Donkey-hide gelatin blood-enriching oral liquid and preparation process thereof

Abstract

The preparation process comprises the following steps: respectively carrying out percolation extraction on codonopsis pilosula, astragalus membranaceus, fructus lycii and bighead atractylodes rhizome by adopting an ethanol percolation method, merging percolation liquid after percolation, and concentrating to obtain percolation concentrated paste; extracting the prepared rehmannia root by adopting a water extraction method, carrying out cold precipitation on the extracted water extract and the percolation concentrated paste, filtering the cold precipitation liquid, and concentrating to obtain water extraction percolation paste; the method comprises the following steps: performing enzymolysis on donkey-hide gelatin by adopting enzyme, and performing enzyme inactivation and degreasing on enzymatic hydrolysate to obtain donkey-hide gelatin enzymatic hydrolysate; performing primary preparation on the water extraction percolation paste, the donkey-hide gelatin enzymatic hydrolysate, a sweetening agent and a preservative, heating, performing cold precipitation, filtering, adding a stabilizer, performing secondary heating, performing cold precipitation, performing centrifugal filling on cold precipitation liquid, and sterilizing. The colla corii asini blood-enriching oral liquid prepared by the preparation process provided by the invention has higher stability in the storage process, can be continuously placed for a long time without generating precipitates, and meanwhile, the nitrogen content in the preparation is increased.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology and relates to an oral liquid for replenishing blood with donkey-hide gelatin and its preparation process. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Donkey-hide gelatin oral liquid is made from donkey-hide gelatin, prepared rehmannia root, codonopsis root, astragalus root, wolfberry fruit, and atractylodes rhizome through water extraction and percolation processes. Due to its effects of replenishing qi and blood, nourishing yin and moistening the lungs, it has long been widely used in the treatment of chronic illness, weakness, consumptive cough, and qi and blood deficiency. However, during the water extraction and percolation processes of the traditional Chinese medicine, substances such as proteins, sugars, and tannins dissolve, which, after formulation and high-temperature sterilization, produce a series of non-water-soluble substances, resulting in unsatisfactory clarity in its liquid preparation.

[0004] Research on the clarification of traditional Chinese medicine extracts still primarily focuses on natural clarifying agents. These agents mainly include diatomaceous earth, gelatin, chitosan, 101 clarifying agent, and activated carbon. Among them, 101 clarifying agent, derived from food-grade raw materials, primarily consists of modified starch. Its clarification principle utilizes a dual process of adsorption and coagulation, causing large molecular impurities in the extract to rapidly coagulate and precipitate, separating the supernatant from the residue, thus achieving clarification. Gelatin flocculation mainly leverages the advantages of gelatin's large surface area and strong adsorption capacity to adsorb substances such as proteins, polysaccharides, and tannins, thereby improving the clarity of oral liquids. Chitosan, also a deacetylated chitin, possesses good biocompatibility, suitability, and safety. Chitosan primarily exerts its clarifying effect under acidic conditions by interacting with negatively charged substances such as cellulose and tannins through its positive charge. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a blood-tonifying oral liquid made from donkey-hide gelatin and its preparation process. The blood-tonifying oral liquid made from donkey-hide gelatin prepared by the process provided by the present invention has higher stability during storage and can be stored continuously for a long time without precipitation. At the same time, it increases the nitrogen content in the preparation.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A preparation process for a blood-tonifying oral liquid made from donkey-hide gelatin includes the following steps: The ethanol percolation method was used to extract Codonopsis pilosula, Astragalus membranaceus, Lycium barbarum and Atractylodes macrocephala. The percolates were combined and concentrated to obtain a concentrated percolation extract. The prepared Rehmannia root was extracted using water extraction. The extracted water extract and the percolated concentrate were subjected to cold precipitation. The precipitate was filtered and concentrated to obtain the water-extracted percolated concentrate. Enzymes were used to hydrolyze donkey-hide gelatin. The hydrolysate was then inactivated by enzymes and deesterified to obtain donkey-hide gelatin hydrolysate. The above-mentioned water-extracted percolate, donkey-hide gelatin enzymatic hydrolysate, sweetener, and preservative are prepared once, heated, cooled and filtered, stabilized, heated a second time, cooled and filtered, and the cooled sediment is centrifuged, filled, and sterilized.

