Preparation method for improving quality and efficiency of blood-raising granules

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparation, and provides a quality-improving and effect-enhancing preparation method of blood-raising granules. The preparation method comprises the following steps: concentrating water decoction of astragalus membranaceus, hawthorn and jujube, adding ethanol, and filtering to obtain filtrate and precipitate; and concentrating the filtrate into clear paste, adding water to dissolve the precipitate to obtain a precipitate solution, firstly mixing the precipitate solution with a new donkey-hide gelatin solution to react under an acidic condition, then adding a melanterite solution to react under a near-neutral condition to obtain a liquid medicine, mixing the liquid medicine with the clear paste, drying, and preparing particles with auxiliary materials. According to the invention, the alcohol precipitate is also utilized, so that the utilization rate of the medicine is improved; through an improved method and on the premise of not obviously changing a preparation prescription, inorganic iron is changed into organic iron by changing a preparation process, so that the rust taste of an original preparation is eliminated or reduced, the palatability of the preparation is improved, the irritation to the stomach is reduced, the compliance of the blood-raising granules is obviously improved, and meanwhile, the iron absorption amount is obviously increased; and the curative effect of treating iron-deficiency anemia is obviously improved.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine preparation, and relates to a preparation method of Chinese patent medicine Shengxue granules. Background Art

[0002] The disclosure of this background information is intended to enhance understanding of the general background of the invention and should not necessarily be taken as an acknowledgment or any form of suggestion that this information constitutes the prior art already known to a person skilled in the art.

[0003] Shengxue Granule is a product included in the Chinese Pharmacopoeia. It has the function of replenishing qi and blood, and can be used for pale complexion, dizziness, palpitations, fatigue, and shortness of breath caused by qi and blood deficiency. Because the prescription contains alum (FeSO4·7H2O), it also has a good effect on iron deficiency anemia.

[0004] According to the prescription amount of 4.97g of alum, 298.1g of astragalus, 298.1g of hawthorn, 99.4g of new donkey-hide gelatin and 99.4g of jujube in the pharmacopoeia, it is prepared according to the following method: add equal amount of sucrose to alum and new donkey-hide gelatin to make fine powder; decoct the other three flavors such as astragalus with water twice, combine the decoction, filter, concentrate the filtrate to an appropriate amount, add 1.5 times of ethanol, let it stand for 24 hours, take the supernatant, recover the ethanol and concentrate it to an appropriate amount, add appropriate amount of auxiliary materials, mix with the above fine powder, make granules, dry, and make 1000g. However, the alum in the blood-raising granules is inorganic iron, which makes the blood-raising granules have two major disadvantages. First, it has a very obvious rusty taste and can also produce a large irritation to the stomach, so it is difficult to take and easy to cause vomiting, and the compliance is poor; second, the absorption of iron is poor, which affects its effect in treating iron deficiency anemia.

[0005] How to improve the compliance of Shengxue Granules and enhance its efficacy in treating iron deficiency anemia without changing the original formula is the focus of further development. Summary of the invention

[0006] In view of the problems of poor compliance and poor iron absorption of the current blood-raising granules, the present invention provides a preparation method for improving the quality and efficiency of blood-raising granules: a decoction of astragalus, hawthorn and jujube is concentrated and ethanol is added, and a filtrate and a precipitate are obtained by filtering; the filtrate is concentrated into a clear paste, the precipitate is dissolved in water to obtain a precipitation solution, which is first mixed with a new donkey-hide gelatin solution and reacted under acidic conditions, and then a soap alum solution is added to react under near-neutral conditions to obtain a medicinal solution and a clear paste, which is mixed and dried with auxiliary materials to prepare granules; the method can improve the rust taste, reduce gastric irritation, and improve iron absorption efficiency.

[0007] To achieve the above purpose, the present invention adopts the following technical solution.

[0008] A preparation method for improving the quality and efficiency of Shengxue granules comprises the following steps: (1) Take the prescribed amount of alum and new donkey-hide gelatin and add water to make a solution; (2) Take the prescribed amount of Astragalus, Hawthorn and Jujube, add water and boil twice, combine the decoctions, filter, concentrate the filtrate, add ethanol to obtain a mixed solution, let it stand and filter to obtain a filtrate and precipitate; (3) recovering ethanol from the filtrate of step (2) and concentrating it into a clear paste; (4) adding water to the precipitate obtained in step (2) to dissolve the precipitate, and filtering to obtain a precipitate solution; (5) Mixing the new donkey-hide gelatin solution and the precipitation solution under heating and stirring conditions, adjusting the pH to 3.5-4.5, and reacting to obtain a mixed solution I; (6) Under heating and stirring conditions, the mixed solution I is added to the soap alum solution and mixed; then the pH is adjusted to 5-7 for reaction to obtain a mixed solution II; (7) Mix the mixed drug solution II and the clear paste and dry them to obtain a dry powder; (8) The dry powder and excipients are mixed to prepare granules.

