Composition, preparation method and application thereof

Abstract

The invention relates to a composition, a preparation method thereof and application of the composition as a tablet auxiliary material. Specifically, the invention relates to a composition, which takes sugar-rich traditional Chinese medicinal materials and starch-rich traditional Chinese medicinal materials as raw materials, and can completely or partially replace auxiliary materials such as corn starch, maltodextrin, microcrystalline cellulose, cane sugar and the like in a tablet formula, so that on the premise of ensuring the flowability, lubricity, compressibility and disintegration of tableting materials, the content of the traditional Chinese medicinal materials in the tableting materials can be greatly reduced, and the content of the traditional Chinese medicinal materials is increased. The requirements of food cleaning labels are met, and meanwhile the health care function and function customization are provided.

Description

Technical Field

[0001] The invention relates to a composition that meets the requirements of food clean labeling and has health-care functions, a preparation method thereof and use of the composition as a tablet auxiliary material. Background Art

[0002] As people's living standards improve, consumers are paying more and more attention to food clean labels. The concept of clean label originated in Europe, with the aim of maintaining the natural properties of food in the label ingredient column by controlling the product formula composition. Food clean labels were originally intended to facilitate consumers to identify food additives, including pigments, preservatives, acidity regulators, flavor regulators, thickeners, anti-caking agents, disintegrants, etc. However, with the implementation of the Healthy China strategy, consumers have higher and higher requirements for food clean labels. In addition to food additives, higher requirements are put forward for auxiliary materials in food formulas, such as maltodextrin, microcrystalline cellulose, starch, sucrose, etc., hoping that only natural food ingredients will be retained in food formulas, or the introduction of non-natural food ingredients will be minimized. As a consumer trend and development criterion, products that meet food clean labels are increasingly in demand in the current consumer market.

[0003] Tablets are one of the common dosage forms in food and medicine. They are obtained by mixing the active ingredient or main ingredient with tablet excipients and then pressing them into a solid tablet. Tablet excipients are an important component in the tablet formula, generally including diluents, binders, disintegrants, lubricants, etc. Excipients account for 40-80% of the tablet formula and are key components to ensure the fluidity, lubricity, compressibility and disintegration of the tableting material. However, the commonly used tablet excipients currently do not obviously meet consumers' demand for clean food labels. Summary of the invention

[0004] In order to overcome the deficiencies of the prior art, the present invention provides a composition which has health care functions, can be used as an auxiliary material for tablets, and meets the requirements of food clean labels.

[0005] Specifically, the present invention provides a composition that can be used as a tablet excipient with health care function. The composition uses natural Chinese medicinal materials as raw materials and can completely or partially replace the excipients in traditional tablet formulas, such as corn starch, maltodextrin, microcrystalline cellulose, sucrose, etc., while ensuring the fluidity, lubricity, compressibility and disintegration of the tableting material. It meets the requirements of food clean labels and provides health care functions and function customization.

[0006] The present invention further provides a composition, characterized in that it is made of the following raw materials in parts by weight: 10-20 parts of component A, 50-100 parts of component B, and 0.5-1.25 parts of component C; wherein component A and component C are from starch-rich Chinese medicinal materials, and component B is from sugar-rich Chinese medicinal materials. Preferably, the starch content of the starch-rich Chinese medicinal materials is about 40-70%. Preferably, the starch-rich Chinese medicinal materials are selected from lotus seeds, Euryale ferox, yam, and Pueraria lobata. Preferably, the sugar content of the sugar-rich Chinese medicinal materials is about 50-80%. Preferably, the sugar-rich Chinese medicinal materials can be selected from red dates, wolfberries, and longan meat.

[0007] The present invention also provides a composition, which is made from raw materials selected from any one of the following compositions:

[0008] Composition 1)

[0009] Component A: lotus seeds, 15 parts;

[0010] Component B red dates, 75 parts;

[0011] Component C: lotus seeds, 1 part;

[0012] Composition 2)

[0013] Component A: Chinese yam, 20 parts;

[0014] Component B: longan pulp, 100 parts;

[0015] Component C: Chinese yam, 0.5 part;

[0016] Composition 3)

[0017] Component A: Euryale ferox, 10 parts;

[0018] Component B wolfberry, 60 parts;

[0019] Component C: Gorgon fruit, 0.6 parts.

[0020] The composition provided by the present invention meets the requirements of food clean labels.

[0021] The composition provided by the invention also has health care functions, and the health care functions can be customized.

[0022] The present invention also provides a method for preparing the composition, comprising the following steps:

[0023] 1) mixing 10-20 parts by weight of component A with 50-100 parts by weight of component B, and rapidly stirring and shearing under heating and boiling until obvious gelation occurs and then stopping; obtaining a powdery product after drying and sieving; wherein the component A is derived from a Chinese medicinal material rich in starch, and the component B is derived from a Chinese medicinal material rich in sugar;

[0024] 2) sieving the component A, and selecting the fine powder with a particle size of 60-120 mesh as the component C, the amount of which is 0.5-1.25 parts;

[0025] 3) Add component C from step 2) to the product from step 1) and mix thoroughly.

[0026] Preferably, the heating and boiling temperature in step 1) of the above method is 70-90°C.