[0007] In some implementation schemes, the percolation process for Atractylodes macrocephala and Lycium barbarum involves using 60% ethanol as a solvent. Specifically, the Atractylodes macrocephala and Lycium barbarum are soaked before percolation, with the solvent volume being 8 to 10 times that of the medicinal materials, and the percolation time is 24 hours.

[0008] In some implementation schemes, the percolation process for Codonopsis pilosula and Astragalus membranaceus involves using 25% ethanol as a solvent. Specifically, before percolation, the Codonopsis pilosula and Astragalus membranaceus are soaked in a solvent solution that is 8 to 10 times the volume of the medicinal materials, and the percolation time is 24 hours.

[0009] In some implementation schemes, the percolates of Atractylodes macrocephala and Lycium barbarum are combined with the percolates of Codonopsis pilosula and Astragalus membranaceus, then filtered, and the filtrate is concentrated.

[0010] In some implementation schemes, the water extraction process of Rehmannia glutinosa involves: decocting Rehmannia glutinosa with water to obtain a decoction, and then filtering the decoction to obtain a filtrate. Specifically, the decoction is performed at least three times, with each decoction lasting 1.5 to 2.5 hours, and the decoctions are then combined.

[0011] In some implementation schemes, the enzymatic hydrolysis process of donkey-hide gelatin is as follows: donkey-hide gelatin is pulverized, dissolved in water, then enzymatically hydrolyzed, deesterified, and filtered for later use.

[0012] In some embodiments, the sweetener includes, but is not limited to, white sugar; the preservative includes, but is not limited to, sodium benzoate; and the stabilizer is sodium carboxymethyl cellulose.

[0013] In some implementation schemes, the primary preparation heating temperature is 100°C for 30 minutes; the secondary preparation heating temperature is 121°C for 30 minutes.

[0014] In some implementation schemes, the cooling temperature after the first preparation and heating is 2-8°C, and the time is 24-48 hours; the cooling temperature after the second preparation and heating is 2-8°C, and the time is 24-48 hours.

[0015] Specifically, the preferred steps of the preparation process are: 1. Soak coarse Atractylodes macrocephala powder and Lycium barbarum in 0.8 times their volume of 60% ethanol at room temperature for 0.5 hours. Then, add 60% ethanol to submerge the surface of the herbs. After soaking for 24 hours, percolate. The total amount of 60% ethanol used for soaking, macerating, and percolating the coarse Atractylodes macrocephala powder and Lycium barbarum should be 10 times their volume. Soak coarse Astragalus membranaceus powder and Codonopsis pilosula powder in 0.8 times their volume of 25% ethanol at room temperature for 0.5 hours. Then, add 25% ethanol to submerge the herbs. After soaking for 24 hours, percolate. The total amount of 25% ethanol used for soaking, macerating, and percolating the coarse Astragalus membranaceus powder and Codonopsis pilosula should be 10 times their volume. Combine the percolates, let stand for 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15-1.20 (80℃). Set aside. 2. Soak Rehmannia glutinosa in 8 times its volume of water for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 4 times and 3 times the volume of water respectively, for 1.5 hours each time. Filter the decoction and combine the extracts. 3. Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2~10℃ for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15-1.20 (80℃). 4. Grind the donkey-hide gelatin into coarse powder, add 5 times the amount of water, boil to dissolve the gelatin for 30 minutes, cool to below 50℃, add 2% (by weight) of collagenase, and maintain at 50℃ for enzymatic hydrolysis for 5 hours. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 1% (by weight) of activated charcoal, stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. 5. Add appropriate amounts of white sugar and sodium benzoate to 3 times the amount of water, boil to dissolve, and set aside as a sugar solution. 6. Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2-8℃ for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add 0.5%-1% sodium carboxymethyl cellulose to prepare the liquid, keep at 60℃ and stir for 30 minutes, heat to 121℃ and keep for 30 minutes, cool and settle at 2-8℃ for 24 hours, centrifuge, fill and sterilize.