[0009] Preferably, in step (1), the concentration of the alum solution is 1%-3% (g / mL); the concentration of the new donkey-hide gelatin solution is 2%-5%; in order to increase the dissolution rate of the new donkey-hide gelatin, it can be crushed and / or dissolved in water at 50°C-80°C.

[0010] Preferably, in step (2), the first amount of water added is 10 times the amount, the second amount of water added is 8 times the amount, and each decoction is performed for 1 hour; the mixture is concentrated to a concentrated solution with a relative density of 1.02-1.05 (60°C); the amount of ethanol added to the mixed solution is 1.5 times the amount of the concentrated solution (V / V), and the mixture is allowed to stand for 12h-24h.

[0011] In step (3), the relative density of the clear paste is 1.02-1.05 (60°C).

[0012] In step (4), the amount of water added is twice the mass of the precipitate.

[0013] In steps (5) and (6), the heating temperature is 50°C-60°C; the reaction time is 60min-90min. A blood-raising granule prepared by the above method.

[0014] The present invention has the following advantages: The present invention also utilizes the alcohol precipitate, thereby improving the utilization rate of the drug; through the improved method, the inorganic iron is converted into organic iron by changing the preparation process without significantly changing the preparation prescription, thereby eliminating or reducing the rust taste of the original preparation, increasing the palatability of the preparation, reducing the irritation to the stomach, and significantly improving the compliance of the Shengxue granules. More importantly, after being converted into organic iron, the iron absorption amount is significantly increased, and the efficacy of the granules in treating iron deficiency anemia is significantly improved. DETAILED DESCRIPTION

[0015] A preparation method for improving the quality and efficiency of Shengxue granules comprises the following steps: (1) Take the prescribed amount of alum and new donkey-hide gelatin in Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 1%-3% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of hot water (temperature 50℃-80℃) to dissolve it to a concentration of 2%-5% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and decompress the decoctions to a concentrated solution with a relative density of 1.02-1.05 (60°C). After the concentrated solution is cooled, add ethanol so that the amount of ethanol in the mixed solution is 1.5 times that of the concentrated solution, let it stand for 12h-24h, filter, and obtain a filtrate and a precipitate; (3) Recover ethanol from the filtrate and concentrate it to a clear paste with a relative density of 1.02-1.05 (60°C); (4) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (5) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 50-60°C, add dilute hydrochloric acid to make its pH value 3.5-4.5, add alum solution, stir well, maintain 50-60°C, and continue stirring for 60-90 minutes. Then add 1% sodium hydroxide solution to make its pH value 5.0-7.0, stir well, maintain 50-60°C, and continue stirring for 60-90 minutes to obtain a mixed solution; (6) Mixing the mixed drug solution and the clear paste, spray drying, and obtaining a spray-dried powder; (7) Mix the spray-dried powder with appropriate amounts of flavor enhancers, fillers and other auxiliary materials, and dry-press them into granules to obtain rust-free, effective blood-raising granules.

[0016] The present invention is further described below in conjunction with specific embodiments. Unless otherwise specified, the prescription amount is the prescription of "Shengxue Granules" in the "Chinese Pharmacopoeia 2020 Edition". Per 1000g Shengxue Granules: 4.97g of alum, 298.1g of astragalus, 298.1g of hawthorn, 99.4g of new donkey-hide gelatin, and 99.4g of jujube.

[0017] Example 1 Preparation of blood granules 1. Screening of acidic pH (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 3% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 12 hours, and filter to obtain a filtrate and a precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 55°C, add dilute hydrochloric acid to adjust its pH to 3.0-5.0, add alum solution, stir well, maintain 55°C and continue stirring for 75 minutes.

[0018] The amount of free iron ions in the solution obtained by the above method was determined according to the method reported by Xu Yi (Preparation and Characterization of Sika Deer Blood Peptide Chelated Iron and Study on Cell Absorption Characteristics [D]. Jilin: Changchun University of Technology, 2023) and the percentage of iron ions added to the soap alum was calculated. At the same time, the solution with different pH values ​​was tasted to identify the rust smell.

