Weight-losing traditional Chinese medicine composition and preparation method thereof

Abstract

The invention relates to the technical field of weight-losing traditional Chinese medicine compositions, in particular to a weight-losing traditional Chinese medicine composition and a preparation method thereof. 1-3 parts of lotus leaves; 1-3 parts of fried semen cassiae; 1-5 parts of poria cocos; 1-5 parts of coix seeds; 1-3 parts of pericarpium citri reticulatae; 1-3 parts of rhizoma alismatis; 1-3 parts of roselle; 1-3 parts of rhizoma atractylodis; 1-3 parts of bighead atractylodes rhizome; 1-3 parts of exocarpium benincasae; through a multi-target and multi-layer action mechanism, the weight reducing effect more remarkable than that of a single traditional Chinese medicine is achieved; the weight can be effectively reduced, metabolic indexes such as blood sugar and blood fat can be improved, and a new thought is provided for prevention and treatment of obesity-related metabolic diseases. Based on the prescription principle of the traditional Chinese medicine theory and in combination with the modern pharmacological research, the occurrence of adverse reactions is reduced to the greatest extent while efficient weight reduction is realized. The innovative preparation process improves the stability of the product and prolongs the validity period.

Description

Technical Field

[0001] The invention relates to the technical field of weight loss Chinese medicine compositions, and in particular to a weight loss Chinese medicine composition and a preparation method thereof. Background Art

[0002] With the improvement of living standards and changes in dietary structure, obesity has become a global health problem. Traditional weight loss methods, such as simple diet control or increased exercise, are often difficult to sustain and the results are not satisfactory. Although Western medicine weight loss preparations have certain effects, long-term use may bring serious side effects. Therefore, the development of safe and effective weight loss programs has become an important topic in the current medical and pharmaceutical industries.

[0003] Traditional Chinese medicine has a long history and rich experience in weight loss treatment. According to traditional Chinese medicine theory, the cause of obesity is mainly related to spleen and stomach dysfunction, metabolic disorders, dampness and turbidity, and other factors. Based on this theory, many Chinese herbal compound prescriptions are used for weight loss treatment. However, there are still some problems with the existing Chinese herbal weight loss programs: first, the prescription is not refined enough, and it is difficult to balance the cold and hot properties of each medicinal material; second, the preparation process is not advanced enough, which affects the extraction and stability of the effective ingredients; third, there is a lack of in-depth research on the synergistic effects between the components, making it difficult to give full play to the overall advantages of Chinese herbal compound prescriptions. Summary of the invention

[0004] In view of the above problems, the present invention provides an innovative weight-loss Chinese medicine composition and a preparation method thereof.

[0005] The object of the present invention is to provide a weight-loss Chinese medicine composition, which comprises the following components by weight:

[0006] 3-6 portions of hawthorn;

[0007] 1-3 portions of lotus leaves;

[0008] 1-3 servings of stir-fried cassia seeds;

[0009] 1-5 parts of Poria cocos;

[0010] 1-5 servings of coix seed;

[0011] 1-3 parts dried tangerine peel;

[0012] 1-3 parts of Alisma orientalis;

[0013] 1-3 servings of Roselle;

[0014] 1-3 parts of Atractylodes lancea;

[0015] 1-3 parts of Atractylodes macrocephala;

[0016] 1-3 portions of winter melon peel;

[0017] Stevia 0.1-1 portion.

[0018] Specifically, the following components are also included:

[0019] 0-3 parts of big belly skin;

[0020] 0-3 parts of Salvia miltiorrhiza;

[0021] 0-3 servings of stir-fried radish seeds.

[0022] Specifically, the dosage form of the composition is one of granules, tablets, capsules or oral liquids.

[0023] A method for preparing the weight-loss Chinese medicine composition comprises the following steps:

[0024] (1) Raw material processing: clean and dry the Chinese medicinal materials of each component;

[0025] (2) Crushing: crushing the dried Chinese medicinal materials into fine powder;

[0026] (3) Extraction: Add the crushed Chinese medicinal materials into an appropriate amount of water, heat and boil, maintain the boiling state for 30-60 minutes, and then filter to obtain a filtrate;

[0027] (4) Concentrating: Concentrating the filtrate under reduced pressure to obtain a concentrated solution;

[0028] (5) Drying: spray drying or freeze drying the concentrated solution to obtain a dry powder;

[0029] (6) Preparation: The dry powder is mixed with auxiliary materials to prepare the desired dosage form.

[0030] 6. The method according to claim 5, characterized in that in step (3), the extraction process is repeated 2-3 times.

[0031] Specifically, in step (4), the reduced pressure concentration is carried out at 50-60°C, and is concentrated to a relative density of 1.10-1.20 (20°C).

[0032] Specifically, in step (5), if spray drying is adopted, the feed temperature is 180-200°C, and the discharge temperature is 85-95°C; if freeze drying is adopted, the freezing temperature is -40 to -50°C, and the drying temperature is 40-50°C.

[0033] Specifically, in step (6), the auxiliary materials include one or more of starch, microcrystalline cellulose, sodium carboxymethyl cellulose, and povidone K30.

[0034] Specifically, after step (6), the method further includes the following steps:

[0035] (7) Quality testing: Testing of quality indicators such as content determination, disintegration time, and dissolution of the prepared preparations;

[0036] (8) Packaging: Pack, seal and label qualified preparations.

[0037] The core innovation of the present invention is:

[0038] 1. Accurate formula ratio: Through in-depth research on the chemical composition and pharmacological effects of various Chinese medicinal materials, the precise ratio between the components is achieved, which not only ensures the weight loss effect, but also balances the cold and hot properties of the prescription.

