Good vision brightening series traditional Chinese medicine composition for liver and kidney deficiency and fire excess from yin deficiency type cataract and preparation method of good vision brightening series traditional Chinese medicine composition

Abstract

The invention relates to a good-vision-brightening series traditional Chinese medicine composition for liver and kidney deficiency and fire excess from yin deficiency type cataract and a preparation method of the good-vision-brightening series traditional Chinese medicine composition. The traditional Chinese medicine composition comprises cornu bubali concentrated powder. The preparation method of the cornu bubali concentrated powder comprises the following steps: (1) treating cornu bubali tip parts; (2) treating a corner pile part; and (3) preparing the buffalo horn concentrated powder. According to the buffalo horn extraction method, an extraction mode of combining enzymolysis of two enzymes with ultrasound is adopted, and the enzymolysis time and the ultrasound time are controlled at the same time, so that the buffalo horn extraction effect is improved to the maximum extent, and the horn pile extraction rate, the total nitrogen content of concentrated powder, the tryptophan content of the concentrated powder and the water-soluble extract content of the concentrated powder in the buffalo horn are greatly improved.

Description

Technical Field

[0001] The present invention belongs to the field of medicine technology, and specifically relates to a Haoshiliang series of traditional Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and hyperactivity of fire type cataracts and a preparation method thereof, and more particularly relates to a preparation method of buffalo horn concentrated powder and a Haoshiliang series of traditional Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and hyperactivity of fire type cataracts containing the buffalo horn concentrated powder and a preparation method thereof. Background Art

[0002] Cataracts are the leading cause of blindness worldwide. The incidence of cataracts increases significantly with age. Besides age, factors such as excessive eye use, eye trauma, and ultraviolet radiation exposure can also contribute to the premature development of cataracts.

[0003] Cataracts are an eye disease in which the lens, the originally clear, light-refracting lens in the eye, becomes cloudy and no longer translucent due to aging or other reasons, making it difficult to see clearly. The most common symptom of cataracts is painless, gradually blurred vision. While normal vision is like seeing through a piece of clear glass, a cataract sufferer's vision is like seeing through a piece of frosted glass, making everything appear hazy. Vision can also worsen year by year, with colors becoming less vivid or appearing darker. Glasses may not help correct vision—all symptoms of cataracts. Liver and kidney yin deficiency accelerates lens degeneration, increasing the risk of cataracts. Liver and kidney yin deficiency results in a loss of yin fluid, which prevents the eye from moisturizing and nourishing it, impairing the normal metabolism and function of the lens. Chronic eye discomfort can accelerate lens degeneration, ultimately leading to cataracts. Yin deficiency also weakens the pupil's ability to contract, leading to symptoms such as blurred vision and dark shadows before the eyes, further exacerbating the development of cataracts.

[0004] Chinese patent application publication number CN104740334A discloses a traditional Chinese medicine composition for treating cataracts and a specific method for preparing the composition. However, the patent application uses traditional alcohol and water extraction methods to prepare a clear paste, which results in inadequate extraction and severe loss of active ingredients.

[0005] Chinese patent application publication number CN102258692A discloses a Dendrobium Noctilucent Pill, characterized by: All medicinal materials except concentrated buffalo horn powder are ground into fine powder; the buffalo horn powder and the above powders are ground, sieved, and mixed, then an appropriate amount of water or excipients are added to form pills, and dried to produce the pill product. However, the water-honeyed pills produced using this method in this patent application exhibit poor molding quality, unstable content test results, and difficulty controlling for differences in filling volume.

[0006] Moreover, the buffalo horns involved in the above two patent applications are all buffalo horn concentrated powder, and the extraction method is water extraction. This method has a long extraction time, poor extraction efficiency, and low medicinal material utilization rate, which indirectly reduces the therapeutic effect of the product. Summary of the Invention

[0007] In order to overcome the defects of the above-mentioned prior art, especially the problems of poor extraction efficiency and low utilization rate of buffalo horn, the present invention provides a method for preparing buffalo horn concentrated powder and a Haoshiliang series of traditional Chinese medicine compositions containing the buffalo horn concentrated powder for treating liver and kidney deficiency and yin deficiency and fire excess type cataracts and a preparation method thereof.

[0008] One object of the present invention is to provide a method for preparing buffalo horn concentrated powder.

[0009] Another object of the present invention is to provide a Haoshiliang series of traditional Chinese medicine compositions for liver and kidney deficiency and yin deficiency and fire excess type cataracts, which contain the buffalo horn concentrated powder prepared by the above method.

[0010] Another object of the present invention is to provide a method for preparing the aforementioned Chinese medicine composition. The Haoshiliang series of Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and fire excess cataracts comprise 25 Chinese medicinal materials. All ingredients, except for buffalo horn, are extracted from the original source, preserving their active ingredients to the greatest extent possible. Furthermore, the buffalo horn, which is difficult for the human body to absorb, is efficiently extracted and used as a medicinal material, comprehensively improving the product's medical quality.

[0011] In one aspect, the present invention provides a method for preparing buffalo horn concentrated powder, the preparation method comprising the following steps:

[0012] (1) Processing of corner tips

[0013] Take the solid core part of the tip of the buffalo horn (commonly known as the "horn tip"), disinfect it, and crush it into fine powder to obtain the horn tip fine powder;

[0014] (2) Corner pile part processing

[0015] Dispersion stage: Take the remaining part of the buffalo horn (commonly known as the "horn pile") and crush it into fine particles. Add water to make it evenly dispersed;

[0016] First enzymatic hydrolysis: adding trypsin, stirring for the first enzymatic hydrolysis, ultrasonic extraction, and centrifugal filtration after ultrasonication to obtain the first filtrate and the first filter residue;

[0017] Second enzymatic hydrolysis: add water to the first filter residue, add pepsin, stir for the second enzymatic hydrolysis, ultrasonic extraction, centrifuge and filter to obtain the second filtrate;

[0018] Filtrate mixing: combining the first filtrate and the second filtrate, filtering, and concentrating the filtrate to obtain a concentrate;

[0019] (3) Preparation of buffalo horn concentrated powder

[0020] The buffalo horn powder obtained in step (1) is added to the concentrated solution obtained in step (2), mixed evenly, dried, cooled, and then ground into fine powder, which is then sieved to obtain buffalo horn concentrated powder.

[0021] Preferably, in step (1), ethanol is used for disinfection, preferably 75% ethanol is used for disinfection.

[0022] Preferably, in step (2), the remaining part of the buffalo horn (commonly known as "horn pile") is crushed into fine particles, passed through an 80-mesh sieve, and then water is added.

[0023] Preferably, in step (2), during the dispersion stage, the mass of water added is 3-8 times, preferably 5 times, the mass of the fine particles.

[0024] Preferably, in step (2), in the first enzymatic hydrolysis stage, the mass of trypsin added is 3-8%, preferably 4%, of the mass of the fine particles.

[0025] Preferably, in step (2), in the first enzymatic hydrolysis stage, the enzyme activity of the added trypsin is ≥50,000 u / g.

[0026] Preferably, in step (2), the first enzymatic hydrolysis time is 10-40 min.

[0027] Preferably, in step (2), during the first enzymatic hydrolysis stage, the ultrasonic extraction time is 5-30 min.

[0028] Preferably, in step (2), after adding water to the first filter residue and before adding pepsin, the pH value is adjusted to 2.0-4.0. For example, an inorganic acid such as hydrochloric acid can be used to adjust the pH value.

[0029] Preferably, in step (2), the amount of pepsin added is 0.8-2% of the mass of the fine particles, preferably 1%.

[0030] Preferably, in step (2), the enzyme activity of the added pepsin is ≥3000u / g.

[0031] Preferably, in step (2), the second enzymatic hydrolysis time is 10-40 min.

[0032] Preferably, in step (2), during the second enzymatic hydrolysis stage, the ultrasonic extraction time is 5-30 min.

[0033] Preferably, in step (2), during the second enzymatic hydrolysis stage, after ultrasonic extraction and before centrifugation, the pH value is adjusted to neutral, that is, the pH value is adjusted to 7, for example, by adding 1 mol / L sodium hydroxide solution.

[0034] Preferably, in step (3), the drying temperature is 60-75°C;

[0035] Preferably, in step (3), the drying time is 5 h;

[0036] Preferably, in step (3), sieving refers to sieving through a 100-mesh sieve.

[0037] In one embodiment, the method for preparing buffalo horn concentrated powder comprises the following steps:

[0038] (1) Processing of corner tips

[0039] Wash the entire buffalo horn and then cut it into pieces. Select the solid core part at the tip (commonly known as the "horn tip"), soak it in 75% ethanol for disinfection, and then grind it into fine powder.

[0040] (2) Corner pile part processing

[0041] The rest (commonly known as "corner piles") are crushed into fine particles (passing through an 80-mesh sieve).

[0042] Extraction method of horn pile: take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed; add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and hydrolyze for 10-40min, ultrasonic enzymatic extraction for 5-30min, let it stand for 5min after ultrasonication, centrifuge and filter to obtain a first filtrate and a first filter residue (first enzymatic hydrolysis); add 1900g of water to the first filter residue, then adjust the pH value to 2.0-4.0 with hydrochloric acid, add 5.2g of pepsin (enzyme activity ≥3000u / g), stir and hydrolyze for 10-40min, ultrasonic enzymatic extraction for 5-30min, add 1mol / L sodium hydroxide solution after ultrasonication to adjust the pH value to 7.0, centrifuge and filter to obtain a second filtrate; combine the first filtrate and the second filtrate, filter, and concentrate the filtrate to 200-300ml.

[0043] (3) Preparation of buffalo horn concentrated powder

[0044] Take 120 g of the horn tip fine powder in step (1) and add it to the concentrated solution obtained in step (2), mix well, dry at 60-75°C for 5 hours, cool and then grind into fine powder, pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0045] In another aspect, the present invention provides a Haoshiliang series of traditional Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and fire excess type cataracts. The traditional Chinese medicine compositions are prepared from the following raw materials in parts by weight:

[0046] 45-150 parts of Dendrobium, 180-500 parts of Ginseng, 65-200 parts of Chinese Yam, 185-390 parts of Poria, 48-160 parts of Licorice, 50-175 parts of Cistanche, 68-210 parts of Lycium barbarum, 66-200 parts of Cuscuta, 90-280 parts of Rehmannia, 90-280 parts of Rehmannia glutinosa, 48-155 parts of Schisandra chinensis, 175-380 parts of Asparagus cochinchinensis, 90-240 parts of Radix Ophiopogonis 40-1000 parts of goat horn, and 20-280 parts of the above-mentioned buffalo horn concentrated powder.

