Rhizoma coptidis stir-fried with bran and processing method therefor, weight loss composition, and weight loss product

Abstract

Rhizoma coptidis stir-fried with bran and a processing method therefor, a weight loss composition, and a weight loss product. The processing method for the rhizoma coptidis stir-fried with bran comprises: putting wheat bran into a container for stir-frying, adding rhizoma coptidis decoction pieces when smoke is generated, and stir-frying the rhizoma coptidis decoction pieces over low heat until the surfaces thereof turn yellow or dark yellow to obtain the rhizoma coptidis stir-fried with bran. The weight loss composition comprises rhizoma coptidis stir-fried with bran, and radix aucklandiae, and further comprises at least one of fructus evodiae, rhizoma curcumae longae, flos lonicerae confusae and rhizoma dioscoreae. The weight loss product comprises the weight loss composition.

Description

Fried coptis root with bran, preparation method thereof, weight loss composition and weight loss product Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a bran-fried coptis root and a preparation method thereof, a weight loss composition and a weight loss product. Background Art

[0002] Obesity is a serious public health issue plaguing both developed and developing countries, and is closely linked to rising mortality rates and declining quality of life. Obesity is a condition characterized by excess energy intake, resulting from energy expenditure. Normal energy balance is influenced by genetic, epigenetic, lifestyle, and environmental factors. Obesity increases the risk of developing and promotes the development of numerous chronic diseases, including type 2 diabetes, hypertension, non-alcoholic fatty liver disease, cardiovascular disease, mental illness, and cancer.

[0003] Drug treatment generally works by suppressing appetite, increasing energy expenditure, and inhibiting intestinal digestion and absorption. Weight-loss medications that suppress appetite by regulating the nervous system, such as sibutramine, generally have severe toxic side effects and have been withdrawn from clinical use. Currently, the only safe and effective oral weight-loss medication in clinical practice is orlistat. Orlistat is a new weight-loss medication approved for marketing in China in 2001. Orlistat acts primarily locally in the gastrointestinal tract, inhibiting pancreatic and gastric lipase, thereby inhibiting approximately 30% of dietary fat absorption. Orlistat is highly specific for lipase and has no significant inhibitory effect on other digestive enzymes. The most common adverse effects of orlistat are gastrointestinal. 15-30% of patients treated with orlistat experience oily stools and urgency during bowel movements, and 7% experience fecal incontinence. Furthermore, long-term use of orlistat can lead to deficiencies in fat-soluble vitamins. Some Chinese medicines and compound prescriptions have the effect of treating simple obesity. Single Chinese medicines such as raw rhubarb, knotweed, and Alisma orientale; Chinese medicine compound prescriptions based on dialectical treatment such as Xiao Chengqi Decoction with added ingredients and Shenling Baizhu San with added ingredients all have the effect of losing weight.

[0004] Currently, there are numerous reports on the use of traditional Chinese medicines containing coptis root for weight loss, particularly berberine. There are also reports on the use of traditional Chinese patent medicines containing coptis root for weight loss. Xianglian Pills, a compound derived from "Li Jiang Bingbu Shouji Fang" (prefaces to the collection of prescriptions for the military department) cited in Volume 7 of the Zhenghe Materia Medica, are composed of cornus officinalis, coptis root, and costus root. They are known to clear heat and dampness, promote qi circulation, and relieve pain. They are used to treat dysentery caused by damp-heat in the large intestine, characterized by bloody stools, tenesmus, fever, and abdominal pain. Studies have also shown that Xianglian Pills have some weight loss benefits, but their efficacy is limited.

[0005] Summary of the Invention

[0006] In response to the above-mentioned problems existing in the prior art, the present invention provides a bran-fried coptis chinensis and a preparation method thereof, a weight loss composition and a weight loss product. In terms of weight loss effect, the coptis chinensis slices fried with bran have significantly improved weight loss effects compared with conventional coptis chinensis slices. The bran-fried coptis chinensis slices are combined with medicinal materials such as costus root to obtain a preparation that has a significant therapeutic effect on obesity and can prevent various diseases caused by obesity.

[0007] To achieve the above-mentioned purpose, the technical solution adopted by the present invention to solve the technical problem is:

[0008] A method for preparing bran-fried coptis root comprises the following steps: placing wheat bran in a container and stir-frying, adding coptis root slices when smoke appears, and stir-frying over low heat until the surface of the coptis root slices turns yellow or dark yellow.

[0009] A bran-fried coptis root is prepared by adopting the method.

[0010] The application of the bran-fried coptis root in the preparation of weight loss products.

[0011] A weight loss composition comprises the fried coptis root and costus root, wherein the mass ratio of the fried coptis root to costus root is 4:0.4-4.

[0012] Furthermore, it also includes at least one of Evodia rutaecarpa, Curcuma longa, Honeysuckle and Chinese yam.

[0013] A weight loss product comprises the weight loss composition.

[0014] Furthermore, the dosage forms include pills, capsules, tablets, granules, syrups or mixtures.