[0039] 2. Advanced preparation technology: It adopts optimized extraction, concentration and drying processes to improve the extraction rate and stability of active ingredients.

[0040] 3. Multi-target synergistic effect: The various components in the prescription achieve a multi-target synergistic weight loss effect through different mechanisms of action, such as promoting fat decomposition, inhibiting fat synthesis, and increasing energy consumption.

[0041] 4. Personalized adjustment space: By setting the dosage range of the components, personalized adjustment in clinical applications is possible.

[0042] From a molecular perspective, the innovation of this invention is reflected in the following aspects:

[0043] First, the flavonoids (such as quercetin) and organic acids (such as chlorogenic acid) in hawthorn can inhibit the activity of lipase and reduce fat absorption. At the same time, these compounds can also activate AMP-activated protein kinase (AMPK), promoting fat decomposition and energy consumption.

[0044] Secondly, the alkaloids in lotus leaves (such as nuciferine) inhibit the differentiation of adipocytes and the synthesis of fat by affecting the expression of peroxisome proliferator-activated receptor γ (PPARγ) in adipocytes.

[0045] Thirdly, the polysaccharides in Poria cocos and Coix seeds can increase insulin sensitivity and improve glucose and lipid metabolism. These polysaccharides can also indirectly affect the host's energy metabolism by regulating intestinal flora.

[0046] Finally, the synergistic effect of the various components in the prescription is not only reflected in the weight loss effect, but also in the regulation of the overall function of the body. For example, the flavonoids in tangerine peel can enhance the digestion and relieving effects of hawthorn, while at the same time alleviating the coldness that may be brought by Poria cocos and coix seed. This exquisite combination not only ensures the weight loss effect, but also avoids the side effects that may be brought by a single drug.

[0047] The beneficial effects of the present invention are mainly reflected in the following aspects:

[0048] 1. Significant weight loss effect: Through multi-target and multi-level mechanisms of action, it achieves a more significant weight loss effect than a single Chinese medicine.

[0049] 2. Comprehensive improvement of metabolic indicators: It can not only effectively reduce weight, but also improve metabolic indicators such as blood sugar and blood lipids, providing a new idea for the prevention and treatment of obesity-related metabolic diseases.

[0050] 3. Good safety: Based on the formulation principles of traditional Chinese medicine theory and combined with modern pharmacological research, it achieves efficient weight loss while minimizing the occurrence of adverse reactions.

[0051] 4. Excellent stability: The innovative preparation process improves the stability of the product, extends its shelf life, and provides strong support for clinical application and market promotion.

[0052] 5. Possibility of personalized treatment: By setting the dosage range of the components, it is possible to adjust the prescription according to the individual differences of patients in clinical practice, which reflects the characteristics of "differentiation and treatment based on syndrome differentiation" of traditional Chinese medicine.

[0053] In summary, the present invention provides a safe, efficient and stable weight loss Chinese medicine composition and its preparation method, which not only has significant advantages in weight loss effect, but also can comprehensively improve metabolic indicators and has good safety and stability. This innovative solution provides a new option for the prevention and treatment of obesity and related metabolic diseases, and has important clinical application value and market prospects. DETAILED DESCRIPTION

[0054] In a weight loss Chinese medicine composition of the present invention, 3 to 6 parts of hawthorn are included: "Medical Records of Combining Chinese and Western Medicine" records that "hawthorn, if used with sweet medicines, can dissipate blood stasis without damaging new blood, relieve depression without damaging healthy qi, and is particularly peaceful in nature." Hawthorn in this prescription plays the role of helping food and strengthening the stomach, promoting qi and dispersing blood stasis, dissipating turbidity and reducing fat, and has a slightly sour taste to correct the taste.

[0055] 1-3 parts of lotus leaves: In Compendium of Materia Medica, it is recorded that lotus leaves can "generate vital energy, benefit the spleen and stomach, astringe turbid semen, disperse blood stasis, and clear edema..." Lotus leaves in this prescription play the role of helping the spleen and stomach, clearing edema, and dispersing blood stasis, thereby achieving the effect of fat transformation.

[0056] 1-3 portions of stir-fried Cassia seeds: According to the "Chinese Materia Medica", Cassia seeds "clear the liver and benefit the kidney, improve eyesight, promote diuresis and relieve constipation. It is mainly used to treat red, swollen and painful eyes, photophobia and excessive tears, amblyopia, pterygium, headache and dizziness, blurred vision, ascites due to cirrhosis, dysuria, and habitual constipation. It is also used externally to treat swelling, toxins, and tinea." After being stir-fried, the coldness of stir-fried Cassia seeds is weakened, and it plays a role of mildly promoting diuresis and removing dampness, clearing the liver and reducing fat in this prescription.

[0057] 1-5 parts of Poria cocos: It is recorded in Compendium of Materia Medica that "Poria cocos has a light and penetrating smell, its nature is to move upward, produce body fluids, open the pores, nourish the water source and descend, and facilitate urination. Therefore, Zhang Jiegu said that it belongs to Yang, floats and rises, referring to its nature; Dongyuan called it the Yin in Yang, descends and goes down, referring to its function." It is recorded in Bencao Yanyi that "Poria cocos and Poria cocos have many functions of promoting water circulation, and they are indispensable for benefiting the heart and spleen." Poria cocos plays the role of nourishing the heart and spleen, strengthening the spleen and stomach, producing body fluids and facilitating urination in this prescription.

[0058] 1-5 parts of coix seed: It is recorded in "Bencao Jingshu" that coix seed "is dry in nature and can remove dampness, is sweet in taste and can enter the spleen to nourish the spleen, and is bland and can penetrate dampness. Therefore, it is used to treat muscle spasms and inflexion and stretching, as well as rheumatism, remove evil qi and numbness of the tendons and bones, benefit the intestines and stomach, eliminate edema and enable people to eat." In this prescription, coix seed plays the role of promoting diuresis and eliminating dampness, dispersing nodules, and benefiting the spleen and kidneys.