[0019] Table 1 Determination results of free iron ions and rust smell in solutions with different pH values ​​adjusted with dilute hydrochloric acid The test results show that when the pH value is selected at 3.5-4.5, the free iron ion content is low and the rust smell is lighter.

[0020] 2. Screening of acid adjustment reaction temperature (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 3% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let it stand for 24 hours, and filter to obtain a filtrate and a precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 30-70°C, add dilute hydrochloric acid to make its pH value 4.0, add alum solution, stir well, maintain the original temperature and continue stirring for 75 minutes.

[0021] The amount of free iron ions in the liquid obtained by the above method was determined according to the method reported by Xu Yi, and the percentage of iron ions added to the soap alum was calculated. At the same time, different liquids were tasted to identify the degree of rust smell.

[0022] Table 2 Determination results of free iron ions and rust smell in liquid medicine at different temperatures The results in Table 2 show that when the temperature is heated to 50℃-60℃, there are fewer free iron ions and less rust smell.

[0023] 3. Screening of reaction time after acid adjustment (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 3% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let it stand for 24 hours, and filter to obtain a filtrate and a precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 55°C, add dilute hydrochloric acid to make its pH value 4.0, add alum solution, stir well, maintain the original temperature and continue stirring for 30-120 minutes.

[0024] The amount of free iron ions in the liquid obtained by the above method was determined according to the method reported by Xu Yi, and the percentage of iron ions added to the soap alum was calculated. At the same time, different liquids were tasted to identify the degree of rust smell.

[0025] Table 3 Determination results of free iron ions and rust smell in the solution at different reaction times The test results show that when the stirring reaction time is maintained at 60min-90min, the free iron ion content obtained is low and the rust smell is small.

[0026] 4. Alkaline pH Screening (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 4% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 18 hours, and filter to obtain a filtrate and a precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 55°C, add dilute hydrochloric acid to adjust the pH value to 4.0, add the alum solution, stir well, maintain the original temperature and continue stirring for 70 min; (5) Adjust the pH value of the drug solution in step (4) to 4.0-8.0 with 1% NaOH solution, stir well, maintain at 55°C, and continue stirring for 70 minutes.

[0027] The amount of free iron ions in the liquid obtained by the above method was determined according to the method reported by Xu Yi, and the percentage of iron ions added to the soap alum was calculated. At the same time, different liquids were tasted to identify the degree of rust smell.

[0028] Table 4 Determination results of free iron ions and rust smell in solutions with different pH values ​​adjusted with 1% sodium hydroxide solution It can be seen from the test results that the free iron ion content of the solution obtained by adjusting the pH value to 5.0-7.0 with 1% sodium hydroxide solution is about 10%, and there is basically no detectable rust smell when tasting it.

[0029] 5. Screening of alkali adjustment reaction temperature (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 3% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules and add water to decoct twice, add 10 times the amount of water for the first time and 8 times the amount for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 20 hours, filter, and obtain a filtrate and precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 55°C, add dilute hydrochloric acid to adjust the pH value to 4.0, add the alum solution, stir well, maintain the original temperature and continue stirring for 70 min; (5) Adjust the pH value of the drug solution in step (4) to 6.0 with 1% NaOH solution, stir well, maintain at 50-80°C, and continue stirring for 70 minutes.

[0030] The amount of free iron ions in the liquid obtained by the above method was determined according to the method reported by Xu Yi, and the percentage of iron ions added to the soap alum was calculated. At the same time, different liquids were tasted to identify the degree of rust smell.

[0031] Table 5 Determination results of free iron ions and rust smell in liquid medicine at different temperatures It can be seen from the test results that the solution after adjusting the pH value with 1% sodium hydroxide solution has low free iron ion content and less rust smell at 50℃-60℃.

[0032] 6. Screening of reaction time after alkali adjustment (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 2% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of 80°C hot water to dissolve it to a concentration of 3% (g / mL); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules, add water and decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to obtain a concentrated solution. The relative density of the concentrated solution at 60°C is 1.05. After the concentrated solution is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 16 hours, and filter to obtain a filtrate and a precipitate; (3) Weigh the precipitate, add twice the weight of water to dissolve the precipitate, and filter to obtain the precipitate solution; (4) Mix the new donkey-hide gelatin solution with the precipitation solution, heat it to 55°C, add dilute hydrochloric acid to adjust the pH value to 4.0, add the alum solution, stir well, maintain the original temperature and continue stirring for 70 min; (5) Adjust the pH value of the solution in step (4) to 6.0 with 1% NaOH solution, stir well, maintain at 55°C, and continue stirring for 30-120 minutes.

