Five-herb meconopsis Tibetan medicine composition as well as preparation method and application thereof

Abstract

The invention discloses a five-ingredient meconopsis Tibetan medicine composition as well as a preparation method and application thereof, and relates to the technical field of medicines, the five-ingredient meconopsis Tibetan medicine composition is prepared from the following raw material components in parts by mass: 80-120 parts of meconopsis, 30-70 parts of tabasheer, 80-120 parts of safflower, 80-120 parts of emblic leafflower fruit and 5-15 parts of saffron. The five-ingredient concentrated pill provided by the invention is prepared by adopting a new dosage form, a dosage form compared with a 25-ingredient meconopsis meconopsis pill is changed into the concentrated pill from a watered pill, and the pill is prepared by extracting and concentrating part of medicinal materials, so that the concentration of effective components of the concentrated pill is improved, the bioavailability is good, and the drug effect is improved; the concentrated pill is small in size, small in taking dosage, relatively concentrated in effective components and less in impurities; in the aspect of storage, the concentrated pill is more stable than a water pill and is convenient to carry and store.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a Tibetan medicine composition of five-flavored Meconopsis, its preparation method, and its application. Background Technology

[0002] Non-alcoholic fatty liver disease (NAFLD) is a metabolic disease characterized by excessive fat deposition in the liver. Its onset is not related to alcohol intake, but it is closely associated with obesity, insulin resistance, type 2 diabetes, and metabolic syndrome. In recent years, the global prevalence of NAFLD has shown a significant upward trend. The pathogenesis of NAFLD is complex and is currently widely explained by the "multiple-hit" theory. The first hit mainly stems from lipid metabolism disorders caused by insulin resistance, manifested as excessive transport of free fatty acids to the liver and decreased mitochondrial β-oxidation capacity, leading to lipid accumulation in hepatocytes. The second hit involves oxidative stress and lipid peroxidation, resulting in hepatocyte damage, release of inflammatory factors, and activation of hepatic stellate cells, promoting the progression of fibrosis.

[0003] Epidemiological studies have revealed multiple risk factors for NAFLD. Besides age and sex differences, abnormal metabolic indicators (such as hypertriglyceridemia and low high-density lipoproteinemia) and lifestyle factors (high-calorie diet and sedentary lifestyle) are significantly associated with NAFLD. Children also face serious challenges; the global prevalence of NAFLD in children is projected to reach 30.7% by 2040, and may be as high as 49.7% in Asia. Obese children have a 16% higher risk of cirrhosis in adulthood compared to those of normal weight.

[0004] In the clinical treatment field, a standardized treatment regimen for NAFLD has not yet been established. Regarding drug therapy, while vitamin E and pioglitazone are recommended in some guidelines, their safety remains controversial. Novel targeted drugs, such as farnesoid X receptor (FXR) agonists, have entered clinical trials but have failed to obtain approval due to insufficient efficacy or side effects. This treatment predicament highlights the shortcomings of existing drugs in terms of their singular mechanism of action and long-term safety.

[0005] From a socioeconomic perspective, the disease burden caused by NAFLD is increasingly severe. The United States spends over $100 billion annually on related healthcare, while in my country, direct economic losses due to NAFLD account for more than 40% of total expenditures related to chronic liver disease. There is an urgent need to develop treatment options that combine efficacy and cost-effectiveness. Drug combinations based on natural products can significantly reduce production costs and greatly improve the feasibility of treatment. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a Tibetan medicine composition of five-flavored Meconopsis, its preparation method and application.

[0007] The objective of this invention is achieved through the following technical solution: A Tibetan medicine composition of five flavors of Meconopsis, the raw materials for preparation by mass parts include the following components: 80-120 parts of Meconopsis, 30-70 parts of Bambusa textilis, 80-120 parts of Carthamus tinctorius, 80-120 parts of Phyllanthus emblica, and 5-15 parts of Saffron.