[0027] Preferably, the particle size of the fine powder in step 2) of the above method is 80-100 mesh.

[0028] The gelation in step 1) of the above method is due to a thermal cross-linking reaction.

[0029] Preferably, the starch content of the starch-rich Chinese medicinal material is about 40-70%. Preferably, the starch-rich Chinese medicinal material is selected from lotus seeds, Euryale ferox, Chinese yam, and Pueraria lobata. Preferably, the sugar content of the sugar-rich Chinese medicinal material is about 50-80%. Preferably, the sugar-rich Chinese medicinal material can be selected from red dates, wolfberries, and longan pulp.

[0030] The present invention further provides a method for preparing the composition, comprising the following steps:

[0031] 1) Take Chinese medicinal materials rich in starch, clean and sterilize them, dry them below 80° C., grind them into 60-200 mesh fine powder, mix them evenly, and obtain component A for later use;

[0032] 2) Take the Chinese medicinal materials rich in sugar, add water to extract twice, add 7-8 times of water for the first time, boil for 30-40 minutes, add 6-7 times of water for the second time, boil for 20-30 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain component B, cool it, and set aside;

[0033] 3) Component A in step 1) is taken, and fine powder with a particle size of 60-120 mesh is sieved to obtain component C for later use;

[0034] 4) Take component B, place it in a shearing tank, add component A, start stirring and shearing, mix evenly, heat and boil until obvious gelation occurs, and then stop to obtain AB mixed paste;

[0035] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven, and then crushing it in a grinder, passing it through an 80-mesh sieve to obtain AB mixed powder;

[0036] 6) Add component C to the AB mixed powder obtained in step 5) and mix thoroughly to obtain the final composition.

[0037] Preferably, the purification and sterilization method described in step 1) is an ultrasound-UV combined method, and the specific conditions are: frequency 20-50kHz, temperature 25-45°C, ultraviolet wavelength 200-280nm, and sterilization time 5-10 minutes.

[0038] Preferably, the pulverizing method in step 1) is an ultrafine airflow pulverizing method, and the specific conditions are: gas pressure 0.6-1.2 MPa, pulverizing speed 3000-5000 r / min.

[0039] Preferably, the particle size of the fine powder sieved in step 3) is 80-100 mesh.

[0040] Preferably, the heating and boiling temperature in step 4) is 70-90°C.

[0041] The gelation in step 4) is caused by a thermal cross-linking reaction.

[0042] Preferably, in step 4), the amount of component A and component B added is 10-20 parts by weight of component A and 50-100 parts by weight of component B.

[0043] Preferably, the drying in a vacuum drying oven described in step 5) is carried out at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80°C.

[0044] Preferably, the amount of component C added in step 6) is 0.5-1.25 parts by weight.

[0045] Preferably, the starch content of the starch-rich Chinese medicinal material is about 40-70%. Preferably, the starch-rich Chinese medicinal material is selected from lotus seeds, Euryale ferox, Chinese yam, and Pueraria lobata. Preferably, the sugar content of the sugar-rich Chinese medicinal material is about 50-80%. Preferably, the sugar-rich Chinese medicinal material can be selected from red dates, wolfberries, and longan pulp.

[0046] The present invention also relates to the use of the composition of the present invention as a tablet excipient.

[0047] The composition of the present invention meets the requirements of food clean labels.

[0048] The composition of the present invention also has health care functions, and the health care functions can be customized.

[0049] The present invention uses Chinese medicinal materials rich in starch, such as lotus seeds, Euryale ferox, yam, and kudzu vine, in combination with Chinese medicinal materials rich in sugar, such as red dates, wolfberries, and longan pulp. The prepared composition can be used as a tablet excipient to replace traditional excipients such as maltodextrin, starch, microcrystalline cellulose, and sucrose commonly used in the original tablet formula, and achieves the requirements of food clean labels while having both tablet compressibility and disintegration. At the same time, according to the functional requirements of different products, suitable Chinese medicinal materials can be selected for combination, so as to achieve customization of different health functions of the composition and enhance the overall health function of the obtained tablet product.

[0050] The pharmacological effects of each Chinese medicinal material raw material in the present invention are as follows:

[0051] Lotus seeds: neutral in nature, sweet and astringent in taste; enter the spleen, kidney and heart meridians; tonify the spleen and stop diarrhea, stop leukorrhea, benefit the kidney and astringe spermatorrhea, nourish the heart and calm the mind. Used for diarrhea due to spleen deficiency, leukorrhea, spermatorrhea, palpitations and insomnia.

[0052] Gorgon Fruit: neutral in nature, sweet and astringent in taste; enters the spleen and kidney meridians; nourishes the kidney and consolidates essence, tonifies the spleen and stops diarrhea, removes dampness and stops leukorrhea. Used for spermatorrhea, nocturnal emission, frequent urination, chronic diarrhea due to spleen deficiency, leukorrhea, and leukorrhea.

[0053] Chinese Yam: neutral in nature, sweet in taste; enters the spleen, lung, and kidney meridians; nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, nourishes the kidneys and astringes semen. Used for spleen deficiency, poor appetite, chronic diarrhea, asthma and cough due to lung deficiency, spermatorrhea due to kidney deficiency, leucorrhea, frequent urination, and thirst due to deficiency heat.