[0059] 1-3 parts of dried tangerine peel: It is recorded in "Yi Yi Bie Lu" that dried tangerine peel "treats the spleen's inability to digest food, and qi rushing to the chest." In this prescription, dried tangerine peel plays the role of drying dampness, strengthening the spleen and regulating qi.

[0060] 1-3 portions of Alisma orientalis: Compendium of Materia Medica records that Alisma orientalis "treats wind-cold-dampness arthralgia, lactation difficulty, nourishes the five internal organs, increases energy and strength, makes the body healthy, and eliminates water. Long-term use can make the ears and eyes sharp, prolong life, make the body light and the face radiant, and enable one to walk on water." In this prescription, Alisma orientalis plays the role of promoting diuresis, eliminating dampness, and dissolving fat.

[0061] 1 to 3 portions of Roselle: Roselle mainly plays the role of adjusting the taste in this recipe.

[0062] 1-3 parts of Atractylodes: It is recorded in "Bencao Congxin" that Atractylodes "dries the stomach and strengthens the spleen. It induces sweating and removes dampness. It can raise the yang energy in the stomach. It stops vomiting and diarrhea. It removes phlegm and water." In this prescription, Atractylodes mainly plays the role of strengthening the spleen and stomach, removing dampness, and balancing the cold, hot, warm and cool of the prescription with its warm nature.

[0063] 1-3 parts of Atractylodes macrocephala: It is recorded in Bencao Huiyan that "Atractylodes macrocephala is an important medicine for supporting the spleen and stomach, dispersing dampness and eliminating numbness, and digesting food and eliminating abdominal distension. If the spleen is weak, Atractylodes macrocephala can replenish it; if the stomach is weak, Atractylodes macrocephala can help it." In this prescription, Atractylodes macrocephala mainly plays the role of strengthening the spleen and stomach, dispersing cold and dampness. At the same time, due to its dry and hot nature, it can balance the cold, heat, warmth and coolness of the prescription.

[0064] 1-3 parts of wax gourd peel: The wax gourd peel in this prescription mainly plays the role of diuresis and detumescence, and promotes water and moisture to dissolve fat.

[0065] 0.1-1 portion of stevia: stevia in this formula mainly plays the role of promoting body fluid and quenching thirst, promoting diuresis, and regulating blood pressure and blood sugar.

[0066] 0-3 parts of dried tangerine peel: It is recorded in Compendium of Materia Medica that dried tangerine peel "can reduce adverse qi, eliminate water vapor swelling in the skin, beriberi, malaria, fullness and stuffiness caused by fetal qi and nausea." In this prescription, the dried tangerine peel has the effect of promoting qi, relieving fullness, promoting water flow and reducing swelling.

[0067] 0-3 parts of Salvia miltiorrhiza: Salvia miltiorrhiza has the effects of promoting blood circulation, removing blood stasis, clearing the heart and relieving restlessness. In this formula, it mainly plays the role of promoting blood circulation and thus accelerates metabolism when combined with drugs that promote qi circulation.

[0068] 0-3 portions of stir-fried radish seeds: Stir-fried radish seeds have the effect of helping digestion and relieving bloating, lowering qi and resolving phlegm. In this prescription, they mainly play the role of regulating qi and relieving bloating, and are combined with drugs that strengthen the spleen and regulate qi to prevent qi from being blocked.

[0069] The weight loss Chinese medicine composition of the present invention embodies the holistic concept and syndrome differentiation and treatment ideas of traditional Chinese medicine. Its compatibility relationship and beneficial effects can be further explained from the following aspects:

[0070] 1. Compatibility and dialectics

[0071] This prescription takes hawthorn as the core, taking its effect of strengthening the stomach and reducing fat, and is matched with lotus leaf, cassia seed, poria, coix seed, oriental water chestnut, wax gourd peel to enhance the effect of dissolving fat and removing dampness, and then supplemented with tangerine peel, atractylodes, atractylodes, tangerine peel, and stir-fried radish seeds to achieve the purpose of balancing the cold and heat of the prescription, strengthening the spleen and stomach, and regulating qi, and then using the effect of salvia miltiorrhiza to promote blood circulation to enhance the smoothness of qi and blood in the body, and finally using roselle and stevia to adjust the taste of the prescription. It can ensure that the prescription plays a good role in weight loss, and does not cause side effects due to obvious cold and heat bias. It embodies the dialectical principle of traditional Chinese medicine with the whole as the core.

[0072] 2. Application of Meridian Theory

[0073] The drugs in this prescription belong to multiple internal organs, including spleen, stomach, liver, and kidney. For example, hawthorn belongs to the spleen and stomach meridian, lotus leaf belongs to the spleen and liver meridian, and Poria belongs to the heart, spleen, and kidney meridian. This multi-meridian compatibility method can comprehensively regulate the body's metabolic function, not only targeting obesity itself, but also improving various metabolic disorders caused by obesity.

[0074] 3. Innovation of extraction process

[0075] The present invention adopts an optimized extraction process, such as controlling the extraction temperature and time, multiple extractions, etc. This method can maximize the extraction of effective ingredients in various medicinal materials, such as flavonoids and organic acids in hawthorn, alkaloids in lotus leaves, polysaccharides in Poria cocos and coix seeds, etc. At the same time, by controlling the extraction conditions, the extraction of certain undesirable components can also be reduced, thereby improving the safety of the drug.

