A traditional Chinese medicine composition for preventing and controlling fatty liver syndrome of laying hens, a medicine prepared by using the traditional Chinese medicine composition and a preparation method of the medicine

Abstract

The present application belongs to the field of traditional Chinese veterinary medicine, and discloses a traditional Chinese medicine composition for preventing and controlling fatty liver syndrome of laying hens, a medicine prepared by using the traditional Chinese medicine composition and a preparation method of the medicine. The medicine is prepared from 10-25 parts of cyperus rotundus, 5-20 parts of ligusticum chuanxiong, 5-20 parts of atractylodes lancea, 5-20 parts of swertia mileensis, 5-20 parts of elaeagnus pungens, 2-10 parts of jatropha gossypiifolia and 2-15 parts of bletilla striata polysaccharide. The preparation method is as follows: the cyperus rotundus, ligusticum chuanxiong and atractylodes lancea are extracted to obtain volatile oil, and the volatile oil is combined with β-cyclodextrin to form a volatile oil inclusion powder; the residues after extraction of the volatile oil are water-extracted and concentrated to obtain extract; the bletilla striata polysaccharide is dissolved in water to form a glue paste; the extract, the inclusion powder and the glue paste are mixed and granulated to obtain the medicine. The medicine can significantly reduce the liver weight / body weight ratio and the deposition degree of liver fat drops of laying hens, effectively improve the laying rate, and provide a safe and effective, stable quality and convenient solution for green prevention and control of fatty liver syndrome of laying hens.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese veterinary medicine technology, specifically to a traditional Chinese medicine composition for the prevention and control of fatty liver syndrome in laying hens, and also to a drug prepared using this traditional Chinese medicine composition and its preparation method. Background Technology

[0002] Fatty Liver Syndrome (FLS) is a common nutritional and metabolic disease in intensive layer chicken farming, characterized by excessive fat deposition in the liver, hepatocyte damage, and hemorrhage tendency. It severely impacts egg production performance and causes economic losses. Currently, the main prevention and treatment methods include nutritional regulation (such as supplementing with choline, methionine, and vitamin E) and chemical additive intervention. However, these methods often focus on regulating single metabolic processes, and long-term use can lead to unstable efficacy, dependence, or residual risks, making it difficult to achieve safe and sustainable comprehensive prevention and control.

[0003] From the perspective of Traditional Chinese Medicine (TCM), the pathogenesis of FLS in laying hens is the result of multiple factors working together, and its core pathogenesis can be summarized as "liver stagnation, spleen deficiency, and damp-heat." Firstly, high-producing laying hens in intensive cage-rearing environments are chronically in a state of "liver qi stagnation," and this stagnation directly affects the excretion and transport of fat, corresponding to the "disorders of lipoprotein synthesis and export" revealed by modern research. Secondly, long-term consumption of high-energy diets, coupled with insufficient exercise, easily leads to "spleen dysfunction," resulting in abnormal transformation of food essence, accumulation of dampness and phlegm, which transforms into fatty turbidity and deposits in the liver. This is consistent with the pathological process of "excessive energy metabolism and hyperactive fat synthesis." Furthermore, laying hens are considered to have a strong yang constitution, with vigorous egg production metabolism. Combined with factors such as "heat stress," this easily leads to the transformation of yang into heat, resulting in internal damp-heat, further obstructing the flow of liver and gallbladder qi, and triggering oxidative stress and inflammatory damage, exacerbating hepatocyte fatty degeneration and necrosis. Therefore, the prevention and treatment of FLS in laying hens using traditional Chinese medicine should establish a comprehensive treatment principle of "soothing the liver and strengthening the spleen, clearing heat and removing dampness, and promoting digestion and relieving stagnation" in order to regulate the body's Qi, restore its function, and eliminate damp heat, thus achieving both symptomatic and root-cause treatment.