[0047] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 50-100 parts of dendrobium, 200-300 parts of ginseng, 80-150 parts of yam, 210-320 parts of poria, 52-120 parts of liquorice, 55-110 parts of cistanche, 78-160 parts of wolfberry, 75-160 parts of dodder seed, 95-170 parts of rehmannia root, 95-170 parts of prepared rehmannia root, 52-110 parts of schisandra chinensis, 190-3 20 parts, 95-180 parts of ophiopogon japonicus, 85-140 parts of bitter almond, 52-110 parts of siler, 52-110 parts of ligusticum chuanxiong, 48-120 parts of stir-fried aurantium with bran, 48-120 parts of coptis chinensis, 72-145 parts of cyperus rotundus, 72-145 parts of chrysanthemum, 52-130 parts of salt tribulus terrestris, 55-150 parts of amaranth fruit, 80-170 parts of cassia seed, 500-800 parts of goat horn, and 70-200 parts of the above-mentioned buffalo horn concentrated powder.

[0048] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 55-80 parts of dendrobium, 230-270 parts of ginseng, 85-120 parts of yam, 230-280 parts of poria, 58-90 parts of liquorice, 57-80 parts of cistanche, 85-130 parts of wolfberry, 82-135 parts of dodder seed, 110-140 parts of rehmannia root, 110-140 parts of prepared rehmannia root, 58-85 parts of schisandra chinensis, 220-2 85 parts, 105-150 parts of ophiopogon japonicus, 90-110 parts of bitter almond, 58-85 parts of siler, 58-85 parts of ligusticum chuanxiong, 55-90 parts of stir-fried aurantium with bran, 52-80 parts of coptis chinensis, 85-110 parts of cyperus rotundus, 85-110 parts of chrysanthemum, 58-90 parts of salt tribulus terrestris, 58-95 parts of amaranth fruit, 88-120 parts of cassia seed, 550-700 parts of goat horn, and 100-150 parts of the above-mentioned buffalo horn concentrated powder.

[0049] Preferably, the Chinese medicine composition is made from the following raw materials in parts by weight: 64 parts of dendrobium, 254 parts of ginseng, 95 parts of yam, 254 parts of poria, 64 parts of licorice, 64 parts of cistanche, 95 parts of wolfberry, 95 parts of dodder seed, 127 parts of rehmannia, 127 parts of prepared rehmannia, 64 parts of schisandra, 254 parts of asparagus, 127 parts of ophiopogon, 95 parts of bitter almond, 64 parts of siler, 64 parts of ligusticum, 65 parts of stir-fried aurantium, 65 parts of coptis, 95 parts of cyperus, 95 parts of chrysanthemum, 64 parts of salt tribulus, 64 parts of amaranth, 95 parts of cassia seed, 636 parts of goat horn, and 128 parts of the above-mentioned buffalo horn concentrated powder.

[0050] In another aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition, such as a pill, comprising the following steps:

[0051] (1) Crushing and refining honey

[0052] Grinding: Grind the medicinal materials except the buffalo horn concentrated powder, sieve and set aside;

[0053] Refining honey: take honey and add water to refine honey;

[0054] (2) Mixing and sieving

[0055] Mixing the medicinal materials except the goat horn powder and the buffalo horn concentrated powder to obtain a mixed powder, and dividing the mixed powder into three parts, namely a first mixed powder, a second mixed powder, and a third mixed powder;

[0056] Divide the goat horn powder into two parts, namely the first goat horn powder and the second goat horn powder;

[0057] Divide the buffalo horn concentrated powder into two parts, namely, first buffalo horn concentrated powder and second buffalo horn concentrated powder;

[0058] The first goat horn powder and the first buffalo horn concentrated powder are mixed, and then the first mixed powder, the second goat horn powder, the second mixed powder, the second buffalo horn concentrated powder, and the third mixed powder are sequentially added and mixed, and then sieved to obtain a composite mixed powder;

[0059] (3) Hetuo

[0060] Adding the refined honey aqueous solution in batches to the mixed powder of the composition obtained in step (2) to obtain a clumped material;

[0061] (4) Carry out the operations of refining medicine, making pills, covering, drying, selecting pills and packaging in sequence.

[0062] Preferably, in step (1), goat horns are crushed separately;

[0063] Preferably, in step (1), the particle size is controlled so that the proportion of the medicinal material with a particle size between 120-150 μm is higher than 90%.

[0064] Preferably, in step (3), refined honey is added to water to prepare a refined honey aqueous solution;

[0065] Preferably, in step (4), the frequency of the medicine refining machine is 40-50 Hz;

[0066] Preferably, in step (4), the number of times of refining the medicine is at least 2 times;

[0067] Preferably, in step (4), the size of the pellets produced by the pelletizing machine is φ5.0-5.5m, preferably φ5.2m;

[0068] Preferably, in step (4), the size of the pelletizing machine outlet nozzle is φ5.0-5.5 mm, preferably φ5.1 mm;

[0069] Preferably, in step (4), the pushing speed of the pelletizing machine is 20 to 50 Hz, and the cutting speed is 10 to 50 Hz;

[0070] Preferably, in step (4), air is blown into the pot during the covering process; preferably, air is blown into the pot for 5-30 seconds every 5 minutes during the covering process; preferably, air is blown into the pot for 10 seconds every 5 minutes during the covering process;

[0071] Preferably, in step (4), the drying temperature is 60-80°C and the drying time is 4-12h;

[0072] Preferably, in step (4), the tray is threaded up and down during the drying process;

[0073] Preferably, in step (4), the number of small holes of the packaging mold of the bag forming-filling-sealing machine needs to be manually adjusted before packaging.

[0074] In a specific technical solution, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, such as a pill, comprising the following steps:

[0075] (1) Crushing and refining honey

[0076] Crushing: Take the prescribed amount of dendrobium, ginseng, Chinese yam, Poria, liquorice, Cistanche deserticola, wolfberry, Cuscuta australis, Rehmannia root, Rehmannia root prepared, Schisandra chinensis, Asparagus cochinchinensis, Ophiopogon japonicus, bitter almond, Saposhnikovia divaricata, Chuanxiong, fried Citrus aurantium with bran, Coptis chinensis, Achyranthes bidentata, chrysanthemum, salt tribulus terrestris, Coptidis australis, Cassia seed and grind them, install a 100 mesh sieve in the grinder and sieve them for later use;

[0077] Take the prescribed amount of goat horns and grind them separately. Install a 100-mesh sieve in the grinder and sieve them for later use.

[0078] During the pulverization process, the proportion of all medicinal materials with a particle size between 120-150 μm is controlled to be higher than 90%.

[0079] Refining honey: Weigh 28-30 parts of honey and place it in a spherical concentrator, then add 0.5-2 parts of water, stir for 10 minutes and then refine the honey. Control the temperature to 110-120℃, and stop refining the honey when the relative density is 1.37 (100℃). Pass it through 80-mesh silk cloth to remove impurities.

[0080] (2) Mixing and sieving

[0081] Place the 23 crushed herbs except goat horn powder and buffalo horn concentrated powder in a square cone mixer, set the mixer speed to 9 RPM, mix for 5 minutes to obtain a mixed powder, and take it out for later use;

[0082] Weigh the mixed powder ingredients: divide the mixed powder into 3 parts, the first part is 650g, the second part is 900g, and the third part is 900g, set aside;

[0083] Weigh the goat horn powder ingredients: Divide the goat horn powder into 2 parts, 318g for the first part and 318g for the second part, set aside;

[0084] Weigh the buffalo horn concentrated powder ingredients: Divide the buffalo horn concentrated powder into 2 portions, 64g the first portion and 64g the second portion, set aside;

[0085] Take 318g of goat horn powder and 64g of buffalo horn concentrated powder, place them in a square cone mixer, set the mixer speed to 9RPM, and mix for 5 minutes to obtain a mixture (1); take 650g of the mixed powder, add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 5 minutes to obtain a mixture (2); take 318g of goat horn powder and 900g of the mixed powder, continue to add them to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (3); take the remaining 64g of buffalo horn concentrated powder, add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (4); take 900g of the mixed powder, add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (5), set for later use;

[0086] The mixture ⑤ was passed through a 60-mesh stainless steel sieve, and the sieved material was placed in a square cone mixer, and the mixer speed was set to 9RPH, and mixed for 20 minutes to obtain a composite mixed powder, which was discharged and set aside.

[0087] (3) Hetuo

[0088] Weigh 825g of water, place it in a heated stirring tank, heat it to 75°C, start stirring, add 1.65kg of refined honey, place it in a heated stirring tank, stir for 15 minutes, and obtain a refined honey aqueous solution for later use;

[0089] Place the sieved composite powder mixture in a trough mixer, slowly add half of the refined honey aqueous solution, start stirring for 2 minutes, then add the remaining half of the refined honey aqueous solution, mix, mix for 8-15 minutes, discharge and set aside.

[0090] (4) Refining, pill making, covering, drying, pill selection, and packaging

[0091] Refining medicine: Turn on the medicine refining machine, set the frequency of the medicine refining machine to 20-80Hz, put the combined materials into the medicine refining machine and refine them 1-5 times for standby use.

[0092] Pellet making: Select a φ5.0-5.5m pellet making mold and a φ5.0-5.5mm strip nozzle, and check that they are properly installed. Add material to the hopper, control the pushing speed at 20-50Hz and the cutting speed at 10-50Hz, and control the wet pellet weight at 1.15g / 10 pellets. The weight difference during the pellet making process should be controlled within ±8%. The weight of each group of wet pellets (10 pellets / group) should be controlled within the weight difference range. Randomly select 10 groups (10 pellets / group) every 30 minutes and record the pellet weight. Qualified wet pellets should be evenly spread on a stainless steel tray and stored in a pellet drying room. Let the pellets dry for 10 hours before use.