[0054] Puerariae lobata: cool in nature, sweet and pungent in taste; enters the spleen and stomach meridians; relieves muscle and fever, promotes the production of body fluids and quenches thirst, clears rashes, raises yang and stops diarrhea, promotes blood circulation and activates collaterals, and clears alcohol poisoning. It is used for exogenous fever and headache, stiff neck and back pain, thirst, thirst, measles that does not clear up, heat dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning.

[0055] Red dates: warm in nature, sweet in taste; enter the spleen, stomach, and heart meridians; replenish qi, nourish blood, and calm the mind. Used for spleen deficiency, poor appetite, fatigue, loose stools, and irritability in women.

[0056] Lycium barbarum: neutral in nature, sweet in taste; enters the liver and kidney meridians; nourishes the liver and kidneys, improves sperm and improves eyesight. Used for asthenia, spermatorrhea, sore waist and knees, dizziness and tinnitus, impotence and spermatorrhea, internal heat and thirst, blood deficiency and sallow complexion, blurred vision.

[0057] Longan meat: warm in nature, sweet in taste; enters the heart and spleen meridians; nourishes the heart and spleen, nourishes blood and calms the mind. Used for insufficient qi and blood, palpitations, forgetfulness and insomnia, and blood deficiency and sallow complexion.

[0058] The terms used in the present invention have common meanings in the art unless otherwise specified in this application.

[0059] The "sugar" mentioned in the present invention refers to the polysaccharides in Chinese medicinal materials, which are usually composed of monosaccharides such as glucose, galactose, and mannose connected by glycosidic bonds. Starch and cellulose are usually not included.

[0060] The "starch" described in the present invention is a high molecular carbohydrate, which is a polysaccharide formed by the polymerization of glucose molecules. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 This is the electron microscope structure diagram of the loose dispersion of the thermal cross-linked product of component A and component B under low temperature conditions.

[0062] Figure 2 This is a dense cross-linked electron microscope structure diagram of the thermal cross-linked product of component A and component B under appropriate temperature conditions. DETAILED DESCRIPTION

[0063] In order to better achieve the technical effect of the present invention, the present invention has optimized the composition, proportion and heating and boiling temperature of the composition, and the specific process is as follows:

[0064] Preparation method of the composition:

[0065] 1) Take Chinese medicinal materials rich in starch, clean and sterilize them, dry them below 80° C., grind them into 60-200 mesh fine powder, mix them evenly, and obtain component A for later use;

[0066] 2) Take the Chinese medicinal materials rich in sugar, add water to extract twice, add 7-8 times of water for the first time, boil for 30-40 minutes, add 6-7 times of water for the second time, boil for 20-30 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain component B, cool it, and set aside;

[0067] 3) Take component A in step 1), sieve out fine powder with a particle size of 60-120 mesh, and obtain component C for later use;

[0068] 4) Take component B, place it in a shearing tank, add component A, start stirring and shearing, mix evenly, heat and boil until obvious gelation occurs, and then stop to obtain AB mixed paste;

[0069] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven, and then crushing it in a grinder, passing it through an 80-mesh sieve to obtain AB mixed powder;

[0070] 6) Add component C to the AB mixed powder obtained in step 5) and mix thoroughly to obtain the final composition.

[0071] Wherein, the purification and sterilization method described in step 1) is an ultrasound-UV combined method, and the specific conditions are: frequency 20-50kHz, temperature 25-45°C, ultraviolet wavelength 200-280nm, and sterilization time 5-10 minutes.

[0072] The pulverizing method described in step 1) is an ultrafine airflow pulverizing method, and the specific conditions are: gas pressure 0.6-1.2MPa, pulverizing speed 3000-5000r / min.

[0073] Preferably, the particle size of the fine powder in step 3) is 80-100 mesh.

[0074] The heating and boiling temperature in step 4) is 70-90° C. The gelation in step 4) is caused by a thermal cross-linking reaction.

[0075] The drying in the vacuum drying oven described in step 5) is carried out at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80°C.

[0076] Test 1: Screening of composition:

[0077] Since the composition of different compositions has a great influence on the compressibility and disintegration of tablets, 15 parts of component A, 75 parts of component B and 1 part of component C are controlled, and compositions are obtained by the preparation method according to the compositions in the following table, and the performance of different compositions is compared (the performance is divided into five grades: excellent, good, general, poor and very poor). Compressibility scoring rules: under the conditions of the same pressure, tablet weight and mold, the hardness of the obtained tablet is 0-6SCU, which is very poor, the hardness is 7-13SCU, which is poor, the hardness is 14-20SCU, which is general, the hardness is 21-27SCU, which is good, and the hardness is 28-34SCU, which is excellent. If sticking occurs during the tableting process, it is necessary to downgrade the score based on the hardness score and evaluate the final grade. Tablet disintegration scoring rules: Under the conditions of the same pressure, tablet weight, and mold, the resulting tablets are tested for disintegration time according to the General Rules 0921 of Part IV of the Chinese Pharmacopoeia. Combined with product characteristics, when the disintegration time is 0-10min, it is excellent, 11-20min is good, 21-30min is average, 31-40min is poor, and 41-50min is extremely poor. The specific test results are as follows:

[0078]

[0079]

[0080] From the above test data, it can be seen that lotus seeds, Euryale ferox, yam or kudzu vine are selected as component A, red dates, wolfberries or longan meat are selected as component B, and lotus seeds, Euryale ferox, yam or kudzu vine are selected as component C. The performance of the composition obtained by the preparation method of the present invention in terms of compressibility and disintegration is good or excellent, especially the combination of lotus seeds, red dates and lotus seeds, the performance is excellent. Therefore, it is determined that component A is preferably selected from lotus seeds, Euryale ferox, yam, kudzu vine, component B is preferably selected from red dates, wolfberries and longan meat, and component C is preferably selected from lotus seeds, Euryale ferox, yam and kudzu vine.