[0004] Yueju Pill, derived from Danxi Xinfa, is a classic formula for regulating qi and relieving depression. Its basic treatment principle of "soothing the liver and relieving depression, strengthening the spleen and removing dampness" is consistent with the liver depression and spleen deficiency in the pathogenesis of FLS. However, the direct application of traditional Yueju Pill to the prevention and control of FLS in laying hens has the following significant technical defects: (1) The formula is not fully compatible with poultry physiology and FLS pathogenesis: Shenqu in the original formula is a fermented product, and its efficacy depends on the digestive environment of mammals. It is difficult to effectively play the role of digestion and stagnation in poultry. Gardenia clears the fire of the three jiaos, but its heat-clearing and dampness-removing power is relatively weak for the key "damp-heat" pathogenesis in laying hens, and it is difficult to fully address it. Therefore, the original formula is not targeted enough for "damp-heat" and "food stagnation". (2) Poor stability of active ingredients: The volatile oil contained in Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea in the formula is an important active component for soothing the liver and regulating qi. However, it is very easy to volatilize and lose in the traditional decoction or pulverization process, resulting in unstable product quality and low reproducibility of efficacy. (3) Inconvenient dosage form and administration method: Traditional pills and powders have problems such as uneven mixing, poor solubility and poor palatability, which are not suitable for the administration needs of group drinking water and feed mixing in modern intensive farming.

[0005] Therefore, in order to address the shortcomings of existing technologies in treating metabolic diseases in livestock and poultry, there is a need for a drug that can inherit the "soothing the liver and strengthening the spleen" function of Yueju Pill, while also specifically enhancing the effects of "clearing heat and dampness, promoting digestion and relieving stagnation," and can fully adapt to the physiological needs of laying hens and the needs of large-scale farming in terms of process and dosage form. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for the prevention and control of fatty liver syndrome in laying hens. It also provides a drug prepared using the traditional Chinese medicine composition and a method for preparing the drug.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, a traditional Chinese medicine composition for the prevention and control of fatty liver syndrome in laying hens is provided, the composition comprising 10-25 parts of Cyperus rotundus, 5-20 parts of Ligusticum chuanxiong, 5-20 parts of Atractylodes lancea, 5-20 parts of Gentiana scabra, 5-20 parts of Erythrina variegata, and 2-10 parts of Tung oil seed.

[0008] Preferably, the traditional Chinese medicine composition consists of 12-18 parts of Cyperus rotundus, 8-12 parts of Ligusticum chuanxiong, 10-15 parts of Atractylodes lancea, 8-12 parts of Gentiana scabra, 6-10 parts of Erythrina variegata, and 3-6 parts of Tung oil seed.

[0009] More preferably, the traditional Chinese medicine composition consists of 15 parts of Cyperus rotundus, 10 parts of Ligusticum chuanxiong, 10 parts of Atractylodes lancea, 10 parts of Gentiana scabra, 10 parts of Erythrina variegata, and 5 parts of Tung oil seed.

[0010] In a second aspect, a drug for preventing and controlling fatty liver syndrome in laying hens is provided, the drug being prepared from the traditional Chinese medicine composition of the first aspect and 2-15 parts of Bletilla striata polysaccharide.

[0011] Preferably, the amount of Bletilla striata polysaccharide used is 2 to 5 parts.

[0012] More preferably, the amount of Bletilla striata polysaccharide used is 5 parts.

[0013] The volatile oils of Cyperus rotundus, Ligusticum chuanxiong, and Atractylodes lancea are first extracted, and then a volatile oil inclusion complex powder is formed with β-cyclodextrin and added to the drug. The residue after volatile oil extraction is extracted with Gentiana scabra, Erythrina variegata, and Tung oil seed, and then concentrated to obtain an extract. Bletilla striata polysaccharide is dissolved in water to form a paste. The extract is mixed with the inclusion complex powder and the Bletilla striata polysaccharide paste and granulated to obtain the drug.

[0014] Thirdly, a method for preparing the drug described in the second aspect is provided, the specific steps of which are as follows: (1) Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea were extracted by steam distillation to obtain mixed volatile oil; β-cyclodextrin was dissolved in water to make a saturated solution, and the mixed volatile oil was slowly added under high-speed shearing conditions. The mixture was stirred for 2 to 3 hours, cooled, allowed to stand, filtered and dried to obtain inclusion complex powder. (2) The residue after extracting the volatile oil was boiled with water along with *Gentiana scabra*, *Erythrina variegata*, and *Tetracentron sinense*, and concentrated to obtain an extract; (3) Bletilla striata polysaccharide is dissolved in water to form a paste. The inclusion complex powder is mixed with the extract and Bletilla striata polysaccharide paste, and necessary excipients are added. Granulation is then performed to obtain the granulated drug.