[0016] The beneficial effects of this invention are as follows: This invention provides a preparation process for donkey-hide gelatin blood-tonifying oral liquid, and solves the problem of precipitation during storage, thereby improving the nitrogen content index of the preparation and extending the shelf life of the drug. Detailed Implementation

[0017] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific experimental examples.

[0018] The current standard for donkey-hide gelatin oral liquid for replenishing blood is the 2025 edition of the Chinese Pharmacopoeia, Part I: Donkey-hide gelatin oral liquid for replenishing blood, and its preparation method is as follows: (1) Boil Rehmannia glutinosa in water three times. The first time is 2 hours, and the second and third times are 1.5 hours each time. Filter the decoction, combine the filtrates, let stand, and take the supernatant for later use. (2) Atractylodes macrocephala and Lycium barbarum were soaked in 60% ethanol and Codonopsis pilosula and Astragalus membranaceus were soaked in 25% ethanol. The percolate was collected, allowed to stand, filtered, and the ethanol was recovered from the filtrate and concentrated to an appropriate amount for later use. (3) Add an appropriate amount of water to the donkey-hide gelatin, heat to dissolve, filter, mix the filtrate with the above concentrated liquid and the prepared Rehmannia glutinosa extract, filter, add 3g of sodium benzoate or 2g of sorbic acid and an appropriate amount of flavoring agent, heat to boiling, add water to 1000ml, mix well, and you will get the product.

[0019] Experimental Example 1: Study on Percolation Process Process research revealed that, apart from donkey-hide gelatin, the nitrogen content, a key indicator for determining the formulation's content, primarily originates from the percolation process. Further research into the percolation process led to the determination of a more optimal method.

[0020] Table 1 Results of percolation process study

[0021] Continued from Table 1

[0022] Experimental results show that increasing the amount of percolate can effectively increase the nitrogen content in the percolate. Furthermore, increasing the wetting and impregnation processes can also increase the nitrogen content in the percolate. However, changing the concentration of percolate alcohol is not conducive to increasing the nitrogen content in the percolate.

[0023] Experimental Example 2: Purification Study of Percolate Percolation paste is prone to precipitation after preparation. The effects of different processing techniques on the precipitation of the formulation were investigated.

[0024] 187.5g of coarse Atractylodes macrocephala powder and 187.5g of Lycium barbarum were soaked in 300ml of 60% ethanol for 0.5 hours. Then, 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, macerating, and percolating of the coarse Atractylodes macrocephala powder and Lycium barbarum was 3750ml.

[0025] 187.5g of coarse Astragalus powder and 375g of Codonopsis pilosula were soaked in 450ml of 25% ethanol for 0.5 hours. Then, 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was carried out. The total amount of 25% ethanol used for soaking, macerating, and percolating of coarse Astragalus powder and Codonopsis pilosula was 5625ml.

[0026] Combine the percolates, let stand for 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.16 (80℃).

[0027] Extraction process of Rehmannia glutinosa: Soak 375g of Rehmannia glutinosa in 3000ml of water for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 1500ml and 1125ml of water respectively, for 1.5 hours each time. Filter the decoction and combine the decoctions.

[0028] Grind 187.5g of donkey-hide gelatin into coarse powder, add 950ml of water, boil for 30 minutes to dissolve the gelatin, and set the gelatin liquid aside.

[0029] Add appropriate amount of white sugar and 9g of sodium benzoate to 3 times the amount of water, boil and dissolve, then set the sugar solution aside.

[0030] Table 2 Results of purification study of percolate extract

[0031] Experimental results show that water precipitation can delay the formation of sediment in the percolating extract, but the effect is not significant. Purification of the percolating extract using Rehmannia glutinosa extract significantly delays the precipitation time, indicating that Rehmannia glutinosa extract plays a crucial role in the stability of the preparation during purification.