[0081] Test 2: Screening of composition ratio:

[0082] Test method:

[0083] Since the ratio of different compositions has a great influence on the compressibility and disintegration of the compositions, the combination with the best performance in Experiment 1: component A lotus seeds, component B red dates, and component C lotus seeds are used as raw materials, and compositions are obtained according to the compositions in the following table and the preparation methods, and the performance of different compositions is compared (the scoring standard is the same as that in Experiment 1). The specific results are shown in the following table:

[0084]

[0085]

[0086] From the above test results, it can be seen that the compressibility and disintegration performance of the composition prepared by the method of the present invention with the following raw materials are good or excellent: component A 10-20 parts, component B 50-100 parts, component C 0.5-1.25 parts.

[0087] The raw materials preferably have the following compositions: 15 parts of component A, 75 parts of component B, 1 part of component C; 20 parts of component A, 100 parts of component B, 0.5 parts of component C; 20 parts of component A, 75 parts of component B, 0.5 parts of component C. The performance of the compositions obtained therefrom is excellent.

[0088] Therefore, it is determined that the raw material composition of the composition of the present invention is preferably: component A 10-20 parts, component B 50-100 parts, component C 0.5-1.25 parts.

[0089] Test 3: Screening of heating and boiling temperature:

[0090] Test method:

[0091] Since the heating and boiling temperature in step 4) of the preparation method has a great influence on the thermal crosslinking effect of component A and component B, the compressibility and disintegration of the composition are very different. The combination with the best performance in test 1: component A lotus seeds, component B red dates, component C lotus seeds, is used as the raw material, and the best performance ratio in test 2: component A 15 parts, component B 75 parts, component C 1 part, as the formula ratio, according to the heating and boiling temperature in the table below, the composition is obtained according to the preparation method, and the effects of different temperatures on the performance of the obtained composition (scoring standard is the same as above) are compared. The specific results are shown in the following table:

[0092]

[0093] The experimental data show that the heating and boiling temperature in step 4) of the preparation method has a great influence on the performance of the composition. The inventors of the present invention have found that the appropriate temperature promotes the breaking of hydrogen bonds of starch molecules in component A, and then thermally cross-links with sugars in component B, thereby forming a dense cross-linked structure (such as Figure 1 and Figure 2 The structure is more conducive to improving the compressibility of the tablet. Too low a temperature is not conducive to the breaking of hydrogen bonds of the starch molecules in component A, while too high a temperature is prone to burning during the heating and boiling process, producing burnt crumbs and unpleasant odors. Therefore, the heating and boiling temperature in step 4) of the preparation method is preferably: 70-90°C.

[0094] Example

[0095] The present invention is further described below by examples, but the scope of protection is not limited to the scope described in the examples. These examples are only used to illustrate the present invention, but are not used to limit the scope of the present invention. In addition, after reading the content of the present invention, those skilled in the art can make various modifications to the present invention, and these equivalent changes also fall within the scope limited by the appended claims of the present invention.

[0096] In addition, in order to verify the use of the composition obtained according to the present invention as a tablet excipient, the composition prepared by the embodiment and the comparative example was applied to a best-selling health food tablet of the company - Echinacea health tablets. Echinacea fitness tablets are commercially available, and their original formula is: by weight, echinacea citrus mixture (40 parts), corn starch (28 parts), microcrystalline cellulose (27 parts), other ingredients (5 parts).

[0097] Embodiment 1:

[0098] Preparation of lotus seed and red date composition

[0099] Raw material composition :

[0100] By weight, component A 15 parts, component B 75 parts, component C 1 part.

[0101] Preparation process:

[0102] 1) Take lotus seeds, sterilize them by ultrasound-UV combination, the specific sterilization conditions are: frequency 45kHz, temperature 45℃, ultraviolet wavelength 280nm, sterilization time 10 minutes. After sterilization, dry below 80℃, crush them by ultrafine airflow, the specific crushing conditions are: gas pressure 0.8MPa, crushing speed 5000r / min, crush them into 60-200 mesh fine powder, mix them evenly, obtain component A, and set aside;

[0103] 2) Take red dates Chinese medicinal materials, add water to extract twice, add 8 times water for the first time, boil for 30 minutes, add 7 times water for the second time, boil for 20 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain a clear paste to obtain component B, cool it, and set aside;

[0104] 3) Take component A in step 1), sieve out 80-100 mesh fine powder therein to obtain component C for later use;

[0105] 4) Component B (75 parts) was placed in a shearing tank, and component A (15 parts) was added, stirring and shearing were started, mixed evenly, and heated and boiled to 80° C. until gelation occurred to obtain AB mixed paste;

[0106] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80° C., and then crushing it in a pulverizer and passing it through an 80-mesh sieve to obtain AB mixed powder;

[0107] 6) Add component C (1 part) to the AB mixed powder obtained in step 5), and mix thoroughly to obtain a lotus seed and red date composition.

