A kind of Huangqi Shengmai drink composition and preparation method thereof

By adding specific stabilizers and process flow to the Astragalus Shengmai Drink, the problem of unstableness during storage of Astragalus Shengmai Drink is solved, and the long-term stability and quality of the product are improved.

CN115887675BActive Publication Date: 2025-05-16JIANGZHONG PHARMA CO LTD
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Patent Information

Application Number
CN202211741771.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-12-30
Publication Date
2025-05-16
Estimated Expiration
2042-12-30

AI Technical Summary

Technical Problem

The existing finished products of Astragalus Shengmai Drink are unstable during storage and are prone to precipitation and precipitation, which seriously affects the quality of the product.

Method used

The composition of Astragalus Shengmai Drink is prepared with high stability astragalus extract, flavoring agent, preservative and specific stabilizers (such as xanthan gum, sodium alginate and gum arabic) and through a specific process flow, including filtration and shearing treatment.

Benefits of technology

It improves the long-term stability of Astragalus Shengmai Drink, the solution has good clarity, moderate viscosity and good fluidity. The content of Astragalus methylside has not significantly decreased during long-term storage, which promotes the chemical stability of the solution.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention belongs to the field of traditional Chinese medicine, and specifically relates to a Huangqi Shengmai Yin composition and a preparation method thereof. The raw materials of the composition include Huangqi Shengmai Yin fluid extract, a flavoring agent, a preservative and a stabilizer; the stabilizer is selected from at least one of xanthan gum, sodium alginate and gum arabic. The preparation method comprises first adding a flavoring agent, a preservative and water to the Huangqi Shengmai Yin fluid extract, mixing, filtering, and obtaining a solution; then filtering the solution to obtain a filtrate; and finally adding a stabilizer to the filtrate, mixing, and obtaining. The Huangqi Shengmai Yin preparation method provided by the present invention has a simple process, and the obtained Huangqi Shengmai Yin has good clarity and high stability, and has good application prospects.
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Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a Huangqi Shengmai Yin composition and a preparation method thereof. Background Art

[0002] Huangqi Shengmai Yin is a compound oral liquid composed of Astragalus, Codonopsis, Ophiopogon, Schisandra, and Schisandra chinensis. It has the effects of invigorating qi and nourishing yin, nourishing the heart and lungs, and is used for patients with coronary heart disease who have both qi and yin deficiency, palpitations and shortness of breath. This recipe is obtained by adding Huangqi to Shengmai Yin. Shengmai Yin, also known as Shengmai San, comes from "Medical Origin" written by Zhang Yuansu during the Jin and Yuan Dynasties. It has the functions of invigorating qi and restoring pulse, nourishing yin and promoting fluid production. Zhang Yuansu, a doctor in the Jin Dynasty, said: "Ophiopogon has a cold nature and a slightly bitter and sweet taste. It can treat the fire in the lungs and the pulse is about to stop. Add Schisandra and ginseng to make Shengmai San, which can replenish the deficiency of vital energy in the lungs. It must be used." In the original recipe, Shengmai Yin is composed of ginseng, Schisandra, and Ophiopogon. The Codonopsis recipe Shengmai Yin is derived from the traditional ginseng recipe. It also has the effects of invigorating qi and restoring pulse, nourishing yin and promoting fluid production. Codonopsis is milder than ginseng and is generally used for mild and chronic diseases, while the ginseng recipe is used for severe and acute diseases. Huangqi Shengmai Drink is based on the Dangshen recipe of Shengmai Drink and adds astragalus to enhance the drink's qi-replenishing effect.

[0003] However, the existing Huangqi Shengmai Yin finished product is unstable during storage and is prone to precipitate a large amount of precipitation, which seriously affects the quality of the product. Therefore, how to improve the long-term stability of Huangqi Shengmai Yin is an urgent problem to be solved in this field. Summary of the invention

[0004] In view of the deficiencies in the prior art, the present invention provides a Huangqi Shengmai Yin composition and a preparation method thereof. The method has a simple process and the obtained composition has good clarity and high storage stability.

[0005] In order to achieve the purpose of the present invention, the technical solution adopted is as follows:

[0006] A Huangqi Shengmai Yin composition, the raw materials of the composition include Huangqi Shengmai Yin fluid extract, flavor corrective, preservative and stabilizer; the stabilizer is selected from at least one of xanthan gum, sodium alginate and gum arabic.

[0007] Preferably, the stabilizer comprises a mixture of xanthan gum, sodium alginate and gum arabic.

[0008] Preferably, in the composition, the concentrations of xanthan gum, sodium alginate and gum arabic are 0.02-0.03%, 0.04-0.07% and 0.07-0.10%, respectively.

