Radix pseudostellariae treatment method and radix pseudostellariae polysaccharide chewable tablets

Abstract

The invention provides a radix pseudostellariae treatment method and a radix pseudostellariae polysaccharide chewable tablet, and relates to the technical field of traditional Chinese medicine preparations. The radix pseudostellariae treatment method comprises the steps of extracting radix pseudostellariae polysaccharide freeze-dried powder, performing cyclodextrin inclusion and performing coating. In the extraction process, an enzymolysis method is combined with an ultrasonic method, so that the dissolution of radix pseudostellariae polysaccharide is effectively improved, and the dissolution of saponin is inhibited. The cyclodextrin inclusion and coating process can shield the bitter and fishy taste of saponin and avoid moisture absorption of preparation particles, and the stability of the radix pseudostellariae polysaccharide chewable tablet is improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine preparations, and relates to a Pseudostellaria heterophylla treatment method and a Pseudostellaria heterophylla polysaccharide chewable tablet. BACKGROUND

[0002] As a traditional and precious Chinese medicinal material, Pseudostellaria heterophylla contains volatile oil, polysaccharide, cyclic peptide, alkaloid, saponin, phenolic compound and other active ingredients, and exhibits multiple effects such as hypoglycemic effect, anti-inflammatory effect, anticancer effect, cell protection and immunomodulatory effect in modern pharmacological research. Among them, Pseudostellaria heterophylla polysaccharide, as a core active substance, has been systematically studied and confirmed to have significant biological activities such as immunomodulatory effect, antioxidant effect, anti-fatigue effect and blood glucose regulation effect, especially in improving the health status of immunocompromised people, and has a remarkable clinical application effect, and has a high development value and broad market prospect.

[0003] As a solid preparation integrating comfortable taste and convenient taking, the chewable tablet is particularly suitable for children, the elderly and people with dysphagia, and has become a key dosage form in the research and development of functional foods and drugs. However, the current development process of the Pseudostellaria heterophylla polysaccharide chewable tablet is plagued by many technical bottlenecks: ① The traditional water decocting or alcohol precipitation extraction process has the disadvantages of poor polysaccharide purity and limited extraction efficiency, and high-temperature treatment easily leads to polysaccharide structure damage and activity degradation, resulting in a large loss of active ingredients; ② Pseudostellaria heterophylla polysaccharide has strong hygroscopicity, and in the process of preparation processing and storage, it is easy to cause particle adhesion and tablet compression molding difficulty, which seriously affects the product quality uniformity; ③ Pseudostellaria heterophylla itself has a bitter taste in the sweet taste, and the residual bitter taste after the traditional granulation process significantly reduces the patient's medication compliance; ④ As a solid preparation, the complex interaction between the excipients will interfere with the release of the active ingredients, resulting in a much lower bioavailability than liquid preparations.

[0004] Therefore, it is urgent to improve the preparation method of the Pseudostellaria heterophylla polysaccharide chewable tablet to provide technical support for the in-depth development and wide application of Pseudostellaria heterophylla. SUMMARY

[0005] In order to solve the technical problems of low extraction rate of Pseudostellaria heterophylla polysaccharide, poor preparation performance, poor taste and low bioavailability in the prior art, the application provides a Pseudostellaria heterophylla treatment method and a Pseudostellaria heterophylla polysaccharide chewable tablet.

[0006] The technical scheme of the application is as follows:

[0007] A Pseudostellaria heterophylla treatment method, comprising the following steps in sequence:

[0008] Pseudostellaria heterophylla polysaccharide is extracted to obtain Pseudostellaria heterophylla polysaccharide freeze-dried powder;

[0009] The Pseudostellaria heterophylla polysaccharide freeze-dried powder is subjected to cyclodextrin inclusion to obtain Pseudostellaria heterophylla polysaccharide inclusion.

[0010] The inclusion of the P. notoginseng polysaccharide is coated to obtain pre-coated P. notoginseng polysaccharide.

[0011] Preferably, the P. notoginseng is pre-crushed into D 90 P. notoginseng micro-powder with a particle size of less than or equal to 20 microns.

[0012] Preferably, the extraction is by enzymatic hydrolysis combined with ultrasonic method.

[0013] The crude product after extraction is vacuum freeze-dried to obtain the P. notoginseng polysaccharide freeze-dried powder.

[0014] Preferably, the inclusion is that the cyclodextrin is prepared into a cyclodextrin aqueous solution and uniformly mixed with the P. notoginseng polysaccharide freeze-dried powder to obtain an inclusion solution.

[0015] The inclusion solution is spray-dried to obtain the inclusion of P. notoginseng polysaccharide.

[0016] More preferably, the concentration of the cyclodextrin aqueous solution is 500-900 g / L.

[0017] The weight ratio of the cyclodextrin aqueous solution to the P. notoginseng polysaccharide freeze-dried powder is 50-100:1.

[0018] Preferably, the coating is by fluidized bed coating process, and the coating material of the coating is hydroxypropyl methyl cellulose.

