Postpartum recovery granules and preparation process thereof

Abstract

The present invention belongs to the technical field of Chinese patent medicines, and specifically relates to a postpartum rehabilitation granule and a preparation process thereof. The present invention prepares a tartaric acid modified gelatin, and adds it as an auxiliary material in the preparation process of the postpartum rehabilitation granule. The present invention finds that the tartaric acid modified gelatin and the Chinese medicine components are decocted together before the first decoction, and the tartaric acid modified gelatin can effectively improve the retention rate and stability of various components in the process, and finally improve the extraction effect of the medicinal material and the stability of the product.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and specifically relates to postpartum recovery granules and a preparation process thereof. Background Art

[0002] Postpartum rehabilitation is an important stage of women's health. As society pays more and more attention to women's postpartum health management, the market demand for postpartum conditioning drugs is increasing year by year. As a traditional Chinese medicine preparation, Chanfukang Granules have been recognized by consumers and clinicians in terms of safety and medical properties, with an expanding market demand and a good reputation. Its market covers many aspects such as postpartum recovery, repair of irregularities, physical weakness, etc., especially in the fields of postpartum care and rehabilitation, where it has significant market advantages.

[0003] However, with the development of modern medical technology and changes in consumer demand, there is room for improvement in dosage form, drug solubility, bioavailability and ease of administration of traditional Fukang granules.

[0004] With the rapid development of modern pharmaceutical theory and technology, the process and preparation types of traditional Chinese medicine preparations are facing new opportunities and challenges. The improvement of Chinese medicine preparations can not only improve the efficacy, but also improve its stability, convenience of taking and bioavailability. The introduction of modern pharmaceutical technology, such as micronization technology, nanotechnology, spray drying, controlled release technology and sustained-release preparations, has provided innovative directions for the preparation process of traditional Chinese medicine. At the same time, in-depth research on new excipient systems and active ingredients of traditional Chinese medicine has also laid the foundation for the development of innovative preparations of traditional Chinese medicine.

[0005] In the innovative research of modern Chinese medicine preparations, the secondary development of traditional Chinese patent medicines is an important direction. This is not only because these Chinese patent medicines have obvious clinical cures and an expanded market base, but also because they can greatly improve their market cost-effectiveness, patient compliance and overall treatment after being improved by modern technology. Therefore, choosing postpartum rehabilitation granules that are fatal, safe and reliable, and have a large market demand for secondary development can not only further improve their clinical efficacy, but also enhance their market competitiveness and meet the needs of modern consumers for safe, efficient and convenient drugs. Development has a greater sense of smell and market prospects, and is an important object for the modernization of Chinese medicine preparations.

[0006] CN 101461877B discloses a pharmaceutical composition for restoring physical strength of women, which adopts spray drying one-step granulation to replace the traditional wet granulation process, retains the effective ingredients in the prescription to a greater extent, improves the auxiliary materials in the prescription, and improves the original specification of 20g / bag of sugar-containing type to 5g / bag of sugar-free type, thereby reducing the dosage, reducing the production cost, expanding the scope of application (especially for patients who avoid sugar and obese patients), improving product quality, and enhancing the competitiveness of similar products at home and abroad.

[0007] However, herbs such as Leonurus japonicus, Angelica sinensis, Astragalus membranaceus, and Polygonum multiflorum contain volatile components or essential oils, which are easy to evaporate or decompose at higher temperatures and may partially lose their medicinal properties during the extraction process. Summary of the invention

[0008] In view of the deficiencies in the prior art, the present invention provides a postpartum recovery granule and a preparation process thereof.

[0009] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0010] 18-22 parts of motherwort, 5-7 parts of peach kernel, 2-4 parts of ginseng, 8-12 parts of rehmannia root, 8-10 parts of angelica root, 6-10 parts of vinegar-cooked cyperus, 8-10 parts of astragalus, 8-12 parts of polygonum multiflorum, 4-6 parts of kelp, 4-6 parts of atractylodes, 5-7 parts of pollen cattail, 4-6 parts of black fungus, 1-3 parts of modified gelatin, and 1-3 parts of stevioside.

[0011] The preparation method of the modified gelatin comprises the following steps:

[0012] S1: Dissolve 90-100 g of gelatin in 400-600 mL of water in a water bath at 45-60°C and stir until the gelatin is completely dissolved to obtain a gelatin solution;

[0013] S2 uses a 0.4-0.6 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 8.5-9.5, and then adds a 5.5-6.5 mol / L tartaric acid aqueous solution at a rate of 1-3 ml / min, the mass ratio of tartaric acid to gelatin is 1: (4.5-5.5), and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1-2 hours, and then 90-100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate, and the precipitate obtained is filtered, washed, and dried to obtain the modified gelatin.