[0015] Preferably, the weight ratio of the mixed volatile oil to β-cyclodextrin is 1:6-8. When preparing the inclusion complex powder, the saturated β-cyclodextrin solution is subjected to high-speed shearing at 40-50°C and 8000-12000 rpm, while the mixed volatile oil is slowly added simultaneously. Encapsulating the volatile oil with β-cyclodextrin aims to improve the stability and efficacy of volatile active ingredients in traditional Chinese medicine, thus ensuring therapeutic efficacy.

[0016] Preferably, in step (2), water is added and boiled twice, the decoctions are combined, and the relative density of the extract obtained after concentration is 1.1 to 1.15.

[0017] Preferably, the Bletilla striata polysaccharide paste is formed by dissolving Bletilla striata polysaccharide in 20 times its volume of water. Specifically, Bletilla striata polysaccharide is mixed with water and stirred and swollen in a water bath at 70-80°C for 1-2 hours. In this medicine, Bletilla striata polysaccharide serves both as a binder and stabilizer, and also exerts its astringent, hemostatic, and gastrointestinal mucosal protective effects.

[0018] In actual breeding production, the drug of this invention is added to the daily diet of chickens at 0.5% to 1.5% of the total daily weight, or dissolved in drinking water at a rate of 1 to 2 grams per liter of drinking water. It is recommended to administer the drug in a pulsed manner at the dosage of 10 days as a course of treatment to achieve preventive and therapeutic effects.

[0019] This formula follows the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in its formulation, targeting the core pathogenesis of FLS in laying hens: "liver stagnation, spleen deficiency, damp-heat, and food stagnation." The formulation principle is as follows: The principal herbs are Cyperus rotundus and Ligusticum chuanxiong. Together, they primarily enter the liver meridian, focusing on unblocking the flow of qi, relieving "liver qi stagnation," and restoring the normal excretion and transport functions of fat, thus treating the root cause of the disease.

[0020] Assistant herbs: Atractylodes lancea, Gentiana scabra, and Erythrina variegata. Atractylodes lancea dries dampness and strengthens the spleen, enhancing digestion and reducing the formation of dampness and turbidity at the source; Gentiana scabra and Erythrina variegata clear damp-heat from the liver and gallbladder, clearing heat and detoxifying, targeting heat stress and inflammatory damage. The combination of these two herbs strengthens the spleen and clears heat simultaneously, addressing both the symptoms and the underlying cause.

[0021] Adjuvant herbs: Tung seeds and Bletilla striata polysaccharides. Tung seeds promote qi circulation and digestion, clear residual heat, and help resolve the problem of food stagnation. Bletilla striata polysaccharides achieve "medicine and adjuvant integration" in this formula, acting as a binder to improve the formulation and palatability, and also exerting its astringent, hemostatic, and gastrointestinal mucosal protective effects.

[0022] The combined effects of all the herbs in the formula work together to soothe the liver and strengthen the spleen, clear heat and promote diuresis, and aid digestion and relieve stagnation. It is a synergistic system designed to address the overall pathogenesis of FLS in laying hens.

[0023] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in: (1) Scientific formulation and strong targeting: In response to the problem pointed out in the background art that the traditional Yueju Pill formulation is not fully compatible with the pathogenesis of FLS in poultry, this invention, based on traditional Chinese medicine theory, removes the Liu Shen Qu (a type of medicinal preparation) which has uncertain effects in poultry and the Gardenia (a herb with weak heat-clearing properties), and adds the powerful "heat-clearing and dampness-removing" herbs Qingye Dan (a type of herb) and Elephant Ear (a type of herb), and introduces Qitongzi (a type of herb) to "promote digestion and relieve stagnation". The improved formulation closely follows the complex pathogenesis of FLS, namely "liver stagnation, spleen deficiency, damp heat, and food stagnation", and achieves precise intervention. Experimental results show that the drug of this invention is significantly more effective than the traditional Yueju Pill powder group in improving liver fat droplet deposition, with an improvement rate of 37.1% in liver fat droplet deposition score, directly proving the scientific nature and necessity of the improved formulation of this invention.