[0093] Covering: Place the wet pills in the sugar coating machine, start the sugar coating machine, set the speed to F20, and after the wet pills roll at a uniform speed, spray purified water evenly three times (the amount of purified water sprayed = the weight of the wet pills × 5%), and control each time for 5 seconds. After the wet pills are evenly moistened, continue to rotate the sugar coating machine to round them for 40 minutes. During the covering process, blow air into the pot for 5-30 seconds every 5 minutes. After the covering is completed, spread the material evenly and flatly on a stainless steel plate.

[0094] Drying: Put the wet pills after covering into the hot air circulation oven, set the drying temperature to 60-80℃, dry for 4-12 hours, and put them on the plate up and down after drying. After drying, take them out and set aside.

[0095] Pill selection: After drying, the dried pills are manually selected to remove broken pills, sticky pills, and pills with irregular shapes.

[0096] Packaging: Randomly select 10 groups of water-honeyed pills (10 pills per group), weigh them separately, and calculate the average pill weight.

[0097] Theoretical number of pills = 7.3g ÷ average pill weight, round up to the nearest integer, manually adjust the number of small holes in the packaging mold of the bag forming-filling-sealing machine according to the theoretical number of pills, pour the dried water-honeyed pills into the packaging mold for packaging.

[0098] During the packaging process, operators randomly select 10 bags every hour to check the filling quantity. The filling quantity difference should be within the range of ±4.0%.

[0099] Compared with the existing technology, this application has achieved at least the following excellent technical effects:

[0100] 1. The present invention discloses a method for extracting buffalo horn, which uses an extraction method combining two enzyme hydrolysis and ultrasound, while controlling the enzymatic hydrolysis time to 10-40 minutes, for example, 15 minutes, and the ultrasound time to 5-30 minutes, for example, 10 minutes, to maximize the extraction effect of buffalo horn, thereby increasing the extraction rate of buffalo horn piles from 1.14% to 5.83%, the total nitrogen content of concentrated powder from 16.27% to 34.18%, and the extraction rate of the total nitrogen content of concentrated powder by 2.1 times. The content of concentrated pink amino acid increased from 0.03% to 0.82%, and the content of concentrated pink amino acid increased by 27.3 times. The content of water-soluble extract in concentrated powder increased from 4.23% to 12.56%, and the extraction rate of water-soluble extract in concentrated powder increased by nearly 3 times. Based on this, the drying temperature of buffalo horn concentrated powder was determined to be 65°C and the drying time to be 5 hours. Compared to drying at 70°C, the total nitrogen content of the concentrated powder increased by 13.87%, the tryptophan content increased by 17.1%, and the water-soluble extract content of the concentrated powder increased by 9.0%. Tryptophan increases tear synthesis, improves eye moisture, and improves blood circulation. This increased tryptophan content fundamentally enhances the therapeutic effect of the medicinal material on cataracts, thereby increasing the therapeutic efficacy of the drug.

[0101] 2. The Chinese medicine composition of the present invention is composed of 25 medicinal materials. In its preparation process, goat horn and the remaining 23 medicinal materials except buffalo horn concentrated powder are pulverized separately to perform medicinal material pulverization. At the same time, the proportion of medicinal material particle size between 120-150 μm is controlled to be higher than 90%. The pulverized particle size is uniform and there is no flying powder phenomenon, so that the fine powder is easy to mix evenly. After the product is made into pills, the effective ingredients are evenly distributed and the effect is constant.

[0102] 3. The mixing method disclosed in the present invention is to mix 23 medicinal materials into 3 parts of mixed powder, 2 parts of goat horn powder, and 2 parts of buffalo horn concentrated powder (see Experimental Example 5 for detailed mixing method). This mixing method minimizes the RSD value of dendrobium alkaloid content, berberine hydrochloride content, ginsenoside content, total nitrogen content, and water-soluble extract content in the product. At the same time, the RSD value of each active ingredient is less than 2%. The material prepared using this mixing method is mixed uniformly and stably. The high-precision and efficient mixing process greatly improves the uniformity of the drug, thereby stabilizing product quality testing and avoiding the instability of the active ingredients during long-term quality testing due to mixing process problems.

[0103] 4. The method of adding refined honey water in batches to form a lump adopted in the present invention can effectively avoid the loss of fine powder and make the material evenly distributed after the lump is formed; at the same time, a medicine refining machine is used to refine the medicine instead of the awakening process. This improved method saves 460 minutes of operating time for this process step, greatly improving the industrial production efficiency of this process step. At the same time, the best material state is obtained by adopting the method of refining the medicine twice, and the pilling rate is as high as 98.6%, which further reduces the loss of discarded pills.

[0104] 5. The present invention selects a φ5.2m pelletizing die and a φ5.1mm stripping nozzle as the combined pelletizing device, while controlling the specific process parameters of a pusher speed of 35Hz and a cutter speed of 25Hz. This ensures that the pellets prepared according to this process do not exceed the weight variation limit for each sample. Furthermore, the wet pellet weight is within the 0.9% range of the standard requirement. Under the premise of a pellet weight of only 0.1g, the relative standard deviation of the dry pellet weight is only 1.34%. This indicates that the pellets prepared by this process are uniform in size with minimal variability, achieving strict quality control in the production process, thereby ensuring stable product quality and no significant variability between batches of samples. This can effectively improve the therapeutic effect of patients.

[0105] 6. Because charge variation is difficult to control in this invention, the packaging equipment is improved by adding holes to the rotating disc used for bagging. After preparing individual pills, their average weight is calculated, thereby determining the theoretical charge quantity. The number of small holes in the bag forming, filling, and sealing machine's filling mold is manually adjusted based on the theoretical charge quantity. This improved manual adjustment of the charge quantity addresses the production challenges of charge variation. This overcomes the practical process challenges associated with slight variations in pill weight while also preventing material waste due to unqualified charge variations. DETAILED DESCRIPTION

[0106] The present invention will be further described below in conjunction with specific examples, but the examples do not limit the present invention in any form. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art. Unless otherwise specified, the reagents and materials used in the present invention are commercially available.

[0107] Example 1: Preparation of buffalo horn concentrated powder

[0108] Wash and split 640g of buffalo horn. Select the solid core (commonly known as the "horn tip"), soak it in 75% ethanol for disinfection, and then grind it into a fine powder. Grind the remaining portion (commonly known as the "horn stump") into fine particles (pass through an 80-mesh sieve).

[0109] Extraction method of buffalo horn pile: take 520g of buffalo horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and enzymolyze for 15min, ultrasonic enzymatic extraction for 10min, let it stand for 5min after ultrasonication, centrifuge and filter, and the filtrate is reserved; add 1900g of water to the filter residue, then adjust the pH value to 2.5 with hydrochloric acid, add 5.2g of pepsin (enzyme activity ≥3000u / g), stir and enzymolyze for 15min, ultrasonic enzymatic extraction for 10min, add 1mol / L sodium hydroxide solution after ultrasonication to adjust the pH value to 7.0, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of the above-mentioned buffalo horn tip fine powder, mix well, dry at 65℃ for 5h, grind into fine powder after cooling, pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0110] In the following examples, unless otherwise specified, the buffalo horn concentrated powder used was the buffalo horn concentrated powder prepared in Example 1.

[0111] Example 2: Haoshiliang series of Chinese medicine compositions for liver and kidney deficiency and yin deficiency and fire excess type cataract

[0112] A prescription for a Haoshiliang series of traditional Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and fire excess type cataracts: 64g of dendrobium, 254g of ginseng, 95g of yam, 254g of poria, 64g of licorice, 64g of cistanche, 95g of wolfberry, 95g of dodder seed, 127g of rehmannia root, 127g of prepared rehmannia root, 64g of schisandra chinensis, 254g of asparagus, 127g of ophiopogon, 95g of bitter almond, 64g of siler, 64g of ligusticum chuanxiong, 65g of stir-fried aurantium with bran, 65g of coptis chinensis, 95g of cyperus rotundus, 95g of chrysanthemum, 64g of salt tribulus terrestris, 64g of amaranth fruit, 95g of cassia seed, 636g of goat horn, and 128g of buffalo horn concentrated powder.

[0113] The preparation method is as follows:

[0114] (1) Crushing and refining honey

[0115] Grinding: Take the prescribed amount of dendrobium, ginseng, yam, poria, licorice, cistanche, wolfberry, dodder seed, rehmannia, prepared rehmannia, schisandra, asparagus, ophiopogon, bitter almond, siler, ligusticum, chuanxiong, fried aurantium, coptis, cyperus, chrysanthemum, salt tribulus, amaranth, cassia seed, and other medicinal materials for grinding, install a 100-mesh sieve in the grinder, and set aside.

[0116] Take the prescribed amount of goat horns and grind them separately. Install a 100-mesh screen in the grinder and sieve them. During the grinding process, control the proportion of all medicinal materials with a particle size between 120-150 μm to be greater than 90%.

[0117] Refining honey: Weigh 2.0 kg of honey and place it in a spherical concentrator, then add 70 g of water and stir for 10 minutes to refine the honey. Control the temperature to 115°C and stop refining when the relative density is 1.37 (100°C). Pass the honey through an 80-mesh silk cloth to remove impurities.