[0015] The method for preparing the above-mentioned weight loss product comprises the following steps:

[0016] (1) extracting the fried coptis root with bran by percolation using a sulfuric acid aqueous solution, and collecting the percolation liquid;

[0017] (2) adding lime or calcium hydroxide to the percolation liquid to adjust the pH value of the percolation liquid to 3-6, then dialyzing and concentrating the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 50-150 Da to obtain a concentrate, and then continuing to dialyze the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 450-550 Da to dialyze the active ingredients to the outside of the membrane, and collecting the dialysate;

[0018] (3) adding sodium chloride to the dialysate for precipitation, and collecting the precipitate; further adding sodium chloride and zinc chloride to the dialysate for precipitation, collecting the precipitate, and combining the two precipitates to obtain a Coptis chinensis extract;

[0019] (4) decoct the costus root with water, collect the costus root volatile oil and extract, and concentrate them to obtain the costus root extract and volatile oil;

[0020] (5) Grinding the remaining medicinal materials to obtain medicinal powder; or boiling the remaining medicinal materials with water to extract, collecting and concentrating the extract to obtain medicinal extract;

[0021] (6) Mixing the coptis chinensis extract in step (3), the costus root extract and volatile oil in step (4), and the Chinese medicinal powder or medicinal material extract in step (5), and then adding auxiliary materials thereto to obtain the product.

[0022] Furthermore, in step (2), the concentration is performed until the concentration of total alkaloids in the concentrated solution is 50-200 mg / ml or 1 g crude drug / mL, and the concentration is stopped to obtain a concentrated solution.

[0023] Furthermore, after sodium chloride is added to the concentrated solution for the first time in step (3), the mass concentration of sodium chloride in the concentrated solution is 0.5-5%, after sodium chloride is added to the concentrated solution for the second time, the total mass concentration of sodium chloride in the concentrated solution reaches 10-30%, and after zinc chloride is added, the mass concentration of zinc chloride in the concentrated solution reaches 0.1-1%.

[0024] The beneficial effects produced by the present invention are:

[0025] 1. After being fried with bran, the weight-loss activity of Coptis chinensis slices was significantly improved compared with that of conventional Coptis chinensis slices. From the perspective of traditional Chinese medicine, the possible reason is that the bran-fried Coptis chinensis has enhanced effects on the stomach meridian and regulating the gastrointestinal tract after being processed. Obesity is mainly caused by damp-heat in the gastrointestinal tract and gastrointestinal dysfunction. Coptis chinensis clears damp-heat in the gastrointestinal tract. Frying with wheat bran enhances its effect of regulating damp-heat in the gastrointestinal tract, thereby enhancing its weight-loss effect. From the perspective of modern medicine, obesity is highly correlated with intestinal microbial flora. Intestinal flora is the second gene bank of humans. The destruction of intestinal flora balance is an important factor leading to obesity. Coptis chinensis alkaloids themselves are antibacterial substances with a bidirectional effect of regulating intestinal flora (inhibiting harmful microorganisms and increasing beneficial microorganisms). After the Coptis chinensis slices are fried with bran, the organic matter in the wheat bran interacts with the organic matter in the Coptis chinensis, resulting in an increase in the content and type of organic matter in the Coptis chinensis. The organic matter enhances the ability of Coptis chinensis alkaloids to repair intestinal flora, thereby improving the weight-loss effect of Coptis chinensis.

[0026] 2. The combination of fried Coptis chinensis slices with costus root can further improve the therapeutic effect on obesity; and combined with other medicinal materials such as Evodia rutaecarpa, turmeric, honeysuckle and yam, it can also further improve the therapeutic effect.

[0027] 3. In the preparation process of the present application, during the extraction of the fried coptis chinensis with bran, an aqueous sulfuric acid solution is used for infiltration, which can dissolve the active ingredients in the coptis chinensis, and lime or calcium hydroxide is added to the percolation liquid to utilize the calcium ions therein to neutralize part of the sulfate radicals. In this process, the amount of calcium ions used is too large, resulting in an increase in calcium impurities in the extract, and the amount of calcium ions used is too small, resulting in increased acidity in the concentrated liquid, which causes the active ingredients in the coptis chinensis percolation liquid to be destroyed during concentration; in the present application, semipermeable membranes of different pore sizes are used to infiltrate the percolation liquid. The filtration effect of the semipermeable membrane can remove impurities in the percolation liquid, and at the same time, it can also achieve the effect of concentration, thereby improving the purity of the active ingredients and reducing the volume of the extract, making it easier for patients to take;

[0028] 4. The first step is to add sodium chloride to the concentrate, causing the coptis alkaloids to form a precipitate with chloride ions. Even with a small amount of sodium chloride, the vast majority of the coptis alkaloids can be precipitated, resulting in less inorganic salts carried over from the mother liquor in the precipitate and a high product purity. The second step is to add sodium chloride to the concentrate to increase the chloride ion concentration, while zinc ions are simultaneously added. Zinc ions, which are in a colloidal state under neutral or weakly acidic conditions, adsorb more coptis alkaloids and precipitate them, further increasing the extraction yield of the coptis alkaloids and ensuring full extraction of the alkaloids from the concentrate (extraction rate exceeding 98%). The second step results in a smaller amount of precipitation, resulting in less impurities carried over from the mother liquor. These combined measures ensure both the extraction rate of the total coptis alkaloids and the purity of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG1 is a high performance liquid chromatogram of total alkaloids in the Coptidis rhizome extract in Example 1;

[0030] Figure 2 is a physical diagram of the experimental process;

[0031] Figure 3 is a physical picture of mice in different groups;

[0032] Figure 4 is a physical picture of fat in different groups of mice;

[0033] Figure 5 is a statistical diagram of the heart-body ratio of mice;

[0034] Figure 6 is a statistical diagram of mouse liver-to-body ratio;

[0035] Figure 7 is a statistical diagram of the spleen-body ratio of mice;

[0036] Figure 8 is a statistical diagram of mouse lung-to-body ratio;

[0037] FIG9 is a statistical diagram of the kidney-to-body ratio in mice. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention. That is, the embodiments described are only part of the embodiments of the present invention, rather than all embodiments.