[0024] (2) Stable and uniform product quality: To address the problem of easy loss of volatile oils in traditional processes, this invention uses β-cyclodextrin inclusion technology to stabilize the volatile oil active ingredients in Cyperus rotundus, Ligusticum chuanxiong, and Atractylodes lancea. For example, in a specific embodiment, after 12 months of storage at room temperature, the volatile oil retention rate of the inclusion product is still above 90%, ensuring the stability of the product's efficacy and batch-to-batch reproducibility.

[0025] (3) Suitable dosage form and convenient application: Overcoming the defects of poor palatability and uneven mixing of traditional powders, the drug dosage form prepared by this invention is granules, which makes it more soluble and fluid, and can be conveniently administered by drinking water or mixing with feed, greatly improving the operability on the breeding site. Detailed Implementation

[0026] The present invention will be further described in detail below with reference to embodiments, but the scope of protection of the present invention is not limited thereto. All raw materials used are commercially available. Example 1

[0027] A drug for the prevention and control of fatty liver syndrome in laying hens is prepared from the following traditional Chinese medicine composition and Bletilla striata polysaccharide in parts by weight: Cyperus rotundus 15 parts, Ligusticum chuanxiong 10 parts, Atractylodes lancea 10 parts, Gentiana scabra 10 parts, Erythrina variegata 10 parts, Tung oil 5 parts, and Bletilla striata polysaccharide 5 parts.

[0028] The specific steps for preparing this drug are as follows: (1) Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea were extracted by steam distillation to obtain mixed volatile oil; β-cyclodextrin was dissolved in water to make a saturated solution, and the weight ratio of mixed volatile oil to β-cyclodextrin was 1:7. The β-cyclodextrin saturated solution was subjected to high-speed shearing at 45℃ and 10000 rpm. The mixed volatile oil was slowly added while the high-speed shearing was performed, and the mixture was stirred continuously for 2.5 hours. After cooling, standing, filtering and drying, the inclusion complex powder was obtained. (2) The residue after extracting the volatile oil was boiled twice with water along with Qingyedan, Elei, and Qitongzi. The decoctions were combined and concentrated to obtain an extract with a relative density of 1.12.

[0029] (3) Mix Bletilla striata polysaccharide with 20 times the amount of water and stir and swell in a 75°C water bath for 1.5 hours to make Bletilla striata polysaccharide slurry. Mix Bletilla striata polysaccharide slurry with the inclusion complex powder from step (1) and the extract from step (2), add necessary excipients (maltodextrin), granulate, and obtain the granulated drug. Example 2

[0030] A drug for the prevention and control of fatty liver syndrome in laying hens is prepared from the following traditional Chinese medicine composition and Bletilla striata polysaccharide in parts by weight: Cyperus rotundus 18 parts, Ligusticum chuanxiong 12 parts, Atractylodes lancea 15 parts, Gentiana scabra 12 parts, Erythrina variegata 10 parts, Tung oil 6 parts, and Bletilla striata polysaccharide 5 parts.

[0031] The specific steps for preparing this drug are as follows: (1) Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea were extracted by steam distillation to obtain mixed volatile oil; β-cyclodextrin was dissolved in water to make a saturated solution, and the weight ratio of mixed volatile oil to β-cyclodextrin was 1:8. The β-cyclodextrin saturated solution was subjected to high-speed shearing at 50℃ and 12000 rpm. The mixed volatile oil was slowly added while the high-speed shearing was performed. The mixture was stirred continuously for 3 hours, cooled, allowed to stand, filtered and dried to obtain inclusion complex powder. (2) The residue after extracting the volatile oil was boiled twice with water along with Qingyedan, Elei, and Qitongzi. The decoctions were combined and concentrated to obtain an extract with a relative density of 1.15.

[0032] (3) Mix Bletilla striata polysaccharide with 20 times the amount of water and stir and swell in an 80°C water bath for 2 hours to make Bletilla striata polysaccharide slurry. Mix Bletilla striata polysaccharide slurry with the inclusion complex powder from step (1) and the extract from step (2), add necessary excipients (such as maltodextrin), granulate, and obtain the granulated drug. Example 3

[0033] A drug for the prevention and control of fatty liver syndrome in laying hens is prepared from the following traditional Chinese medicine composition and Bletilla striata polysaccharide in parts by weight: Cyperus rotundus 10 parts, Ligusticum chuanxiong 5 parts, Atractylodes lancea 5 parts, Gentiana scabra 5 parts, Erythrina variegata 5 parts, Tung oil 2 parts, and Bletilla striata polysaccharide 2 parts.