[0032] Experimental Example 3: Study on the gelatinization of donkey-hide gelatin The preparation contained an oily suspension, which, according to research, was caused by donkey-hide gelatin. Furthermore, incomplete gelatinization may have led to precipitation in the preparation. Therefore, further research is needed on the gelatinization process.

[0033] Preparation of concentrated extract from medicinal herbs: 187.5g of coarse Atractylodes macrocephala powder and 187.5g of Lycium barbarum were soaked in 300ml of 60% ethanol for 0.5 hours, then 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, percolation, and percolation of Atractylodes macrocephala powder and Lycium barbarum was 3750ml. 187.5g of coarse Astragalus membranaceus powder and 375g of Codonopsis pilosula powder were soaked in 450ml of 25% ethanol for 0.5 hours, then 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was performed. The total amount of 25% ethanol used for soaking, percolation, and percolation of Astragalus membranaceus powder and Codonopsis pilosula was 5625ml. The percolates were combined, allowed to stand for 4 hours, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.17 (80℃).

[0034] Soak 375g of prepared Rehmannia root in 3000ml of water for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 1500ml and 1125ml of water respectively, for 1.5 hours each time. Filter the decoctions and combine them. Add the decoction to the above percolated concentrate, stir for 30 minutes, and allow to settle at 2-10℃ for 48 hours. Filter the solution and concentrate it under reduced pressure to a relative density of 1.16 (80℃).

[0035] Table 3. Results of the study on gelatinization of donkey-hide gelatin.

[0036] Experimental results show that enzymatic hydrolysis can slow down the formation of precipitate in donkey-hide gelatin, but enzymatic hydrolysis cannot solve the problem of oily substances. Therefore, adding activated carbon treatment can effectively solve the problem of oily substances, while delaying the formation of precipitate and improving the stability of the preparation.

[0037] Experimental Example 4: Formulation Study While methods such as percolation treatment and gelatin dissolution can address some of the sedimentation issues in donkey-hide gelatin oral liquid, they do not completely resolve the problem. Therefore, further formulation methods are used to enhance the stability of the preparation.

[0038] Preparation of concentrated extract from medicinal herbs: 187.5g of coarse Atractylodes macrocephala powder and 187.5g of Lycium barbarum were soaked in 300ml of 60% ethanol for 0.5 hours, then 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, percolation, and percolation of Atractylodes macrocephala powder and Lycium barbarum was 3750ml. 187.5g of coarse Astragalus membranaceus powder and 375g of Codonopsis pilosula powder were soaked in 450ml of 25% ethanol for 0.5 hours, then 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was performed. The total amount of 25% ethanol used for soaking, percolation, and percolation of Astragalus membranaceus powder and Codonopsis pilosula was 5625ml. The percolates were combined, allowed to stand for 4 hours, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.17 (80℃).

[0039] Soak 375g of prepared Rehmannia root in 3000ml of water for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 1500ml and 1125ml of water respectively, for 1.5 hours each time. Filter the decoctions and combine them. Add the decoction to the above percolated concentrate, stir for 30 minutes, and allow to settle at 2-10℃ for 48 hours. Filter the solution and concentrate it under reduced pressure to a relative density of 1.16 (80℃).

[0040] Gelatinizing process: Grind 187.5g of donkey-hide gelatin into coarse powder, add 5 times the amount of water, boil for 30 minutes to gelatinize, cool to below 50℃, add 2% (by weight) collagenase of donkey-hide gelatin, and maintain at 50℃ for 5 hours of enzymatic hydrolysis. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 1% (by weight) activated charcoal of the hydrolysate, stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. Sugar solution preparation: Add appropriate amount of white sugar and 9g of sodium benzoate to 3 times the amount of water, boil and dissolve, and set the sugar solution aside; Table 3. Results of the study on gelatin stabilizers.

