Preparation process of traditional Chinese medicine tablets

Abstract

The invention discloses a preparation process of traditional Chinese medicine tablets, and belongs to the technical field of traditional Chinese medicine preparations. The preparation process comprises the following steps: mixing and crushing the monarch drug, the ministerial drug, the adjuvant drug and the conductant drug to obtain mixed powder, mixing the mixed powder with water to obtain a suspension, adjusting the suspension to a weak acid environment, and mixing the suspension with cellulase and pectinase to obtain enzymatic hydrolysate; mixing and decocting the enzymatic hydrolysate and water to obtain traditional Chinese medicine dispersion liquid; mixing the traditional Chinese medicine dispersion liquid, sodium alginate and calcium chloride injection to obtain medicine-carrying gel; drying the medicine-carrying gel by hot air, grinding into medicine powder, mixing the medicine powder, the filling agent and the wetting agent, granulating, and treating the traditional Chinese medicine tablet by a tablet press. According to the invention, rhizoma alismatis and hawthorn are taken as monarch drugs, radix salviae miltiorrhizae is taken as a ministerial drug, semen cassiae and rhizoma polygonati are taken as adjuvant drugs, and liquorice, jujube and pericarpium citri reticulatae are taken as conductant drugs, drug-loaded gel is prepared through a compatibility principle of monarch, ministerial, assistant and conductant and then through biological enzyme wall breaking, and finally, the traditional Chinese medicine tablet for treating hyperlipidemia is formed.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to a preparation process of a traditional Chinese medicine tablet for lowering blood lipids. Background Art

[0002] With the continuous development of society, people's living standards have gradually improved, and hyperlipidemia has become a common sub-health disease for modern people. In recent years, cardiovascular and cerebrovascular diseases and non-alcoholic fatty liver disease caused by hyperlipidemia have increased, and the age of patients has tended to be younger. Blood lipids include cholesterol, triglycerides and phospholipids, which are lipid components in the blood and are essential for the normal physiological functions of the human body. They are mainly formed through dietary intake and synthesis in the body. Cholesterol is an important component of cell membranes and a precursor for synthesizing hormones and vitamin D. It is taken in through animal fat in food and synthesized by the liver. It is combined with low-density lipoprotein (LDL) and high-density lipoprotein (HDL) and transported in the blood; triglycerides are composed of glycerol and three molecules of fatty acids and are the main form of energy storage. It is mainly taken in through fat in food, absorbed by the digestive system, and transported to adipose tissue and liver; phospholipids are basic components of cell membranes and participate in the structure and function of cell membranes. They are provided by diet and synthesis in the body. Blood lipids play a role in the body through the transportation and metabolism of cholesterol and triglycerides. Blood lipids within the normal range help maintain cell function, hormone synthesis and energy storage. However, when blood lipid levels are abnormal, especially when cholesterol and triglyceride levels are too high, it can be harmful to health. High cholesterol (especially LDL cholesterol) levels can cause cholesterol to deposit on the inner walls of blood vessels, forming atherosclerotic plaques. This plaque will gradually increase in size, causing blood vessel narrowing and increasing the risk of heart disease, high blood pressure and stroke. Excessive triglycerides can cause blood viscosity and increase the possibility of thrombosis, which is related to cardiovascular diseases such as coronary heart disease and angina pectoris.

[0003] Western medicine for the treatment of hyperlipidemia mainly includes statins (such as simvastatin and amostatin, commonly used drugs for the treatment of high cholesterol, which reduce cholesterol synthesis and lower LDL cholesterol levels by inhibiting cholesterol synthase (HMG-CoA reductase)), fibrates (such as fenofibrate and gemfibrozil, which reduce triglycerides by increasing fatty acid oxidation and improving lipoprotein metabolism), bile acid sequestrants (such as cholestyramine, which works by binding to bile acids to reduce cholesterol reabsorption, thereby lowering cholesterol levels) and cholesterol absorption inhibitors (such as ezetimibe, which lowers cholesterol levels by inhibiting intestinal absorption of cholesterol). Western medicine treatment of dyslipidemia may bring a series of side effects, such as muscle pain, abnormal liver function and indigestion. These side effects not only affect the patient's quality of life and cause unpredictable health problems, but also over time, patients are likely to develop drug resistance, resulting in reduced drug effectiveness.