[0008] The preferred composition is 100 parts of Meconopsis, 50 parts of Bambusa textilis, 100 parts of Carthamus tinctorius, 100 parts of Phyllanthus emblica, and 10 parts of Saffron.

[0009] A third aspect of this invention provides a method for preparing the above-mentioned five-flavor Meconopsis Tibetan medicine composition, comprising the following steps: S1. Weigh out hydrophilic medicinal materials, including Meconopsis, Bambusa textilis, Carthamus tinctorius, and Phyllanthus emblica, and extract them by heating and reflux. After concentration, obtain a thick paste. S2. Weigh the medicinal materials containing volatile components, including saffron, and pulverize and sieve them to obtain raw powder; S3. Mix the thick paste and raw starch evenly to obtain the Tibetan medicine composition.

[0010] The heating and reflux extraction step is as follows: each medicinal material is ground into powder and sieved, 1.3L of water is added for every 100g of the prescription amount, and the mixture is refluxed for 1 hour and then filtered. The residue is refluxed again for extraction, and the extraction is repeated 4 times. The filtrates are combined for subsequent concentration.

[0011] The concentration is carried out under reduced pressure conditions, with a vacuum degree of -0.050 to -0.080 MPa and a concentration temperature of 60°C.

[0012] Specifically, the density of the concentrated paste in S1 is 1.03-1.05 g / ml.

[0013] Furthermore, in S3, when the thick paste and the raw starch are mixed, excipients are added for mixing. The percentage of the excipients in the total mass of the thick paste and raw starch is 90%-110%. The excipients include microcrystalline cellulose and hydroxypropyl methylcellulose. The mixing ratio of microcrystalline cellulose to hydroxypropyl methylcellulose is 280-320:10-30.

[0014] When mixing, first mix the cornstarch and auxiliary materials evenly, then add the thick paste in two batches and mix evenly.

[0015] The third aspect of this invention provides the application of the above-mentioned five-flavor Meconopsis Tibetan medicine composition in the treatment of liver diseases.

[0016] In the five-ingredient Meconopsis Tibetan medicine composition provided in this application: Meconopsis is the principal ingredient. The core pathology of NAFLD is abnormal lipid deposition in hepatocytes (phlegm turbidity), often accompanied by inflammatory activity (damp-heat). In Tibetan medicine theory, Meconopsis has comprehensive effects of clearing liver and gallbladder heat, promoting diuresis and relieving jaundice, and promoting blood circulation and removing blood stasis. It can both clear damp-heat in the liver and gallbladder and resolve blood stasis. That is, Meconopsis can both clear heat and promote diuresis to remove phlegm turbidity and promote blood circulation to unblock the meridians, comprehensively targeting the core pathogenesis of NAFLD, and in a heavy dose, hence it is the principal ingredient. Saffron and Safflower are the assistant ingredients. In the later stages of NAFLD, liver meridian obstruction will occur, aggravating the condition. Saffron (Tibetan saffron) is a top-grade medicine for promoting blood circulation and removing blood stasis, with strong efficacy, and is good at cooling blood and detoxifying, resolving blood stasis and dispersing nodules. Safflower is a classic medicine for promoting blood circulation, unblocking menstruation, dispersing blood stasis and relieving pain, with a wide range of strong medicinal effects. The two herbs work synergistically to greatly enhance the blood-activating and stasis-removing effects of the principal herb, *Meconopsis*, jointly clearing the liver meridians, improving liver microcirculation, and preventing the disease from progressing to fibrosis. Furthermore, saffron, being cooling in nature, also assists the principal herb in clearing heat and toxins from the blood. *Bamboo shavings* is used as an adjuvant herb. NAFLD patients often suffer from spleen and stomach damage due to excessive consumption of rich and fatty foods, leading to impaired digestion and the accumulation of dampness and phlegm, which then transforms into heat, forming "phlegm-heat." Phlegm-dampness is a direct manifestation of lipid deposition and an important basis for blood stasis. *Bamboo shavings* has the effects of clearing heat and resolving phlegm, calming the mind and relieving anxiety. In this formula, it mainly undertakes the task of "clearing heat and resolving phlegm," removing the pathological product of obstructed qi flow—phlegm-heat. *Eupatorium fortunei* is used as the guiding herb. *Eupatorium fortunei* is cooling in nature and has a sweet, sour, and astringent taste. It has a comprehensive effect of clearing heat and cooling blood, promoting body fluid production and relieving cough, and aiding digestion and strengthening the stomach. The principal, assistant, and adjuvant herbs in this formula are mostly heat-clearing, blood-activating, and phlegm-resolving, with a tendency towards aggressive effects. Phyllanthus emblica, with its sour and sweet properties that nourish Yin, can prevent the excessive dispersing and purging effects of other herbs from damaging the spleen and stomach, depleting Yin fluids, and protecting the body's vital energy. Furthermore, Phyllanthus emblica itself can clear liver heat and assist in the treatment of the primary symptoms. At the same time, it can harmonize the properties of other herbs, making the overall effect of the formula more moderate, lasting, safe, and effective.