[0009] Preferably, in the composition, the concentrations of xanthan gum, sodium alginate and gum arabic are 0.03%, 0.05% and 0.08%, respectively.

[0010] Preferably, the Huangqi Shengmai Drink fluid extract is obtained by extracting, concentrating and precipitating astragalus, Codonopsis pilosula, Ophiopogon japonicus and Schisandra chinensis with alcohol; the flavoring agent is stevioside, and the preservative is sodium benzoate.

[0011] Another object of the present invention is to provide a method for preparing the above composition, comprising the following steps:

[0012] (1) adding a flavoring agent, a preservative and water to Huangqi Shengmai Yin fluid extract, mixing the mixture and filtering the mixture to obtain a solution;

[0013] (2) filtering the solution to obtain a filtrate;

[0014] (3) Add a stabilizer to the filtrate and mix.

[0015] Preferably, the mixing temperature in step (1) is 45-55° C.; the volume ratio of Huangqi Shengmai Yin fluid extract to water is 1:3, and the filtration is performed through a 200-mesh filter cloth.

[0016] Preferably, the filtration in step (2) is filtering through an SCP334 filter plate.

[0017] Preferably, the mixing in step (3) is performed by first stirring for 25-35 minutes and then shearing at 10000-15000 rpm for 3-8 minutes.

[0018] Preferably, the mixing in step (3) is followed by sterilization at 100-110° C. for 35-45 min.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] (1) The present invention adds a specific stabilizer to improve the stability of Huangqi Shengmai Yin, make the solution clear, have moderate viscosity and good fluidity.

[0021] (2) After adding the stabilizer of the present invention to Huangqi Shengmai Decoction, the content of astragaloside IV did not decrease significantly after long-term storage of the sample, thereby promoting the chemical stability of the solution.

[0022] (3) The present invention further found that different filtering methods and times have important effects on the physical and chemical stability of Huangqi Shengmai Yin. The present invention adopts one-time filtration through the SCP334 filter plate, and the obtained sample has the best clarity and the highest stability.

[0023] (4) In addition, the present invention has added different amounts of single stabilizers such as xanthan gum, gum arabic, CMC-Na and sodium alginate to investigate the viscosity of Huangqi Shengmai Yin. Xanthan gum has the greatest impact on the viscosity of the sample. When the amount of xanthan gum is 0.05%, the sample viscosity is 4.7 mPa·s. As the amount increases, the sample viscosity increases exponentially. The viscosity of the samples with the other three stabilizers is less than 4 mPa·s, and the fluidity is good. Among them, the viscosity of the sample with the addition of gum arabic is almost unaffected by the increase in the amount of gum arabic, and the viscosity is between 1 mPa·s and 2.2 mPa·s. The overall viscosity of the sample with the addition of CMC-Na and sodium alginate is greater than that of the sample with the addition of gum arabic. As the amount of the two stabilizers increases, the sample viscosity increases slightly, and the increase is small and has almost no effect. The viscosity of the two samples is between 2 mPa·s and 4 mPa·s. The viscosity of laboratory pure water is 2.02 mPa·s, indicating that except for the sample with the addition of xanthan gum, the viscosity of the other samples is within an acceptable range and the fluidity is good. DETAILED DESCRIPTION

[0024] The present invention will be further described below in conjunction with specific implementation modes.

[0025] Example 1

[0026] (1) Preparation method of fluid extract: 300g of Astragalus, 200g of Codonopsis, 200g of Radix Ophiopogonis, 100g of Fructus Schisandrae Chinensis, 100g of Fructus Schisandrae Chinensis, add water and boil twice, add 5 times the amount of water for the first time and boil for 2h, add 4 times the amount of water for the second time and boil for 1.5h, filter through 200 mesh, combine the filtrate, concentrate to 400mL, add ethanol to make the alcohol content reach 60%, let stand for 24h, take the supernatant, filter, spin dry the residue, filter the liquid, combine the filtrate, recover the ethanol, and concentrate to 250mL.

[0027] (2) Add 1.2 g of stevia and 3 g of sodium benzoate to 250 ml of the fluid extract, heat at 50° C. with stirring, add water to about 1000 mL, filter through a 200-mesh filter cloth, boil for 15 min, cool, and dilute to 1000 mL to obtain a solution;

[0028] (3) Filter the solution once using an SCP334 filter plate to obtain a filtrate;

[0029] (4) Add the filtrate to the stabilizer (mixture of xanthan gum, sodium alginate and gum arabic), stir for 30 minutes, shear with a shearing machine (13000rpm, 5 minutes), package, cover, and steam sterilize at 105°C for 40 minutes to obtain the Huangqi Shengmai Yin composition. The mass concentrations of xanthan gum, sodium alginate and gum arabic in the Huangqi Shengmai Yin composition are 0.03%, 0.05% and 0.08%, respectively.