[0004] Traditional Chinese medicine emphasizes the holistic concept and believes that the occurrence of disease is the result of overall dysfunction of the body. Traditional Chinese medicine restores the overall balance of the body by regulating the functions of internal organs, harmonizing qi and blood, and balancing yin and yang, thereby improving blood lipid metabolism levels. Traditional Chinese medicine not only focuses on lowering blood lipid indicators, but also focuses on regulating the functions of internal organs and improving overall health. According to traditional Chinese medicine theory, dyslipidemia is often related to liver, spleen and kidney dysfunction. By regulating the functions of these internal organs, blood lipid metabolism can be fundamentally improved and the risk of recurrence can be reduced. In addition, most of the ingredients of traditional Chinese medicine are natural plants. By regulating the functions of the body rather than directly intervening in specific metabolic pathways, there are fewer side effects and long-term use is safer.

[0005] Patent CN102058761A discloses a Chinese medicine composition for lowering blood lipids. The invention is based on extensive research on Qi and blood treatment prescriptions, and streamlines two medicinal materials, red peony root and fructus aurantii, and then adds one medicinal material, Allium macrostemon, to obtain a Chinese medicine composition with blood lipid lowering function.

[0006] Patent CN116370549A discloses a Chinese medicine composition for treating hyperlipidemia and its preparation method. The invention uses Atractylodes lancea, Magnolia officinalis and Scutellaria baicalensis as main medicines, which play the main functions of tonifying the liver and kidney, lowering blood lipids, digesting food and eliminating accumulation, and promoting blood circulation and removing blood stasis; it is supplemented with papaya, wolfberry and chrysanthemum to remove dampness, clear heat and quench thirst; Astragalus membranaceus and jujube can tonify kidney essence, clear the liver and moisten the intestines to promote bowel movements, thereby achieving the effect of reducing hyperlipidemia.

[0007] Patent CN112057536A discloses a Chinese medicine composition for preventing and / or treating dyslipidemia and its application. The invention treats the causes of dyslipidemia of phlegm and blood stasis type symptomatically, and is composed of a variety of Chinese medicine ingredients including coptis root, frankincense, myrrh, blood clotting, pinellia tuber, trichosanthes root, gynostemma pentaphyllum, tuckahoe and rhizoma dioscoreae. The active ingredients of the medicines work synergistically with each other. Pinellia tuber, tuckahoe and trichosanthes root in the formula directly target phlegm and turbidity formed by greasy food; while blood clotting, frankincense and myrrh have good therapeutic effects on blood stasis caused by various pathological factors, and are particularly suitable for clinical syndromes of phlegm and blood stasis. A multi-link comprehensive treatment is adopted for the causes of dyslipidemia of phlegm and blood stasis type, and the treatment effect is fast and the effect is rapid.

[0008] Although the above-mentioned Chinese medicines have good therapeutic effects in treating hyperlipidemia, the dosage ratio of various drugs in the Chinese medicine formula plays a key role in ensuring the safety and pertinence of the Chinese medicine formula. Chinese medicine emphasizes overall control and compatibility of drugs, fundamentally strengthening the body, regulating the balance of yin and yang, and activating self-repair capabilities. In terms of compatibility of drugs, the basis of "monarch, minister, assistant and messenger" is emphasized, which can not only make the drug properties play a good role and be effective for the symptoms, but also reduce or even avoid the adverse reactions of the drugs.