[0017] The beneficial effects of this invention are: This study comprehensively considered the properties of the various medicinal materials in the formula. Hydrophilic materials such as *Meconopsis* and safflower were extracted with water and concentrated into a thick paste under reduced pressure. Saffron was pulverized and passed through a 100-mesh pharmacopoeia sieve. The paste, powder, and excipients were then mixed to prepare concentrated pills, ultimately achieving the goal of reducing toxicity and enhancing efficacy of the original formula. This study also investigated the pharmacological effects of the Five-Flavor *Meconopsis* Concentrated Pill using a rat model of non-alcoholic fatty liver disease (NAFLD), comparing its efficacy with positive control drugs and Twenty-Five-Flavor *Meconopsis* Pill. The results showed that the improved formula was significantly more effective than the existing formula in treating NAFLD.

[0018] The Five-Flavor Concentrated Pills provided in this application are prepared using a new dosage form. Compared to the Twenty-Five Flavor Artemisia Pills, the dosage form has been changed from water pills to concentrated pills. By extracting and concentrating some of the medicinal materials before making the pills, the concentration of the effective ingredients in the concentrated pills is increased, the bioavailability is better, and the efficacy is enhanced. The concentrated pills are small in size, require a smaller dosage, have a relatively concentrated effective ingredient, and contain fewer impurities. In terms of storage, the concentrated pills are more stable than water pills and are easier to carry and store. Attached Figure Description

[0019] Figure 1 A statistical graph showing the changes in body weight of rats in each group; Figure 2 The morphology of liver tissue in each group of rats; Figure 3 The changes in liver weight, liver coefficient, epididymal fat weight, and epididymal fat coefficient of rats in each group were recorded. Figure 4 HE staining results of liver tissue from rats in each group; Figure 5 HE staining scores for rats in each group; Figure 6 Graphs showing the analysis of serum liver function indicators and four lipid parameters in rats of each group; Figure 7 A statistical graph showing the serum inflammatory factor levels in rats from each group. Detailed Implementation

[0020] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] Example 1 Weigh out the hydrophilic medicinal materials, including 100g of Meconopsis, 50g of Bambusa textilis, 100g of Carthamus tinctorius, and 100g of Phyllanthus emblica. Grind each medicinal material into powder and pass it through a 24-mesh Pharmacopoeia No. 2 sieve. Add 1.3L of RO water per 100g of the prescription amount, heat and reflux for 1 hour, then filter through a 100-mesh Pharmacopoeia No. 6 sieve. Reflux the residue again, repeating the process 4 times. Combine the filtrates and concentrate under reduced pressure (rotary evaporation) at 60℃ to a thick paste with a density of 1.02 g / ml. The vacuum degree during concentration is -0.050~-0.080Mpa.

[0022] Take 10g of saffron, grind it into powder, and pass it through a 100-mesh Pharmacopoeia No. 6 sieve to obtain raw starch.