[0034] (1) Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea were extracted by steam distillation to obtain mixed volatile oil; β-cyclodextrin was dissolved in water to make a saturated solution, and the weight ratio of mixed volatile oil to β-cyclodextrin was 1:6. The β-cyclodextrin saturated solution was subjected to high-speed shearing at 40℃ and 8000 rpm. The mixed volatile oil was slowly added while the high-speed shearing was performed. The mixture was stirred continuously for 2 hours, cooled, allowed to stand, filtered and dried to obtain inclusion complex powder. (2) The residue after extracting the volatile oil was boiled twice with water along with Qingyedan, Elei, and Qitongzi. The decoctions were combined and concentrated to obtain an extract with a relative density of 1.1.

[0035] (3) Mix Bletilla striata polysaccharide with 20 times the amount of water and stir and swell in a 70°C water bath for 1 hour to make Bletilla striata polysaccharide slurry. Mix Bletilla striata polysaccharide slurry with the inclusion complex powder from step (1) and the extract from step (2), add necessary excipients (such as maltodextrin), granulate, and obtain the granulated drug. Example 4

[0036] A drug for the prevention and control of fatty liver syndrome in laying hens is prepared from the following traditional Chinese medicine composition and Bletilla striata polysaccharide in parts by weight: Cyperus rotundus 25 parts, Ligusticum chuanxiong 20 parts, Atractylodes lancea 20 parts, Gentiana scabra 20 parts, Erythrina variegata 20 parts, Tung oil 10 parts, and Bletilla striata polysaccharide 15 parts.

[0037] The preparation method of the above-mentioned drug is the same as that in Example 1. The weight ratio of the mixed volatile oil to β-cyclodextrin is 1:8. Example 5

[0038] A drug for the prevention and control of fatty liver syndrome in laying hens is prepared from the following traditional Chinese medicine composition and Bletilla striata polysaccharide in parts by weight: Cyperus rotundus 12 parts, Ligusticum chuanxiong 8 parts, Atractylodes lancea 10 parts, Gentiana scabra 8 parts, Erythrina variegata 6 parts, Tung oil 3 parts, and Bletilla striata polysaccharide 2 parts.

[0039] The preparation method of the above-mentioned drug is the same as that in Example 1. The weight ratio of the mixed volatile oil to β-cyclodextrin is 1:7.

[0040] Comparative Example 1 Prepare a powder according to the original formula in "Danxi Xinfa" (equal parts of Cyperus rotundus, Ligusticum chuanxiong, Atractylodes lancea, Medicated Leaven, and Gardenia jasminoides).

[0041] Comparative Example 2 Referring to the raw material dosage of Example 1, each herb in the traditional Chinese medicine composition was taken, decocted with water, concentrated into an extract, and then Bletilla striata polysaccharide was added. The preparation method differed from that of Example 1 in that: the volatile oils of Cyperus rotundus, Ligusticum chuanxiong, and Atractylodes lancea were not extracted and encapsulated separately, while the remaining preparation steps and parameters were the same as in Example 1.

[0042] Comparative Example 3 Referring to the dosage of the traditional Chinese medicine composition in Example 1 and steps (1) and (2), volatile oil inclusion complex powder and extract were prepared, the difference being that: no Bletilla striata polysaccharide was added, and conventional binder (10% starch paste) was used for granulation, the rest being the same as in Example 1.

[0043] Experiment Example 1: Stability Test The granules prepared in Example 1 were stored at room temperature (25℃±2℃, RH 60%±10%), and the volatile oil retention rate was monitored periodically. The results are shown in Table 1. The results show that the volatile oil retention rate of the granules remained at 93.6% after 12 months, indicating that the encapsulation treatment can effectively protect the volatile oil and ensure the quality stability of the product during long-term storage.

[0044]

[0045] The volatile oil retention rate of the product prepared in Example 2 was periodically tested, and its volatile oil retention rate after 12 months of storage at room temperature was 94.3%, which also showed excellent stability.