[0009] Therefore, it is of great significance to design a traditional Chinese medicine tablet for treating hyperlipidemia based on the compatibility principle of "monarch, minister, assistant and envoy". Summary of the invention

[0010] In view of the deficiencies of the prior art, the present invention uses oriental rhizome and hawthorn as the main medicine, salvia miltiorrhiza as the ministerial medicine, cassia seed and polygonatum as the adjuvant medicine, licorice, jujube and tangerine peel as the guiding medicine, and then breaks the wall of biological enzymes to prepare a drug-loaded gel, and finally forms a traditional Chinese medicine tablet for treating hyperlipidemia, thereby solving the problems raised in the background technology. Specifically, the technical solution of the present invention includes the following contents:

[0011] One of the purposes of the present invention is to provide a preparation process of a Chinese medicine tablet, the preparation process comprising the following steps:

[0012] The main drug, the auxiliary drug, the adjuvant drug and the auxiliary drug are mixed and crushed to obtain a mixed powder, wherein the mixed powder and water are mixed in a mass ratio of 1:10-15 to prepare a suspension;

[0013] The suspension is adjusted to a weakly acidic environment, and then mixed with cellulase and pectinase in a mass ratio of 1:0.002-0.003:0.002-0.003 for enzymolysis to obtain an enzymolysis solution;

[0014] The enzymatic hydrolysate and water are mixed in a mass ratio of 1:20-30 and heated to 90°C-100°C and boiled for 20-30 minutes, and then filtered to remove residue to obtain a traditional Chinese medicine dispersion;

[0015] The traditional Chinese medicine dispersion: sodium alginate: calcium chloride injection are mixed and stirred at a mass ratio of 1-5:1-2:100-300 for 5-10 minutes and then allowed to stand for 8-15 hours to obtain a drug-loaded gel;

[0016] The drug-loaded gel is dried with hot air and then ground into drug powder; the drug powder, filler and wetting agent are mixed and granulated; and the traditional Chinese medicine tablets are processed by a tablet press.

[0017] Furthermore, the monarch medicine is orientalis and hawthorn, the ministerial medicine is salvia miltiorrhiza, the adjuvant medicine is cassia seed and polygonatum, and the guiding medicine is liquorice, jujube and tangerine peel.

[0018] Furthermore, the weight ratio of Alisma: Hawthorn: Salvia: Cassia: Polygonatum: Licorice: Jujube: Tangerine Peel is 11-16 weight parts: 11-13 weight parts: 7-9 weight parts: 2-4 weight parts: 2-3 weight parts: 1-2 weight parts: 0.5-1 weight part: 0.5-1 weight part.

[0019] Furthermore, the mesh size of the mixed powder is 200-300 mesh.

[0020] Furthermore, the pH value of the weakly acidic environment is 4.5-6.

[0021] Furthermore, the pH of the weak acid environment is buffered and adjusted by acetic acid or carbonic acid.

[0022] Furthermore, the enzymatic hydrolysis conditions include a hydrolysis temperature of 40° C. to 50° C. and an enzymatic hydrolysis time of 1 h to 2 h.

[0023] Furthermore, the concentration of the calcium chloride injection is 3% to 5%.

[0024] Furthermore, the mass ratio of the medicinal powder: filler: wetting agent is 1:1-1.2:0.1-0.2.

[0025] Furthermore, the filler includes pregelatinized starch, dextrin and mannitol.

[0026] Furthermore, the wetting agent includes water or ethanol.

[0027] The second object of the present invention is to provide a traditional Chinese medicine tablet prepared by a preparation process of traditional Chinese medicine tablets, wherein the dosage form of the traditional Chinese medicine tablet is a tablet.