[0023] For every 900g of thick paste, add 10g of tomato peanut powder, 940g of microcrystalline cellulose, and 50g of hydroxypropyl methylcellulose. First, add the microcrystalline cellulose, peanut powder, and hydroxypropyl methylcellulose to a high-shear wet granulator and mix for 5 minutes at 220 rpm and a cutter speed of 1500 rpm to ensure the excipients are evenly mixed. Adjust the high-shear wet granulator parameters to 250 rpm and a cutter speed of 2300 rpm. Slowly pour the thick paste into the high-shear wet granulator in stages: first add 50% of the prescribed amount, then add the remaining 50% in stages. After the thick paste is added, adjust the high-shear wet granulator parameters to 300 rpm and a cutter speed of 2800 rpm. Add an appropriate amount of purified water via spray (spray pressure 0.19 MPa) and continue stirring until the soft material is evenly mixed.

[0024] The prepared soft material is fed into an extrusion rounding and coating machine. The first extrusion is set at a speed of 35 rpm, and the second extrusion is set at a speed of 10 rpm. After the soft material is extruded, it is placed in a rounding disc. The rounding speed is set to 100 rpm - 300 rpm - 500 rpm - 600 rpm - 700 rpm - 300 rpm, with corresponding holding times of 20 seconds - 20 seconds - 20 seconds - 630 seconds - 60 seconds - 270 seconds. The fan speed is set to a range of 800-2000 rpm. After rounding, the wet pills are removed and placed in a cool, dry place for 12 hours. Then, they are dried in an oven at 75℃ for 2 hours to obtain the finished product, the Five-Flavor Meconopsis Tibetan Medicine Pills.

[0025] Example 2 Weigh out the hydrophilic medicinal materials, including 120g of Meconopsis, 70g of Bambusa textilis, 120g of Carthamus tinctorius, and 120g of Phyllanthus emblica. Grind each medicinal material into powder and pass it through a 24-mesh Pharmacopoeia No. 2 sieve. Add 1.3L of RO water per 100g of the prescription amount, heat and reflux for 1 hour, filter through a 100-mesh Pharmacopoeia sieve, and reflux the residue again. Repeat this process 4 times. Combine the filtrates and concentrate under reduced pressure (rotary evaporation) at 60℃ to a thick paste with a density of 1.03g / ml. The vacuum degree during concentration is -0.050~-0.080Mpa.

[0026] Take 15g of saffron, grind it into powder, and pass it through a 100-mesh sieve from the pharmacopoeia to obtain raw starch.

[0027] For every 900g of thick paste, add 15g of tomato peanut powder, 945g of microcrystalline cellulose, and 50g of hydroxypropyl methylcellulose. First, add the microcrystalline cellulose, peanut powder, and hydroxypropyl methylcellulose to a high-shear wet granulator and mix for 5 minutes at 220 rpm and a cutter speed of 1500 rpm to ensure the excipients are evenly mixed. Adjust the high-shear wet granulator parameters to 250 rpm and a cutter speed of 2300 rpm. Slowly pour the thick paste into the high-shear wet granulator, adding it in stages: first, add 50% of the prescribed amount, then add the remaining 50%. After the thick paste is added, adjust the high-shear wet granulator parameters to 300 rpm and a cutter speed of 2800 rpm. Add an appropriate amount of purified water via spray (spray pressure 0.19 MPa) and continue stirring until the soft material is evenly mixed.

[0028] The prepared soft material is fed into an extrusion rounding and coating machine. The first extrusion is set at a speed of 35 rpm, and the second extrusion is set at a speed of 10 rpm. After the soft material is extruded, it is placed in a rounding disc. The rounding speed is set to 100 rpm - 300 rpm - 500 rpm - 600 rpm - 700 rpm - 300 rpm, with corresponding holding times of 20 seconds - 20 seconds - 20 seconds - 630 seconds - 60 seconds - 270 seconds. The fan speed is set to a range of 800-2000 rpm. After rounding, the wet pills are removed and placed in a cool, dry place for 12 hours. Then, they are dried in an oven at 75℃ for 2 hours to obtain the finished product, the Five-Flavor Meconopsis Tibetan Medicine Pills.