[0033] The amount of free iron ions in the liquid obtained by the above method was determined according to the method reported by Xu Yi, and the percentage of iron ions added to the soap alum was calculated. At the same time, different liquids were tasted to identify the degree of rust smell.

[0034] Table 6 Determination results of free iron ions and rust smell at different stirring times It can be seen from the test results that when the solution after adjusting the pH value with 1% sodium hydroxide solution continues to be kept warm and stirred for 60min-90min, the free iron ion content is low and the rust smell is less.

[0035] Example 2 Preparation of blood granules (1) Take the amount of alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 1.5% (g / ml); crush the new donkey-hide gelatin appropriately, add an appropriate amount of hot water (temperature 80±2℃) to dissolve it, and make a solution with a concentration of 3% (g / ml); (2) Take the amount of Astragalus, Hawthorn and Jujube in the prescription of Shengxue Granules and add water to decoct twice, add 10 times the amount of water for the first time and 8 times the amount for the second time, decoct for 1 hour each time, filter, combine the decoctions, and decompress the decoctions to a concentrate with a relative density of 1.04 (60°C). After the concentrate is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 12 hours, and filter to obtain a filtrate and precipitate; (3) Recover ethanol from the filtrate and concentrate it to a clear paste with a relative density of 1.03 (60°C); (4) Weigh the precipitate and add twice the weight of water to dissolve the precipitate to obtain the precipitate solution; (5) Mix the new donkey-hide gelatin solution and the precipitation solution, heat them to 55±2℃, add dilute hydrochloric acid to make the pH value 4.0, add alum solution, stir well, maintain 55±2℃, and continue stirring for 70 minutes; then add 1% sodium hydroxide solution to make the pH value 6.0, stir well, maintain 55±2℃, and continue stirring for 70 minutes to obtain a mixed solution; (6) mixing the mixed drug solution with the clear paste obtained after recovering the ethanol, and spray drying to obtain a spray-dried powder; (7) Mix the spray-dried powder with an appropriate amount of sucrose powder and dry starch, and dry-press the granules to obtain rust-free, effective blood-raising granules.

[0036] Example 3 Preparation of blood granules (1) Take the alum and new donkey-hide gelatin in the prescription of Shengxue Granules, dissolve the alum in water to make a solution with a concentration of 3% (g / mL); crush the new donkey-hide gelatin appropriately, add an appropriate amount of hot water (temperature 80±2℃) to dissolve it to obtain a 4% (g / mL) solution; (2) Take the astragalus, hawthorn and jujube in the prescription of Shengxue Granules and add water to decoct twice, add 10 times the amount of water for the first time and 8 times the amount for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to a concentrate with a relative density of 1.03 (60°C). After the concentrate is cooled, add 1.5 times the amount of ethanol% (v / v), stir well, let stand for 24 hours, and filter to obtain the filtrate and precipitate; (3) Recover ethanol from the filtrate and concentrate it to a clear paste with a relative density of 1.04 (60°C); (4) Weigh the precipitate, add water twice the weight of the precipitate to dissolve the precipitate to obtain a precipitate solution; (5) Mix the new donkey-hide gelatin solution and the precipitation solution, heat them to 58±2℃, add dilute hydrochloric acid to make the pH value 3.5, add alum solution, stir well, maintain 58±2℃, and continue stirring for 60min; then add 1% sodium hydroxide solution to make the pH value 6.0, stir well, maintain 58±2℃, and continue stirring for 90min to obtain a mixed solution; (6) mixing the mixed drug solution with the clear paste obtained after recovering the ethanol, and spray drying to obtain a spray-dried powder; (7) Mix the spray-dried powder with an appropriate amount of sucrose powder and dry starch, and dry-press the granules to obtain rust-free, effective blood-raising granules.