[0030] Example 2

[0031] (1) Preparation method of fluid extract: 300g of Astragalus, 200g of Codonopsis, 200g of Radix Ophiopogonis, 100g of Fructus Schisandrae Chinensis, 100g of Fructus Schisandrae Chinensis, add water and boil twice, add 5 times the amount of water for the first time and boil for 2h, add 4 times the amount of water for the second time and boil for 1.5h, filter through 200 mesh, combine the filtrate, concentrate to 400mL, add ethanol to make the alcohol content reach 60%, let stand for 24h, take the supernatant, filter, spin dry the residue, filter the liquid, combine the filtrate, recover the ethanol, and concentrate to 250mL.

[0032] (2) Add 1.2 g of stevia and 3 g of sodium benzoate to 250 ml of the fluid extract, heat at 50° C. with stirring, add water to about 1000 mL, filter through a 200-mesh filter cloth, boil for 15 min, cool, and dilute to 1000 mL to obtain a solution;

[0033] (2) Filter the solution once through a SCP334 filter plate to obtain a filtrate;

[0034] (3) Add the filtrate to the stabilizer (mixture of xanthan gum, sodium alginate and gum arabic), stir for 25 minutes, shear with a shearing machine (10000 rpm, 5 minutes), package, cover, and steam sterilize at 100°C for 45 minutes to obtain the Huangqi Shengmai Yin composition. The mass concentrations of xanthan gum, sodium alginate and gum arabic in the Huangqi Shengmai Yin composition are 0.02%, 0.07% and 0.07%, respectively.

[0035] Example 3

[0036] (1) Preparation method of fluid extract: 300g of Astragalus, 200g of Codonopsis, 200g of Radix Ophiopogonis, 100g of Fructus Schisandrae Chinensis, 100g of Fructus Schisandrae Chinensis, add water and boil twice, add 5 times the amount of water for the first time and boil for 2h, add 4 times the amount of water for the second time and boil for 1.5h, filter through 200 mesh, combine the filtrate, concentrate to 400mL, add ethanol to make the alcohol content reach 60%, let stand for 24h, take the supernatant, filter, spin dry the residue, filter the liquid, combine the filtrate, recover the ethanol, and concentrate to 250mL.

[0037] (2) Add 1.2 g of stevia and 3 g of sodium benzoate to 250 ml of the fluid extract, heat at 50° C. with stirring, add water to about 1000 mL, filter through a 200-mesh filter cloth, boil for 15 min, cool, and dilute to 1000 mL to obtain a solution;

[0038] (2) Filter the solution once through a SCP334 filter plate to obtain a filtrate;

[0039] (3) Add the filtrate to the stabilizer (mixture of xanthan gum, sodium alginate and gum arabic), stir for 35 minutes, shear with a shearing machine (15000 rpm, 5 minutes), package, cover, and steam sterilize at 110°C for 35 minutes to obtain the Huangqi Shengmai Yin composition. The mass concentrations of xanthan gum, sodium alginate and gum arabic in the Huangqi Shengmai Yin composition are 0.03%, 0.04% and 0.10%, respectively.

[0040] Comparative Example 1

[0041] The stabilizer of this comparative example and its concentration in the composition are as follows in Table 1:

[0042] Table 1

[0043]

[0044] Comparative Example 2

[0045] The stabilizer of this comparative example is 0.04% xanthan gum, 0.04% CMC-Na, 0.028% sodium alginate and 0.056% gum arabic. The rest is prepared according to the method of Example 1.

[0046] Comparative Example 3

[0047] The stabilizers in this comparative example and their concentrations in the composition are 0.04% xanthan gum, 0.03% sodium alginate, and 0.06% gum arabic. The rest are prepared according to the method of Example 1.

[0048] Comparative Example 4

[0049] The filter plate used in step (3) of this comparative example is SCP312 (3-6 μm), and the rest is prepared according to the method of Example 1.

[0050] Comparative Example 5

[0051] The filter plate used in step (3) of this comparative example is JH203 (1-2 μm), and the rest is prepared according to the method of Example 1.

[0052] Comparative Example 6

[0053] In step (3) of this comparative example, filtration was performed twice using an SCP334 filter plate, and the rest was prepared according to the method of Example 1.

[0054] Sample properties and content determination

[0055] The astragaloside content and the stability prediction results of multiple light scattering were used as evaluation indicators to study the stability of the samples of Examples 1-3 and Comparative Examples 1-6.

[0056] (1) Property observation

[0057] The main focus is on observing clarity and precipitation. The evaluation criteria are shown in Table 2 below.