[0029] Example 3 Weigh out the hydrophilic medicinal materials, including 80g of Meconopsis, 30g of Bambusa textilis, 80g of Carthamus tinctorius, and 80g of Phyllanthus emblica. Grind each medicinal material into powder and pass it through a 24-mesh Pharmacopoeia No. 2 sieve. Add 1.3L of RO water per 100g of the prescription amount, heat and reflux for 1 hour, filter through a 100-mesh Pharmacopoeia No. 6 sieve, and reflux the residue again. Repeat this process 4 times. Combine the filtrates and concentrate under reduced pressure (rotary evaporation) at 60℃ to a thick paste with a density of 1.05g / ml. The vacuum degree during concentration is -0.050~-0.080Mpa.

[0030] Take 5g of saffron, grind it into powder, and pass it through a 100-mesh Pharmacopoeia No. 6 sieve to obtain raw starch.

[0031] For every 900g of thick paste, add 5g of tomato peanut powder, 935g of microcrystalline cellulose, and 60g of hydroxypropyl methylcellulose. First, add the microcrystalline cellulose, peanut powder, and hydroxypropyl methylcellulose to a high-shear wet granulator and mix for 5 minutes at 220 rpm and a cutter speed of 1500 rpm to ensure the excipients are evenly mixed. Adjust the high-shear wet granulator parameters to 250 rpm and a cutter speed of 2300 rpm. Slowly pour the thick paste into the high-shear wet granulator in stages: first add 50% of the prescribed amount, then add the remaining 50% in stages. After the thick paste is added, adjust the high-shear wet granulator parameters to 300 rpm and a cutter speed of 2800 rpm. Add an appropriate amount of purified water via spray (spray pressure 0.19 MPa) and continue stirring until the soft material is evenly mixed.

[0032] The prepared soft material is fed into an extrusion rounding and coating machine. The first extrusion is set at a speed of 35 rpm, and the second extrusion is set at a speed of 10 rpm. After the soft material is extruded, it is placed in a rounding disc. The rounding speed is set to 100 rpm - 300 rpm - 500 rpm - 600 rpm - 700 rpm - 300 rpm, with corresponding holding times of 20 seconds - 20 seconds - 20 seconds - 630 seconds - 60 seconds - 270 seconds. The fan speed is set to a range of 800-2000 rpm. After rounding, the wet pills are removed and placed in a cool, dry place for 12 hours. Then, they are dried in an oven at 75℃ for 2 hours to obtain the finished product, the Five-Flavor Meconopsis Tibetan Medicine Pills.

[0033] The specific parameters for the reflux extraction of the thick paste in the examples are shown in Table 1.

[0034] Table 1 Drug efficacy test The pills prepared in Example 1 were used for testing.

[0035] Animal experiments: Eighty-four male SD rats (100-110g) were randomly divided into seven groups (n=12) after a one-week acclimatization period: Control, Model, Positive Drug Group (obeticholic acid: 25mg / kg), Low-dose Concentrated Pill Group (150mg / kg), Middle-dose Concentrated Pill Group (300mg / kg), High-dose Concentrated Pill Group (600mg / kg), and Twenty-Five Flavor Meconopsis Pill Group (ESWWLRHW, 400mg / kg). The Control group was fed a normal maintenance diet, while the other groups were fed a high-fat diet (60% fat) to establish a non-alcoholic fatty liver disease (NAFLD) model. All groups were provided with sufficient drinking water. After four weeks of feeding, the Control and Model groups were administered 0.5% CMC-Na by gavage, while the rats in the other drug groups were administered the corresponding drugs by gavage once a day for six weeks. During the experiment, the mental state, fur, drinking and eating changes of rats in each group were observed, and weight was monitored weekly and changes in weight and food intake were recorded.