[0046] Experiment Example 2: Animal experiments to verify the control effect 1. Experimental Design To verify the beneficial effects of the present invention and to address the problems mentioned in the background art, an animal experiment was designed that included multiple control groups.

[0047] Experimental animals: 300-day-old Hy-Line Brown laying hens from the same batch and under the same feeding and management conditions were selected based on the clinical diagnostic criteria for FLS (obesity, lower-than-normal egg production, elevated serum ALT, etc.). Specific screening criteria were as follows: ① Body weight exceeding the average weight of the same batch by more than 20%; ② Egg production rate lower than the average egg production rate of the same batch by 5 percentage points; ③ Serum alanine aminotransferase (ALT) > 50 U / L. Hens meeting at least two of these criteria were considered to have early symptoms of FLS or be at high risk and were included in the experiment. 350 laying hens with early symptoms of FLS or at high risk were selected according to the criteria and randomly divided into 7 groups of 50 hens each. All experimental chickens underwent a 7-day acclimatization period before being grouped, and basic performance indicators were measured. Results showed that the average weight of the chickens in each group ranged from 2.1 to 2.2 kg, and the average egg production rate ranged from 81% to 83%. Statistical analysis revealed no significant differences in weight and egg production rate among the groups (P>0.05), indicating comparability. After confirming no significant differences in weight and egg production rate among the groups, the formal experiment commenced.

[0048] Experimental period: 7 days of pre-feeding period and 42 days of experimental period.

[0049] Detection indicators: At the end of the experiment, 10 chickens were randomly selected from each group, and blood samples were collected to detect serum ALT levels. After euthanasia, the livers were harvested, weighed, and the liver weight / body weight ratio was calculated. Liver tissue was taken for pathological sections, and the degree of fat droplet deposition in the liver was scored from 0 to 5 points (the higher the score, the more severe the deposition). The average egg production rate throughout the entire experimental period was also recorded.

[0050] 2. Experimental grouping and feeding treatment Blank control group: fed with basal diet.

[0051] Chemical drug control group: basal diet + 0.05% choline chloride.

[0052] The low-dose group of this invention consists of a basal diet plus 0.5% of the granules prepared in Example 1.

[0053] The high-dose group of this invention consists of a basal diet plus 1.5% of the granules prepared in Example 1.

[0054] Control group 1: basal diet + 1.5% of the powder prepared in control group 1.

[0055] Control group 2: basal diet + 1.5% of the granules prepared in control group 2.

[0056] Control group 3: basal diet + 1.5% of the granules prepared in control group 3.

[0057] 3. Experimental Results and Analysis All data are expressed as mean ± standard deviation. Multiple comparisons were performed using SPSS software via one-way ANOVA and Duncan's method. P < 0.05 indicated statistical significance, and P < 0.01 indicated highly statistical significance. Results are shown in Table 2.

[0058]

[0059] 4. Discussion of Results Based on the above experimental comparison results, the following conclusions can be drawn: (1) Superiority of the formulation: The high-dose group of this invention was significantly better than the blank control group and the chemical drug control group in all core indicators (liver weight ratio, liver fat droplet deposition score, serum ALT) (P<0.01). In particular, compared with control group 1, the high-dose group of this invention showed excellent liver fat droplet deposition score and egg production rate, which strongly proves that the formulation of this invention, which is based on the traditional Yueju pill and improves the "clearing heat and dampness, promoting digestion and relieving stagnation" formula, has a significant synergistic effect on the prevention and control of FLS in laying hens.

[0060] (2) Necessity of process improvement: The effect of control group 2 (without volatile oil inclusion complex) was significantly worse than that of the high-dose group of the present invention (P<0.05), and comparable to that of control group 1. This directly confirms that the volatile oil in Cyperus rotundus, Ligusticum chuanxiong, and Atractylodes lancea is the key substance for exerting the effect of soothing the liver and regulating qi. The β-cyclodextrin inclusion stabilization treatment is the core process to ensure the stable efficacy and good reproducibility of the present invention. Combined with the stability data of Experiment Example 1, it can be seen that the inclusion technology of the present invention not only ensures the stability of the volatile oil content during the shelf life, but also confirms the stable efficacy in animal experiments, avoiding the weakening of efficacy due to the loss of volatile oil.