[0108] Preparation of tablets:

[0109] use The formula of the echinacea health-promoting tablets is obtained by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with the prepared lotus seed and red date composition (55 parts), and tableting the resulting final mixture using a tablet press.

[0110] The specific formula of the obtained tablets is: lotus seed and red date composition (55 parts), echinacea and citrus mixture (40 parts), and other ingredients (5 parts).

[0111] Embodiment 2:

[0112] Preparation of Chinese yam and longan pulp composite

[0113] Raw material composition:

[0114] By weight, component A is 20 parts, component B is 100 parts, and component C is 0.5 parts.

[0115] Preparation process:

[0116] 1) Take Chinese yam and sterilize it by ultrasound-UV combination. The specific sterilization conditions are: frequency 50kHz, temperature 40℃, ultraviolet wavelength 260nm, and sterilization time 8 minutes. After sterilization, dry it below 80℃ and crush it by ultrafine airflow. The specific crushing conditions are: gas pressure 1.0MPa, crushing speed 4000r / min, crush it into 60-200 mesh fine powder, mix it evenly, and obtain component A for standby use;

[0117] 2) Take the Chinese medicinal material of longan pulp, add water to extract twice, add 7 times of water for the first time, boil for 40 minutes, add 7 times of water for the second time, boil for 30 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain a clear paste to obtain component B, cool it, and set aside;

[0118] 3) Take component A in step 1), sieve out 80-100 mesh fine powder therein to obtain component C for later use;

[0119] 4) Component B (100 parts) was placed in a shearing tank, and component A (20 parts) was added, stirring and shearing were started, mixed evenly, and heated and boiled to 90° C. until gelation occurred to obtain AB mixed paste;

[0120] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80° C., and then crushing it in a pulverizer and passing it through an 80-mesh sieve to obtain AB mixed powder;

[0121] 6) Add component C (0.5 parts) to the AB mixed powder obtained in step 5), and mix thoroughly to obtain a yam and longan pulp composite.

[0122] Preparation of tablets:

[0123] use The formula of the echinacea health-promoting tablets is obtained by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with the prepared yam and longan pulp composite (35 parts), and tableting the resulting final mixture with a tablet press.

[0124] The specific formula of the obtained tablets is: echinacea-citrus mixture (40 parts), yam and longan pulp composition (35 parts), and other ingredients (5 parts).

[0125] Embodiment 3:

[0126] Preparation of Euryale ferox and wolfberry fruit composition

[0127] Raw material composition:

[0128] By weight, component A is 10 parts, component B is 60 parts, and component C is 0.6 parts.

[0129] Preparation process:

[0130] 1) Take the Chinese medicinal material of Euryale ferox, and sterilize it by ultrasound-UV combination, the specific sterilization conditions are: frequency 35kHz, temperature 43℃, ultraviolet wavelength 250nm, and sterilization time 6 minutes. After sterilization, dry it below 80℃, and crush it by ultrafine airflow, the specific crushing conditions are: gas pressure 1.2MPa, crushing speed 4000r / min, crush it into 60-200 mesh fine powder, mix it evenly, and obtain component A, which is set aside;

[0131] 2) Take Chinese wolfberry fruit, add water to extract twice, add 8 times water for the first time, boil for 30 minutes, add 6 times water for the second time, boil for 20 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain a clear paste to obtain component B, cool it, and set aside;

[0132] 3) Take component A in step 1), sieve out 80-100 mesh fine powder therein to obtain component C for later use;

[0133] 4) Component B (60 parts) was placed in a shearing tank, and component A (10 parts) was added, stirring and shearing were started, mixed evenly, and heated and boiled to 75° C. until gelation occurred to obtain AB mixed paste;

[0134] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80° C., and then crushing it in a pulverizer and passing it through an 80-mesh sieve to obtain AB mixed powder;

[0135] 6) Add component C (0.6 parts) to the AB mixed powder obtained in step 5), and mix thoroughly to obtain a Euryale ferox and wolfberry composition.

[0136] Preparation of tablets:

[0137] use The formula of the echinacea health-promoting tablets is obtained by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with the prepared Euryale ferox and wolfberry composition (20 parts), and tableting the resulting final mixture using a tablet press.

[0138] The specific formula of the obtained tablets is: echinacea-citrus mixture (40 parts), Euryale ferox and wolfberry composition (20 parts), and other ingredients (5 parts).

[0139] The compositions in Comparative Examples 1-3 were prepared using the same raw material composition as in Examples 1-3 but different preparation methods.

[0140] Comparative Example 1:

[0141] Preparation of lotus seed and red date composition (comparative example)

[0142] Raw material composition:

[0143] By weight, component A is 15 parts, component B is 75 parts, and component C is 1 part.