[0036] 1. After a ten-week observation period, it was found that the weight changes of the animals in each experimental group showed differentiated growth characteristics. The weight statistics of rats in each group are as follows: Figure 1 As shown in the figure, compared with the blank control group, the model group animals not only showed a more significant rate of weight accumulation, but their fur also showed a significant improvement in luster. After drug intervention in the fifth week of the experimental cycle, the weight dynamics of the treatment group animals changed significantly: the weight gain rate of the drug-treated group was lower than that of the model group, and as the treatment cycle progressed, the weight gain of each dose-treated group gradually converged to the baseline value of the control group. This metabolic regulation effect showed a clear concentration gradient response characteristic.

[0037] 2. The changes in liver and epididymal fat status in each group of rats were analyzed. The liver tissue morphology of each group of rats is as follows: Figure 2 As shown in the figure, the changes in liver weight, liver coefficient, epididymal fat weight, and epididymal fat coefficient of rats in each group are statistically analyzed. Figure 3(Note: ns: no significant difference; compared with the Control group: # P<0.05, ## P<0.01, ### P<0.005, #### P<0.001; compared with the Model group: * P<0.05, ** P<0.01, *** P<0.005, **** P<0.001). In this experiment, the livers of the Control group were bright red and soft. The livers of the Model group were significantly larger than those of the Control group, with a duller color, rounded edges, a dull surface, unevenness, and even visible granular nodules. The epididymal fat weight was significantly increased, and the liver coefficient and epididymal fat coefficient were increased. With increasing drug dosage, the liver volume, liver coefficient, and epididymal fat coefficient of rats in each drug administration group were significantly improved, and the liver color became increasingly red, gradually returning to normal levels.

[0038] 3. The liver sections of rats in each group were observed and scored using an optical microscope after HE staining. The HE staining results for each group of rats are as follows: Figure 4 Under a 40x objective lens, the hepatocytes in the control group rats were neatly arranged, the liver lobules were normal, and no obvious inflammatory cell aggregation or infiltration was observed. In contrast, the livers of the model group rats fed a high-fat diet showed significant steatosis, with obvious NAFLD lesions such as fat vacuoles and inflammatory cell infiltration. HE staining scores for each group are shown below. Figure 5 As shown in the figure (Note: Compared with the Control group: #### P<0.001; Compared with the Model group: * P<0.05, ** P<0.01, *** P<0.005, **** P<0.001; ns: no significant difference), the NAFLD activity score (NAS) and its sub-scores (Steatosis score, Inflammation score, Ballooning score) were significantly increased. After treatment with each dose, the inflammatory infiltration and fatty degeneration indicators of rats in each treatment group were significantly improved, and the improvement was dose-dependent.

[0039] 4. Changes in liver function and four blood lipid parameters were detected in each group of rats. The results are as follows: Figure 6 As shown (Note: Compared with the Control group: #### P<0.001; Compared with the Model group: * P<0.05, ** P<0.01, *** P<0.005, **** P<0.001; ns: no significant difference.), compared with the Control group fed a normal maintenance diet, the Model group fed a high-fat diet showed significantly increased AST and ALT levels, indicating liver damage in rats. After treatment with various doses of concentrated pills, AST and ALT levels decreased significantly, showing a certain dose-dependent effect.

[0040] The formation of NAFLD is closely related to abnormal lipid metabolism, the most direct manifestation of which is elevated levels of T-CHO (total cholesterol), TG (triglycerides), and LDL-C (low-density lipoprotein cholesterol) or decreased levels of HDL-C (high-density lipoprotein cholesterol). In this experiment, compared with the control group, the Model group showed significantly higher levels of LDL-C, TG, and T-CHO, and a significantly lower level of HDL-C after being fed a high-fat diet. This trend was reversed after treatment with various doses of concentrated pills and positive control drugs, showing a certain dose-dependent effect.