[0039] Therefore, the detailed description of the embodiments of the present invention provided below is not intended to limit the scope of the invention as claimed, but is merely intended to represent selected embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0040] It should be noted that relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0041] The features and performance of the present invention are further described in detail below with reference to the embodiments.

[0042] 1. Effects of Processing Methods on the Active Ingredients in Coptis chinensis

[0043] Example 1

[0044] A bran-fried coptis root comprises the following steps: heating a pan, placing 15 kg of wheat bran in the pan and stir-frying, adding 100 kg of coptis root slices when smoke appears, stir-frying over low heat until the surface of the coptis root slices turns yellow or dark yellow, taking out, sieving out the wheat bran, and cooling to obtain the bran-fried coptis root.

[0045] The prepared bran-fried coptis root is extracted, and the extraction method comprises the following steps:

[0046] (1) 50 kg of bran-fried coptis root was crushed and then percolated with 1000 liters of 0.5% sulfuric acid aqueous solution. The percolation liquid was collected and filtered to remove impurities.

[0047] (2) adding lime or calcium hydroxide to the percolation liquid to adjust the pH value of the percolation liquid to 5.0, then dialyzing and concentrating the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 100 Da to obtain a concentrate having a total alkaloid concentration of 100 mg / ml, then continuing to dialyze the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 500 Da to dialyze the active ingredients to the outside of the membrane, and collecting the dialysate; the dialysate is membrane concentrated or concentrated under reduced pressure to a total alkaloid concentration of 100 mg / ml;

[0048] (3) adding sodium chloride to the concentrated solution for precipitation so that the mass concentration of sodium chloride is 2%, and collecting the precipitate; continuing to add sodium chloride and zinc chloride to the concentrated solution for precipitation so that the total mass concentration of sodium chloride reaches 20% and the mass concentration of zinc chloride reaches 0.5%, collecting the precipitate, and combining the two precipitates to obtain the Coptis chinensis extract.

[0049] Comparative Example 1

[0050] Unprocessed Coptis chinensis slices.

[0051] It was extracted using the same method as in Example 1.

[0052] Comparative Example 2

[0053] The ginger and coptis chinensis is prepared according to the method recorded in the "Chinese Pharmacopoeia". The specific operation is: take 100kg of coptis chinensis, mash it with 12.5kg of ginger, mix it with ginger juice, and simmer it until the ginger juice is absorbed. Put it in a frying pot, heat it with low heat, fry it until it is dry, take it out and let it cool.

[0054] It was extracted using the same method as in Example 1.

[0055] Comparative Example 3

[0056] The wine-cooked coptis root is prepared according to the method recorded in the "Chinese Pharmacopoeia". The specific operation is: take 100 kg of coptis root, mix it with 12.5 kg of rice wine, and let it simmer until the wine is absorbed. Put it in a frying pot, heat it with low heat, fry it until it is dry, take it out and let it cool.

[0057] It was extracted using the same method as in Example 1.

[0058] Comparative Example 4

[0059] The method of preparing Yuzhuyu and Huanglian is as follows: take 10 kg of clean Evodia rutaecarpa, add appropriate amount of water, boil for half an hour, remove the residue and take the juice and mix it into 100 kg of Huanglian, simmer until the Evodia rutaecarpa juice is absorbed, put it in a frying pot, heat it with low heat, fry it until it is dry, take it out and let it cool.

[0060] It was extracted using the same method as in Example 1.

[0061] Comparative Example 5

[0062] According to the method recorded in "Bencao Mengquan" and "Jingyue Quanshu", the pig bile-processed Coptis chinensis is prepared. The specific operation is: take 100 kg of Coptis chinensis and add the bile of 1,000 pigs, mix well, and stir until it is absorbed, then fry until dry.

[0063] It was extracted using the same method as in Example 1.

[0064] Comparative Example 6

[0065] The stir-fried Coptis chinensis was prepared according to the method recorded in Leigong Paozhi Lun. The specific operation was as follows: 100 kg of Coptis chinensis slices were placed in a pot, heated with a slow fire, stir-fried until it turned old yellow, taken out and cooled.

[0066] It was extracted using the same method as in Example 1.

[0067] Comparative Example 7

[0068] The earthy Coptis chinensis is prepared according to the method recorded in "Dan Xi Xin Fa". The specific operation is: take 50 kg of loess and heat it until it is slightly loose, pour in 100 kg of Coptis chinensis slices, stir-fry until it is stained with earth color, take out, let cool, sieve out the earth, and it is prepared.

[0069] It was extracted using the same method as in Example 1.

[0070] The components of the extracts prepared in Example 1 and Comparative Examples 1-7 were detected and analyzed, and the specific detection and analysis results are shown in Table 1; the total alkaloids in the extracts in Example 1 and Comparative Examples 1-7 were detected by high performance liquid chromatography, and the specific detection results are shown in Figure 1.