[0028] The third purpose of the present invention is to provide a Chinese medicine tablet for use in the field of lowering blood lipids.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] (1) The present invention creatively applies the principle of "monarch, minister, assistant and messenger" in the compatibility of traditional Chinese medicine. Hawthorn, the monarch drug, has the effects of promoting blood circulation and removing blood stasis, regulating qi and unblocking meridians, and removing turbidity and reducing lipids. Rhizoma Alismatis has the effects of diuresis and dehumidification, and purging dampness and heat in the lower jiao, which can promote the metabolism of body fat and reduce the absorption of cholesterol. The diuresis and dehumidification of Rhizoma Alismatis and the effect of promoting the metabolism of body fat can enhance the lipid-lowering effect of hawthorn, and can also help remove excess water and moisture in the body and promote cholesterol excretion. Salvia miltiorrhiza, as the minister drug, has the effects of promoting blood circulation and removing blood stasis, cooling blood and reducing swelling, and improving blood circulation, and can reduce blood viscosity, thereby synergistically enhancing the lipid-lowering effect of the monarch drug. Cassia seed, the adjuvant drug, clears the liver and improves eyesight, moistens the intestines and promotes bowel movements, and Polygonatum sibiricum replenishes qi and nourishes yin, and nourishes the spleen and moistens the lungs. Through the purgative effect of Cassia seed and the tonic effect of Polygonatum sibiricum, the monarch drug and the messenger drug are coordinated to regulate the body's metabolism and enhance lipid-lowering on the one hand, and alleviate the damage caused to the body by the excessive medicinal properties of the monarch drug and the minister drug on the other hand. Licorice in the adjuvant has the effect of harmonizing various drugs, relieving pain, enhancing the coordination of various drugs, and alleviating the side effects of drugs. Jujube has the effect of invigorating the middle and replenishing qi, nourishing blood and calming the mind. It can not only enhance the harmonizing effect of drying, but also cooperate with the use of dried tangerine peel to reduce the purgative effect of cassia seed, so that the drug properties are moderate. With oriental rhizome and hawthorn as the monarch drug, it plays a leading role in reducing blood lipids; Salvia miltiorrhiza is used as the minister drug to assist the monarch drug to further enhance the lipid-lowering effect; Cassia seed and Polygonatum odoratum are used as adjuvant drugs, on the one hand, they strengthen the efficacy of the monarch drug and the minister drug, on the other hand, they slowly release the properties of the monarch drug and the minister drug, making their properties mild; licorice, jujube and dried tangerine peel are used as adjuvant drugs to coordinate various drugs, making their properties mild and avoiding conflicts. It can be seen from the test results of Examples 1 to 6 that the present invention improves the function of reducing blood lipids through the synergistic effect of the monarch drug, the minister drug, the adjuvant drug and the adjuvant drug.

[0031] (2) It can be seen from the test results of Example 6 of the present invention and Comparative Examples 1 to 9 that too much or too little of some ingredients will not only interfere with the therapeutic effect of the main drug, resulting in the lack of prominent effect of the main drug, thereby affecting the therapeutic effect of the entire prescription, but may also weaken the synergistic effect between the component drugs, thereby resulting in a weakened overall therapeutic effect, and even a more obvious convulsion side effect. Although the Chinese medicine decoction obtained only by conventional water decoction method and the Chinese medicine tablets without the gel protection structure formed by metal cross-linking have a certain blood lipid lowering function, they may have a low therapeutic effect on hyperlipidemia due to the low active ingredients or the inactivation of some active ingredients caused by high-temperature hot air treatment. On the one hand, the present invention combines the wall-breaking effect of biological enzymes to improve the release efficiency of the active ingredients of Chinese medicine, and on the other hand, forms a drug-loaded gel through metal coordination cross-linking, which is mixed with auxiliary materials (fillers and wetting agents) for granulation and tableting after hot air drying, and finally obtains a Chinese medicine tablet in the form of a sheet. Metal coordination cross-linking can reduce the adverse effects of the inactivation of the active ingredients of the drug caused by high temperature during hot air drying, thereby further improving the therapeutic effect of hyperlipidemia. DETAILED DESCRIPTION

[0032] The technical solution of the present invention will be clearly and completely described below through the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0033] Unless otherwise specified, the raw materials and reagents used in the present invention are commercially available or can be prepared by known methods.