[0058] Table 2 Observation items of properties

[0059]

[0060] (2) Determination of physical and chemical properties

[0061] Turbidity was measured using a benchtop turbidity meter, and viscosity was measured using a viscometer.

[0062] (3) Stability determination

[0063] Take 20 mL of sample, place it in the measuring cell of the multiple light scattering instrument, measure it at 30°C, scan it once every 30 minutes, measure it for 24 hours, and use the stability index TSI to preliminarily judge the stability of the sample within 24 hours.

[0064] The TSI coefficient is a pure mathematical deviation calculation formula that reflects the comprehensive change in the concentration and particle size of the sample during the entire placement time. The TSI curve is used to preliminarily qualitatively characterize the instability of each sample. In the same period of time, the larger the TSI coefficient, the more unstable the sample. If the TSI coefficient is less than 2, the sample can be preliminarily considered to be stable.

[0065] In order to take into account both the clarity and stability of the finished product in the stabilizer experiment, the average value of the transmitted light intensity is used as an indicator to characterize the clarity of the sample.

[0066] (4) Determination of Astragaloside IV Content

[0067] ① Preparation of reference solution

[0068] Accurately weigh 9.955 mg of astragaloside IV reference substance, place it in a 25 mL volumetric flask, add methanol to the mark, and prepare a reference substance solution with a concentration of 385.900 μg / mL.

[0069] ② Preparation of test solution

[0070] Accurately aspirate 10 mL of the sample from Huangqi Shengmai Drink, shake and extract 4 times with water-saturated n-butanol, 20 mL each time, combine the n-butanol solutions, wash twice with ammonia test solution (40% concentrated ammonia solution), 40 mL each time, discard the ammonia solution, evaporate the n-butanol solution, dissolve the residue in methanol, transfer it to a 5 mL volumetric flask, add methanol to the scale, shake well, filter (with a 0.22 μm filter membrane), and take the filtrate to obtain the product.

[0071] ③Chromatographic conditions

[0072] Diamonsil C 18Chromatographic column (4.6mm×250mm, 5μm); mobile phase acetonitrile-water (32:68); flow rate 1.0mL / min; column temperature 30℃; detector: evaporative light scattering detector; nebulization temperature 60℃; drift tube temperature 60℃; gas flow rate 1.6SLM; injection volume 10μL. The loss rate of astragaloside IV was % after the sample was placed in a sealed condition at a temperature of 40±5℃ and a relative air humidity of 75±5% for 1 month.

[0073] The results are shown in Table 3-4.

[0074] Table 3

[0075]

[0076] Table 4 Comparative Example 1 Results

[0077]

[0078]

[0079] Result analysis: The Huangqi Shengmai Decoction prepared by the present invention has better clarity, stability and stability of the effective ingredient astragaloside IV, indicating that the preparation method and raw materials of the present invention are conducive to the quality stability of the product during storage.

[0080] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A Huangqi Shengmai Yin composition, characterized in that: The raw materials of the composition include Huangqi Shengmai Yin fluid extract, flavoring agent, preservative and stabilizer; the stabilizer includes a mixture of xanthan gum, sodium alginate and gum arabic, and the concentrations of the xanthan gum, sodium alginate and gum arabic are 0.02-0.03%, 0.04-0.07% and 0.07-0.10% respectively.

2. The composition according to claim 1, characterized in that In the composition, the concentrations of xanthan gum, sodium alginate and gum arabic are 0.03%, 0.05% and 0.08%, respectively.

3. The composition according to claim 1, characterized in that The Huangqi Shengmai Drink fluid extract is obtained by extracting, concentrating and precipitating astragalus, codonopsis, ophiopogon and schisandra chinensis with alcohol; the flavoring agent is stevioside, and the preservative is sodium benzoate.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that: The steps include: (1) adding a flavoring agent, a preservative and water to Huangqi Shengmai Yin fluid extract, mixing the mixture and filtering the mixture to obtain a solution; (2) filtering the solution to obtain a filtrate; (3) Add a stabilizer to the filtrate and mix.

5. The preparation method according to claim 4, characterized in that: The mixing temperature in step (1) is 45-55° C.; the volume ratio of Huangqi Shengmai Yin fluid extract to water is 1:3, and the filtration is performed through a 200-mesh filter cloth.

6. The preparation method according to claim 4, characterized in that: The filtration in step (2) is filtering through a SCP334 filter plate.

7. The preparation method according to claim 4, characterized in that: The mixing in step (3) is first stirred for 25-35 minutes, and then sheared at 10000-15000 rpm for 3-8 minutes.

8. The preparation method according to claim 4, characterized in that: After mixing in step (3), sterilize at 100-110° C. for 35-45 min.

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