[0118] (2) Mixing and sieving

[0119] Place the crushed 23 medicinal materials (except goat horn powder and buffalo horn concentrated powder) in a square cone mixer, set the mixer speed to 9 RPM, and mix for 5 minutes to obtain a mixed powder, which is then taken out for later use;

[0120] Weigh the mixed powder ingredients: divide the mixed powder into 3 parts, the first part is 650g, the second part is 900g, and the third part is 900g, set aside;

[0121] Weigh the goat horn powder ingredients: Divide the goat horn powder into 2 parts, 318g for the first part and 318g for the second part, set aside;

[0122] Weigh the buffalo horn concentrated powder ingredients: Divide the buffalo horn concentrated powder into 2 portions, 64g the first portion and 64g the second portion, set aside;

[0123] Take 318g of goat horn powder and 64g of buffalo horn concentrated powder, place them in a square cone mixer, set the mixer speed to 9RPM, and mix for 5 minutes to obtain a mixture (1); take 650g of the mixed powder and add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 5 minutes to obtain a mixture (2); take 318g of goat horn powder and 900g of the mixed powder, continue to add them to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (3); take the remaining 64g of buffalo horn concentrated powder, add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (4); take 900g of the mixed powder and add it to the square cone mixer, set the mixer speed to 9RPM, and mix for 10 minutes to obtain a mixture (5), set for later use;

[0124] The mixture ⑤ was passed through a 60-mesh stainless steel sieve, and the sieved material was placed in a square cone mixer, and the mixer speed was set to 9RPH, and mixed for 20 minutes to obtain a composite mixed powder, which was discharged and set aside.

[0125] (3) Hetuo

[0126] Weigh 825g of water, place it in a heated stirring tank, heat it to 75°C, start stirring, add 1.65kg of refined honey, place it in a heated stirring tank, stir for 15 minutes, and obtain a refined honey aqueous solution for later use;

[0127] Place the sieved composite powder mixture in a trough mixer, slowly add half of the refined honey aqueous solution, start stirring for 2 minutes, then add the remaining half of the refined honey aqueous solution, mix, mix for 12 minutes, discharge, and set aside.

[0128] (4) Refining, pill making, covering, drying, pill selection, and packaging

[0129] Refining medicine: Turn on the medicine refining machine, set the frequency of the medicine refining machine to 40Hz, put the combined materials into the medicine refining machine to refine medicine twice, and set aside.

[0130] Pellet making: Select a φ5.2m pellet making mold and a φ5.1mm strip nozzle and check that they are properly installed. Add material to the hopper, control the pushing speed to 35Hz and the cutting speed to 25Hz, and control the wet pellet weight at 1.15g / 10 pellets. The weight difference during the pellet making process should be controlled within ±8%. The weight of each group of wet pellets (10 pellets / group) should be controlled within the weight difference range. Every 30 minutes, 10 groups (10 pellets / group) should be randomly selected and the pellet weight recorded. Qualified wet pellets should be evenly spread on a stainless steel tray and stored in a pellet drying room. Let the pellets dry for 10 hours before use.

[0131] Covering: Put the wet pills into the sugar coating machine, start the sugar coating machine, set the speed to F20, and after the wet pills roll at a uniform speed, spray purified water evenly three times (the amount of purified water sprayed = the weight of the wet pills × 5%), and control each time for 5 seconds. After the wet pills are evenly moistened, continue to rotate the sugar coating machine to round them for 40 minutes. During the covering process, blow air into the pot for 10 seconds every 5 minutes. After the covering is completed, spread the material evenly and flatly on a stainless steel plate.

[0132] Drying: put the wet pellets after covering into a hot air circulation oven, set the drying temperature to 70℃, dry for 8 hours, put them on a plate at the 1st, 3rd, 5th and 7th hour of drying, and discharge them after drying for later use.

[0133] Pill selection: After drying, the dried pills are manually selected to remove broken pills, sticky pills, and pills with irregular shapes.

[0134] Packaging: Randomly select 10 groups of water-honeyed pills (10 pills per group), weigh them separately, and calculate the average pill weight.

[0135] Theoretical number of pills = 7.3g ÷ average pill weight, round up to the nearest integer, manually adjust the number of small holes in the packaging mold of the bag forming-filling-sealing machine according to the theoretical number of pills, pour the dried water-honeyed pills into the packaging mold for packaging.

[0136] During the packaging process, the operator randomly selects 10 bags every hour to check the filling volume. The filling volume difference should be within the range of ±4.0%.

[0137] Experimental Example 1: Comparative Experiment on Different Extraction Methods of Buffalo Horn

[0138] Most current buffalo horn extraction methods follow the extraction method specified in the Chinese Pharmacopoeia, which uses water decoction. This results in ineffective extraction and low medicinal material utilization, impacting the quality of the final product. Therefore, a comprehensive optimization of buffalo horn extraction methods was conducted. The specific test results are shown in Table 1 below. The test methods used were the buffalo horn concentrate powder quality test method specified in the 2020 edition of the Chinese Pharmacopoeia, Part I, and the tryptophan content determination method specified in the 2020 edition of the Chinese Pharmacopoeia, Part II.

[0139] Extraction Method 1: Select the solid core portion of the tip (commonly known as the "horn tip"), soak in 75% ethanol or steam sterilize, and then grind into a fine powder. Grind the remaining portion (commonly known as the "horn pile") into fine granules. Take 520g of the horn pile fine granules and add 10 times the amount of water and boil twice for 10 hours each time. Combine the decoctions, filter, and concentrate the filtrate to 120ml. Add 120g of the above-mentioned horn tip fine powder, mix thoroughly, dry at 70°C for 4 hours, cool, grind into a fine powder, and sieve.

[0140] Extraction method 2: Wash and saw off the buffalo horns, divide them into horn tips and horn stumps, split them into small pieces, sterilize the horn tips with steam, and crush them into 120 mesh fine powder. After the horn stumps are crushed, take 520g of horn stump fine particles, decoct them twice, add 8 times the amount of 0.1mol / L sodium hydroxide aqueous solution each time, and extract for 7 hours. Combine the decoctions, adjust the filtrate to pH 7 with 10% hydrochloric acid solution, let it stand for 12 hours, filter, concentrate the filtrate to 120ml, add the above-mentioned horn tip fine powder, mix well, dry at 70℃ for 4h, grind into fine powder after cooling, and sieve to obtain.

[0141] Extraction Method 3: Wash and split the entire buffalo horn. Select the solid core (commonly known as the "horn tip"), soak it in 75% ethanol for disinfection, and then grind it into a fine powder. Grind the remaining portion (commonly known as the "horn stump") into fine particles (pass through an 80-mesh sieve).

[0142] Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and enzymolyze for 15min, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and enzymolyze for 15min, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of the above-mentioned horn tip fine powder, mix well, dry at 70℃ for 4h, cool and crush into fine powder, pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0143] Experimental Method 4: Wash and cut the entire buffalo horn into pieces. The solid core (commonly known as the "horn tip") is selected and disinfected with 75% ethanol before being crushed into a fine powder. The remaining portion (commonly known as the "horn stump") is crushed into fine particles (passed through an 80-mesh sieve).

[0144] Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, ultrasonicate at 80℃ for 10min, filter after centrifugation, and use the filtrate for later use; add 1900g of water to the filter residue, ultrasonicate at 80℃ for 10min, filter after centrifugation, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of the above-mentioned horn tip fine powder, mix well, dry at 70℃ for 4h, cool and crush into fine powder, pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0145] Extraction Method 5: Wash and split the entire buffalo horn. Select the solid core (commonly known as the "horn tip"), soak it in 75% ethanol for disinfection, and then grind it into a fine powder. Grind the remaining portion (commonly known as the "horn stump") into fine particles (pass through an 80-mesh sieve).

[0146] Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and hydrolyze for 15min, ultrasonic enzymatic extraction for 10min, let it stand for 5min after ultrasonication, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, then adjust the pH value to 2.5 with hydrochloric acid, add 5.2g of pepsin (enzyme activity ≥3000u / g), stir and hydrolyze for 15min, ultrasonic enzymatic extraction for 10min, add 1mol / L sodium hydroxide solution after ultrasonication to adjust the pH value to 7.0, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of the above-mentioned horn tip fine powder, mix well, dry at 70℃ for 4h, grind into fine powder after cooling, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0147] Extraction Method 6: Wash and split the entire buffalo horn. Select the solid core (commonly known as the "horn tip"), soak it in 75% ethanol for disinfection, and then grind it into a fine powder. Grind the remaining portion (commonly known as the "horn stump") into fine particles (pass through an 80-mesh sieve).

[0148] Take 520g of horn pile fine particles, add 1040g of water, heat to boiling, continue to extract in a slightly boiling state for 4h, then separate the extract, continue to add water to the horn pile fine particles and repeat the above steps for extraction twice, combine the extracts and concentrate them for use, and the horn pile fine particles are set aside; add buffalo horn powder into artificial gastric juice (Appendix of "Chinese Pharmacopoeia": 16.4ml of dilute hydrochloric acid, add about 800ml of water and 10g of pepsin, shake well, and dilute with water to 1000ml) for hydrolysis at 39°C for 4 hours, heat to 85°C to inactivate the protease, filter and concentrate the supernatant for use; buffalo horn powder is set aside. This buffalo horn powder is added to artificial gastric juice (Appendix of "Chinese Pharmacopoeia": 16.4ml of dilute hydrochloric acid, add about 800ml of water and 10g of pepsin, shake well, and dilute with water to 1000ml) for hydrolysis at 39°C for 4 hours, heat to 85°C to inactivate the protease, filter and concentrate the supernatant for use; buffalo horn powder is set aside. Artificial intestinal fluid (Appendix of the "Chinese Pharmacopoeia": take 6.8g of potassium dihydrogen phosphate, add 500ml of water to dissolve it, adjust the pH value to 6.8 with 0.1mol / L sodium hydroxide solution, take 10g of pancreatic enzyme, add water to dissolve it, mix the two liquids, and dilute with water to 1000ml) is hydrolyzed at a temperature of 39°C for 8 hours, heated to 85°C to inactivate the protease, filtered, and the supernatant is concentrated for later use; the concentrated solutions obtained in the above two steps are combined and concentrated to 250ml, 120g of the above-mentioned buffalo horn fine powder is added, mixed, dried at 70°C for 4h, crushed into fine powder after cooling, and passed through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0149] Table 1 Test results of different extraction methods of buffalo horn

[0150]

[0151] Conclusion: According to the experimental results, it can be concluded that the extraction effect of buffalo horn using a combination of trypsin, pepsin enzymatic hydrolysis and ultrasound according to extraction method 5 is significant, and the extraction rate of buffalo horn piles reaches 5.62%, which is 5 times higher than that of the original extraction method 1. At the same time, the total nitrogen content of the concentrated powder increased by 17.91%, and the water-soluble extract content of the concentrated powder increased by 8.33%, greatly improving the utilization rate of buffalo horn medicinal materials. At the same time, compared with extraction method 6, the extraction rate of buffalo horn piles increased by 73.5%, the total nitrogen content of the concentrated powder increased by 26.3%, and the tryptophan content in the concentrated powder increased by 2.4 times. The increase in tryptophan content fundamentally improves the therapeutic effect of the medicinal material on cataracts, thereby improving the therapeutic efficiency of the drug. The extraction method of this application further improves the extraction effect of buffalo horn and improves the utilization rate of the medicinal material.