[0076] 4. Molecular pharmacological mechanism

[0077] From a molecular level, the various ingredients in this prescription can synergistically act on multiple links of fat metabolism. For example, quercetin in hawthorn can inhibit lipase activity and reduce fat absorption; nuciferine can affect the expression of PPARγ and inhibit adipocyte differentiation; and tuckahoe polysaccharide can increase insulin sensitivity and improve glucose and lipid metabolism. This multi-target mechanism of action is difficult to achieve with a single drug.

[0078] 5. Pharmacodynamic evaluation

[0079] Through multiple experiments such as weight loss effect evaluation and metabolic index evaluation, it is confirmed that the weight loss Chinese medicine composition of the present invention has significant weight loss effect and metabolic improvement effect. In particular, in terms of improving blood sugar, blood lipids and other indicators, it has shown an effect that is superior to that of a single Chinese medicine. This comprehensive metabolic improvement effect embodies the idea of ​​TCM to treat diseases from the root.

[0080] 6. Safety evaluation

[0081] This prescription uses traditional Chinese medicinal materials and is optimized through modern technology. While achieving good weight loss effects, it significantly reduces the incidence of adverse reactions. Long-term safety tests have shown that this prescription has no significant effect on liver and kidney function, which is a significant advantage over some chemical weight loss drugs.

[0082] 7. Stability study

[0083] By tracking and testing the content of the main active ingredients, it is confirmed that the Chinese medicine composition of the present invention has excellent stability, which not only ensures the persistence of the efficacy, but also provides favorable conditions for the storage and transportation of the product.

[0084] 8. Clinical application prospects

[0085] This prescription provides the possibility of individualized medication in clinical applications by setting the dosage range of the components. Doctors can make appropriate adjustments to the prescription according to the patient's specific conditions, such as obesity level, type of metabolic abnormality, etc., which reflects the TCM principle of "adapting treatment to individual needs".

[0086] In summary, the weight loss Chinese medicine composition of the present invention achieves multi-level beneficial effects through a reasonable compatibility relationship. It not only shows a significant effect in weight loss, but also can comprehensively improve metabolic indicators and has good safety and stability. This innovative solution based on traditional Chinese medicine theory and combined with modern technology provides a new option for the prevention and treatment of obesity and related metabolic diseases, and has important clinical value and broad application prospects.

[0087] Example 1: A Chinese medicine composition for weight loss and its preparation method

[0088] The weight loss Chinese medicine composition of this embodiment includes the following components by weight: 3 parts of hawthorn, 1 part of lotus leaf, 1 part of stir-fried cassia seed, 1 part of Poria cocos, 1 part of coix seed, 1 part of tangerine peel, 1 part of Alisma orientalis, 1 part of roselle, 1 part of atractylodes, 1 part of white atractylodes, 1 part of wax gourd peel, and 0.1 part of stevia.

[0089] The preparation method of the weight-loss Chinese medicine composition comprises the following steps:

[0090] (1) Raw material processing: First, clean the Chinese medicinal materials of each component and dry them under natural conditions.

[0091] (2) Crushing: Secondly, the dried Chinese medicinal materials were crushed into 100-mesh fine powder using a crusher.

[0092] (3) Extraction: Then, add the crushed Chinese medicinal materials to 8 times the amount of water, heat to boiling, maintain boiling for 30 minutes, and then filter to obtain a filtrate. Repeat this extraction process twice.

[0093] (4) Concentration: The filtrate was concentrated under reduced pressure at 50°C to a relative density of 1.10 (20°C).

[0094] (5) Drying: The concentrated solution was spray dried at a feed temperature of 180°C and a discharge temperature of 85°C to obtain a dry powder.

[0095] (6) Preparation: Finally, the dry powder was mixed with 5% starch as an auxiliary material to prepare granules.

[0096] (7) Quality testing: The prepared granules are tested for quality indicators such as content determination, disintegration time, and dissolution rate.

[0097] (8) Packaging: Pack, seal and label qualified granules.

[0098] In this embodiment, hawthorn is used as the main drug, which has the effects of digestion, stomach, qi, blood stasis, turbidity and lipid reduction. Lotus leaf helps the spleen and stomach, clears edema, and disperses blood stasis, thereby achieving the effect of fat. After being fried, the coldness of fried cassia seeds is weakened, which plays a mild role in diuresis and dampness removal, liver and fat removal. Poria nourishes the heart and spleen, strengthens the spleen and stomach, promotes fluid production and promotes urination. Coix seeds promote diuresis and dampness, disperse nodules, and benefit the spleen and kidneys. The synergistic effect of these components can not only promote metabolism, but also regulate the spleen and stomach, and is a gentle and effective weight loss solution.

[0099] Example 2: A Chinese medicine composition for weight loss and its preparation method

[0100] The weight loss Chinese medicine composition of this embodiment includes the following components by weight: 6 parts of hawthorn, 3 parts of lotus leaves, 3 parts of stir-fried cassia seeds, 5 parts of Poria cocos, 5 parts of coix seeds, 3 parts of tangerine peel, 3 parts of Alisma orientalis, 3 parts of roselle, 3 parts of atractylodes, 3 parts of white atractylodes, 3 parts of wax gourd peel, 1 part of stevia, 3 parts of dried tangerine peel, 3 parts of salvia miltiorrhiza, and 3 parts of stir-fried radish seeds.

[0101] The preparation method of the weight-loss Chinese medicine composition comprises the following steps:

[0102] (1) Raw material processing: First, clean the Chinese medicinal materials of each component and dry them in an oven at 50°C for 12 hours.

[0103] (2) Crushing: Secondly, the dried Chinese medicinal materials were crushed into 80-mesh fine powder using a crusher.

[0104] (3) Extraction: Then, the crushed Chinese medicinal materials were added to 10 times the amount of water, heated to boiling, and kept boiling for 60 minutes, and then filtered to obtain a filtrate. This extraction process was repeated 3 times.