[0019] A P. notoginseng polysaccharide chewable tablet, the raw material composition of which comprises: pre-coated P. notoginseng polysaccharide obtained by the P. notoginseng processing method of any one of the embodiments, a flavoring agent, a filler and a lubricant.

[0020] Preferably, the weight percentage of the pre-coated P. notoginseng polysaccharide in the P. notoginseng polysaccharide chewable tablet is 20-45%.

[0021] Preferably, the flavoring agent is selected from one or a combination of two or more of xylitol, blueberry powder, yogurt powder, citric acid and neotame.

[0022] The weight percentage of the flavoring agent in the P. notoginseng polysaccharide chewable tablet is 40-60%.

[0023] Preferably, the weight percentage of the filler in the P. notoginseng polysaccharide chewable tablet is 20-40%, and the weight percentage of the lubricant in the P. notoginseng polysaccharide chewable tablet is 0.5-1%.

[0024] The beneficial effects of the present application are:

[0025] (1) The present application can mask the bad taste of saponin by using cyclodextrin inclusion technology to include the extracted P. notoginseng polysaccharide, and further improve the taste by coating the included P. notoginseng polysaccharide, and avoid the particle aggregation caused by the hygroscopicity of P. notoginseng polysaccharide, thereby improving the preparation performance of the chewable tablets.

[0026] (2) The present application uses micronized P. notoginseng powder as the raw material for extraction, and uses the method of enzymatic hydrolysis combined with ultrasonic method for extraction, which can improve the extraction efficiency and purity of P. notoginseng polysaccharide, and effectively reduce the extraction of saponin and the content of saponin and bitter taste in P. notoginseng polysaccharide.

[0027] (3) The P. notoginseng polysaccharide chewable tablets obtained by the present application have uniform quality, good stability, good taste, and fast release of active ingredients, thereby improving the bioavailability. DETAILED DESCRIPTION

[0028] The technical solutions of the present application are further described and explained below through specific embodiments.

[0029] The P. notoginseng polysaccharide extracted from P. notoginseng contains a high content of saponin, which makes the P. notoginseng polysaccharide bitter and astringent, affecting the taste, especially when used to prepare P. notoginseng polysaccharide chewable tablets, saponin will cause the chewable tablets to have a bitter and fishy smell, which has a more obvious effect on the taste of the chewable tablets. The present application optimizes the extraction process to reduce the content of saponin in the extracted P. notoginseng polysaccharide, and further includes saponin by using cyclodextrin inclusion method to reduce the adverse effect of saponin on taste. Based on this, the present application proposes a P. notoginseng processing method, which comprises the following steps in sequence:

[0030] P. notoginseng polysaccharide is extracted from P. notoginseng to obtain P. notoginseng polysaccharide lyophilized powder;

[0031] The P. notoginseng polysaccharide lyophilized powder is included with cyclodextrin to obtain included P. notoginseng polysaccharide;

[0032] The included P. notoginseng polysaccharide is coated to obtain pre-coated P. notoginseng polysaccharide.

[0033] The present application uses cyclodextrin to include the extracted P. notoginseng polysaccharide lyophilized powder, which is beneficial to mask the bitter and fishy smell of saponin components in P. notoginseng polysaccharide, and reduce the adverse effect of saponin on taste; and further coating the included P. notoginseng polysaccharide to further improve the taste and reduce the hygroscopicity of P. notoginseng polysaccharide, thereby avoiding the hygroscopic agglomeration of the preparation particles, which is beneficial to the subsequent preparation process and the stability of the preparation.

[0034] In some embodiments, the P. notoginseng is pre-crushed to D 90The particle size of the micro-powder of Radix Pseudoginseng is less than or equal to 20 microns. The pre-pulverization of Radix Pseudoginseng into micro-powder with a low particle size is more conducive to the extraction of polysaccharides in Radix Pseudoginseng. There is no particular limitation on the method of pulverizing Radix Pseudoginseng into micro-powder, such as grinding or air-jet milling. Further, the D90 of the micro-powder of Radix Pseudoginseng is less than or equal to 20 microns. 90 The particle size is less than or equal to 15 microns. In order to better pulverize Radix Pseudoginseng, Radix Pseudoginseng can be dried at 40-50°C to a water content of not more than 5wt% before pulverization. In the present application, the D90 of the micro-powder of Radix Pseudoginseng is less than or equal to 15 microns. 90 The particle size can be tested by a laser particle size analyzer.

[0035] In some embodiments, the extraction is by enzymatic hydrolysis combined with ultrasonic method.

[0036] The crude product after extraction is vacuum freeze-dried to obtain Radix Pseudoginseng polysaccharide freeze-dried powder.

[0037] The enzymatic hydrolysis combined with ultrasonic method for extracting Radix Pseudoginseng polysaccharides has the following technical advantages: (1) low temperature, high efficiency, and short extraction time; (2) promotes the dissolution of intracellular Radix Pseudoginseng polysaccharides, and improves the extraction rate of Radix Pseudoginseng polysaccharides; (3) can obtain Radix Pseudoginseng polysaccharides with high purity, and the extraction is carried out at relatively low temperature, which is not conducive to the dissolution of liposoluble saponins, thus effectively reducing the content of saponins in Radix Pseudoginseng polysaccharides.