[0152] Experimental Example 2: Comparative Experiment on Enzymatic Hydrolysis and Ultrasonic Conditions for Buffalo Horn Extraction

[0153] Extracting buffalo horn according to the present extraction method can improve the utilization rate of the medicinal material. However, to achieve the best extraction effect, the enzymatic hydrolysis and ultrasonic conditions are optimized to further improve the extraction efficiency of the buffalo horn medicinal material, thereby achieving the best therapeutic effect. The remaining experimental steps not described in detail in the following experiments are the same as those described in Example 1.

[0154] 1. Comparative experiment of single enzyme hydrolysis

[0155] Experimental method: Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of enzyme, stir and hydrolyze for 30min, centrifuge and filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70℃, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0156] The enzymes used were trypsin, glutamic acid protease, proteolytic enzyme, aspartic acid protease, and pepsin, and the experimental results are shown in Table 2.

[0157] 2. Comparative experiment of two enzyme hydrolysis

[0158] Comparative experiments were conducted using the following enzymatic hydrolysis methods 1-6 to determine the optimal enzymatic hydrolysis combination, thereby improving the extraction efficiency of buffalo horn. The experimental test results are shown in Table 3.

[0159] Enzymatic hydrolysis method 1: Take 520g of horn pile fine particles, add 2600g of water, stir for 5 minutes to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and hydrolyze for 15 minutes, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, add 5.2g of proteolytic enzyme (enzyme activity ≥3000u / g), stir and hydrolyze for 15 minutes, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0160] Enzymatic hydrolysis method 2: Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, then adjust the pH value to 2.5 with hydrochloric acid, add 20.8g of pepsin (enzyme activity ≥5000u / g), stir and hydrolyze for 15min, add 1mol / L sodium hydroxide solution after enzymatic hydrolysis to adjust the pH value to 7.0, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, add 5.2g of proteolytic enzyme (enzyme activity ≥3000u / g), stir and hydrolyze for 15min, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0161] Enzymatic hydrolysis method 3: Take 520g of fine particles of horn pile, add 2600g of water, heat to boiling, continue to extract for 6h in a slightly boiling state after boiling, then separate the extract, extract 3 times, filter and combine the extracts, concentrate and set aside; take the buffalo horn residue after water extraction, add 2600g of water, stir for 5min to make it evenly dispersed, then adjust the pH value to 2.5 with hydrochloric acid, add 20.8g of pepsin (enzyme activity ≥5000u / g), stir and enzymolyze for 15min n, after enzymatic hydrolysis, add 1 mol / L sodium hydroxide solution to adjust the pH to 7.0, centrifuge and filter, and set the filtrate aside; add 1900 g of water to the filter residue, add 5.2 g of trypsin (enzyme activity ≥ 3000 u / g), stir and enzymolyze for 15 minutes, centrifuge and filter, combine the filtrates, filter, concentrate the filtrate to 250 ml, add 120 g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0162] Enzymatic hydrolysis method 4: Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of glutamate protease (enzyme activity ≥50000u / g), stir and hydrolyze for 15min, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, add 5.2g of proteolytic enzyme (enzyme activity ≥3000u / g), stir and hydrolyze for 15min, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0163] Enzymatic hydrolysis method 5: Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and hydrolyze for 15min, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, add 5.2g of aspartic protease (enzyme activity ≥3000u / g), stir and hydrolyze for 15min, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0164] Enzymatic hydrolysis method 6: Take 520g of horn pile fine particles, add 2600g of water, stir for 5min to make it evenly dispersed, add 20.8g of trypsin (enzyme activity ≥50000u / g), stir and hydrolyze for 15min, centrifuge and filter, and the filtrate is set aside; add 1900g of water to the filter residue, then adjust the pH value to 2.5 with hydrochloric acid, add 5.2g of pepsin (enzyme activity ≥3000u / g), stir and hydrolyze for 15min, add 1mol / L sodium hydroxide solution after enzymolysis to adjust the pH value to 7.0, centrifuge and filter, combine the filtrate, filter, concentrate the filtrate to 250ml, add 120g of horn tip fine powder, mix well, dry at 70°C, crush into fine powder, and pass through a 100-mesh sieve to obtain buffalo horn concentrated powder.

[0165] 3. Comparative experiment of enzymatic hydrolysis time

[0166] The experiment was carried out according to the experimental steps described in the above enzymatic hydrolysis method 6, and the enzymatic hydrolysis time was controlled to be 15 minutes, 25 minutes, 35 minutes, 50 minutes, 65 minutes, and 80 minutes. The test results are shown in Table 4.

[0167] 4. Ultrasonic time comparison experiment

[0168] The experiment was conducted according to the experimental steps described in Extraction Method 5 of Experimental Example 1, with the ultrasonic time controlled at 5 min, 10 min, 15 min, and 20 min. The test results are shown in Table 5.

[0169] 5. Comparative experiment of enzymatic hydrolysis time after ultrasonic extraction

[0170] According to the above experimental results, the optimal enzymatic hydrolysis time is 50 min and the optimal ultrasonic time is 10 min. The two are combined to conduct an experiment. The experiment is carried out according to the experimental steps described in the extraction method 5 of Experimental Example 1, the ultrasonic time is controlled to 10 min, and the enzymatic hydrolysis time is selected again as 10 min, 15 min, 25 min, 35 min, 50 min, and 65 min for experiments respectively. The test results are shown in Table 6.

[0171] Table 2 Results of single enzyme enzymolysis comparison experiment

[0172]

[0173] Table 3 Comparative test results of two enzyme hydrolysis experiments

[0174]

[0175] Table 4. Comparative results of enzymatic hydrolysis time test

[0176]

[0177] Table 5 Ultrasonic time comparison test results

[0178]

[0179]

[0180] Table 6 Comparative experimental results of enzymatic hydrolysis time after ultrasonic extraction

[0181]

[0182] Conclusion: Based on the above experimental results, the optimal enzymatic hydrolysis method is to use trypsin for the first hydrolysis, followed by pepsin for the second hydrolysis. An ultrasonic time of 10 minutes was also determined as the optimal extraction condition. The effective ingredient content extracted when the ultrasonic time was 15 minutes was not much different from that when it was 10 minutes. To avoid the extraction of more impurities, an ultrasonic time of 10 minutes was selected. After the ultrasonic time was determined, the enzymatic hydrolysis time was further optimized from the original optimal enzymatic hydrolysis time of 50 minutes to 15 minutes, shortening each extraction time by 25 minutes. This doubled the extraction efficiency and further improved the extraction effect.

[0183] When the enzymatic hydrolysis and ultrasonic conditions were optimized, the technical results exceeded expectations. The extraction rate of buffalo horn increased from 1.35% with a single enzyme hydrolysis to 5.83%, a 4.3-fold increase in the extraction rate of buffalo horn medicinal materials. The total nitrogen content of the concentrated powder increased from 18.69% to 34.18%, a 15.49% increase. The content of concentrated pink amino acids increased from 0.07% to 0.82%, a 11.7-fold increase. The content of water-soluble extracts in the concentrated powder increased from 4.16% to 12.56%, a 3-fold increase. Selecting the optimal enzymatic hydrolysis method, enzymatic hydrolysis time, and ultrasonic time significantly improved the extraction efficiency of buffalo horn medicinal materials, achieving the optimal level of medicinal material utilization, and fundamentally enhancing the therapeutic effect of the drug.

[0184] Experimental Example 3: Comparative Experiment on Different Drying Temperatures of Buffalo Horn Concentrated Powder

[0185] The buffalo horn concentrated powder obtained using Extraction Method 5 in Experimental Example 1 of this application achieved a nearly fivefold increase in extraction yield compared to the original extraction method. However, the total nitrogen content and water-soluble extract content of the concentrated powder only increased by 2-3 times. To maximize the retention of active ingredients, the drying temperature was optimized to further increase the utilization rate of the buffalo horn medicinal material, thereby enhancing the therapeutic efficacy of the drug. The remaining experimental steps not described in detail in the following experiments were the same as those described in Example 1. The test results are shown in Table 7 below.

[0186] Table 7 Comparative test results of buffalo horn concentrated powder at different drying temperatures

[0187]

[0188] Conclusion: Based on the above experimental results, varying the drying temperature of the extract significantly affects the content of active ingredients in buffalo horn concentrated powder. A drying temperature of 65°C maximizes the retention of active ingredients while minimizing drying time. Compared to drying at 70°C, the total nitrogen content of the concentrated powder increased by 13.87%, the amino acid content of the concentrated powder increased by 17.1%, and the water-soluble extract content of the concentrated powder increased by 9.0%. Therefore, the optimal drying temperature for buffalo horn concentrated powder is 65°C and the drying time is 5 hours.

[0189] Experimental Example 4: Comparative Experiment on Different Grinding Methods of the Traditional Chinese Medicine Composition of the Present Application

[0190] Because the 24 medicinal ingredients in this application's composition, excluding the buffalo horn concentrate powder, require pulverization, the original process necessitates pulverization of these ingredients together before proceeding to the next step. However, in practice, this method was found to result in a significant disparity in particle size, so an improvement was implemented. The specific pulverization method is described below, and the experimental results are shown in Table 8.

[0191] Crushing method 1: Take the prescribed amount of dendrobium, ginseng, yam, poria, licorice, cistanche, wolfberry, dodder seed, rehmannia root, rehmannia root, schisandra chinensis, asparagus cochinchinensis, ophiopogon japonicus, bitter almond, siler, ligusticum chuanxiong, fried aurantium, coptis root, cyperus rotundus, chrysanthemum, salt tribulus terrestris, amaranth fruit, cassia seed, and goat horn and crush them at the same time. Install a 100-mesh sieve in the grinder and sieve them for later use.