[0041] Table 4. Results of the study on the heating process of gelatinization.

[0042] Experimental results show that by adding the stabilizer sodium carboxymethyl cellulose and simultaneously using a secondary heating process during formulation, the problem of formulation precipitation can be effectively solved, the formulation properties can be kept stable, and the shelf life can be extended.

[0043] Experimental Example 5: Stability Study Three batches of donkey-hide gelatin blood-tonifying oral liquid samples were prepared according to the optimal research process, and stability studies were conducted. The preparation process of donkey-hide gelatin blood-tonifying oral liquid is as follows: 62.5g donkey-hide gelatin, 125g prepared rehmannia root, 125g codonopsis root Astragalus membranaceus 62.5g, Lycium barbarum 62.5g, Atractylodes macrocephala 62.5g 1. For coarse powdered Atractylodes macrocephala and Lycium barbarum, soak in 0.8 times the volume of 60% ethanol at room temperature for 0.5 hours. Then, add 60% ethanol to submerge the surface of the herbs and soak for 24 hours. Percolate after soaking. The total amount of 60% ethanol used for soaking, macerating, and percolating the coarse powdered Atractylodes macrocephala and Lycium barbarum should be 10 times the volume of the herbs. For coarse powdered Astragalus membranaceus and Codonopsis pilosula, soak in 0.8 times the volume of 25% ethanol at room temperature for 0.5 hours. Then, add 25% ethanol to submerge the herbs and soak for 24 hours. Percolate after soaking. The total amount of 25% ethanol used for soaking, macerating, and percolating the coarse powdered Astragalus membranaceus and Codonopsis pilosula should be 10 times the volume of the herbs. Combine the percolates, let stand for 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15~1.20 (80℃) for later use. 2. Soak Rehmannia glutinosa (processed) in 8 times its volume of water for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 4 times and 3 times the volume of water respectively, for 1.5 hours each time. Filter the decoction and combine the extracts. 3. Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2°C for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15~1.20 (80°C). 4. Grind donkey-hide gelatin into coarse powder, add 5 times the amount of water, boil to dissolve the gelatin for 30 minutes, cool to below 50℃, add 2% (by weight) collagenase of donkey-hide gelatin, and maintain at 50℃ for enzymatic hydrolysis for 5 hours. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 1% (by weight) activated charcoal of the hydrolysate, stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. 5. Add appropriate amounts of white sugar and sodium benzoate to 3 times the amount of water, boil and dissolve to obtain sugar solution, set aside; 6. Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2°C for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add sodium carboxymethyl cellulose at 0.5% of the liquid volume, stir at 60°C for 30 minutes, heat to 121°C, maintain for 30 minutes, cool and settle at 2°C for 24 hours, centrifuge, fill, and sterilize.

[0044] Stability test conditions: Accelerated stability test conditions: 40℃±2℃, relative humidity 75%±5%; Evaluation criteria: Chinese Pharmacopoeia 2025 Edition, Part I: Donkey-hide gelatin oral liquid; Evaluation indicators: appearance, identification, pH value, relative density, and astragaloside A content.

[0045] Table 5 Summary of accelerated stability test results for donkey-hide gelatin blood-tonifying oral liquid (20250401)

[0046] Table 6 Summary of Accelerated Stability Test Results for Donkey-hide Gelatin Blood-tonifying Oral Liquid (20250402)

[0047] Table 7 Summary of Accelerated Stability Test Results for Donkey-hide Gelatin Blood-tonifying Oral Liquid (20250403)

[0048] After six months of accelerated stability testing, the optimized donkey-hide gelatin oral liquid showed stable properties, no precipitation, and all other indicators met the requirements. The experimental results indicate that the quality of the donkey-hide gelatin oral liquid prepared using the new process meets the specifications, and no precipitation occurred during storage, effectively ensuring shelf-life quality and extending shelf life.