[0071] Table 1: Effects of processing on Rhizoma Coptidis extract Note: Organic matter refers to substances other than alkaloids, polysaccharides and proteins that can be decomposed at 550°C, mainly including flavonoids, organic acids, lignin and other organic substances.

[0072] From the data in Table 1, it can be seen that the extract of Coptis chinensis fried with bran in Example 1 is relatively large, and the total alkaloids, polysaccharides and organic matter in the extract account for a large proportion;

[0073] The amount of unprocessed Coptis chinensis slices extract in Comparative Example 1 is reduced relative to that in Example 1, and the proportion of total alkaloids, polysaccharides and organic matter is also reduced accordingly. This may be related to the fact that the plant cell wall of the unprocessed Coptis chinensis is not damaged, so the extraction of various organic matters is more difficult. It may also be related to the low content of alkaloids, polysaccharides and organic matter generated in the Coptis chinensis that has not been stir-fried with bran.

[0074] In Comparative Examples 2-5, after processing, the total alkaloid extraction rate of Coptis chinensis increased in most cases, and the contents of components such as polysaccharides and organic matter increased.

[0075] In comparative examples 6 and 7, the ash content of stir-fried Coptis chinensis and native Coptis chinensis was significantly higher than that of other groups, while the organic matter content was significantly lower than that of other groups, which may be related to the high sediment content; stir-fried Coptis chinensis may be related to the decomposition of organic matter caused by the Coptis chinensis being "burned".

[0076] In the actual high performance liquid chromatography test results, the contents of berberine, coptisine, epiberberine, palmatine and jatrorrhizine in the total alkaloids of Example 1 and Comparative Examples 1-7 were similar, with no significant difference, as shown in Figure 1. Among them, the mass proportion of berberine was about 57%, the mass proportion of coptisine was about 17%, the mass proportion of palmatine was about 15%, and the mass proportion of epiberberine was about 11%.

[0077] 2. Effects of Preparations on Weight Loss

[0078] Example 2

[0079] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1 and 10 kg of costus root.

[0080] A weight loss product is prepared using the above-mentioned weight loss composition, and the specific preparation method is as follows:

[0081] (1) Crush the bran-fried coptis root through a 50-mesh sieve, then percolate and extract with 1000 L of a 0.5% aqueous sulfuric acid solution, and collect the percolate;

[0082] (2) adding lime or calcium hydroxide to the percolation liquid to adjust the pH value of the percolation liquid to 5.0, then dialyzing and concentrating the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 100 Da to obtain a concentrate having a total alkaloid concentration of 100 mg / ml, then continuing to dialyze the percolation liquid using a semipermeable membrane with a dialysis molecular weight of 500 Da to dialyze the active ingredients to the outside of the membrane, and collecting the dialysate; the dialysate is membrane concentrated or concentrated under reduced pressure to a total alkaloid concentration of 100 mg / ml;

[0083] (3) adding sodium chloride to the concentrated solution for precipitation so that the mass concentration of sodium chloride is 2%, and collecting the precipitate; continuing to add sodium chloride and zinc chloride to the concentrated solution for precipitation so that the total mass concentration of sodium chloride reaches 20% and the mass concentration of zinc chloride reaches 0.5%, collecting the precipitate, and combining the two precipitates to obtain a Coptis chinensis extract;

[0084] (4) Add 50 L of water to the root of costus root, decoct and extract for 1 h, and recover the volatile oil; decoct the residue with 30 L of water for 0.5 h; filter, decoct the residue with 30 L of water for 0.5 h; combine the extracts and concentrate under reduced pressure to obtain 3 kg of extract and 50 g of volatile oil;

[0085] (5) The coptis chinensis extract in step (3), the costus root extract in step (4) and the volatile oil are mixed, and then starch is added thereto as an auxiliary material to prepare a Chinese medicine tablet.

[0086] Example 3

[0087] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1 and 40 kg of costus root.

[0088] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0089] Example 4

[0090] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1 and 4 kg of costus root.

[0091] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0092] Example 5

[0093] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1, 10 kg of costus root and 4 kg of evodia rutaecarpa.

[0094] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the Evodia rutaecarpa is crushed and passed through a 50-mesh sieve, and the Evodia rutaecarpa powder is used instead of starch for tableting.

[0095] Example 6

[0096] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1, 10 kg of costus root and 1 kg of turmeric.

[0097] A weight loss product is prepared using the weight loss composition. The preparation method is similar to that of Example 2, except that the turmeric is crushed and passed through a 50-mesh sieve, and turmeric powder is used instead of starch for tableting.

[0098] Example 7

[0099] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1, 10 kg of costus root and 2 kg of honeysuckle.

[0100] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the honeysuckle is crushed and passed through a 50-mesh sieve, and honeysuckle pollen is used instead of starch for tableting.

[0101] Example 8

[0102] A weight-loss composition comprises 40 kg of the braised coptis root of Example 1, 10 kg of costus root and 3 kg of yam.

[0103] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the yam is crushed and passed through a 50-mesh sieve, and yam powder is used instead of starch for tableting.

[0104] Comparative Example 8

[0105] A weight-loss composition comprises 40 kg of the coptis chinensis slices of comparative example 1 and 10 kg of costus root.