[0192] Crushing method 2: Take the prescribed amount of dendrobium, ginseng, yam, poria, licorice, cistanche, wolfberry, dodder seed, rehmannia, prepared rehmannia, schisandra, asparagus, ophiopogon, bitter almond, siler, ligusticum, chuanxiong, fried aurantium, coptis, cyperus, chrysanthemum, salt tribulus, amaranth, cassia seed and crush them, install a 100 mesh sieve in the grinder, and set aside.

[0193] Take the prescribed amount of goat horns and grind them separately. Install a 100-mesh screen cloth on the grinder to sieve them and set aside.

[0194] Crushing method 3: Take the prescribed amount of dendrobium, ginseng, cistanche, rehmannia, prepared rehmannia, schisandra, ligusticum, chuanxiong, coptis, cyperus, and cassia seed and crush them. Install a 100-mesh sieve in the crusher and sieve them for later use.

[0195] Take the prescribed amount of Chinese yam, Poria cocos, licorice, wolfberry, Cuscuta australis, asparagus, ophiopogon, bitter almond, fried aurantium, chrysanthemum, salt tribulus terrestris, and Atractylodes macrocephala for grinding, install a grinder with a 100-mesh screen, and set aside.

[0196] Take the prescribed amount of goat horns and grind them separately. Install a 100-mesh screen cloth on the grinder to sieve them and set aside.

[0197] Table 8 Comparison of crushing results of different crushing methods

[0198]

[0199] Conclusion: The optimal pulverization method yielded uniform fine powder particle size, the best pelleting results, and no flyaway particles. Method 2 produced 95.6% of fine powder particles between 120 and 150 μm, with uniform particle size and no flyaway particles. The active ingredient was evenly distributed after pelleting, with a pelleting rate of 95.6%. Method 3 was comparable to Method 2, but Method 2 was selected to save time and simplify the pulverization process.

[0200] Experimental Example 5: Comparative Experiment of Different Mixing Methods of the Traditional Chinese Medicine Composition of the Present Application

[0201] Because the Chinese medicine composition of the present invention is prepared from a fine powder after pulverization, the mixing process can easily lead to uneven mixing and powder flying due to different weight differences. Therefore, a comparative experiment was conducted on different mixing methods to determine the optimal mixing method. The composition was prepared using 636g of goat horn powder, 128g of buffalo horn concentrated powder, and 2450g of a mixed powder of 23 medicinal herbs. The specific experimental steps are as follows. The formula and other experimental steps not described in detail in the following experiments are the same as those described in Example 2.

[0202] Mixing method 1: Place the crushed 23 medicinal materials (except goat horn powder and buffalo horn concentrated powder) in a square cone mixer, set the mixer speed to 9 RPM, mix for 5 minutes to obtain a mixed powder, and remove it for later use;

[0203] Take 636g of goat horn powder, 128g of buffalo horn concentrated powder, and 2450g of mixed powder and put them into a square cone mixer. Set the mixer speed to 9RPM and mix for 40 minutes to obtain a mixture, which is set aside.

[0204] Mixing method 2: Place the crushed 23 medicinal materials (except goat horn powder and buffalo horn concentrated powder) in a square cone mixer, set the mixer speed to 9 RPM, and mix for 5 minutes to obtain a mixed powder, which is then removed for later use;

[0205] Weigh the mixed powder ingredients: Divide the mixed powder into 2 parts, 1225g for the first part and 1225g for the second part, set aside;

[0206] Weigh the goat horn powder ingredients: Divide the goat horn powder into 2 parts, 318g for the first part and 318g for the second part, set aside;

[0207] Weigh the buffalo horn concentrated powder ingredients: Divide the buffalo horn concentrated powder into 2 portions, 64g the first portion and 64g the second portion, set aside;

[0208] Place 318 g of goat horn powder, 64 g of buffalo horn concentrated powder, and 1225 g of mixed powder in a square-cone mixer, set the mixer speed to 9 RPM, and mix for 20 min to obtain mixture ①; place 318 g of goat horn powder, 64 g of buffalo horn concentrated powder, and 1225 g of mixed powder in a square-cone mixer, set the mixer speed to 9 RPM, and mix for 20 min to obtain mixture ②, which is set for later use.

[0209] Mixing method 3: Place the crushed 23 medicinal materials (except goat horn powder and buffalo horn concentrated powder) in a square cone mixer, set the mixer speed to 9 RPM, and mix for 5 minutes to obtain a mixed powder, which is then removed for later use;

[0210] Weigh the mixed powder ingredients: divide the mixed powder into 3 parts, the first part is 650g, the second part is 900g, and the third part is 900g, set aside;

[0211] Weigh the goat horn powder ingredients: Divide the goat horn powder into 2 parts, 318g for the first part and 318g for the second part, set aside;

[0212] Weigh the buffalo horn concentrated powder ingredients: Divide the buffalo horn concentrated powder into 2 portions, 64g the first portion and 64g the second portion, set aside;

[0213] Place 318g of goat horn powder and 64g of buffalo horn concentrated powder in a square-cone mixer at 9 RPM and mix for 5 minutes to obtain mixture ①. Place 650g of the mixed powder in a square-cone mixer at 9 RPM and mix for 5 minutes to obtain mixture ②. Place 318g of goat horn powder and 900g of the mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ③. Place the remaining 64g of buffalo horn concentrated powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ④. Place 900g of the mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ⑤, set aside.

[0214] Mixing method 4: Place the crushed 23 medicinal materials (except goat horn powder and buffalo horn concentrated powder) in a square cone mixer, set the mixer speed to 9 RPM, mix for 5 minutes to obtain a mixed powder, and remove it for later use;

[0215] Weigh the mixed powder ingredients: divide the mixed powder into 4 portions, 300g for the first portion, 450g for the second portion, 864g for the third portion, and 836g for the fourth portion. Set aside;

[0216] Weigh the goat horn powder ingredients: Divide the goat horn powder into 2 parts, 300g for the first part and 336g for the second part, set aside;

[0217] Place 300g of goat horn powder and 300g of mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ①. Place 128g of buffalo horn concentrated powder and 450g of mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ②. Place 336g of goat horn powder and 864g of mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ③. Place 836g of mixed powder in a square-cone mixer at 9 RPM and mix for 10 minutes to obtain mixture ④, which is set aside.

[0218] Pills were prepared using the four mixing methods described above and tested according to the quality test standards for concentrated powders of ginseng, coptis root, dendrobium, and buffalo horn in the 2020 edition of the Chinese Pharmacopoeia. The test results are shown in Table 9 below.

[0219] Table 9 Comparative experimental test results of different mixing methods (n=6)

[0220]

[0221] Conclusion: Experimental results show that the fine powder mixture prepared using Mixing Method 3 is uniform and free of flying powder. Compared with other mixing methods, Mixing Method 3 has the lowest RSD values ​​for dendrobium alkaloid content, berberine hydrochloride content, total ginsenosides content, total nitrogen content, and water-soluble extract content. Furthermore, the RSD values ​​for each active ingredient are all less than 2%, indicating that the material prepared using this mixing method is uniform and stable. This highly precise and efficient mixing process effectively improves drug uniformity, thereby ensuring stable product quality testing and avoiding the instability of active ingredients during long-term quality testing due to mixing process issues.

[0222] Experimental Example 6: Comparative Experiment on Different Combination Methods of the Traditional Chinese Medicine Composition of the Present Application

[0223] Due to the special properties of the materials being all fine powders, the order and method of adding materials during the clumping process seriously affect the clumping state and material loss. To avoid the occurrence of such process problems, an experiment was conducted on the order and method of adding materials during the clumping process. The experimental content is as follows. The formula and other experimental steps not described in detail in the following experiments are the same as those described in Example 2. The test results are shown in Table 10 below.

[0224] Combining method 1: Place 1.65 kg of refined honey in a heated stirring tank, weigh 825 g of water, add it to the heated stirring tank, heat to 75°C, start stirring, stir for 15 minutes, and obtain a refined honey aqueous solution for later use; place the sieved composite mixed powder in a trough mixer, slowly add the refined honey aqueous solution, combine, combine for 12 minutes, discharge, and set aside.

[0225] Combining method 2: Weigh 825g of water, place it in a heated stirring tank, heat it to 75℃, start stirring, add 1.65kg of refined honey, place it in a heated stirring tank, stir for 15 minutes, and obtain a refined honey aqueous solution, set aside;

[0226] The sieved composite powder mixture was placed in a trough mixer, and the refined honey aqueous solution was slowly added to form a mass. The mixture was mixed for 12 minutes, and then discharged and set aside.

[0227] Combining method 3: Weigh 825g of water, place it in a heated stirring tank, heat it to 75℃, start stirring, add 1.65kg of refined honey, place it in a heated stirring tank, stir for 15 minutes, and obtain a refined honey aqueous solution, set aside;

[0228] Place the sieved composite powder mixture in a trough mixer, slowly add half of the refined honey aqueous solution, start stirring for 2 minutes, then add the remaining half of the refined honey aqueous solution, mix, mix for 10 minutes, discharge, and set aside.

[0229] Table 10 Comparative experimental results of different lumping methods (n=6)

[0230]

[0231] Conclusion: The experimental results show that the RSD values ​​of dendrobium alkaloid content, berberine hydrochloride content, total ginsenosides content, total nitrogen content, and water-soluble extract content in the material obtained by lumping method 3 were all less than 2%, indicating that the active ingredients of the drug were evenly distributed and the process was stable. At the same time, the method of adding refined honey water in batches can effectively avoid the loss of fine powder and ensure the uniform distribution of the material after lumping, which is conducive to the effective implementation of subsequent processes and avoids the loss of raw materials.

[0232] Experimental Example 7: Comparative Experiment on Different Refining Methods of the Traditional Chinese Medicine Composition of the Present Application

[0233] When the experiment was conducted based on the awakening step in the original process, it was found that the material state after awakening was uncontrollable. Sometimes, after awakening, the material would not meet the requirements of subsequent production, seriously delaying the production progress and making the production state uncontrollable. Therefore, the process was improved and the method of refining medicine was used instead of awakening. The specific experimental process is shown below. The formula and other experimental steps not described in detail in the following experiments are the same as those described in Example 2. The experimental test results are shown in Table 11 below.