[0034] Embodiment 1:

[0035] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0036] 11 parts by weight of oriental rhizome, 13 parts by weight of hawthorn, 7 parts by weight of salvia miltiorrhiza, 2 parts by weight of cassia seed, 2 parts by weight of polygonatum, 1 part by weight of liquorice, 0.5 parts by weight of jujube and 0.5 parts by weight of tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 200-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0037] Place the mixed powder in a flask, then add deionized water 10 times the weight of the mixed powder and stir to form a suspension. Use acetic acid to adjust the pH value of the suspension to 4.5, then add cellulase and pectinase to the suspension with a pH of 4.5 according to the mass ratio of suspension, cellulase and pectinase of 1:0.002:0.002, mix and heat to 40°C for 1h of timed enzymolysis treatment. Add 20 times the weight of deionized water to the enzymolysis solution after the enzymolysis treatment, stir and heat to 90°C for 20 minutes. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0038] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 3%) were mixed and stirred at a mass ratio of 1:1:100 for 5 minutes and then allowed to stand for 8 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 110°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and water were mixed at a mass ratio of 1:1:0.1 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0039] Embodiment 2:

[0040] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0041] 12 parts by weight of oriental rhizome, 13 parts by weight of hawthorn, 7 parts by weight of salvia miltiorrhiza, 2 parts by weight of cassia seed, 2 parts by weight of polygonatum, 1 part by weight of liquorice, 0.6 parts by weight of jujube and 0.7 parts by weight of tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 200-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0042] Place the mixed powder in a flask, then add 11 times the mass of the mixed powder to deionized water and stir to form a suspension. Use acetic acid to adjust the pH value of the suspension to 4.5, then add cellulase and pectinase to the suspension with a pH of 4.5 according to the mass ratio of suspension, cellulase and pectinase of 1:0.002:0.002, mix and heat to 40°C for 1h of timed enzymolysis treatment. Add 22 times the mass of deionized water to the enzymolysis solution after the enzymolysis treatment, stir and heat to 90°C for 20min. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0043] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 3%) were mixed and stirred at a mass ratio of 2:1:150 for 6 minutes and then allowed to stand for 10 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 110°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and water were mixed at a mass ratio of 1:1:0.2 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0044] Embodiment 3:

[0045] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0046] 13 parts by weight of oriental rhizome, 12 parts by weight of hawthorn, 8 parts by weight of salvia miltiorrhiza, 3 parts by weight of cassia seed, 2 parts by weight of polygonatum, 1 part by weight of liquorice, 0.7 parts by weight of jujube and 0.8 parts by weight of tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 200-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0047] Place the mixed powder in a flask, then add 12 times the mass of the mixed powder to deionized water and stir to form a suspension. Use acetic acid to adjust the pH value of the suspension to 5.0, then add cellulase and pectinase to the suspension with a pH of 5.0 according to the mass ratio of suspension, cellulase and pectinase of 1:0.002:0.002, mix and heat to 45°C for 1h of timed enzymolysis treatment. Add 24 times the mass of deionized water to the enzymolysis solution after the enzymolysis treatment, stir and heat to 95°C for 25min. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0048] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 4%) were mixed and stirred at a mass ratio of 3:1.5:200 for 7 minutes and then allowed to stand for 12 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 110°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and water were mixed at a mass ratio of 1:1.1:0.1 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0049] Embodiment 4:

[0050] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0051] 14 parts by weight of oriental rhizome, 12 parts by weight of hawthorn, 8 parts by weight of salvia miltiorrhiza, 3 parts by weight of cassia seed, 3 parts by weight of polygonatum, 2 parts by weight of liquorice, 0.7 parts by weight of jujube and 0.8 parts by weight of tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 300-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0052] Place the mixed powder in a flask, then add 13 times the mass of the mixed powder, deionized water, and stir to form a suspension. Use carbonic acid to adjust the pH value of the suspension to 5.5, then add cellulase and pectinase to the suspension with a pH of 5.5 according to the mass ratio of suspension, cellulase and pectinase of 1:0.003:0.003, mix and heat to 45°C for 2h of timed enzymolysis. Add 26 times the mass of deionized water to the enzymolysis solution after the enzymolysis treatment, mix and stir, and heat to 95°C for 25min. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0053] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 4%) were mixed and stirred at a mass ratio of 4:1.5:250 for 8 minutes and then allowed to stand for 14 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 120°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and ethanol were mixed at a mass ratio of 1:1.1:0.2 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0054] Embodiment 5:

[0055] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0056] 15 parts by weight of oriental rhizome, 11 parts by weight of hawthorn, 9 parts by weight of salvia miltiorrhiza, 4 parts by weight of cassia seed, 3 parts by weight of polygonatum, 2 parts by weight of liquorice, 0.9 parts by weight of jujube and 1 part by weight of dried tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 300-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0057] Place the mixed powder in a flask, then add 14 times the mass of the mixed powder, deionized water, and stir to form a suspension. Use carbonic acid to adjust the pH value of the suspension to 5.5, then add cellulase and pectinase to the suspension with a pH of 5.5 in a mass ratio of 1:0.003:0.003, mix and heat to 50°C for 2h of timed enzymolysis. Add 28 times the mass of deionized water to the enzymolysis solution after the enzymolysis treatment, mix and stir, and heat to 100°C for 25min. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0058] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 5%) were mixed and stirred at a mass ratio of 5:2:300 for 9 minutes and then allowed to stand for 15 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 120°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and ethanol were mixed at a mass ratio of 1:1.2:0.1 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0059] Embodiment 6:

[0060] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0061] 16 parts by weight of oriental rhizome, 11 parts by weight of hawthorn, 9 parts by weight of salvia miltiorrhiza, 4 parts by weight of cassia seed, 3 parts by weight of polygonatum, 2 parts by weight of liquorice, 1 part by weight of jujube and 1 part by weight of dried tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 300-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0062] Place the mixed powder in a flask, then add 15 times the mass of the mixed powder to deionized water and stir to form a suspension. Use carbonic acid to adjust the pH value of the suspension to 6, then add cellulase and pectinase to the suspension with a pH of 6 according to the mass ratio of suspension, cellulase and pectinase of 1:0.003:0.003, mix and heat to 50°C for 2h of timed enzymolysis. Add 30 times the mass of deionized water to the enzymolysis solution after the enzymolysis treatment, stir and heat to 100°C for 25min. After the decoction is completed, remove the remaining solid residue with a filter to obtain a traditional Chinese medicine dispersion.

[0063] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 5%) were mixed and stirred at a mass ratio of 5:2:300 for 10 minutes and then allowed to stand for 15 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 120°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and ethanol were mixed at a mass ratio of 1:1.2:0.2 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0064] Comparative Example 1:

[0065] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0066] Remove the oriental rhizome in Example 6, and the rest is consistent with Example 6.

[0067] Comparative Example 2:

[0068] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0069] The oriental water chestnuts in Example 6 were removed and the amount of mountain slag was increased to 24 parts by weight, while the rest remained the same as in Example 6.

[0070] Comparative Example 3:

[0071] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0072] The amount of Salvia miltiorrhiza in Example 6 was increased to 10 parts by weight, and the rest was the same as in Example 6.

[0073] Comparative Example 4:

[0074] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0075] The weight of Cassia seed in Example 6 was increased to 5 parts, and the rest was the same as in Example 6.

[0076] Comparative Example 5:

[0077] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0078] The weight of the liquorice in Example 6 was increased to 5 parts, and the rest was the same as in Example 6.