[0106] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0107] Comparative Example 9

[0108] A weight-loss composition comprises 40 kg of the turmeric and coptis root of comparative example 2 and 10 kg of costus root.

[0109] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0110] Comparative Example 10

[0111] A weight-loss composition comprises 40 kg of the wine-sweetened coptis root of comparative example 3 and 10 kg of costus root.

[0112] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0113] Comparative Example 11

[0114] A weight-loss composition comprises 40 kg of the Rhizoma Zingiberis officinalis in comparative example 4 and 10 kg of Radix Aucklandiae lappa.

[0115] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0116] Comparative Example 12

[0117] A weight-loss composition comprises 40 kg of pig gallbladder-processed coptis root in comparative example 5 and 10 kg of costus root.

[0118] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0119] Comparative Example 13

[0120] A weight-loss composition comprises 40 kg of stir-fried coptis root in comparative example 6 and 10 kg of costus root.

[0121] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0122] Comparative Example 14

[0123] A weight-loss composition comprises 40 kg of the locally processed coptis chinensis of comparative example 7 and 10 kg of costus root.

[0124] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0125] Comparative Example 15

[0126] A weight loss product comprising 40 kg of fried coptis root with bran and 50 kg of costus root.

[0127] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0128] Comparative Example 16

[0129] A weight-loss composition comprises 40 kg of fried coptis root with bran and 2 kg of costus root.

[0130] A weight loss product is prepared using the above-mentioned weight loss composition, and its preparation method is the same as that of Example 2.

[0131] Comparative Example 17

[0132] A weight-loss composition comprises 40 kg of coptis root slices, 10 kg of costus root and 4 kg of evodia rutaecarpa.

[0133] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the Evodia rutaecarpa is crushed and passed through a 50-mesh sieve, and the Evodia rutaecarpa powder is used instead of starch for tableting.

[0134] Comparative Example 18

[0135] A weight-loss composition comprises 40 kg of coptis root slices, 10 kg of costus root and 1 kg of turmeric.

[0136] A weight loss product is prepared using the weight loss composition. The preparation method is similar to that of Example 2, except that the turmeric is crushed and passed through a 50-mesh sieve, and turmeric powder is used instead of starch for tableting.

[0137] Comparative Example 19

[0138] A weight-loss composition comprises 40 kg of coptis root slices, 10 kg of costus root and 2 kg of honeysuckle.

[0139] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the honeysuckle is crushed and passed through a 50-mesh sieve, and honeysuckle powder is used instead of starch for tableting.

[0140] Comparative Example 20

[0141] A weight-loss composition comprises 40 kg of coptis root slices, 10 kg of costus root and 3 kg of yam.

[0142] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the yam is crushed and passed through a 50-mesh sieve, and yam powder is used instead of starch for tableting.

[0143] Comparative Example 21

[0144] A weight-loss composition comprises 40 kg of fried coptis root with bran, 10 kg of costus root and 4 kg of hawthorn.

[0145] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the hawthorn is crushed and passed through a 50-mesh sieve, and hawthorn powder is used instead of starch for tableting.

[0146] Comparative Example 22

[0147] A weight-loss composition comprises 40 kg of fried coptis root with bran, 10 kg of costus root and 4 kg of chicken's gizzard lining.

[0148] A weight loss product is prepared using the above-mentioned weight loss composition. The preparation method thereof is similar to that of Example 2, except that the chicken's gizzard lining is crushed and passed through a 50-mesh sieve, and the chicken's gizzard lining powder is used instead of starch for tableting.

[0149] Comparative Example 23

[0150] A weight loss product is prepared by weighing berberine in an amount equal to that of the coptis chinensis extract in Example 2 and starch, and pressing the mixture into tablets.

[0151] Comparative Example 24

[0152] A weight loss product is prepared by weighing an amount of coptisine equal to that of the coptis chinensis extract in Example 2 and starch, and pressing the mixture into tablets.

[0153] Comparative Example 25

[0154] A weight loss product is prepared by weighing an amount of palmatine equal to that of the coptis chinensis extract in Example 2 and starch, and pressing the mixture into tablets.

[0155] Comparative Example 26

[0156] A weight loss product is prepared by weighing an amount of epiberberine equal to that of the Coptidis rhizome extract in Example 2 and starch, and pressing the mixture into tablets.

[0157] Comparative Example 27

[0158] A weight loss product is prepared by weighing four alkaloid monomers, preparing a total alkaloid composition according to the ratio of the coptis chinensis alkaloid content (berberine by weight accounts for 57%, coptisine by weight accounts for 17%, bamipine by weight accounts for 15%, and epiberberine by weight accounts for 11%), weighing an amount of total alkaloids equal to that of the coptis chinensis extract in Example 2, weighing starch, and pressing the mixture into tablets to prepare tablets.

[0159] Comparative Example 28

[0160] A weight loss product is prepared by taking the coptis chinensis extract prepared by the coptis chinensis extract preparation process in Example 1, weighing the coptis chinensis extract in an amount equal to that in Example 2, weighing starch, and pressing the tablets to prepare tablets.

[0161] Comparative Example 29

[0162] A weight loss product is provided. The bran-fried coptis chinensis extract prepared by the bran-fried coptis chinensis extract preparation process in Example 1 is used as the basis, equal amounts of coptis chinensis alkaloids and starch are weighed, and the mixture is compressed to prepare tablets.