[0234] Refining method 1: Place the combined materials in a stainless steel barrel, let them rest for 8 hours, and set aside.

[0235] Refining method 2: Turn on the medicine refining machine, set the frequency of the medicine refining machine to 40Hz, put the combined materials into the medicine refining machine to refine the medicine once, and set aside.

[0236] Refining method 3: Turn on the medicine refining machine, set the frequency of the medicine refining machine to 40Hz, put the combined materials into the medicine refining machine and refine them twice, and set aside.

[0237] Refining method 4: Turn on the medicine refining machine, set the frequency of the medicine refining machine to 40Hz, put the combined materials into the medicine refining machine and refine them 3 times, and set aside.

[0238] Table 11 Comparative experimental results of different refining methods

[0239]

[0240]

[0241] Conclusion: This application adopts a medicine refining machine to replace the awakening process, which saves 460 minutes of operation time of this process step, greatly improving the industrial production efficiency of this process step. At the same time, the two-time medicine refining method is used to obtain the best material state, with a pilling rate of up to 98.6%. The weight difference meets the standard requirements (standard requirements: ±8%), which is conducive to the smooth progress of the pill making process.

[0242] Experimental Example 8: Comparative Experiment on Different Pill-Making Methods of the Traditional Chinese Medicine Composition of the Present Application

[0243] According to the pill preparation process, selecting an appropriate pill-making mold is the key to controlling the weight of the pills. In order to make the Chinese medicine composition of the present invention meet the weight difference requirement after pill formation, the mold and pill-making method are screened to determine the optimal pill-making conditions so that it meets the weight difference standard requirement. The detailed preparation method is as follows. The experimental test results are shown in Table 12 below. The prescription and the remaining experimental steps not described in detail in the following experiments are all the same as those described in Example 2.

[0244] Pellet making method 1: Select a φ5.1m pellet making mold and a φ5.1mm strip nozzle and check that they are properly installed. Add material to the hopper, control the pushing speed to 35Hz and the cutting speed to 25Hz, and control the wet pellet weight at 1.15g / 10 pellets. The weight difference during the pellet making process should be controlled within the range of ±8%. The weight of each group of wet pellets (10 pellets / group) should be controlled within the weight difference range. Every 30 minutes, 10 groups (10 pellets / group) should be randomly selected and the pellet weights recorded. Qualified wet pellets should be evenly spread on a stainless steel tray and stored in a pellet drying room. Let the pellets dry for 10 hours before use.

[0245] Pellet making method 2: Select a φ5.2m pellet making mold and a φ5.2mm strip nozzle and check that they are properly installed. Add material to the hopper, control the pushing speed to 35Hz and the cutting speed to 25Hz, and control the wet pellet weight at 1.15g / 10 pellets. The weight difference during the pellet making process should be controlled within the range of ±8%. The weight of each group of wet pellets (10 pellets / group) should be controlled within the weight difference range. Every 30 minutes, 10 groups (10 pellets / group) should be randomly selected and the pellet weights should be recorded. Qualified wet pellets should be evenly spread on a stainless steel tray and stored in a pellet drying room. Let the pellets dry for 10 hours before use.

[0246] Pellet making method 3: Select a φ5.2m pellet making mold and a φ5.1mm strip nozzle and check that they are properly installed. Add material to the hopper, control the pushing speed to 35Hz and the cutting speed to 25Hz, and control the wet pellet weight at 1.15g / 10 pellets. The weight difference during the pellet making process should be controlled within the range of ±8%. The weight of each group of wet pellets (10 pellets / group) should be controlled within the weight difference range. Every 30 minutes, 10 groups (10 pellets / group) should be randomly selected and the pellet weights should be recorded. Qualified wet pellets should be evenly spread on a stainless steel tray and stored in a pellet drying room. Let the pellets dry for 10 hours before use.

[0247] Table 12 Comparative experimental results of different pill making methods

[0248]

[0249] Conclusion: Through multiple improvements, a φ5.2m pelletizing die and a φ5.1mm strip outlet were selected. At the same time, the pushing speed was controlled at 35Hz and the cutting speed was controlled at 25Hz. The prepared pills met the wet pill weight difference control standard, ensuring that each production met the weight difference requirements.

[0250] Experimental Example 9: Comparative Experiment on Different Covering Methods of the Traditional Chinese Medicine Composition of the Present Application

[0251] To ensure that the prepared pills achieve optimal properties, such as uniformity and non-stickiness, the precise capping process is crucial. Researchers employed different capping methods, resulting in significant variations in the resulting pills. The specific experimental steps are described below. The results are shown in Table 13. The formulation and remaining experimental steps not described in detail in the following experiments were the same as those described in Example 2.

[0252] Covering method 1: Place the wet pills in the sugar coating machine, start the sugar coating machine, set the speed to F20, wait for the wet pills to roll at a uniform speed, and evenly spray purified water (the amount of purified water sprayed = the weight of the wet pills × 5%). After the wet pills are evenly moistened, continue to rotate the sugar coating machine to round them for 40 minutes. After the covering is completed, spread the material evenly and flatly on a stainless steel plate.

[0253] Covering method 2: Place the wet pills in the sugar coating machine, start the sugar coating machine, set the speed to F20, and after the wet pills roll at a uniform speed, spray purified water evenly three times (the amount of purified water sprayed = the weight of the wet pills × 5%), and control each time for 5 seconds. After the wet pills are evenly moistened, continue to rotate the sugar coating machine to round them for 40 minutes. After the covering is completed, spread the material evenly and flatly on a stainless steel plate.

[0254] Covering method 3: Place the wet pills in the sugar coating machine, start the sugar coating machine, set the speed to F20, and after the wet pills roll at a uniform speed, spray purified water evenly three times (the amount of purified water sprayed = the weight of the wet pills × 5%), and control each time for 5 seconds. After the wet pills are evenly moistened, continue to rotate the sugar coating machine to round them for 40 minutes. During the covering process, blow air into the pot for 10 seconds every 5 minutes. After the covering is completed, spread the material evenly and flatly on a stainless steel plate.

[0255] Table 13 Comparative experimental results of different covering methods (weight difference standard requirement: ±8%, n=10)

[0256]

[0257] Conclusion: By controlling the method and speed of adding water during the covering process in the above-mentioned covering method 3, the pellets can be made round and shiny. At the same time, blowing air into the pot for 10 seconds every 5 minutes prevents pellets from sticking. The pellet yield rate reaches as high as 99.2%, effectively improving the product pellet yield and reducing the loss of raw materials caused by substandard products produced during the covering process.

[0258] Experimental Example 10: Comparative Experiment on Different Drying Methods and Drying Temperatures of the Traditional Chinese Medicine Composition of the Present Application

[0259] Since the Chinese medicine composition of the present invention is prepared as a pill, the conditions and method of the drying process seriously affect the properties and quality of the finished product. Therefore, the drying conditions are fully controlled to produce a product with stable quality. The experimental details of the specific drying method are as follows. The test results are shown in Table 14 below. The formula and other experimental steps not described in detail in the following experiments are the same as those described in Example 2.

[0260] Drying method 1: Place the covered wet pills at room temperature to dry for 24 hours and set aside after drying.

[0261] Drying method 2: Put the covered wet pellets into a hot air circulation oven, set the drying temperature to 75°C, dry for 8 hours, and then discharge the pellets for later use.

[0262] Drying method 3: Place the covered wet pellets into a hot air circulation oven at 75°C for 8 hours. The pellets are then placed on a plate at the 1st, 3rd, 5th, and 7th hour of drying. After drying, the pellets are discharged and set aside. The drying temperature was optimized, and the drying temperatures were set at 55°C, 60°C, 65°C, 70°C, 75°C, and 80°C, respectively, according to the steps of drying method 3. The specific experimental results are shown in Table 15 below.

[0263] Table 14 Comparative experimental test results of different drying methods

[0264]

[0265] Table 15 Comparative experimental test results of different drying temperatures

[0266]

[0267] Conclusion: The experimental results above indicate that the berberine hydrochloride content in the pills prepared using drying method 3 and controlling the drying temperature to 65°C is the highest, the moisture content is moderate, and the dissolution time meets the requirements without premature dissolution (standard requirement: complete dissolution within 1 hour). This effectively ensures that the drug reaches the site of action and improves the therapeutic effect. Drying conditions, such as the drying method and drying temperature, have a significant impact on the state and quality of the finished pills. Precise drying conditions fundamentally avoid inferior pills such as broken, cracked, and sticky pills caused by this process step, reduce material loss, and improve the pill yield.

[0268] Experimental Example 11: Comparative Experiment on Different Packaging Methods of the Traditional Chinese Medicine Composition of the Present Application

[0269] Since the weight difference requirement for a single pill is 8%, while the weight difference requirement for the entire bag is 4%, the phenomenon of acceptable weight difference for each pill but unacceptable weight difference for the bagged product may occur, therefore, the packaging method was studied to make the packaging process suitable for industrial production. The specific optimization experiment content is described below. The experimental results are shown in Table 16 below. The formula and other experimental procedures not described in detail in the following experiments are the same as those described in Example 2.

[0270] Packaging method 1: Pour the dried water-honeyed pills directly into a 73-hole bag forming-filling-sealing machine for packaging.

[0271] Packaging method 2: Randomly select 10 groups of water-honeyed pills (10 pills per group), weigh them separately, and calculate the average pill weight.

[0272] Theoretical number of pills = 7.3g ÷ average pill weight, round up to the nearest integer, manually adjust the number of small holes in the packaging mold of the bag forming-filling-sealing machine according to the theoretical number of pills, pour the dried water-honeyed pills into the packaging mold for packaging.

[0273] During the packaging process, the operator randomly selects 10 bags every hour to check the filling volume. The filling volume difference should be within the range of ±4.0%.