[0144] Preparation process:

[0145] 1) Take lotus seeds, wash them with running water, dry and sterilize them at 90°C, grind them into 60-200 mesh fine powder with a conventional grinder, mix them well, and obtain component A for later use;

[0146] 2) Take red dates Chinese medicinal materials, add water to extract twice, add 8 times water for the first time, boil for 30 minutes, add 7 times water for the second time, boil for 20 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain a clear paste to obtain component B, cool it, and set aside;

[0147] 3) Take component A in step 1), sieve out the powder with a mesh size of 80-100 to obtain component C for later use;

[0148] 4) Take component B (75 parts), place it in a shearing tank, add component A (15 parts), start stirring and shearing, mix evenly, heat and boil to 60° C. to obtain AB mixed paste;

[0149] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80° C., and then crushing it in a pulverizer and passing it through an 80-mesh sieve to obtain AB mixed powder;

[0150] 6) Add component C (1 part) to the AB mixed powder obtained in step 5) and mix thoroughly to obtain a lotus seed and red date composition (comparative example).

[0151] Preparation of tablets:

[0152] use The formula of the echinacea health tablets is obtained by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with 55 parts of the prepared lotus seed and red date composition (comparative example), and tableting the resulting final mixture with a tablet press.

[0153] The specific formula of the obtained tablets is: lotus seed and red date composition (comparative example) (55 parts), echinacea and citrus mixture (40 parts), and other ingredients (5 parts).

[0154] Comparative Example 2:

[0155] Chinese yam and longan pulp composition (comparative example)

[0156] Raw material composition:

[0157] By weight, component A is 20 parts, component B is 100 parts, and component C is 0.5 parts.

[0158] The preparation process includes the following steps:

[0159] 1) Take Chinese yam and sterilize it by ultrasound-UV combination. The specific sterilization conditions are: frequency 50kHz, temperature 40℃, ultraviolet wavelength 260nm, and sterilization time 8 minutes. After sterilization, dry it below 80℃ and crush it by ultrafine airflow. The specific crushing conditions are: gas pressure 1.0MPa, crushing speed 4000r / min, crush it into 60-200 mesh fine powder, mix it evenly, and obtain component A for standby use;

[0160] 2) Take the Chinese medicinal material of longan pulp, sterilize it by ultrasound-UV combination, the specific sterilization conditions are: frequency 50kHz, temperature 40℃, ultraviolet wavelength 260nm, sterilization time 8 minutes. After sterilization, dry it below 80℃, and crush it by ultrafine airflow, the specific crushing conditions are: gas pressure 1.0MPa, crushing speed 4000r / min, crush it into 60-200 mesh fine powder, mix it evenly, and obtain component B, which is set aside;

[0161] 3) Take component A in step 1), sieve out 80-100 mesh fine powder therein to obtain component C for later use;

[0162] 4) Take component A (20 parts) and component B (100 parts), mix them thoroughly, place them in an oven, and heat them to 90° C. to obtain AB mixed powder.

[0163] 5) The AB mixed powder obtained in step 4) was fully mixed with component C (0.5 parts) to obtain a yam and longan pulp composite material (comparative example).

[0164] Preparation of tablets:

[0165] use The formula of the echinacea health-promoting tablets is prepared by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with 35 parts of the prepared yam and longan pulp composition (comparative example), and tableting the resulting final mixture using a tablet press to obtain the tablets.

[0166] The specific formula of the obtained tablets is: yam and longan pulp composition (comparative example) (35 parts), echinacea and citrus mixture (40 parts), and other ingredients (5 parts).

[0167] Comparative Example 3:

[0168] Preparation of Euryale ferox and wolfberry composition (comparative example)

[0169] Raw material composition:

[0170] By weight, component A is 10 parts, component B is 60 parts, and component C is 0.6 parts.

[0171] Preparation process:

[0172] 1) Take Chinese wolfberry fruit, sterilize it by ultrasound-UV combination, the specific sterilization conditions are: frequency 35kHz, temperature 43°C, UV wavelength 250nm, sterilization time 6 minutes. After sterilization, dry it below 80°C, crush it by ultrafine airflow, the specific crushing conditions are: gas pressure 1.2MPa, crushing speed 4000r / min, crush it into 60-200 mesh fine powder, mix it evenly, and obtain component A, which is set aside;

[0173] 2) Take the Chinese medicinal material Euryale ferox, add water to extract twice, add 8 times of water for the first time, boil for 30 minutes, add 6 times of water for the second time, boil for 20 minutes, filter, combine the filtrate, and concentrate under reduced pressure to a clear paste to obtain component B, cool it, and set aside;

[0174] 3) Take component A in step 1), sieve out 80-100 mesh fine powder therein to obtain component C for later use;

[0175] 4) Take component B (60 parts), place it in a shearing tank, add component A (10 parts), start stirring and shearing, mix evenly, heat and boil to 75° C. to obtain AB mixed paste;

[0176] 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven at a vacuum degree of -0.02 to -0.08 MPa and a temperature of 60 to 80° C., and then crushing it in a pulverizer and passing it through an 80-mesh sieve to obtain AB mixed powder;

[0177] 6) Component C (0.6 parts) was added to the AB mixed powder obtained in step 5), and the mixture was thoroughly mixed to obtain a Euryale ferox and wolfberry composition (comparative example).