[0163] The formulas of the weight loss compositions in Examples 2-10 and Comparative Examples 8-28 are shown in Table 2:

[0164] Table 2: Formulation and dosage

[0165] A weight loss test was conducted on the products of Examples 2-10 and Comparative Examples 8-29.

[0166] Weight loss experimental methods

[0167] Materials: the products of Examples 2-8 and Comparative Examples 8-29.

[0168] Experimental method: The weight loss experimental method was carried out in accordance with the "Guiding Principles for Research on New Drugs of Natural Medicines (Traditional Chinese Medicines)": C57BL / 6J mice were divided into 31 groups, with 10 mice in each group, of which one group was taken as a blank group (10 mice) and given normal feed, and the remaining 30 groups were high-fat groups (300 mice) and given high-fat feed; after 8 weeks, the body weight index was detected to confirm that the high-fat mouse model was successfully established; then, a group of high-fat group mice with successful modeling was taken as the model group and continued to be given a high-fat feed, and the remaining 29 groups of high-fat group mice were used as the experimental group, and continued to be given a high-fat feed while being given the corresponding traditional Chinese medicine preparations in Examples 2-8 and Comparative Examples 8-29, administered once a day, and each administration controlled the total alkaloid dose of Coptis chinensis to be 100 mg / kg; the blank group and the model group were given normal saline, respectively; they were gavage-fed for 8 weeks, and then the body weight index of each group of mice was detected. The specific results are shown in Table 3.

[0169] The mice were then sacrificed and blood was collected for liver and kidney function tests. Each group of mice was dissected, and their hearts, livers, spleens, lungs, kidneys, and fat were removed. The heart-to-body ratio, liver-to-body ratio, spleen-to-body ratio, lung-to-body ratio, and kidney-to-body ratio were measured to analyze the effects of long-term product use on various health indicators. Specific results are shown in Table 4 and Figures 2-9.

[0170] Heart-to-body ratio (%) = heart weight / mouse body weight*100%

[0171] Liver to body ratio (%) = liver weight / mouse body weight * 100%

[0172] Spleen to body ratio (%) = spleen weight / mouse body weight * 100%

[0173] Lung to body ratio (%) = lung weight / mouse body weight*100%

[0174] Kidney to body ratio (%) = kidney weight / mouse body weight*100%

[0175] Table 3: Weight loss effects of different products (n=10) Note: △P # Compared with the normal group; △P ＊ Compared with the model group.

[0176] As can be seen from Table 3, after 8 weeks of high-fat diet, the body weight of the model group mice was significantly higher than that of the normal group, reaching an extremely significant level (△P ### <0.001), indicating that the model was successfully established (compared with the blank group and the model group).

[0177] Compared with the model group, the body weight of the experimental mice decreased. Specifically, compared with the model group, the body weight of the mice in comparative examples 23-26 decreased, but only berberine and coptisine reached a significant level (△P ＊ <0.05); the weight loss effect of the total alkaloids of Coptis chinensis compounded in Comparative Example 27 is slightly better than that of the alkaloid monomers in Comparative Examples 23-26, but there is no significant difference; the weight loss effect of the Coptis chinensis decoction piece extract in Comparative Example 28 is slightly better than that of the compound Coptis chinensis alkaloids in Comparative Example 27, but the difference is not large; the weight loss effect of the bran-fried Coptis chinensis extract in Comparative Example 29 is further improved compared with Comparative Example 28, but still does not reach a significant level.

[0178] After the braised coptis root and costus root in Example 2-4 were combined, the weight loss effect of the preparation was very obvious, reaching a very significant level compared with the model group (△P ＊＊<0.01), and the possible reasons are: in Traditional Chinese Medicine, obesity is closely related to dampness and heat. Coptis chinensis clears heat and dries dampness, thus having a certain weight-loss effect. After being stir-fried with bran, Coptis chinensis’s function in the stomach meridian is enhanced, thus enhancing its heat-clearing and damp-drying properties, further removing dampness and heat from the stomach and enhancing its weight-loss effect. Muxiang (costus root) is a qi-regulating herb that enters the spleen, stomach, and large intestine meridians, promoting qi regulation and digestion. Muxiang (costus root) has a warming effect, which can reduce the coldness of Coptis chinensis. When used in combination with Coptis chinensis, Muxiang can enhance Coptis chinensis’s gastrointestinal regulating effects, thus enhancing the weight-loss effect.

[0179] In Examples 5-8, on the basis of bran-fried coptis root and costus root, Evodia rutaecarpa, turmeric, honeysuckle, Chinese yam, etc. were further added, and the weight loss effect was further improved. Especially after the addition of Evodia rutaecarpa, the weight loss effect increased significantly (△P ＊＊＊ <0.001), suggesting that the possible reason is that the addition of gastrointestinal regulating herbs can further enhance the gastrointestinal regulating effects of coptis chinensis and costus root, further enhancing the weight loss effect. However, the study found that not all gastrointestinal regulating herbs can enhance the weight loss effect of coptis chinensis, indicating that the mechanism by which gastrointestinal regulating herbs enhance the weight loss effect of coptis chinensis requires further study.