[0079] Comparative Example 6:

[0080] The mixed powder obtained by crushing various Chinese medicines in Example 6 is directly mixed with 20 times of deionized water, heated to 100°C and boiled for 20 minutes. The filtered residue is added with 20 times of deionized water again, mixed and heated to 100°C and boiled for 20 minutes. The filtered residue is added with 20 times of deionized water again, mixed and heated to 100°C and boiled for 10 minutes. Filter, and mix the filtrates after three filtrations to obtain a Chinese medicine dispersion as a Chinese medicine decoction for treating hyperlipidemia.

[0081] Comparative Example 7:

[0082] The Chinese medicine dispersion obtained in Example 6 is directly used as a Chinese medicine decoction for treating hyperlipidemia.

[0083] Comparative Example 8:

[0084] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0085] The traditional Chinese medicine dispersion obtained in Example 6 was directly dried and solidified in a hot air environment at 120°C and then ground into powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed in proportions of 0.4:0.4:0.2 by weight) and ethanol were mixed in a mass ratio of 1:1.2:0.2 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0086] Comparative Example 9:

[0087] A preparation process of a traditional Chinese medicine tablet, specifically comprising the following steps:

[0088] 16 parts by weight of oriental rhizome, 11 parts by weight of hawthorn, 9 parts by weight of salvia miltiorrhiza, 4 parts by weight of cassia seed, 3 parts by weight of polygonatum, 2 parts by weight of liquorice, 1 part by weight of jujube and 1 part by weight of dried tangerine peel are chopped and put into an ultrafine grinder for grinding, then filtered and sieved with a 300-mesh sieve, and the filtrate after sieving is collected to obtain a mixed powder.

[0089] The mixed powder was placed in a flask, and then 30 times the mass of the mixed powder was added with deionized water, mixed and stirred to form a suspension, and heated to 100° C. and boiled for 25 minutes. After boiling, the remaining solid residue was removed with a filter to obtain a traditional Chinese medicine dispersion.

[0090] While hot, the traditional Chinese medicine dispersion, sodium alginate and calcium chloride injection (concentration of 5%) were mixed and stirred at a mass ratio of 5:2:300 for 10 minutes and then allowed to stand for 15 hours to obtain a drug-loaded gel. The drug-loaded gel was dried and solidified in a hot air environment at 120°C and then ground into a powder. The powder, filler (pregelatinized starch, dextrin and mannitol were mixed at a weight ratio of 0.4:0.4:0.2) and ethanol were mixed at a mass ratio of 1:1.2:0.2 to prepare a soft material, which was then granulated through a 16-mesh sieve. The obtained wet granules were dried at 40°C and placed in a tablet press for tableting to obtain traditional Chinese medicine tablets.

[0091] The therapeutic effects of the Chinese medicine tablets and Chinese medicine decoctions of test examples 1 to 6 and comparative examples 1 to 9 on hyperlipidemia:

[0092] (1) Establishment of animal model:

[0093] Forty-two healthy male SD rats were divided into a blank group (14 rats), a model group (14 rats), an embodiment group (6 rats) and a control group (8 rats). The blank group was fed with conventional feed, while the model group, the embodiment group and the control group were fed with conventional feed supplemented with 2% cholesterol, 7% whole milk powder, 13% lard, 7% egg yolk powder and 0.3% bile salts by total weight of the conventional feed.

[0094] (2) Feeding method:

[0095] The blank group was fed with regular feed for the first six weeks, and then gavaged with normal saline for another six weeks after the six-week regular feed feeding.

[0096] The model group was fed with a conventional diet combined with 2% cholesterol, 7% whole milk powder, 13% lard, 7% egg yolk powder and 0.3% bile salt by weight for the first six weeks. After the six-week feeding, the rats were gavaged with normal saline for another six weeks.

[0097] The Example group was fed with conventional feed combined with 2% cholesterol, 7% whole milk powder, 13% lard, 7% egg yolk powder and 0.3% bile salt by total weight of conventional feed for the first six weeks. After the six-week feeding, the mice were gavaged with 1% of the weight of the Chinese medicine tablets of Examples 1 to 6 for another six consecutive weeks.