[0014] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0015] (1) Mix 18-22 parts of Leonurus japonicus, 5-7 parts of peach kernel, 2-4 parts of ginseng, 8-12 parts of Rehmannia root, 8-10 parts of Angelica sinensis, 6-10 parts of Cyperus rotundus, 8-10 parts of Astragalus, 8-12 parts of Polygonum multiflorum, 4-6 parts of Kelp, 4-6 parts of Atractylodes macrocephala, 5-7 parts of Pollen Typhae, 4-6 parts of Auricularia auricula, and 1-3 parts of modified gelatin to obtain a raw material;

[0016] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:(4-5), boiling at 90-100° C. and 0.1-0.2 MPa pressure for 1-3 h, and then filtering through a 200-300 mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:(4-6), boiling at 90-100° C. and 0.1-0.2 MPa pressure for 1-3 h, and then filtering through a 200-300 mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0017] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.02 to -0.04 MPa and 70 to 80° C. to obtain a concentrated solution having a volume of 64 to 68% of the volume of the Chinese medicine extract, and then standing for 12 to 24 hours, filtering through a 400 to 600 mesh filter to obtain a concentrated filtrate;

[0018] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.04 to -0.08 MPa and 70 to 80° C., and stopping the concentration when the volume of the concentrated filtrate is 14 to 16% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0019] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0020] Beneficial effects of the present invention:

[0021] The present invention prepares a tartaric acid modified gelatin, and adds it as an auxiliary material in the preparation process of postpartum recovery granules. The present invention finds that decocting the tartaric acid modified gelatin and the traditional Chinese medicine components together before the first decoction can effectively increase the content of the active ingredients in the product.

[0022] The present invention believes that the addition of tartaric acid modified gelatin can provide certain protection and synergistic effects on the extraction process of Chinese medicine ingredients by forming a colloidal protective film. The colloidal film of tartaric acid modified gelatin can cover some Chinese medicine ingredients during the decoction process, and play a role in isolating oxygen. This isolation can effectively prevent certain easily oxidized ingredients from being connected in series at high temperatures, thereby maintaining the activity of the medicinal materials. The amidated structure in tartaric acid modified gelatin forms its stronger stability and heat resistance, so that it can maintain film-forming properties during high-temperature decoction. The colloidal film can isolate the easily oxidized ingredients from the air, reduce the chance of oxidation reactions, and maintain the activity and stability of the ingredients. After tartaric acid modified gelatin forms a colloidal solution in water, it will wrap the fine particles of the medicinal materials, reducing the direct contact of these ingredients with high-temperature water. Through the isolation of the colloidal film, it can achieve the effect of buffering temperature fluctuations, thereby delaying the thermal decomposition of the ingredients.

[0023] In addition, tartaric acid-modified gelatin can slowly release the encapsulated medicinal ingredients during decoction, allowing these ingredients to be continuously released into the solution during the heating process rather than being dissolved all at once. This increases the contact time and dissolution rate of the ingredients in water, and improves the concentration of active ingredients and the extraction effect.

[0024] Finally, the dense membrane structure formed by tartaric acid during the heating process can produce a sealing effect on the volatile components. Through physical isolation, these volatile components are destroyed and lost to the air during the decoction process, maintaining their concentration in the extract.

[0025] In summary, the role of tartaric acid modified gelatin added before the first decoction is mainly reflected in isolation protection, delayed dissolution, inhibition of volatilization and improvement of solubility. Through these mechanisms of action, tartaric acid modified gelatin can effectively improve the retention rate and stability of various components in the process, and ultimately improve the extraction effect of medicinal materials and the stability of the product. DETAILED DESCRIPTION

[0026] The experimental methods in the following examples are conventional methods unless otherwise specified. The medicinal materials, reagents, etc. used in the following examples are commercially available products unless otherwise specified.

[0027] Gelatin, item number: 1, Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0028] Tartaric acid, CAS: 526-83-0.

[0029] Example 1

[0030] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0031] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0032] The preparation method of the modified gelatin comprises the following steps:

[0033] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0034] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:5, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0035] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0036] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0037] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0038] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0039] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0040] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0041] Example 2

[0042] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0043] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Auricularia auricula, and 2 parts of stevioside.