[0061] (3) The scientific nature of “drug and excipient integration”: The effect of control group 3 (without Bletilla striata polysaccharide) was also significantly inferior to that of the high-dose group of the present invention, indicating that Bletilla striata polysaccharide not only played its pharmacological role in protecting the gastrointestinal mucosa and promoting absorption, but also could be used as a binder excipient to stabilize the dosage form, thus achieving the synergistic effect of “drug and excipient integration”, which is an indispensable component of the formulation of the present invention.

[0062] (4) Safe and productive: During the experiment, no adverse reactions occurred in any of the drug administration groups, and the egg production rate of the high-dose group was improved, indicating that the composition of the present invention is green and safe and has no negative impact on production performance.

[0063] In summary, this invention, through scientific formulation and preparation process, successfully solves the technical challenges of applying traditional prescriptions to control FLS in laying hens. Its superiority and innovation are fully supported by rigorous animal experimental data.

[0064] This invention is not limited to the specific embodiments described above. Within the spirit and essence of the technical solution of this invention, those skilled in the art can make equivalent substitutions or improvements based on the disclosed technical content and professional knowledge, and such substitutions or improvements should also be considered to fall within the protection scope of this invention.

Claims

1. A traditional Chinese medicine composition for the prevention and control of fatty liver syndrome in laying hens, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Cyperus rotundus 10-25 parts, Ligusticum chuanxiong 5-20 parts, Atractylodes lancea 5-20 parts, Gentiana scabra 5-20 parts, Erythrina variegata 5-20 parts, and Tung oil seed 2-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Cyperus rotundus 12-18 parts, Ligusticum chuanxiong 8-12 parts, Atractylodes lancea 10-15 parts, Gentiana scabra 8-12 parts, Erythrina variegata 6-10 parts, and Tung oil 3-6 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts Cyperus rotundus, 10 parts Ligusticum chuanxiong, 10 parts Atractylodes lancea, 10 parts Gentiana scabra, 10 parts Erythrina variegata, and 5 parts Tung oil.

4. A drug for the prevention and control of fatty liver syndrome in laying hens, characterized in that, The drug is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 3 and Bletilla striata polysaccharide, wherein the amount of Bletilla striata polysaccharide is 2 to 15 parts.

5. The drug according to claim 4, characterized in that, The amount of Bletilla striata polysaccharide used is 2 to 5 parts.

6. The drug according to claim 5, characterized in that, The amount of Bletilla striata polysaccharide used is 5 parts.

7. The drug according to any one of claims 4 to 6, characterized in that, The volatile oils of Cyperus rotundus, Ligusticum chuanxiong, and Atractylodes lancea are first extracted, and then a volatile oil inclusion complex powder is formed with β-cyclodextrin and added to the drug. The residue after volatile oil extraction is extracted with Gentiana scabra, Erythrina variegata, and Tung oil seed, and then concentrated to obtain an extract. Bletilla striata polysaccharide is dissolved in water to form a paste. The extract is mixed with the inclusion complex powder and the Bletilla striata polysaccharide paste and granulated to obtain the drug.

8. The method for preparing the drug according to any one of claims 4 to 7, characterized in that, The preparation method includes the following steps: (1) Cyperus rotundus, Ligusticum chuanxiong and Atractylodes lancea were extracted by steam distillation to obtain mixed volatile oil; β-cyclodextrin was dissolved in water to make a saturated solution, and the mixed volatile oil was slowly added under high-speed shearing conditions. The mixture was stirred for 2 to 3 hours, cooled, allowed to stand, filtered and dried to obtain inclusion complex powder. (2) The residue after extracting the volatile oil was boiled with water along with *Gentiana scabra*, *Erythrina variegata*, and *Tetracentron sinense*, and concentrated to obtain an extract; (3) Bletilla striata polysaccharide is dissolved in water to form a paste. The inclusion complex powder is mixed with the extract and Bletilla striata polysaccharide paste, and necessary excipients are added. The mixture is then granulated to obtain the final product.

9. The preparation method according to claim 8, characterized in that, In step (1), when preparing the inclusion complex powder, the weight ratio of the mixed volatile oil to β-cyclodextrin is 1:6 to 8.

10. The preparation method according to claim 8, characterized in that, The Bletilla striata polysaccharide paste is made by dissolving Bletilla striata polysaccharide in 15 to 20 times its volume of water.

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