[0037] Comparative Example 1 Preparation of 1-liter blood granules (1) Take the prescribed amount of alum and new donkey-hide gelatin, add equal amounts of sucrose to each and make into fine powder; (2) Take the prescribed amount of Astragalus, Hawthorn and Jujube, add water and decoct twice, add 10 times the amount of water for the first time and 8 times the amount for the second time, decoct for 1 hour each time, filter, combine the decoctions, and concentrate the decoctions under reduced pressure to a concentrate with a relative density of 1.03 (60°C). After the concentrate is cooled, add 1.5 times the amount of ethanol (v / v), stir well, let stand for 24 hours, and filter to obtain a filtrate and precipitate; (3) Recover ethanol from the filtrate, concentrate to a clear paste with a relative density of 1.04 (60°C), and then mix with an appropriate amount of sucrose powder, dry starch and the two fine powders in step (1); (4) Wet granulation and drying to obtain pharmacopoeial blood-raising granules.

[0038] Example 4 The blood-replenishing effects of different blood-raising granules Take the improved blood-raising granules in Example 3 and the blood-raising granules prepared by the pharmacopoeia method in Comparative Example 1, add water to dissolve them, and prepare a solution with the same drug concentration. According to the method reported by Ren Chengyuan et al. (Evaluation of the iron supplement effect of glutamate iron chelate on iron-deficiency anemia mice [J]. Journal of Hebei University (Natural Science Edition) 2024, 44 (4): 365-372), mice were modeled, and after successful modeling, two solutions of blood-raising granules were administered, and the mice were divided into a normal control group, anemia group, pharmacopoeia blood-raising granules group, and improved blood-raising granules group. After 4 weeks of administration, hemoglobin (HGB), red blood cell count (RBC), serum iron (SI), total iron binding capacity (TIBC), and transferrin (TRF) were measured.

[0039] Table 7 Comparison of blood-replenishing effects of pharmacopoeial Shengxue granules and improved Shengxue granules Note: ✱ Comparison between improved method and pharmacopoeia method P <0.05.

[0040] The test results show that both the common Shengxue Granules and the Shengxue Granules produced by the invention process can improve the biochemical indicators related to anemia, and all indicators are close to the normal group. The effect of the invention group is more obvious than that of the common group, among which the effect of improving hemoglobin (HGB), serum iron (SI), and total iron binding capacity (TIBC) is significantly better in the invention group than in the common group ( P <0.05).

[0041] The above is only an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A method for preparing Shengxue granules for improving quality and efficiency, characterized in that: The following steps are involved: (1) Take the prescribed amount of alum and new donkey-hide gelatin and add water to make a solution; (2) Take the prescribed amount of Astragalus, Hawthorn and Jujube, add water and boil twice, combine the decoctions, filter, concentrate the filtrate, add ethanol to obtain a mixed solution, let it stand and filter to obtain a filtrate and precipitate; (3) recovering ethanol from the filtrate of step (2) and concentrating it into a clear paste; (4) adding water to the precipitate obtained in step (2) to dissolve the precipitate, and filtering to obtain a precipitate solution; (5) Mixing the new donkey-hide gelatin solution and the precipitation solution under heating and stirring conditions, adjusting the pH to 3.5-4.5, and reacting to obtain a mixed solution I; (6) Under heating and stirring conditions, the mixed solution I is added to the soap alum solution to mix and react; then the pH is adjusted to 5-7 to react to obtain a mixed solution II; (7) Mix the mixed drug solution II and the clear paste and dry them to obtain a dry powder; (8) The dry powder and excipients are mixed to prepare granules.

2. The preparation method according to claim 1, characterized in that: In step (1), the concentration of the alum solution is 1%-3% (g / mL); the concentration of the new donkey-hide gelatin solution is 2%-5%; the new donkey-hide gelatin solution is prepared by crushing the new donkey-hide gelatin and / or dissolving it in water at 50°C-80°C.

3. The preparation method according to claim 1, characterized in that: In step (2), the first amount of water added is 10 times the amount, and the second amount of water added is 8 times the amount, and each time is boiled for 1 hour; the mixture is concentrated to a concentrated solution with a relative density of 1.02-1.05 (60°C); the volume of ethanol added to the mixed solution is 1.5 times the volume of the concentrated solution, and the standing time is 12h-24h.

4. The preparation method according to claim 1, characterized in that: In step (3), the relative density of the clear paste is 1.02-1.05 (60°C).

5. The preparation method according to claim 1, characterized in that: In step (4), the amount of water added is twice the mass of the precipitate.

6. The preparation method according to claim 1, characterized in that: In steps (5) and (6), the heating temperature is 50°C-60°C; and the reaction time is 60min-90min.

7. A blood-raising granule obtained by the preparation method according to any one of claims 1 to 6.

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