[0044] The preparation method of the modified gelatin comprises the following steps:

[0045] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0046] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:6, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0047] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0048] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0049] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, adding 2 parts of modified gelatin, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0050] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0051] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0052] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are mixed uniformly by weight, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0053] Example 3

[0054] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0055] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0056] The preparation method of the modified gelatin comprises the following steps:

[0057] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0058] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:5, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0059] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0060] (1) By weight, 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia glutinosa, 9 parts of Angelica sinensis, 8 parts of Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, and 5 parts of Auricularia auricula were mixed to obtain a raw material;

[0061] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0062] (3) Mixing 2 parts of modified gelatin and the Chinese medicine extract obtained in step (2) by weight, concentrating at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, and then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0063] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0064] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are mixed uniformly by weight, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0065] Example 4

[0066] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0067] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0068] The preparation method of the modified gelatin comprises the following steps:

[0069] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0070] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:5, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0071] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0072] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0073] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0074] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0075] (4) Mixing 2 parts of modified gelatin and the concentrated filtrate obtained in step (3) by weight, and performing secondary concentration at -0.06 MPa and 75° C. until the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling to obtain a postpartum recovery granule fluid extract;

[0076] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are mixed uniformly by weight, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0077] Example 5

[0078] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0079] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0080] The preparation method of the modified gelatin comprises the following steps:

[0081] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0082] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:3, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0083] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0084] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0085] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0086] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0087] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0088] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0089] Example 6

[0090] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0091] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0092] The preparation method of the modified gelatin comprises the following steps:

[0093] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0094] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L tartaric acid aqueous solution at a rate of 2 ml / min, the mass ratio of tartaric acid to gelatin is 1:8, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0095] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0096] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0097] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0098] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0099] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0100] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0101] Comparative Example 1

[0102] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0103] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0104] The preparation method of the modified gelatin comprises the following steps:

[0105] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0106] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L citric acid aqueous solution at a rate of 2 ml / min, the mass ratio of citric acid to gelatin is 1:5, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0107] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0108] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0109] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0110] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0111] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0112] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0113] Comparative Example 2

[0114] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0115] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar-cooked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside.

[0116] The preparation method of the modified gelatin comprises the following steps:

[0117] S1: Dissolve 100 g of gelatin in 500 mL of water in a 50°C water bath and stir until the gelatin is completely dissolved to obtain a gelatin solution.

[0118] S2 uses a 0.5 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 9, and then adds a 6 mol / L gallic acid aqueous solution at a rate of 2 ml / min, the mass ratio of gallic acid to gelatin is 1:5, and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1.5 hours, and then 100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate. The precipitate is filtered, washed, and dried to obtain the modified gelatin.

[0119] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0120] (1) By weight, 20 parts of motherwort, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of rehmannia root, 9 parts of angelica, 8 parts of vinegar cyperus, 9 parts of astragalus, 10 parts of polygonum multiflorum, 5 parts of kelp, 5 parts of atractylodes, 6 parts of pollen, 5 parts of black fungus, and 2 parts of modified gelatin were mixed to obtain a raw material;

[0121] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0122] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0123] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0124] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0125] Comparative Example 3

[0126] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0127] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Auricularia auricula, and 2 parts of stevioside.

[0128] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0129] (1) By weight, 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia glutinosa, 9 parts of Angelica sinensis, 8 parts of Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, and 5 parts of Auricularia auricula were mixed to obtain a raw material;

[0130] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0131] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0132] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0133] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0134] Comparative Example 4

[0135] A postpartum recovery granule, composed of the following raw materials in parts by weight:

[0136] 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia root, 9 parts of Angelica sinensis, 8 parts of vinegar Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of Gelatin, and 2 parts of Stevioside.

