reduction compared to the blank control group, but a slight increase compared to Formula 2 and Formula 3. They also slightly increased the content of triglycerides in feces, which increased by 19.58% compared to the blank control group and decreased by 11.35% compared to Formula 2 and Formula 3.

[0132] Formula 6 and Formula 7: The lipid-lowering and liver-protective effects of Formula 6 and Formula 7 were similar to those of Formula 4 and Formula 5. In terms of body weight, the mice in Formula 6 and Formula 7 groups showed a slight decrease from the trend of continuous increase in body weight, with the average body weight maintained at 39.59g, indicating a certain intervention effect. In terms of body size, the mice in Formula 6 and Formula 7 groups were relatively small, with little difference from the high-fat model group. In terms of organ morphology, the liver tissue volume in Formula 6 and Formula 7 groups was approximately 2.2×2.8cm, similar to that in Formula 4 and Formula 5 groups. In terms of liver damage indicators, blood lipid levels, and fecal fat content, Formula 6 and Formula 7 showed a smaller decrease compared to the blank control group, but a slight increase compared to Formula 4 and Formula 5. The effect on increasing fecal TG content was relatively small, increasing by 8.97% compared to the blank control group and decreasing by 10.61% compared to Formula 4 and Formula 5.

[0133] Therapeutic Effects of Comparative Formula 1: The lipid-lowering and hepatoprotective effects of Comparative Formula 1 were significantly lower than those of Formula 6 and Formula 7. In terms of body weight, the mice in the Comparative Formula 1 group showed a continuous upward trend, maintaining an average weight of 40.72g, which was lower than that of the high-fat model group, but not significantly so, indicating that the intervention effect of Comparative Formula 1 on body weight was not significant. In terms of body size, the mice in the Comparative Formula 1 group were similar in size to those in Formula 6 and Formula 7. In terms of organ morphology, the liver tissue volume in the Comparative Formula 1 group was approximately 2.2 x 3.0 cm, similar to that of the high-fat model group. Comparative Formula 1 showed no significant reduction in liver damage indicators, blood lipid levels, and fecal lipid content compared to the blank control group, but showed significant increases compared to Formulas 6 and 7. The effect on fecal triglyceride content was also not significant, increasing by 2.54% compared to the blank control group, decreasing by 6.43% compared to Formulas 6 and 7, and decreasing by 36.88% compared to Formula 1.

[0134] The results in Example 3 show that the effects of the formulas formed under different ratios in terms of lipid lowering and liver protection are roughly in the order of Formula 1 > Formulas 2 and 3 > Formulas 4 and 5 > Formulas 6 and 7 > Comparative Formula 1. Combined with Example 2, it is further verified that the Chinese medicine composition of the present invention has the effects of alleviating liver tissue damage, lowering blood lipids, effectively increasing the content of TG in feces, excreting more triglycerides from the body, effectively resisting the symptoms of lipid metabolism disorders caused by a high-fat diet, and maintaining weight under a high-fat diet.

[0135] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical principles disclosed herein are intended to be covered by the claims of the present invention.

Claims

1. A Chinese medicine composition suitable for lowering blood lipids and protecting the liver, characterized in that it comprises the following components: 10-50 parts by weight of red kidney beans, 10-40 parts by weight of red yeast rice, 10-50 parts by weight of yam, 3-30 parts by weight of dendrobium, 6-30 parts by weight of wolfberry, 6-30 parts by weight of hawthorn, 1-15 parts by weight of lily, 6-30 parts by weight of coix seed, 3-20 parts by weight of white hyacinth bean, 5-30 parts by weight of perilla seed, 5-30 parts by weight of cassia seed, 1-15 parts by weight of ginger, 5-30 parts by weight of polygonatum, 5-20 parts by weight of flaxseed, and 10-30 parts by weight of black fungus.

2. The Chinese medicine composition according to claim 1, characterized in that it comprises the following components: 25-40 parts by weight of red kidney beans, 15-30 parts by weight of red yeast rice, 25-40 parts by weight of yam, 8-20 parts by weight of dendrobium, 8-20 parts by weight of wolfberry, 10-25 parts by weight of hawthorn, 1-10 parts by weight of lily, 10-25 parts by weight of coix seed, 8-18 parts by weight of white hyacinth bean, 10-25 parts by weight of perilla seed, 8-20 parts by weight of cassia seed, 1-10 parts by weight of ginger, 10-25 parts by weight of polygonatum, 6-15 parts by weight of flax seed, and 15-25 parts by weight of black fungus.

3. The Chinese medicine composition according to claim 1, characterized in that Includes the following components: 30-35 parts by weight of red kidney beans, 20-25 parts by weight of red yeast rice, 30-35 parts by weight of yam, 10-15 parts by weight of dendrobium, 10-15 parts by weight of wolfberry, 15-20 parts by weight of hawthorn, 2-5 parts by weight of lily, 15-20 parts by weight of coix seed, 10-15 parts by weight of white hyacinth bean, 15-20 parts by weight of perilla seed, 10-15 parts by weight of cassia seed, 2-5 parts by weight of ginger, 15-20 parts by weight of polygonatum, 8-12 parts by weight of flax seed, and 18-22 parts by weight of black fungus.

4. A Chinese medicine extract, which is obtained by extracting effective ingredients from the Chinese medicine composition according to any one of claims 1 to 3.

5. A method for preparing the Chinese medicine extract according to claim 4, characterized in that: The method comprises the steps of: (1) Add appropriate amount of purified water to Chinese yam, dendrobium, wolfberry, hawthorn, lily, coix seed, white hyacinth bean, perilla seed, cassia seed, ginger, polygonatum, flax seed, and black fungus according to the proportion, soak, boil, and filter in sequence; (2) The filtered juice is concentrated over low heat until the concentrated liquid is sticky on the spoon, and then red kidney beans and red yeast rice powder are added according to the proportion.

6. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine extract according to claim 4 in the preparation of a medicine having any of the following effects: (1) Lowering and / or regulating blood lipids; (2) prevention and / or treatment of dyslipidemia; (3) Alleviate and / or eliminate liver tissue damage; (4) Assist and / or regulate blood sugar; (5) Protect the liver.

7. The use according to claim 6, characterized in that The dyslipidemia is hyperlipidemia, hypercholesterolemia or atherosclerosis.

8. The use according to claim 6, characterized in that The liver tissue damage includes fatty liver, alcoholic liver, cirrhosis and liver fibrosis.

9. A traditional Chinese medicine preparation comprising a therapeutically effective amount of the traditional Chinese medicine extract according to claim 4 and one or more conventional pharmaceutically acceptable excipients.

10. The Chinese medicine preparation according to claim 9, characterized in that The Chinese medicine preparation is one of clinically acceptable pills, powders, tablets, granules, oral pastes, tea bags, meal replacement powders, capsules or oral liquid preparations.

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