[0178] Preparation of tablets:

[0179] use The formula of the echinacea health-promoting tablets is obtained by replacing the corn starch (28 parts) and microcrystalline cellulose (27 parts) in the original formula with 20 parts of the prepared Euryale ferox and wolfberry composition (comparative example), and tableting the resulting final mixture with a tablet press.

[0180] The specific formula of the obtained tablets is: Euryale ferox and wolfberry composition (comparative example) (20 parts), Echinacea citrus mixture (40 parts), and other ingredients (5 parts).

[0181] Example 4

[0182] The commercially available Echinacea tablets were used as comparative samples. Under the same main pressure of 20 KN, the same mold (0.42-inch arc triangle) was used, and the tablet weight was adjusted to 500 mg to perform tablet compression tests. The tablet compression data of the tablets obtained in Examples 1-3 and Comparative Examples 1-3 were collected respectively, and the specific results are shown in the following table:

[0183]

[0184]

[0185] According to the classification of the Chinese Pharmacopoeia, Echinacea Tablets belong to ordinary oral tablets. Hardness, friability and disintegration time are common physical evaluation indicators of tablets, which can intuitively reflect the compressibility of the composition for tableting. According to the requirements of the Chinese Pharmacopoeia, the friability of tablets is required to be less than 1%, and the disintegration time is required to be less than 60 minutes, but the Chinese Pharmacopoeia has no specific requirements for the hardness of tablets. Generally speaking, under the same pressure, tablet weight, and shape conditions, while maintaining good friability and disintegration time, the higher the hardness, the better the tableting performance. This means that in the production process, the desired tablet hardness can be obtained with less pressure, thereby effectively improving production efficiency and reducing equipment wear caused by pressure.

[0186] By comparing the data of Example 1, Comparative Example 1 and the commercially available Echinacea tablets shown in the above table, it can be found that the hardness of the tablets prepared by Example 1 reaches 30.2 SCU, which is about 20% higher than the hardness of the commercially available Echinacea tablets, and the performance of friability and disintegration time are also improved.

[0187] The tablets obtained from Comparative Example 1 are inferior to the commercially available Echinacea tablets in terms of hardness and friability, and are also far inferior to the tablets obtained from Example 1. By comparing Example 1 and Comparative Example 1, it can be found that the tablet formula composition of the two is exactly the same, but the heating and boiling temperatures after the mixing of component A and component B in the preparation process of the composition are different. Without being bound by any theory, the too low heating and boiling temperature in Comparative Example 1 results in the failure to form an effective thermal cross-linking reaction, and thus the resulting composition fails to produce the desired effect when used as a tablet excipient. It can be seen that the heating and boiling temperature after the mixing of component A and component B in the preparation method of the composition of the present invention is an important parameter.

[0188] By comparing the tableting data of Example 2, Comparative Example 2 and the commercially available Echinacea tablets shown in the above table, it can be found that Example 2 uses 35 parts of the composition to replace 55 parts of excipients in the original formula of the commercially available Echinacea tablets, which significantly reduces the amount of excipients used, and the hardness of the tablets prepared by Example 2 is as high as 32.7 SCU. Compared with the commercially available Echinacea tablets, the hardness performance is improved by 30%, and the friability and disintegration time performance are also improved.

[0189] The tablets obtained by Comparative Example 2 are not as good as the commercially available Echinacea tablets in terms of hardness and friability, and are also far inferior to the tablets obtained in Example 2. By comparing Example 2 and Comparative Example 2, it can be found that the tablet formula composition of the two is exactly the same, but the specific preparation methods are significantly different. Not to be bound by any theory, the different preparation methods that deviate from the method described in the present invention in Comparative Example 2 result in the inability to achieve an effective thermal cross-linking reaction, and thus the resulting composition fails to produce the desired effect when used as a tablet excipient. It can be seen that the composition obtained by deviating from the preparation method of the present invention will have an adverse effect on its effect as a tablet excipient.

[0190] By comparing the tableting data of Example 3, Comparative Example 3 and the commercially available Echinacea tablets shown in the above table, it can be found that Example 3 uses 20 parts of the composition to replace 55 parts of excipients in the original formula of the commercially available Echinacea tablets, which significantly reduces the amount of excipients used, and the hardness of the tablets prepared by Example 3 is as high as 33.5 SCU. Compared with the commercially available Echinacea tablets, the hardness performance is improved by 33.5%, and the performance of friability and disintegration time is also improved.

[0191] The tablets obtained from Comparative Example 3 are not as good as the commercially available Echinacea tablets in terms of hardness and friability, and are also far inferior to the tablets obtained in Example 3. By comparing Comparative Example 3 with Example 3, it can be found that in Comparative Example 3, component A (Gorgon fruit) and component B (wolfberry) used in Example 3 are interchanged, so that in the preparation process of the composition, the starch-rich Chinese medicinal materials are extracted and concentrated, and the sugar-rich Chinese medicinal materials are crushed and screened. Not to be bound by any theory, the different preparation methods that deviate from the method described in the present invention in Comparative Example 3 lead to the failure of the key thermal cross-linking reaction in the preparation method described in the present invention, and thus the resulting composition fails to produce the desired effect when used as a tablet excipient. This further verifies that the composition obtained by deviating from the preparation method of the present invention will have an adverse effect on its use effect as a tablet excipient.