[0105] (4) Concentration: The filtrate was concentrated under reduced pressure at 60°C to a relative density of 1.20 (20°C).

[0106] (5) Drying: The concentrated solution was freeze-dried at a freezing temperature of -50°C and a drying temperature of 50°C to obtain a dry powder.

[0107] (6) Preparation: Finally, the dry powder was mixed with 10% microcrystalline cellulose as an excipient to prepare tablets.

[0108] (7) Quality testing: The tablets are tested for quality indicators such as content determination, disintegration time, and dissolution.

[0109] (8) Packaging: Pack, seal and label qualified tablets.

[0110] In this embodiment, in addition to the effects of the components mentioned in Example 1, dried tangerine peel plays the role of drying dampness, strengthening the spleen and regulating qi, oriental water-draining and dehumidifying, roselle regulating the taste, atractylodes and atractylodes not only strengthen the spleen and stomach and remove dampness, but also balance the cold, hot, warm and cool of the prescription. Winter melon peel is diuretic and detumescent, diuretic, detumescent. Stevia rebaudiana promotes thirst, diuresis, and regulates blood pressure and blood sugar. Cibotium bark promotes qi and relieves swelling, promotes water and detumescence, salvia miltiorrhiza promotes blood circulation and removes blood stasis, clears the heart and removes vexation, and accelerates metabolism, and stir-fried radish seeds promote digestion and dissipate swelling, and lowers qi and resolves phlegm. This prescription achieves a more comprehensive weight loss effect through a multi-pathway and multi-level mechanism of action.

[0111] Example 3: A Chinese medicine composition for weight loss and its preparation method

[0112] The weight loss Chinese medicine composition of this embodiment includes the following components by weight: 4.5 parts of hawthorn, 2 parts of lotus leaf, 2 parts of stir-fried cassia seed, 3 parts of Poria, 3 parts of coix seed, 2 parts of tangerine peel, 2 parts of Alisma orientalis, 2 parts of roselle, 2 parts of atractylodes, 2 parts of white atractylodes, 2 parts of wax gourd peel, 0.5 parts of stevia, 1.5 parts of dried tangerine peel, 1.5 parts of salvia miltiorrhiza, and 1.5 parts of stir-fried radish seeds.

[0113] The preparation method of the weight-loss Chinese medicine composition comprises the following steps:

[0114] (1) Raw material processing: First, clean the Chinese medicinal materials of each component and dry them in an oven at 60°C for 8 hours.

[0115] (2) Crushing: Secondly, the dried Chinese medicinal materials were crushed into 90-mesh fine powder using a crusher.

[0116] (3) Extraction: Then, the crushed Chinese medicinal materials were added to 9 times the amount of water, heated to boiling, maintained in a boiling state for 45 minutes, and then filtered to obtain a filtrate. This extraction process was repeated 2 times.

[0117] (4) Concentration: The filtrate was concentrated under reduced pressure at 55°C to a relative density of 1.15 (20°C).

[0118] (5) Drying: The concentrated solution was spray dried at a feed temperature of 190°C and a discharge temperature of 90°C to obtain a dry powder.

[0119] (6) Preparation: Finally, the dry powder was mixed with 7.5% sodium carboxymethyl cellulose as an excipient to prepare capsules.

[0120] (7) Quality testing: The prepared capsules are tested for quality indicators such as content determination, disintegration time, and dissolution.

[0121] (8) Packaging: Pack, seal and label qualified capsules.

[0122] In this embodiment, this formula not only ensures the weight loss effect, but also improves safety and taste through reasonable dosage ratio, which embodies the medication principle of "monarch, minister, assistant and messenger" in traditional Chinese medicine.

[0123] Example 4: A Chinese medicine composition for weight loss and its preparation method

[0124] The weight loss Chinese medicine composition of this embodiment includes the following components by weight: 5 parts of hawthorn, 2.5 parts of lotus leaf, 2.5 parts of stir-fried cassia seeds, 4 parts of Poria cocos, 4 parts of coix seeds, 2.5 parts of tangerine peel, 2.5 parts of Alisma orientalis, 2.5 parts of roselle, 2.5 parts of atractylodes, 2.5 parts of white atractylodes, 2.5 parts of wax gourd peel, 0.8 parts of stevia, 2 parts of dried tangerine peel, 2 parts of salvia miltiorrhiza, and 2 parts of stir-fried radish seeds.

[0125] The preparation method of the weight-loss Chinese medicine composition comprises the following steps:

[0126] (1) Raw material processing: First, clean the Chinese medicinal materials of each component and dry them in an oven at 55°C for 10 hours.

[0127] (2) Crushing: Secondly, the dried Chinese medicinal materials were crushed into 85-mesh fine powder using a crusher.

[0128] (3) Extraction: Then, the crushed Chinese medicinal materials were added to 9.5 times the amount of water, heated to boiling, and kept boiling for 50 minutes, and then filtered to obtain a filtrate. This extraction process was repeated 3 times.

[0129] (4) Concentration: The filtrate was concentrated under reduced pressure at 58°C to a relative density of 1.18 (20°C).

[0130] (5) Drying: The concentrated solution is freeze-dried at a freezing temperature of -45°C and a drying temperature of 45°C to obtain a dry powder.

[0131] (6) Preparation: Finally, the dry powder was mixed with 8% povidone K30 as an excipient to prepare an oral solution.

[0132] (7) Quality testing: The oral liquid is tested for content, pH value, clarity and other quality indicators.

[0133] (8) Packaging: Pack, seal and label the qualified oral liquid.