[0041] 5. Changes in serum inflammatory factor levels in each group of rats were detected using an ELISA kit, such as... Figure 7 As shown (Note: Compared with the Control group: #### P<0.001; Compared with the Model group: * P<0.05, ** P<0.01, *** P<0.005, **** P<0.001; ns: no significant difference.), compared with the Control group, the serum IL-13 and IL-4 levels in the Model group were significantly decreased, while the levels of pro-inflammatory factors IL-18 and IL-1β were significantly increased, indicating that there was a significant inflammatory response in the Model group rats. After treatment with various doses of drugs, the serum IL-13 and IL-4 levels in each treatment group rats were significantly restored, while the levels of pro-inflammatory factors IL-18 and IL-1β were significantly decreased, showing a certain dose-dependent relationship.

[0042] The pills prepared in Examples 2-3 can also achieve the above experimental results.

[0043] The above description is merely a preferred embodiment of the present invention. It should be understood that the present invention is not limited to the forms disclosed herein and should not be construed as excluding other embodiments. It can be used in various other combinations, modifications, and environments, and can be altered within the scope of the concept described herein through the above teachings or related technologies or knowledge. Modifications and variations made by those skilled in the art that do not depart from the spirit and scope of the present invention should be within the protection scope of the appended claims.

Claims

1. A Tibetan medicinal composition containing five flavors of *Meconopsis*, characterized in that, The raw materials prepared by weight include the following components: 80-120 parts of Meconopsis, 30-70 parts of Bambusa textilis, 80-120 parts of Carthamus tinctorius, 80-120 parts of Phyllanthus emblica, and 5-15 parts of Saffron.

2. The Tibetan medicinal composition of five-flavor Meconopsis according to claim 1, characterized in that, The raw materials prepared by weight include the following components: 100 parts of Meconopsis, 50 parts of Bambusa textilis, 100 parts of Carthamus tinctorius, 100 parts of Phyllanthus emblica, and 10 parts of Saffron.

3. A method for preparing the Tibetan medicinal composition of *Meconopsis quinquefolia* according to any one of claims 1-2, characterized in that, Includes the following steps: S1. Weigh out hydrophilic medicinal materials, including Meconopsis, Bambusa textilis, Carthamus tinctorius, and Phyllanthus emblica, and extract them by heating and reflux. After concentration, obtain a thick paste. S2. Weigh the medicinal materials containing volatile components, including saffron, and pulverize and sieve them to obtain raw powder; S3. Mix the thick paste and raw starch evenly to obtain the Tibetan medicine composition.

4. The preparation method according to claim 3, characterized in that, The heating and reflux extraction step is as follows: each medicinal material is ground into powder and sieved, 1.3L of water is added for every 100g of the prescription amount, and the mixture is refluxed for 1 hour and then filtered. The residue is refluxed again for extraction, and the extraction is repeated 4 times. The filtrates are combined for subsequent concentration.

5. The preparation method according to claim 3, characterized in that: The concentration is carried out under reduced pressure conditions, with a vacuum degree of -0.050 to -0.080 MPa and a concentration temperature of 60°C.

6. The preparation method according to claim 3, characterized in that: The density of the concentrated paste in S1 is 1.03-1.05 g / ml.

7. The preparation method according to claim 3, characterized in that: When the thick paste and cornstarch described in S3 are mixed, auxiliary materials are added for mixing. The percentage of the added auxiliary materials in the total mass of the thick paste and cornstarch is 90%-110%.

8. The preparation method according to claim 7, characterized in that: The excipients include microcrystalline cellulose and hydroxypropyl methylcellulose, with a mixing ratio of 280-320:10-30 for microcrystalline cellulose and hydroxypropyl methylcellulose.

9. The preparation method according to claim 7, characterized in that: When mixing, first mix the cornstarch and auxiliary materials evenly, then add the thick paste in two batches and mix evenly.

10. The application of the Five-Flavor Meconopsis Tibetan Medicine Composition according to claims 1-2 in the treatment of liver diseases.

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