[0049] Example 1 1. 62.5 kg of coarse Atractylodes macrocephala powder and 62.5 kg of Lycium barbarum fruit were soaked in 100 L of 0.8 times their volume of 60% ethanol at room temperature for 0.5 hours. Then, 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, macerating, and percolating of the coarse Atractylodes macrocephala powder and Lycium barbarum fruit was 1250 L (10 times the volume). 2. 62.5 kg of coarse Astragalus membranaceus powder and 125 kg of Codonopsis pilosula powder were soaked in 150 L of 0.8 times their volume of 25% ethanol at room temperature for 0.5 hours. Then, 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was performed. The total amount of 25% ethanol used for soaking, macerating, and percolating of the coarse Astragalus membranaceus powder and Codonopsis pilosula fruit was 1875 L (10 times the volume). The percolates were combined, allowed to stand for 4 hours, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.17 (80℃) for later use. 2. Soak 125 kg of prepared Rehmannia root in 1000 L of water (8 times the volume) for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 500 L (4 times the volume) and 375 L (3 times the volume) of water respectively, for 1.5 hours each time. Filter the decoctions and combine them. 3. Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2°C for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15 (80°C). 4. Take 62.5 kg of donkey-hide gelatin, grind it into coarse powder, add 312.5 L of water (5 times the amount of gelatin), boil for 30 minutes to dissolve the gelatin, cool to below 50℃, add 1.25 kg of collagenase (2% of the weight of the donkey-hide gelatin), and maintain at 50℃ for enzymatic hydrolysis for 5 hours. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 3.1 kg of activated charcoal (1% of the hydrolysate), stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. 5. Add 40 kg of white sugar and 3 kg of sodium benzoate to 130 L of water (3 times the amount of water), boil and dissolve to obtain sugar solution, set aside. 6. Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2°C for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add 5 kg of sodium carboxymethyl cellulose (0.5% of the liquid volume), stir at 60°C for 30 minutes, heat to 121°C, maintain for 30 minutes, cool and settle at 2°C for 24 hours, centrifuge, fill, and sterilize.

[0050] Example 2 1. 62.5 kg of coarse Atractylodes macrocephala powder and 62.5 kg of Lycium barbarum fruit were soaked in 100 L of 0.8 times their volume of 60% ethanol at room temperature for 0.5 hours. Then, 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, macerating, and percolating of the coarse Atractylodes macrocephala powder and Lycium barbarum fruit was 1000 L (8 times the volume). 2. 62.5 kg of coarse Astragalus membranaceus powder and 125 kg of Codonopsis pilosula were soaked in 150 L of 0.8 times their volume of 25% ethanol at room temperature for 0.5 hours. Then, 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was performed. The total amount of 25% ethanol used for soaking, macerating, and percolating of the coarse Astragalus membranaceus powder and Codonopsis pilosula fruit was 1875 L (10 times the volume). The percolates were combined, allowed to stand for 4 hours, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.15 (80℃) for later use. 2. Soak 125 kg of prepared Rehmannia root in 1000 L of water (8 times the volume) for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 500 L (4 times the volume) and 375 L (3 times the volume) of water respectively, for 1.5 hours each time. Filter the decoctions and combine them. 3. Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2°C for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.18 (80°C). 4. Take 62.5 kg of donkey-hide gelatin, grind it into coarse powder, add 312.5 L of water (5 times the amount of gelatin), boil for 30 minutes to dissolve the gelatin, cool to below 50℃, add 1.25 kg of collagenase (2% of the weight of the donkey-hide gelatin), and maintain at 50℃ for enzymatic hydrolysis for 4 hours. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 3.1 kg of activated charcoal (1% of the hydrolysate), stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. 5. Add 40kg of white sugar and 3kg of sodium benzoate to 130L of water (3 times the amount of water), boil and dissolve to obtain sugar solution, set aside. 6. Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2°C for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add 10 kg of sodium carboxymethyl cellulose (1% of the liquid volume), stir at 60°C for 30 minutes, heat to 121°C, maintain for 30 minutes, cool and settle at 2°C for 24 hours, centrifuge, fill, and sterilize.