[0134] In this embodiment, the ratio of each component is further optimized, highlighting the core effect of weight loss. The dosage of hawthorn, lotus leaf, stir-fried cassia seed, Poria cocos, and coix seed is relatively high, which strengthens the effects of digestion and stomach, diuresis and dampness, and turbidity and lipid reduction. At the same time, through the compatibility of atractylodes, white atractylodes, and dried orange peel, a good spleen and stomach conditioning effect is obtained. The dosage form of oral liquid is made to improve the absorption rate and bioavailability of the drug, making the weight loss effect more significant.

[0135] These four embodiments cover different proportions of all components in the present invention, as well as various parameter changes in the preparation method, fully demonstrating the feasibility and flexibility of the present invention. Through different proportions of components and preparation processes, personalized weight loss programs can be provided for people with different physiques and weight loss needs.

[0136] Comparative Example 1: Weight loss effect of a single Chinese herbal medicine

[0137] This comparative example is intended to verify the synergistic effect of the Chinese medicine composition of the present invention. Hawthorn, the single Chinese medicine with the largest dosage in Example 1, was selected for the comparative test.

[0138] The comparative composition comprises only 3 parts of hawthorn by weight.

[0139] The preparation method is the same as that in Example 1, comprising the following steps:

[0140] (1) Raw material processing: Wash the hawthorn and dry it under natural conditions.

[0141] (2) Crushing: The dried hawthorn is crushed into 100-mesh fine powder using a crusher.

[0142] (3) Extraction: Add 8 times the amount of water to the crushed hawthorn, heat to boiling, maintain boiling for 30 minutes, and then filter to obtain a filtrate. Repeat this extraction process twice.

[0143] (4) Concentration: The obtained filtrate was concentrated under reduced pressure at 50°C to a relative density of 1.10 (20°C).

[0144] (5) Drying: The concentrated solution was spray dried at a feed temperature of 180°C and a discharge temperature of 85°C to obtain a dry powder.

[0145] (6) Preparation: The dry powder is mixed with 5% starch as an auxiliary material to prepare granules.

[0146] (7) Quality inspection and (8) packaging steps are the same as in Example 1.

[0147] By comparing with Example 1, it can be observed that although the single Chinese medicinal material hawthorn has certain effects of digestion, stomachic, qi-promoting, blood stasis-dispersing, turbidity-removing and lipid-lowering, it lacks the synergistic effect of other Chinese medicinal materials, such as the effect of lotus leaf in promoting spleen and stomach and clearing edema, and the effect of stir-fried cassia seed in promoting water and removing dampness, etc. This comparison highlights the integrity and synergistic advantages of the Chinese medicine composition of the present invention.

[0148] Comparative Example 2: Weight Loss Effect of Lack of Key Components

[0149] This comparative example is intended to verify the importance of certain key components in the present invention. Based on Example 2, the two important components, Poria cocos and Coix seeds, which have the effect of promoting diuresis and removing dampness, are removed.

[0150] The comparative composition includes the following components by weight: 6 parts of hawthorn, 3 parts of lotus leaves, 3 parts of fried cassia seeds, 3 parts of tangerine peel, 3 parts of oriental rhizome, 3 parts of roselle, 3 parts of atractylodes, 3 parts of white atractylodes, 3 parts of wax gourd peel, 1 part of stevia, 3 parts of tangerine peel, 3 parts of salvia miltiorrhiza, and 3 parts of fried radish seeds.

[0151] The preparation method is basically the same as that of Example 2, with only slight adjustments in the raw material processing, crushing and extraction steps to adapt to the changes in components. Other steps, including concentration, drying, formulation, quality inspection and packaging are the same as those of Example 2.

[0152] By comparing with Example 2, it can be observed that the lack of Poria cocos and Coix seed may weaken the efficacy of the formula in promoting diuresis and eliminating dampness, and tonifying the heart and spleen. This comparison highlights the rational compatibility and complementary effects of the components in the present invention, and embodies the principle of "monarch, minister, assistant and messenger" in traditional Chinese medicine.

[0153] Comparative Example 3: Weight Loss Effect of Imbalanced Component Ratio

[0154] This comparative example is intended to verify the scientificity and rationality of the proportions of the components in the present invention. Based on Example 3, the amount of hawthorn was significantly increased and the amounts of other components were reduced.

[0155] The comparative composition includes the following components by weight: 9 parts of hawthorn, 1 part of lotus leaf, 1 part of stir-fried cassia seed, 1.5 parts of Poria cocos, 1.5 parts of coix seed, 1 part of tangerine peel, 1 part of Alisma orientalis, 1 part of roselle, 1 part of atractylodes, 1 part of white atractylodes, 1 part of wax gourd peel, 0.25 part of stevia, 0.75 part of tangerine peel, 0.75 part of salvia miltiorrhiza, 0.75 part of stir-fried radish seed, 1 part of wax gourd peel, and 0.25 part of licorice.

[0156] The preparation method is basically the same as that in Example 3, except that in the extraction step, the extraction time is extended to 60 minutes due to the increase in the amount of hawthorn. Other steps, including raw material processing, crushing, concentration, drying, preparation, quality inspection and packaging are the same as those in Example 3.

[0157] By comparing with Example 3, it can be observed that although the digestion, stomach strengthening, qi-promoting and blood-stasis-dispersing effects of hawthorn may be enhanced, the effects of other components may be relatively weakened, which may lead to an imbalance in the overall weight loss effect. At the same time, due to the imbalance in the proportion of the components, adverse reactions such as acid reflux are likely to occur. This comparison highlights the importance of precise control of the proportion of each component in the present invention for achieving the best weight loss effect.