[0137] The present invention also provides a preparation process of postpartum recovery granules, comprising the following steps:

[0138] (1) By weight, 20 parts of Leonurus japonicus, 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia glutinosa, 9 parts of Angelica sinensis, 8 parts of vinegar-sweetened Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Auricularia auricula, and 2 parts of gelatin were mixed to obtain a raw material;

[0139] (2) mixing the raw material obtained in step (1) with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water in a mass ratio of 1:5, boiling at 100° C. and 0.15 MPa pressure for 2 h, and then filtering through a 200-mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract;

[0140] (3) concentrating the Chinese medicine extract obtained in step (2) at -0.03 MPa and 75° C. to obtain a concentrated solution with a volume of 66% of the volume of the Chinese medicine extract, then standing for 24 hours and filtering through a 400-mesh filter to obtain a concentrated filtrate;

[0141] (4) performing secondary concentration on the concentrated filtrate obtained in step (3) at -0.06 MPa and 75° C., stopping the concentration process when the volume of the concentrated filtrate is 15% of the concentrated filtrate, and cooling the filtrate to obtain a postpartum recovery granule fluid extract;

[0142] (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

[0143] Test Example 1:

[0144] Postpartum rehabilitation granules are composed of twelve Chinese medicines, including motherwort, angelica, ginseng, and astragalus. The prescription composition of this product is relatively complex, and the components interfere with each other greatly, making content determination difficult. Stachydrine is one of the main active ingredients in motherwort, and motherwort is the main drug of postpartum rehabilitation granules; thin layer identification of this product can clearly detect stachydrine hydrochloride, and there is a stachydrine hydrochloride reference substance for content determination (China Food and Drug Biological Products Control Institute). Therefore, we choose it as an indicator component for quantification to control the quality of this product.

[0145] Instruments, reagents, and medicines:

[0146] Swiss CAMAG TLC SCANNER3 thin layer chromatography scanner; CAMAG AUTOMATICALTLC SAMPLE4 thin layer automatic sampler; stachydrine hydrochloride reference substance (712-200105, for content determination, China Food and Drug Administration); reagents: ethanol, anhydrous ethanol, acetone, hydrochloric acid, ammonia water are all of analytical grade; strong acid styrene series cation exchange resin (type 732, Guangzhou Guanglianjin Chemical Co., Ltd.); domestic prefabricated silica gel G (Qingdao Ocean Chemical Plant).

[0147] Sample preparation:

[0148] Reference solution: Accurately weigh the stachydrine hydrochloride reference substance dried to constant weight at 105°C, and dissolve it in ethanol to prepare the reference solution (each 1 ml contains 2.00 mg of stachydrine hydrochloride).

[0149] Test solution: grind the postpartum rehabilitation granules prepared in Examples 1 to 6 and Comparative Examples 1 to 2, mix them, take 5.0 g, accurately weigh, dissolve them in 30 ml of hot water, adjust the pH to 1 to 2 with hydrochloric acid, mix them with about 50 g of the treated strong acid cation exchange resin, wet-load the column, wash with water until the washing liquid has no sugar reaction (α-naphthol-concentrated sulfuric acid reaction), then add 200 ml of ethanol: ammonia water (80:20) for elution, collect the eluate, evaporate to dryness, add ethanol to dissolve the residue, and quantitatively transfer it to a 2 ml volumetric flask, add ethanol to the scale, shake well, and use it as the test solution.

[0150] Negative control solution: 5 g of the postpartum rehabilitation granules prepared in Examples 1 to 6 and Comparative Examples 1 to 2 are used as the basis, and the following medicinal materials that are lacking in the prescription are taken according to the prescription ratio: 6 parts of peach kernel, 3 parts of ginseng, 10 parts of Rehmannia glutinosa, 9 parts of Angelica sinensis, 8 parts of vinegar-soaked Cyperus rotundus, 9 parts of Astragalus, 10 parts of Polygonum multiflorum, 5 parts of Kelp, 5 parts of Atractylodes macrocephala, 6 parts of Pollen Typhae, 5 parts of Black Fungus, 2 parts of modified gelatin, and 2 parts of stevioside. A negative sample is prepared according to the prescription process, and then the negative control solution is prepared according to the preparation operation of the test solution.

[0151] Chromatographic conditions and scanning method:

[0152] Chromatographic conditions: Domestic prefabricated silica gel G was activated at 105°C for 1 hour and placed in a dryer for use. Development conditions: acetone-anhydrous ethanol-hydrochloric acid (10:6:1), development, removal, and air drying. Color development conditions: Bake at 105°C for about 20 minutes, spray with modified potassium bismuth iodide: 1% ferric chloride solution (100:1), and blow dry with cold air. Scanning method: Dual wavelength reflection method scanning, λR=700nm as reference wavelength, λS=525nm as measurement wavelength. The test solution, reference solution, and negative control solution were spotted on the same thin layer plate, and after development and color development, chromatographic scanning was performed according to the Appendix VI B method of the Chinese Pharmacopoeia 2000 edition. The results are shown in Table 1.