[0180] In comparative examples 8-14, after the fried coptis chinensis was replaced with coptis chinensis prepared by other methods, the results showed that the weight loss effect was slightly increased relative to the model group, but not obvious, and the weight loss effect was significantly lower than the weight loss effect in Example 2. The reason for this may be that new active ingredients were produced in the fried coptis chinensis, and the new active ingredients acted in the stomach, increasing the weight loss effect, while the coptis chinensis prepared by other methods did not produce new ingredients, resulting in a decrease in the weight loss effect.

[0181] In Comparative Examples 15-16, the dosage of costus root was adjusted. The results show that after the dosage of costus root was adjusted, the weight loss effect of the preparation decreased compared with Example 2. The reason for this may be that after the dosage of costus root was adjusted, the synergistic effect of costus root and coptis root decreased, resulting in a worse weight loss effect.

[0182] In comparative examples 17-20, compared with examples 5-8, the weight loss effect decreased after the fried coptis chinensis was replaced with coptis chinensis slices. It is speculated that the possible reason is that new effective ingredients are produced in the fried coptis chinensis, which leads to an enhanced weight loss effect. However, when ordinary coptis chinensis is used in combination with costus root, the synergistic effect between the two is limited, resulting in a limited weight loss effect.

[0183] Comparing Comparative Examples 21-22 with Examples 5-8, hawthorn and chicken's gizzard lining were used in combination with fried coptis chinensis and costus root. However, the results show that the weight loss effect in Comparative Examples 21-22 is not as good as that in Examples 5-8. The reason for this may be that although hawthorn and chicken's gizzard lining are drugs that act on the stomach, they do not have a synergistic effect with coptis chinensis and costus root. Therefore, the weight loss effect becomes relatively worse after use in combination, which further proves that not all drugs that regulate gastrointestinal function can improve the weight loss effect.

[0184] Table 4: Effects of different products on the liver and kidneys of mice

[0185] As can be seen from Table 4, there was no change in renal function (creatinine and urea nitrogen) between the groups compared with the model group and the blank group, indicating that the groups had no effect on the renal function of the experimental mice. Compared with the blank group, the liver function of the model group increased, especially the alanine aminotransferase increased significantly (△P # <0.05), indicating that high-fat diet will induce fatty liver and certain inflammation in the liver of mice (Figure 4 liver-to-body ratio increased significantly); all drug groups can reduce the degree of fatty liver and liver inflammation, especially after the bran-fried coptis root and costus root are combined, the reduction of fatty liver and inflammation levels is more obvious. After adding Evodia rutaecarpa, turmeric, honeysuckle, Chinese yam and other Chinese herbs to the bran-fried coptis root + costus root, the effect of eliminating liver inflammation is more obvious, reaching a significant level (△P * <0.05). This indicates that this product not only has a good weight loss effect, but can also prevent fatty liver and eliminate liver inflammation.

[0186] Figure 2 is a physical diagram of the experimental process;

[0187] FIG3 is a physical picture of mice in different groups. It can be seen from FIG3 that the body size of mice in the model group, groups 27 and 28 is larger than that of mice in other groups, which proves that palmatine and epiberberine have basically no weight loss effect.

[0188] Figure 4 is a physical picture of fat in different groups of mice. It can be seen from Figure 4 that the fat volume of the model group mice, group 27 and group 28 mice is larger than that of the mice in other groups. It can be seen that as the weight of the mice decreases, the amount of fat also decreases.

[0189] Figure 5 is a statistical graph of the mouse heart-to-body ratio, Figure 7 is a statistical graph of the mouse spleen-to-body ratio, Figure 8 is a statistical graph of the mouse lung-to-body ratio, and Figure 9 is a statistical graph of the mouse kidney-to-body ratio. It can be seen from Figures 5 and 7-9 that there is no significant difference in the data between different groups, which means that the drug has no effect on the mouse heart, spleen, lungs and kidneys.

[0190] Figure 6 is a statistical chart of the liver-to-body ratio of mice. It can be seen from Figure 6 that the liver weight of the mice in the model group increased, and the increase in liver weight of the mice in other groups was smaller, indicating that the drugs in other groups have a certain effect in preventing and treating fatty liver.

[0191] 3. Safety Study of Composition

[0192] Materials: the products of Examples 2-8 and Comparative Examples 8-29.

[0193] The experimental method is as follows: 300 7-week-old KM mice (weighing about 20 g) were balanced in a barrier isolation system for 3 to 5 days with sufficient sterile feed and water, and the mice were randomly divided into 30 groups, 10 mice in each group; the test products in Examples 2-8 and Comparative Examples 8-29 were respectively formulated into solutions with a mass concentration of 10%, and 29 groups of mice were gavaged with each product, 0.6 mL each time, once every 8 hours, for three consecutive times (the total dose of three gavages was 9 g / Kg in terms of drug value, taking Example 2 as an example, the drug here refers to fried coptis root and costus root), and the last group of mice was gavaged with normal saline, 0.6 mL each time, once every 8 hours, for three consecutive times, and then the mice were allowed to eat freely. The body weight was detected after 3 days, and the mortality rate of each group was counted after 15 days. The results are shown in Table 4.