[0158] Comparative Example 4: Weight Loss Effect of Variation of Preparation Process Parameters

[0159] This comparative example is intended to verify the scientificity and rationality of the preparation process parameters of the present invention. Based on Example 4, the parameters of the extraction and drying steps were significantly changed.

[0160] The components of the comparative composition are exactly the same as those of Example 4.

[0161] The preparation method is basically the same as that of Example 4, but adjustments are made in the following steps:

[0162] (3) Extraction: Add 5 times the amount of water to the crushed Chinese herbal medicine, heat to boiling, maintain boiling for 90 minutes, and then filter to obtain a filtrate. Only one extraction is performed.

[0163] (5) Drying: The concentrated solution was freeze-dried at a freezing temperature of -30°C and a drying temperature of 60°C to obtain a dry powder.

[0164] The other steps, including raw material processing, crushing, concentration, formulation, quality inspection and packaging are the same as those in Example 4.

[0165] By comparing with Example 4, it can be observed that the reduction of the number of extractions and the extension of the extraction time may affect the extraction efficiency of the effective components, while the increase of the drying temperature may cause the destruction of certain heat-sensitive components. This comparison highlights the importance of precise control of the preparation process parameters of the present invention for ensuring the quality and effect of the Chinese medicine composition.

[0166] Comparative Example 5: Weight loss effects of different dosage forms

[0167] This comparative example is intended to verify the effects of different dosage forms of the present invention on weight loss effects. Based on Example 1, the dosage form is changed from granules to oral liquid.

[0168] The components of the comparative composition are exactly the same as those of Example 1.

[0169] The preparation method is basically the same as that of Example 1, but adjustments are made in the following steps:

[0170] (5) Drying: This step was omitted.

[0171] (6) Preparation: The concentrate is directly mixed with 5% glycerol and 0.1% potassium sorbate to prepare an oral solution.

[0172] The other steps, including raw material processing, crushing, extraction, concentration, quality inspection and packaging are the same as those in Example 1, but the quality inspection indicators need to be adjusted accordingly according to the oral liquid dosage form.

[0173] By comparing with Example 1, it can be observed that the change of dosage form may affect the absorption rate and bioavailability of the drug, thereby affecting the weight loss effect. This comparison highlights the scientificity and rationality of the present invention in selecting the most suitable dosage form.

[0174] Comparative Example 6: Weight loss effect of adding western medicine ingredients

[0175] This comparative example is intended to verify the difference in weight loss effect and safety between the pure Chinese medicine composition of the present invention and the compound containing western medicine ingredients. Based on Example 2, the common weight loss western medicine ingredient orlistat was added.

[0176] The Chinese medicinal components of the comparative composition are exactly the same as those of Example 2, and 0.5 parts of orlistat is additionally added.

[0177] The preparation method is basically the same as that of Example 2, but adjustments are made in the preparation steps:

[0178] (6) Preparation: The dry powder was mixed with 10% microcrystalline cellulose and 0.5 parts of orlistat to prepare tablets.

[0179] The other steps, including raw material processing, crushing, extraction, concentration, drying, quality inspection and packaging are the same as those in Example 2.

[0180] By comparing with Example 2, it can be observed that adding western medicine ingredients may enhance the short-term weight loss effect, but at the same time may increase the risk of side effects, such as gastrointestinal discomfort, etc. This comparison highlights the advantages of the pure Chinese medicine composition of the present invention in terms of safety and long-term use.

[0181] Through these six comparative examples, the innovation and scientificity of the present invention in terms of composition ratio, preparation process, dosage form selection, etc. These comparisons not only cover the endpoint values ​​and intermediate values ​​of the formula and process parameters, but also prove the synergistic effect, safety and overall superiority of the Chinese medicine composition of the present invention from multiple perspectives.

[0182] In order to comprehensively evaluate the weight loss Chinese medicine composition of the present invention, the following experiments were designed:

[0183] 1. Evaluation of weight loss effect

[0184] First, 120 volunteers with a body mass index (BMI) between 28 and 35 were selected and randomly divided into 6 groups, each with 20 people. Four of the groups used the Chinese medicine compositions of Examples 1 to 4, one group used the single Chinese medicinal material (crataegus pinnatifida) of Comparative Example 1, and one group served as a placebo control group. The experiment lasted for 12 weeks, and the weight, waist circumference and body fat percentage of the subjects were recorded every week.

[0185] 2. Metabolic Index Assessment

[0186] Secondly, all subjects underwent blood biochemical tests before the start of the experiment, in the middle of the experiment (week 6), and at the end of the experiment, including blood glucose, blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol), liver function (ALT, AST), and kidney function (creatinine, urea nitrogen) indicators.

[0187] 3. Assessment of appetite and gastrointestinal function

[0188] Then, all subjects were asked to fill in appetite and gastrointestinal symptom questionnaires every week to evaluate the effects of the Chinese herbal composition on appetite suppression and the digestive system.

[0189] 4. Safety Assessment

[0190] Again, all subjects were closely monitored for adverse reactions, and a comprehensive safety assessment was performed at the end of the experiment.

[0191] 5. Testing of the content and stability of effective ingredients in traditional Chinese medicine

[0192] Finally, the Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-6 were subjected to high performance liquid chromatography (HPLC) analysis to detect the content of the main active ingredients and their stability under different storage conditions.

[0193] The experimental results are as follows:

[0194] Table 1. Comparison of weight loss effects after 12 weeks

[0195]

[0196] Table 2. Improvement of metabolic indicators after 12 weeks

[0197]

[0198] Table 3. Content and stability of main active ingredients (taking chlorogenic acid in hawthorn as an example)

[0199]

[0200] The experimental results are analyzed as follows:

[0201] 1. Weight loss effect: As can be seen from Table 1, the four examples of the present invention all showed significant weight loss effects, especially Example 4, where the average weight loss reached 7.9 kg, which was much better than a single Chinese medicinal material (Comparative Example 1) and a placebo. This proves the synergistic weight loss effect of the Chinese medicinal composition of the present invention.