[0153] Table 1: Stachydrine hydrochloride content

[0154] Stachydrine hydrochloride content (mg / g) Example 1 1.216 Example 2 1.180 Example 3 1.150 Example 4 1.132 Example 5 1.203 Example 6 1.171 Comparative Example 1 1.100 Comparative Example 2 1.120 Comparative Example 3 0.957 Comparative Example 4 1.012

[0155] As can be seen from Table 1, Example 1 uses tartaric acid modified gelatin and adds it together with the medicinal materials before one decoction, which can protect the effective ingredients of the medicinal materials and reduce their loss in the pharmaceutical process. The present invention believes that the addition of tartaric acid modified gelatin can provide certain protection and synergistic effects on the extraction process of Chinese medicine ingredients by forming a colloidal protective film. The colloidal film of tartaric acid modified gelatin can cover some Chinese medicine ingredients during the decoction process, and play the role of isolating oxygen. This isolation can effectively prevent certain easily oxidized ingredients from being connected in series at high temperatures, thereby maintaining the activity of the medicinal materials. The amidated structure in tartaric acid modified gelatin forms its stronger stability and heat resistance, so that it can maintain film-forming properties during high-temperature decoction. The colloidal film can isolate the easily oxidized ingredients from the air, reduce the chance of oxidation reactions, and maintain the activity and stability of the ingredients. After tartaric acid modified gelatin forms a colloidal solution in water, it will wrap the fine particles of the medicinal materials, reduce the direct contact of these ingredients with high-temperature water, and through the isolation of the colloidal film, it can achieve the effect of buffering temperature fluctuations, thereby delaying the thermal decomposition of the ingredients. In addition, tartaric acid-modified gelatin can slowly release the encapsulated medicinal ingredients during decoction, so that these ingredients can be continuously released into the solution during the heating process, rather than being dissolved all at once. This increases the contact time and dissolution rate of the ingredients in water, improving the concentration of active ingredients and the extraction effect. Finally, the dense membrane structure formed by tartaric acid-produced gelatin during the heating process can have a sealing effect on volatile components. Through physical isolation, these volatile components are destroyed from being lost into the air during the decoction process, and their concentration in the extract is maintained.

[0156] Comparing Example 1 with Examples 2 to 4, it can be seen that the best effect is achieved by adding tartaric acid-modified gelatin and Chinese medicine components together before a decoction. This indicates that tartaric acid-modified gelatin can provide protection during the extraction process to prevent degradation or loss of components caused by high temperature or solvent changes during the extraction process. Comparison of Example 1 with Examples 5 and 6 shows that when the mass ratio of tartaric acid to gelatin is 1:5, the proportion of amide bonds formed is moderate, which can effectively improve the thermal stability and film-forming properties of gelatin and protect the effective ingredients of the product. When the ratio is 1:3, the degree of amidation is high and the structure is more compact, but the speed may slightly affect the dissolution, resulting in a slight reduction in the amount of extraction. When the ratio is 1:8, the degree of amidation is low and the protective effect is weakened. Comparison of Example 1 and the comparative example shows that the effect of tartaric acid-modified gelatin is better than that of citric acid and gallic acid-modified gelatin, and the effects of simply adding gelatin and not adding gelatin are lower than those of Example 1 with tartaric acid-modified gelatin added. It can be proved that tartaric acid-modified gelatin can be used in the production process of postpartum rehabilitation particles to effectively protect product components.