[0051] Example 3 1. 62.5 kg of coarse Atractylodes macrocephala powder and 62.5 kg of Lycium barbarum fruit were soaked in 100 L of 0.8 times their volume of 60% ethanol at room temperature for 0.5 hours. Then, 60% ethanol was added to submerge the surface of the herbs. After soaking for 24 hours, percolation was performed. The total amount of 60% ethanol used for soaking, macerating, and percolating of the coarse Atractylodes macrocephala powder and Lycium barbarum fruit was 1250 L (10 times the volume). 2. 62.5 kg of coarse Astragalus membranaceus powder and 125 kg of Codonopsis pilosula powder were soaked in 150 L of 0.8 times their volume of 25% ethanol at room temperature for 0.5 hours. Then, 25% ethanol was added to submerge the herbs. After soaking for 24 hours, percolation was performed. The total amount of 25% ethanol used for soaking, macerating, and percolating of the coarse Astragalus membranaceus powder and Codonopsis pilosula fruit was 1500 L (8 times the volume). The percolates were combined, allowed to stand for 4 hours, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.20 (80℃) for later use. 2. Soak 125 kg of prepared Rehmannia root in 1000 L of water (8 times the volume) for 0.5 hours, then heat and extract for 2 hours. Filter the decoction. Extract the residue twice, adding 500 L (4 times the volume) and 375 L (3 times the volume) of water respectively, for 1.5 hours each time. Filter the decoctions and combine them. 3. Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2°C for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.20 (80°C). 4. Take 62.5 kg of donkey-hide gelatin, grind it into coarse powder, add 312.5 L of water (5 times the amount of gelatin), boil for 30 minutes to dissolve the gelatin, cool to below 50℃, add 1.25 kg of collagenase (2% of the weight of the donkey-hide gelatin), and maintain at 50℃ for enzymatic hydrolysis for 6 hours. After enzymatic hydrolysis, boil the hydrolysate for 10 minutes to inactivate the enzyme, cool to room temperature, add 3.2 kg of activated charcoal (1% of the hydrolysate), stir for 10 minutes, let stand for 2 hours, filter, and reserve the filtrate. 5. Add 40kg of white sugar and 3kg of sodium benzoate to 130L of water (3 times the amount of water), boil and dissolve to obtain sugar solution, set aside. 6. Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2°C for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add 8 kg of sodium carboxymethyl cellulose with a liquid fraction of 0.8%, keep at 60°C and stir for 30 minutes, heat to 121°C and keep for 30 minutes, cool and settle at 2°C for 24 hours, centrifuge, fill and sterilize.

Claims

1. A preparation process for a blood-tonifying oral liquid made from donkey-hide gelatin, characterized in that, Includes the following steps: (1) Codonopsis pilosula, Astragalus membranaceus, Lycium barbarum and Atractylodes macrocephala were extracted by ethanol percolation. The percolates were combined and concentrated to obtain a concentrated percolation extract. (2) The prepared Rehmannia glutinosa was extracted by water extraction. The extracted water extract and the percolation concentrate were subjected to cold precipitation. The cold precipitation was filtered and concentrated to obtain the water extract percolation concentrate. (3) Enzymes are used to hydrolyze donkey-hide gelatin. The hydrolysate is then inactivated by enzymes and deesterified to obtain donkey-hide gelatin hydrolysate. (4) The above-mentioned water-extracted percolate, donkey-hide gelatin hydrolysate, sweetener, and preservative are prepared once and then heated. After cold sedimentation and filtration, sodium carboxymethyl cellulose is added and heated a second time. The first preparation involves heating at 100℃ for 30 minutes; the second preparation involves heating at 121℃ for 30 minutes. After the first preparation and heating, the cooling temperature is 2-8℃ and the time is 24-48 hours; after the second preparation and heating, the cooling temperature is 2-8℃ and the time is 24-48 hours. The solution is heated twice and then cooled and settled. The settled solution is then centrifuged, filled, and sterilized.

2. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 1, characterized in that, The percolation process for Atractylodes macrocephala and Lycium barbarum involves using 60% ethanol as a solvent.

3. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 2, characterized in that, Before percolation, soak Atractylodes macrocephala and Lycium barbarum in a solvent that is 8 to 10 times the volume of the herbs, and percolate for 24 hours.

4. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 1, characterized in that, The percolation process for Codonopsis pilosula and Astragalus membranaceus is as follows: percolation is carried out using 25% ethanol as a solvent.

5. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 4, characterized in that, Before percolation, soak the Codonopsis pilosula and Astragalus membranaceus in a solvent that is 8 to 10 times the volume of the herbs, and percolate for 24 hours.

6. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 1, characterized in that, Prepared Rehmannia root is decocted with water to obtain a decoction, which is then filtered to obtain a filtrate.

7. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 1, characterized in that, Enzymes were used to hydrolyze donkey-hide gelatin. The hydrolysate was then inactivated by enzymes and deesterified to obtain donkey-hide gelatin hydrolysate.

8. The preparation process of the donkey-hide gelatin blood-tonifying oral liquid according to claim 1, characterized in that, The sweetener is white sugar, and the preservative is sodium benzoate.

9. The preparation process of a blood-tonifying oral liquid with donkey-hide gelatin according to any one of claims 1-8, characterized in that, Includes the following steps: (1) Soak coarse powder of Atractylodes macrocephala and Lycium barbarum in 0.8 times the amount of 60% ethanol at room temperature for 0.5 hours, then add 60% ethanol to submerge the surface of the medicinal materials. After soaking for 24 hours, percolate. The total amount of 60% ethanol used for soaking, macerating and percolating of coarse powder of Atractylodes macrocephala and Lycium barbarum is 10 times the amount of ethanol. Soak coarse powder of Astragalus membranaceus and Codonopsis pilosula in 0.8 times the amount of 25% ethanol at room temperature for 0.5 hours, then add 25% ethanol to submerge the medicinal materials. After soaking for 24 hours, percolate. The total amount of 25% ethanol used for soaking, macerating and percolating of coarse powder of Astragalus membranaceus and Codonopsis pilosula is 10 times the amount of ethanol. Combine the percolates, let stand for 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15-1.20 at 80℃ for later use. (2) Soak Rehmannia glutinosa in 8 times the amount of water for 0.5 hours, heat and extract for 2 hours, and filter the decoction. Extract the residue twice, adding 4 times and 3 times the amount of water respectively, and extract for 1.5 hours each time. Filter the decoction and combine the decoctions. (3) Add the decoction of Rehmannia glutinosa to the above percolation concentrate, stir for 30 minutes, cool and settle at 2~10℃ for 48 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15-1.20 at 80℃; (4) Grind the donkey-hide gelatin into coarse powder, add 5 times the amount of water, boil and dissolve the gelatin for 30 minutes, cool to below 50°C, add 2% of the donkey-hide gelatin mass fraction of collagenase, and keep at 50°C for 5 hours of enzymatic hydrolysis; after the enzymatic hydrolysis is completed, boil the hydrolysate for 10 minutes to inactivate it, cool to room temperature, add 1% of the hydrolysate fraction of activated carbon, stir for 10 minutes, let stand for 2 hours, filter, and keep the filtrate for later use. (5) Add 3 times the amount of water to white sugar and sodium benzoate, boil and dissolve to obtain sugar solution, set aside; (6) Mix the concentrated extract of medicinal slices, the enzymatic hydrolysate of donkey-hide gelatin, and the sugar solution, stir for 30 minutes, boil for 30 minutes, cool and settle at 2~8℃ for 48 hours, centrifuge, add water to the centrifuged liquid to the specified volume, add 0.5%~1% sodium carboxymethyl cellulose in the liquid preparation, keep at 60℃ and stir for 30 minutes, heat to 121℃, keep for 30 minutes, cool and settle at 2~8℃, cool and settle for 24 hours, centrifuge, fill and sterilize.

Images