[0192] In summary, the composition prepared according to the method described in the present invention has excellent performance as a tablet excipient, and can effectively reduce the amount of excipients in the tablet while ensuring the compressibility and friability of the tablet. In addition, the formulation of the tablet prepared using the composition of the present invention as an excipient is cleaner and greener, meeting the requirements of the food clean label.

[0193] Example 5

[0194] 60 volunteers aged 18-60 were recruited to take the tablets obtained in Examples 1-3 and commercially available Echinacea tablets (provided by Amway) three times a day, one tablet each time, for two consecutive weeks. The volunteers scored the taste, improvement of fatigue, improvement of spleen and stomach, improvement of sleep, etc., with each item scored 10 points, and the average was calculated. The experimental results are as follows:

[0195]

[0196]

[0197] From the above scoring results, it can be considered that the total score of the tablets of Example 1 reached 35.91 points, which is much higher than the commercially available Echinacea tablets, achieving an improvement in product taste, and can strengthen the product's ability to regulate immunity and health care functions, such as fatigue improvement, and spleen and stomach improvement and sleep improvement are significantly better than the commercially available Echinacea tablets, achieving a qualitative improvement in the overall health care function of regulating immunity of the commercially available Echinacea tablets. The total score of Example 2 and Example 3 is also much higher than the commercially available Echinacea tablets, and there is also a significant improvement in taste and health care functions.

[0198] The series of detailed descriptions listed above are only specific descriptions of feasible implementation methods of the present invention. They are not intended to limit the scope of protection of the present invention. Any equivalent implementation methods or changes that do not deviate from the technical spirit of the present invention should be included in the scope of protection of the present invention.

[0199] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A composition, characterized in that The invention is prepared from the following raw materials in parts by weight: 10-20 parts of component A, 50-100 parts of component B, and 0.5-1.25 parts of component C; wherein component A and component C are from traditional Chinese medicines rich in starch, and component B is from traditional Chinese medicines rich in sugar.

2. The composition according to claim 1, characterized in that The starch content of the starch-rich Chinese medicinal material is about 40-70%.

3. The composition according to claim 1, characterized in that The starch-rich Chinese medicinal materials are selected from lotus seeds, Euryale ferox, yam and Pueraria lobata.

4. The composition according to claim 1, characterized in that The sugar content of the sugar-rich Chinese medicinal material is about 50-80%.

5. The composition according to claim 1, characterized in that The Chinese medicinal materials rich in sugar are selected from red dates, wolfberries and longan pulp.

6. The composition according to claim 1, which is made from a raw material selected from any one of the following compositions: Composition 1) Component A: lotus seeds, 15 parts; Component B red dates, 75 parts; Component C: lotus seeds, 1 part; Composition 2) Component A: Chinese yam, 20 parts; Component B: longan pulp, 100 parts; Component C: Chinese yam, 0.5 part; Composition 3) Component A: Euryale ferox, 10 parts; Component B wolfberry, 60 parts; Component C: Gorgon fruit, 0.6 parts.

7. A method for preparing the composition according to any one of claims 1 to 6, comprising the steps of: 1) 10-20 parts by weight of component A and 50-100 parts by weight of component B are mixed, and the mixture is rapidly stirred and sheared under heating and boiling until obvious gelation occurs; After drying and sieving, a powdery product is obtained; The component A is derived from a Chinese medicinal material rich in starch, and the component B is derived from a Chinese medicinal material rich in sugar; 2) sieving the component A, and selecting the fine powder with a particle size of 60-120 mesh as the component C, the amount of which is 0.5-1.25 parts; 3) Add component C of step 2) to the product of step 1), and mix thoroughly to obtain the final composition.

8. The method according to claim 7, wherein the heating and boiling temperature in step 1) is 70-90°C.

9. A method for preparing a composition according to any one of claims 1 to 6, comprising the steps of: 1) Take Chinese medicinal materials rich in starch, clean and sterilize them, dry them below 80°C, grind them into 60-200 mesh fine powder, mix them evenly, and obtain component A for later use; 2) Take the Chinese medicinal materials rich in sugar, add water to extract twice, add 7-8 times of water for the first time, boil for 30-40 minutes, add 6-7 times of water for the second time, boil for 20-30 minutes, filter, combine the filtrate, and concentrate under reduced pressure to obtain component B, cool it, and set aside; 3) Take component A in step 1), sieve out fine powder with a particle size of 60-120 mesh, and obtain component C for later use; 4) Take 50-100 parts of component B, place it in a shearing tank, add 10-20 parts of component A, start stirring and shearing, mix evenly, heat and boil until obvious gelation occurs, and then stop to obtain AB mixed paste; 5) drying the AB mixed paste obtained in step 4) in a vacuum drying oven, and then crushing it in a grinder and passing it through an 80-mesh sieve to obtain AB mixed powder; 6) Add 0.5-1.25 parts of component C to the AB mixed powder obtained in step 5), and mix thoroughly to obtain the final composition.

10. The method according to claim 9, characterized in that The heating and boiling temperature in step 4) is 70-90°C.

11. Use of the composition according to any one of claims 1 to 6 as a tablet excipient.

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