[0194] Table 4: Product safety test results (n=10)

[0195] As can be seen from Table 4, when mice were given large doses of drugs orally within one day, their weight decreased to varying degrees, and some groups even died. In Comparative Examples 23-24, after taking large doses of berberine and coptisine orally, the weight of mice decreased significantly, reaching a significant level (△P ＊ <0.05), and a small number of deaths occurred; although the weight loss from palmatine and epiberberine in Comparative Examples 25-26 did not reach a significant level, there were still some deaths, indicating that the Rhizoma Coptidis alkaloid monomers have certain side effects and are not safe; although there were no deaths in the total alkaloid group composed of four alkaloids in Comparative Example 28, the weight loss was very significant, and it was the group with the largest weight loss other than the monomers, indicating that pure Rhizoma Coptidis alkaloid monomers and their complexes have certain side effects. In Comparative Examples 28-29, the total alkaloids extracted from Rhizoma Coptidis decoction pieces and the total alkaloids extracted from Rhizoma Coptidis bran-fried mice showed a smaller weight loss, and their safety was improved.

[0196] In Examples 2-4 and Comparative Examples 15-16, after the fried coptis chinensis and costus root were combined, the extent of weight loss in mice was greatly reduced, indicating that the safety was significantly improved. This may be because costus root is "warm in nature", and after the combination, the "cold nature" of coptis chinensis is reduced, thereby reducing the side effects of coptis chinensis.

[0197] In Examples 5-8 and Comparative Examples 21-22, on the basis of the compound of fried coptis chinensis and costus root, Chinese medicinal materials belonging to the stomach meridian were further supplemented, and there was almost no decrease in body weight, indicating that the safety was very high. Especially after the compound of fried coptis chinensis, costus root and Evodia rutaecarpa, there was a certain auxiliary increase in body weight, indicating that the safety was very high.

[0198] In Comparative Examples 8 and 17-20, the safety of coptis chinensis and costus root is also improved after compounding; and the safety is further improved by adding Chinese medicinal materials belonging to the stomach meridian on the basis of compounding coptis chinensis and costus root.

[0199] The safety of the processed coptis chinensis in comparative examples 9-14 was improved compared with that in comparative example 8, which was not processed. This may be related to the fact that the processing eliminated the side effects of coptis chinensis.

[0200] The above content is a further detailed description of the present invention in conjunction with specific embodiments, and the specific implementation of the present invention should not be considered to be limited to these descriptions. For those skilled in the art of the present invention, without departing from the concept of the present invention, several simple deductions or substitutions can be made, which should be considered to fall within the scope of protection of the present invention.

Claims

1. A method for preparing fried coptis root with bran, characterized in that: The following steps are involved: Put wheat bran in a container and stir-fry, add coptis slices when smoke appears, and stir-fry over low heat until the surface of the coptis slices turns yellow or dark yellow.

2. A bran-fried coptis root, characterized in that: The method according to claim 1 is adopted to prepare the present invention.

3. Use of the fried coptis root with bran as claimed in claim 2 in the preparation of weight loss products.

4. A weight loss composition, characterized in that: The invention comprises the fried coptis root and costus root as claimed in claim 2, wherein the mass ratio of the fried coptis root and costus root is 4:0.4-4.

5. The weight loss composition according to claim 4, characterized in that It also includes at least one of Evodia rutaecarpa, Curcuma longa, Honeysuckle and Chinese yam.

6. A weight loss product, characterized in that: The invention comprises the weight loss composition according to claim 4 or 5.

7. The weight loss product according to claim 6, characterized in that: The dosage forms include pills, capsules, tablets, granules, syrups, powders or mixtures.

8. The method for preparing the weight loss product according to claim 6 or 7, characterized in that: The following steps are involved: (1) extracting Rhizoma Coptidis by percolation with aqueous sulfuric acid solution, and collecting the percolation liquid; (2) adding lime or calcium hydroxide to the permeate to adjust the pH value of the permeate to 3-6, then dialyzing and concentrating the permeate using a semipermeable membrane with a dialysis molecular weight of 50-150 Da to obtain a concentrated solution, and then continuing to dialyze using a semipermeable membrane with a dialysis molecular weight of 450-550 Da to dialyze the active ingredients to the outside of the membrane, and collecting the dialysate; (3) After the dialysate is membrane concentrated or concentrated under reduced pressure, sodium chloride is added to the dialysate for precipitation, and the precipitate is collected; sodium chloride and zinc chloride are further added to the dialysate for precipitation, and the precipitate is collected, and the two precipitates are combined to obtain a Coptis chinensis extract; (4) decoct the costusroot with water, collect the volatile oil and extract and concentrate them to obtain costusroot extract and Volatile oil; (5) crushing the remaining medicinal materials to obtain medicinal powder; or boiling the remaining medicinal materials with water to extract, collecting and concentrating the extract to obtain medicinal extract; (6) Mixing the coptis chinensis extract in step (3), the costusroot extract and volatile oil in step (4), and the Chinese medicinal powder or medicinal material extract in step (5), and then adding auxiliary materials thereto to obtain the product.

9. The method for preparing a weight loss product according to claim 8, characterized in that: In step (2), the concentration is continued until the concentration of total alkaloids in the concentrated solution is 50-200 mg / ml, and then the concentration is stopped to obtain a concentrated solution.

10. The method for preparing a weight loss product according to claim 8, characterized in that: After sodium chloride is added to the dialysate for the first time in step (3), the mass concentration of sodium chloride in the dialysate is 0.5-5%, after sodium chloride is added to the dialysate for the second time, the total mass concentration of sodium chloride in the dialysate reaches 10-30%, and after zinc chloride is added, the mass concentration of zinc chloride in the dialysate reaches 0.1-1%.

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