[0274] Table 16 Comparative experiment of different packaging methods

[0275]

[0276] Conclusion: Bagging according to the packaging process equipment designed in this invention can ensure that the weight difference of each batch of samples after bagging meets the requirement of ±4% on the basis of the qualified weight difference of single pills, fundamentally solving the problem of loading quantity difference in industrial production and avoiding unnecessary product waste due to unqualified loading quantity.

Claims

1. A method for preparing buffalo horn concentrated powder, the method comprising the following steps: (1) Processing of corner tips Take the solid core part of the buffalo horn (commonly known as the "horn tip"), disinfect it, and crush it into fine powder to obtain the horn tip fine powder; (2) Corner pile part processing Dispersion stage: Take the remaining part of the buffalo horn (commonly known as the "horn pile") and grind it into fine particles. Add water to make it evenly dispersed; First enzymatic hydrolysis: adding trypsin, stirring for the first enzymatic hydrolysis, ultrasonic extraction, and centrifugal filtration after ultrasonication to obtain the first filtrate and the first filter residue; Second enzymatic hydrolysis: add water to the first filter residue, add pepsin, stir for the second enzymatic hydrolysis, ultrasonic extraction, centrifuge and filter to obtain the second filtrate; Filtrate mixing: combining the first filtrate and the second filtrate, filtering, and concentrating the filtrate to obtain a concentrate; (3) Preparation of buffalo horn concentrated powder The buffalo horn powder obtained in step (1) is added to the concentrated solution obtained in step (2), mixed evenly, dried, cooled, and then ground into fine powder, which is then sieved to obtain buffalo horn concentrated powder.

2. The method according to claim 1, wherein In step (1), ethanol is used for disinfection, preferably 75% ethanol is used for disinfection.

3. The method according to claim 1 or 2, wherein: In step (2), the remaining part of the buffalo horn (commonly known as "horn pile") is crushed into fine particles, passed through an 80-mesh sieve, and then water is added; Preferably, in step (2), during the dispersion stage, the mass of water added is 3-8 times the mass of the fine particles, preferably 5 times; Preferably, in step (2), in the first enzymatic hydrolysis stage, the mass of trypsin added is 3-8% of the mass of the fine particles, preferably 4%; Preferably, in step (2), in the first enzymatic hydrolysis stage, the enzyme activity of the added trypsin is ≥50000u / g; Preferably, in step (2), the first enzymatic hydrolysis time is 10-40 min; Preferably, in step (2), during the first enzymatic hydrolysis stage, the ultrasonic extraction time is 5-30 min.

4. The method according to any one of claims 1 to 3, wherein In step (2), after adding water to the first filter residue and before adding pepsin, the pH value is adjusted to 2.0-4.0; for example, an inorganic acid such as hydrochloric acid can be used to adjust the pH value; Preferably, in step (2), the amount of pepsin added is 0.8-2% of the mass of the fine particles, preferably 1%; Preferably, in step (2), the enzyme activity of the added pepsin is ≥3000u / g; Preferably, in step (2), the second enzymatic hydrolysis time is 10-40 min; Preferably, in step (2), during the second enzymatic hydrolysis stage, the ultrasonic extraction time is 5-30 min; Preferably, in step (2), during the second enzymatic hydrolysis stage, after ultrasonic extraction and before centrifugation, the pH value is adjusted to neutral, that is, the pH value is adjusted to 7, for example, by adding 1 mol / L sodium hydroxide solution.

5. The method according to any one of claims 1 to 3, wherein in, In step (3), the drying temperature is 60-75°C; Preferably, in step (3), the drying time is 5 h; Preferably, in step (3), sieving refers to sieving through a 100-mesh sieve.

6. A Haoshiliang series of traditional Chinese medicine compositions for treating liver and kidney deficiency and yin deficiency and fire excess type cataracts, the composition comprising the following raw materials in parts by weight: 45-150 parts of Dendrobium, 180-500 parts of Ginseng, 65-200 parts of Chinese Yam, 185-390 parts of Poria, 48-160 parts of Licorice, 50-175 parts of Cistanche, 68-210 parts of Lycium barbarum, 66-200 parts of Cuscuta, 90-280 parts of Rehmannia, 90-280 parts of Rehmannia glutinosa, 48-155 parts of Schisandra chinensis, 175-380 parts of Asparagus cochinchinensis, 90-240 parts of Ophiopogon japonicus, 70-200 parts of Bitter Apricot Kernel 48-160 parts of siler leaves, 48-160 parts of ligusticum chuanxiong, 45-150 parts of stir-fried aurantium with bran, 45-150 parts of coptis chinensis, 65-230 parts of cyperus rotundus, 65-230 parts of chrysanthemum, 48-180 parts of salt tribulus terrestris, 48-180 parts of amaranth seeds, 68-240 parts of cassia seeds, 440-1000 parts of goat horn, and 20-280 parts of buffalo horn concentrated powder prepared according to any one of claims 1 to 5; Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 50-100 parts of dendrobium, 200-300 parts of ginseng, 80-150 parts of yam, 210-320 parts of poria, 52-120 parts of liquorice, 55-110 parts of cistanche, 78-160 parts of wolfberry, 75-160 parts of dodder seed, 95-170 parts of rehmannia root, 95-170 parts of prepared rehmannia root, 52-110 parts of schisandra chinensis, 190-320 parts of asparagus, 95-180 parts of ophiopogon, 0 parts, 85-140 parts of bitter almonds, 52-110 parts of siler, 52-110 parts of ligusticum chuanxiong, 48-120 parts of stir-fried fructus aurantii with bran, 48-120 parts of coptis chinensis, 72-145 parts of cyperus rotundus, 72-145 parts of chrysanthemum, 52-130 parts of salt tribulus terrestris, 55-150 parts of amaranth seeds, 80-170 parts of cassia seeds, 500-800 parts of goat horn, and 70-200 parts of buffalo horn concentrated powder prepared according to any one of claims 1 to 5; Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 55-80 parts of dendrobium, 230-270 parts of ginseng, 85-120 parts of yam, 230-280 parts of poria, 58-90 parts of liquorice, 57-80 parts of cistanche, 85-130 parts of wolfberry, 82-135 parts of dodder seed, 110-140 parts of rehmannia root, 110-140 parts of prepared rehmannia root, 58-85 parts of schisandra chinensis, 220-285 parts of asparagus, 105-140 parts of ophiopogon, 105-140 parts of celery root ... 150 parts, 90-110 parts of bitter almonds, 58-85 parts of siler, 58-85 parts of ligusticum, 58-85 parts of chuanxiong, 55-90 parts of stir-fried aurantium with bran, 52-80 parts of coptis, 85-110 parts of cyperus, 85-110 parts of chrysanthemum, 58-90 parts of salt tribulus, 58-95 parts of amaranth, 88-120 parts of cassia seed, 550-700 parts of goat horn, and 100-150 parts of buffalo horn concentrated powder prepared according to any one of claims 1 to 5; Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 64 parts of dendrobium, 254 parts of ginseng, 95 parts of yam, 254 parts of poria, 64 parts of liquorice, 64 parts of cistanche, 95 parts of wolfberry, 95 parts of dodder seed, 127 parts of rehmannia, 127 parts of prepared rehmannia, 64 parts of schisandra, 254 parts of asparagus, 127 parts of ophiopogon, 95 parts of bitter apricot, 64 parts of siler, 64 parts of ligusticum, 65 parts of stir-fried aurantium, 65 parts of coptis, 95 parts of achyranthes, 95 parts of chrysanthemum, 64 parts of salt tribulus, 64 parts of amaranth, 95 parts of cassia seed, 636 parts of goat horn, and 128 parts of buffalo horn concentrated powder prepared according to any one of claims 1 to 5.

7. A method for preparing the Chinese medicine composition according to claim 6, such as a pill, comprising the following steps: (1) Crushing and refining honey Grinding: Grind the medicinal materials except the buffalo horn concentrated powder, sieve and set aside; Refining honey: take honey and add water to refine honey; (2) Mixing and sieving Mixing the medicinal materials except the goat horn powder and the buffalo horn concentrated powder to obtain a mixed powder, and dividing the mixed powder into three parts, namely a first mixed powder, a second mixed powder, and a third mixed powder; Divide the goat horn powder into two parts, namely the first goat horn powder and the second goat horn powder; Divide the buffalo horn concentrated powder into two parts, namely, first buffalo horn concentrated powder and second buffalo horn concentrated powder; The first goat horn powder and the first buffalo horn concentrated powder are mixed, and then the first mixed powder, the second goat horn powder, the second mixed powder, the second buffalo horn concentrated powder, and the third mixed powder are sequentially added and mixed, and then sieved to obtain a composite mixed powder; (3) Hetuo Adding the refined honey aqueous solution in batches to the mixed powder of the composition obtained in step (2) to obtain a clumped material; (4) Carry out the operations of refining medicine, making pills, covering, drying, selecting pills and packaging in sequence.

8. The method according to claim 7, wherein: In step (1), goat horns are crushed separately; Preferably, in step (1), the particle size is controlled so that the proportion of the medicinal material with a particle size between 120-150 μm is greater than 90%; Preferably, in step (3), refined honey is added to water to prepare a refined honey aqueous solution.

9. The method according to claim 7 or 8, wherein In step (4), the frequency of the medicine refining machine is 40-50 Hz; Preferably, in step (4), the number of times of refining the medicine is at least 2 times; Preferably, in step (4), the size of the pellets produced by the pelletizing machine is φ5.0-5.5m, preferably φ5.2m; Preferably, in step (4), the size of the pelletizing machine outlet nozzle is φ5.0-5.5 mm, preferably φ5.1 mm; Preferably, in step (4), the pushing speed of the pelletizing machine is 20 to 50 Hz, and the cutting speed is 10 to 50 Hz.

10. The method according to any one of claims 7 to 9, wherein In step (4), air is blown into the pot during the covering process; preferably, air is blown into the pot for 5-30 seconds every 5 minutes during the covering process; preferably, air is blown into the pot for 10 seconds every 5 minutes during the covering process; Preferably, in step (4), the drying temperature is 60-80°C and the drying time is 4-12h; Preferably, in step (4), the tray is threaded up and down during the drying process; Preferably, in step (4), the number of small holes of the packaging mold of the bag forming-filling-sealing machine needs to be manually adjusted before packaging.

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