Claims

1. A postpartum recovery granule, characterized in that: By weight, it is made from the following raw materials: 18-22 parts of motherwort, 5-7 parts of peach kernel, 2-4 parts of ginseng, 8-12 parts of rehmannia root, 8-10 parts of angelica root, 6-10 parts of vinegar cyperus, 8-10 parts of astragalus, 8-12 parts of polygonum multiflorum, 4-6 parts of kelp, 4-6 parts of atractylodes, 5-7 parts of pollen, 4-6 parts of black fungus, 1-3 parts of modified gelatin, and 1-3 parts of stevioside; The preparation method of the modified gelatin comprises the following steps: S1: Dissolve 90-100 g of gelatin in 400-600 mL of water in a water bath at 45-60°C and stir until the gelatin is completely dissolved to obtain a gelatin solution; S2 uses a 0.4-0.6 mol / L sodium hydroxide aqueous solution to adjust the pH value of the gelatin solution obtained in step S1 to 8.5-9.5, and then adds a 5.5-6.5 mol / L tartaric acid aqueous solution at a rate of 1-3 ml / min, the mass ratio of tartaric acid to gelatin is 1: (4.5-5.5), and stirring is maintained during the addition. After the addition is completed, the reaction is stirred at a constant temperature for 1-2 hours, and then 90-100 mL of anhydrous ethanol is added to terminate the reaction and promote the formation of a precipitate, and the precipitate is filtered, washed, and dried to obtain the modified gelatin; The preparation method of the postpartum recovery granules comprises the following steps: (1) Mix 18-22 parts of Leonurus japonicus, 5-7 parts of peach kernel, 2-4 parts of ginseng, 8-12 parts of Rehmannia root, 8-10 parts of Angelica sinensis, 6-10 parts of Cyperus rotundus, 8-10 parts of Astragalus, 8-12 parts of Polygonum multiflorum, 4-6 parts of Kelp, 4-6 parts of Atractylodes macrocephala, 5-7 parts of Pollen Typhae, 4-6 parts of Auricularia auricula, and 1-3 parts of modified gelatin to obtain a raw material; (2) mixing the raw material obtained in step (1) with water, boiling for 1 to 3 hours, and then filtering through a 200-300 mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water, boiling for 1 to 3 hours, and then filtering through a 200-300 mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract; (3) concentrating the Chinese medicine extract obtained in step (2) to obtain a concentrated solution with a volume of 64-68% of the volume of the Chinese medicine extract, then standing for 12-24 hours, filtering through a 400-600 mesh filter to obtain a concentrated filtrate; (4) performing secondary concentration on the concentrated filtrate obtained in step (3), and stopping the concentration when the volume of the concentrated filtrate is 14-16% of the concentrated filtrate, and cooling the concentrated filtrate to obtain a postpartum recovery granule fluid extract; (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

2. A method for preparing the postpartum rehabilitation granules according to claim 1, characterized in that: The following steps are involved: (1) Mix 18-22 parts of Leonurus japonicus, 5-7 parts of peach kernel, 2-4 parts of ginseng, 8-12 parts of Rehmannia root, 8-10 parts of Angelica sinensis, 6-10 parts of Cyperus rotundus, 8-10 parts of Astragalus, 8-12 parts of Polygonum multiflorum, 4-6 parts of Kelp, 4-6 parts of Atractylodes macrocephala, 5-7 parts of Pollen Typhae, 4-6 parts of Auricularia auricula, and 1-3 parts of modified gelatin to obtain a raw material; (2) mixing the raw material obtained in step (1) with water, boiling for 1 to 3 hours, and then filtering through a 200-300 mesh filter to obtain a primary extract and a filter residue; mixing the filter residue with water, boiling for 1 to 3 hours, and then filtering through a 200-300 mesh filter to obtain a secondary extract; mixing the primary extract and the secondary extract to obtain a Chinese medicine extract; (3) concentrating the Chinese medicine extract obtained in step (2) to obtain a concentrated solution with a volume of 64-68% of the volume of the Chinese medicine extract, then standing for 12-24 hours, filtering through a 400-600 mesh filter to obtain a concentrated filtrate; (4) performing secondary concentration on the concentrated filtrate obtained in step (3), and stopping the concentration when the volume of the concentrated filtrate is 14-16% of the concentrated filtrate, and cooling the concentrated filtrate to obtain a postpartum recovery granule fluid extract; (5) The postpartum recovery granules fluid extract obtained in step (4) and 2 parts of stevioside are evenly mixed, and then spray-dried and granulated to obtain the postpartum recovery granules.

3. The method for preparing the postpartum rehabilitation granules according to claim 2, characterized in that: The mass ratio of raw materials to water in step (2) is 1:(4-5).

4. The method for preparing the postpartum rehabilitation granules according to claim 2, characterized in that: In step (2), the mass ratio of the filter residue to water is 1:(4-6).

5. The method for preparing the postpartum rehabilitation granules according to claim 2, characterized in that: The decocting conditions in step (2) are 90-100° C. and 0.1-0.2 MPa.

6. The method for preparing the postpartum rehabilitation granules according to claim 2, characterized in that: The conditions for concentration in step (3) are 0.02 to -0.04 MPa and 70 to 80°C.

7. The method for preparing the postpartum rehabilitation granules according to claim 2, characterized in that: The concentration conditions in step (4) are 0.04 to -0.08 MPa and 70 to 80°C.