[0202] 2. Metabolic improvement: Table 2 shows that the Chinese medicine composition of the present invention can not only effectively reduce weight, but also significantly improve metabolic indicators. Example 4 performed best in improving blood sugar and blood lipids, which may be due to its more balanced composition ratio and more optimized preparation process.

[0203] 3. Stability: Table 3 shows the stability of the Chinese medicine composition of the present invention by taking chlorogenic acid in hawthorn as an example. During the 6-month storage period, the reduction in the content of the active ingredient in Examples 1-4 was less than that in Comparative Example 1, which indicates that the formulation and preparation process of the present invention improve the stability of the product.

[0204] The present invention also has unexpected technical effects:

[0205] 1. Synergistic effect: The Chinese medicine composition of the present invention is significantly better than a single Chinese medicine in terms of weight loss effect. This synergistic effect may be due to the interaction between the components. For example, the digestion and stomach function of hawthorn and the lipid-dissolving function of lotus leaf promote each other, while the diuretic and dampness-removing effects of Poria cocos and coix seed further enhance the weight loss effect.

[0206] 2. Comprehensive improvement of metabolism: In addition to the expected weight loss effect, the Chinese medicine composition of the present invention also shows the effect of comprehensively improving metabolic indicators. This may be because the formula contains ingredients that regulate blood sugar (such as stevia) and improve blood lipids (such as hawthorn and cassia seed). This multi-target mechanism of action is difficult to achieve with a single ingredient.

[0207] 3. High stability: The Chinese medicine composition of the present invention shows better stability than that of a single Chinese medicinal material, which may be due to the formation of a protective interaction between the components in the compound, which slows down the degradation rate of the active ingredients.

[0208] 4. Improved safety: During the experiment, the Chinese medicine combination group of the present invention showed a lower incidence of adverse reactions, which may be due to the mutual restraint of the various medicinal materials in the formula, reducing the side effects that may be caused by a single medicinal material.

[0209] 5. Appetite regulation: Through the appetite questionnaire survey, it was found that the subjects who took the Chinese medicine composition of the present invention generally reported that their appetite was well controlled, and this effect was not obvious in the single Chinese medicine group. This may be because the formula contains a variety of herbs that have the effect of strengthening the spleen and replenishing qi, which can suppress appetite without causing excessive hunger.

[0210] Based on the above experimental results and analysis, it can be considered that the weight loss Chinese medicine composition of the present invention is not only significantly superior to a single Chinese medicinal material in weight loss effect, but also has advantages in many aspects such as improving metabolic indicators, improving stability, and enhancing safety. These advantages are derived from the innovations of the present invention in terms of formula proportions, preparation processes, etc., and embody the overall concept and syndrome differentiation and treatment ideas of traditional Chinese medicine. Among them, Example 4 shows the best comprehensive effect and can be used as the best embodiment of the present invention. This innovative method based on traditional Chinese medicine theory and combined with modern pharmaceutical technology provides new ideas and possibilities for developing safe and effective weight loss products.

[0211] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for weight loss, characterized in that: By weight, it includes the following components: 3-6 portions of hawthorn; 1-3 portions of lotus leaves; 1-3 servings of stir-fried cassia seeds; 1-5 parts of Poria cocos; 1-5 parts coix seeds; 1-3 parts dried tangerine peel; 1-3 parts of Alisma orientalis; 1-3 servings of Roselle; 1-3 parts of Atractylodes lancea; 1-3 parts of Atractylodes macrocephala; 1-3 portions of winter melon peel; Stevia 0.1-1 portion.

2. The weight loss Chinese medicine composition according to claim 1, characterized in that Also includes the following components: 0-3 parts of big belly skin; 0-3 parts of Salvia miltiorrhiza; 0-3 servings of stir-fried radish seeds.

3. The weight loss Chinese medicine composition according to any one of claims 1-2, characterized in that: The dosage form of the composition is one of granules, tablets, capsules or oral liquids.

4. A method for preparing the weight loss Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Raw material processing: clean and dry the Chinese medicinal materials of each component; (2) Crushing: crushing the dried Chinese medicinal materials into fine powder; (3) Extraction: Add the crushed Chinese medicinal materials into an appropriate amount of water, heat and boil, maintain the boiling state for 30-60 minutes, and then filter to obtain a filtrate; (4) Concentrating: Concentrating the filtrate under reduced pressure to obtain a concentrated solution; (5) Drying: spray drying or freeze drying the concentrated solution to obtain a dry powder; (6) Preparation: The dry powder is mixed with auxiliary materials to prepare the desired dosage form.

5. The method according to claim 4, characterized in that In step (3), the extraction process is repeated 2-3 times.

6. The method according to claim 4, characterized in that In step (4), the reduced pressure concentration is carried out at 50-60°C to a relative density of 1.10-1.20 (20°C).

7. The method according to claim 4, characterized in that In step (5), if spray drying is adopted, the feed temperature is 180-200°C and the discharge temperature is 85-95°C; if freeze drying is adopted, the freezing temperature is -40 to -50°C and the drying temperature is 40-50°C.

8. The method according to claim 4, characterized in that In step (6), the auxiliary materials include one or more of starch, microcrystalline cellulose, sodium carboxymethyl cellulose, and povidone K30.

9. The method according to any one of claims 4 to 8, characterized in that: After step (6), the method further includes the following steps: (7) Quality testing: Testing of quality indicators such as content determination, disintegration time, and dissolution of the prepared preparations; (8) Packaging: Pack, seal and label qualified preparations.

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