[0098] The control group was fed with conventional feed combined with 2% cholesterol, 7% whole milk powder, 13% lard, 7% egg yolk powder and 0.3% bile salt by total weight of conventional feed for the first six weeks. After six weeks of feeding, the mice were gavaged with 1% of the weight of the Chinese medicine tablets and Chinese medicine decoctions of Comparative Examples 1 to 9 for six consecutive weeks.

[0099] After all feeding was completed, all mice were anesthetized by intraperitoneal injection, and then blood was collected to test CHO (cholesterol), LDL (low-density lipoprotein) and TG (triglyceride). The results are shown in the following table:

[0100]

[0101]

[0102] The above-described embodiments provide a detailed description of the technical solutions and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected.

Claims

1. A process for preparing a traditional Chinese medicine tablet, characterized in that: The preparation process comprises the following steps: The main drug, the auxiliary drug, the adjuvant drug and the auxiliary drug are mixed and crushed to obtain a mixed powder, wherein the mixed powder and water are mixed in a mass ratio of 1:10-15 to prepare a suspension; The suspension is adjusted to a weakly acidic environment, and then mixed with cellulase and pectinase in a mass ratio of 1:0.002-0.003:0.002-0.003 for enzymolysis to obtain an enzymolysis solution; The enzymatic hydrolysate and water are mixed in a mass ratio of 1:20-30 and heated to 90°C-100°C and boiled for 20-30 minutes, and then filtered to remove residue to obtain a traditional Chinese medicine dispersion; The traditional Chinese medicine dispersion: sodium alginate: calcium chloride injection are mixed and stirred at a mass ratio of 1-5:1-2:100-300 for 5-10 minutes and then allowed to stand for 8-15 hours to obtain a drug-loaded gel; The drug-loaded gel is dried with hot air and then ground into drug powder; the drug powder, filler and wetting agent are mixed and granulated; and the traditional Chinese medicine tablets are processed by a tablet press.

2. The preparation process of a traditional Chinese medicine tablet according to claim 1, characterized in that: The monarch drugs are orientalis and hawthorn, the ministerial drug is salvia miltiorrhiza, the adjuvant drugs are cassia seed and polygonatum, and the guiding drugs are liquorice, jujube and tangerine peel.

3. The preparation process of a traditional Chinese medicine tablet according to claim 2, characterized in that: The weight ratio of oriental rhizome: hawthorn: salvia miltiorrhiza: cassia seed: polygonatum: liquorice: jujube: tangerine peel is 11-16 weight parts: 11-13 weight parts: 7-9 weight parts: 2-4 weight parts: 2-3 weight parts: 1-2 weight parts: 0.5-1 weight part: 0.5-1 weight part.

4. The preparation process of a traditional Chinese medicine tablet according to claim 1, characterized in that: The mesh size of the mixed powder is 200-300 meshes.

5. The preparation process of a traditional Chinese medicine tablet according to claim 1, characterized in that: The pH value of the weakly acidic environment is 4.5-6.

6. The preparation process of a traditional Chinese medicine tablet according to claim 1, characterized in that: The enzymatic hydrolysis conditions include a hydrolysis temperature of 40° C. to 50° C. and a hydrolysis time of 1 h to 2 h.

7. The preparation process of a traditional Chinese medicine tablet according to claim 1, characterized in that: The concentration of the calcium chloride injection is 3% to 5%.

8. The process for preparing a traditional Chinese medicine tablet according to claim 1, characterized in that: The mass ratio of the medicinal powder: filler: wetting agent is 1:1-1.2:0.1-0.

2.

9. A Chinese medicine tablet prepared by the preparation process of a Chinese medicine tablet according to any one of claims 1 to 8, characterized in that: The dosage form of the traditional Chinese medicine tablet is a tablet.

10. Use of a Chinese medicine tablet prepared by the preparation process of a Chinese medicine tablet according to any one of claims 1 to 8 or the Chinese medicine tablet according to claim 9 in the field of lowering blood lipids.

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