[0038] For enzymatic hydrolysis, cellulase can be used to destroy the cell wall of Radix Pseudoginseng, and the weight ratio of cellulase to Radix Pseudoginseng can be 1-10:100, or further, the weight ratio can be 1-8:100. For ultrasonic method, the ultrasonic power can be 300-800W, and the ultrasonic time can be 30-60min, or further, the ultrasonic power can be 300-500W, and the ultrasonic time can be 30-45min.

[0039] For the solvent used for extraction, it can be pure water. There is no particular limitation on the number of times of extraction of Radix Pseudoginseng, and from the perspective of making the best use of Radix Pseudoginseng raw materials, the number of times of extraction can be 2-3 times. For the extraction temperature, it can be 25-50°C, or further, 35-50°C.

[0040] The extract after extraction is an aqueous dispersion, which is concentrated and then subjected to alcohol precipitation with high-concentration ethanol aqueous solution (ethanol volume concentration of 90% or more), and the obtained precipitate is dissolved in pure water and then subjected to alcohol precipitation with high-concentration ethanol aqueous solution again, i.e., the crude product is obtained after 2 times of alcohol precipitation. The crude product is vacuum freeze-dried to obtain Radix Pseudoginseng polysaccharide freeze-dried powder.

[0041] In some embodiments, the inclusion is that cyclodextrin is prepared into a cyclodextrin aqueous solution and uniformly mixed with Radix Pseudoginseng polysaccharide freeze-dried powder to obtain an inclusion solution.

[0042] The inclusion solution is subjected to spray drying to obtain the inclusion of the polysaccharide of Radix Pseudoginseng.

[0043] The cyclodextrin molecule has a slightly conical hollow cylindrical three-dimensional ring structure, and can be used as a host to envelope various appropriate guests. The inclusion performance of cyclodextrin mainly depends on the cavity size, and generally can include small molecules with a molecular size of not more than 1 nm. The molecular weight of the polysaccharide of Radix Pseudoginseng is generally tens of thousands to hundreds of thousands of Da, and the hydrodynamic radius is in the range of 5-50 nm. The larger the molecular weight, the larger the hydrodynamic radius. It is found in the present application that although the cavity size of cyclodextrin is much lower than the hydrodynamic radius of the polysaccharide of Radix Pseudoginseng, the taste of saponin is still shielded, and the possible reason is that the molecular weight of saponin is much lower than that of the polysaccharide of Radix Pseudoginseng, generally 500-2000 Da, which can be partially or completely included by the cavity of cyclodextrin. Therefore, in the present application, the inclusion of cyclodextrin on the polysaccharide of Radix Pseudoginseng is actually the inclusion of saponin in the polysaccharide of Radix Pseudoginseng, and there is no or less inclusion of the polysaccharide of Radix Pseudoginseng, so that the interference of cyclodextrin on the release of the polysaccharide of Radix Pseudoginseng can be avoided, and the bioavailability of the polysaccharide of Radix Pseudoginseng can be improved. The cyclodextrin is not particularly limited in the present application, and can be α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, hydroxypropyl-β-cyclodextrin, methyl-β-cyclodextrin, etc. Further, the cyclodextrin can be methyl-β-cyclodextrin. Saponin is fat-soluble, and methyl-β-cyclodextrin can better include saponin and reduce the bitter and fishy smell of saponin.

[0044] In some embodiments, the concentration of the aqueous cyclodextrin solution is 500-900 g / L;

[0045] The weight ratio of the aqueous cyclodextrin solution to the freeze-dried powder of the polysaccharide of Radix Pseudoginseng is 50-100:1.

[0046] For example, the concentration of the aqueous cyclodextrin solution can be any value or any value between 500 g / L, 550 g / L, 600 g / L, 650 g / L, 700 g / L, 750 g / L, 800 g / L, 850 g / L, 900 g / L, or further, the concentration of the aqueous cyclodextrin solution is 500-700 g / L; the weight ratio of the aqueous cyclodextrin solution to the freeze-dried powder of the polysaccharide of Radix Pseudoginseng can be any value or any value between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1.

[0047] For the above-mentioned inclusion solution preparation, the specific process can be as follows: the freeze-dried powder of panax notoginseng polysaccharide and the aqueous solution of cyclodextrin are mixed, and then stirred at an inclusion temperature of 25-60℃ for 1-12h to realize the inclusion of cyclodextrin, so as to obtain the inclusion solution. Further, the inclusion temperature can be 30-60℃, and the inclusion time can be 4-12h. The process of spray drying can be as follows: the inclusion solution is concentrated to a relative density of not less than 1.24, degassed (such as degassing for 30min under-0.08MPa) to remove bubbles, then a pressure atomizer is used, the atomization pressure is 10-15MPa, the mixed solution is broken into micron-level droplets of 10-200μm, the inlet air temperature is 100-150℃, the outlet air temperature is 70-90℃, and the feeding rate is 5-10mL / min, so that the mist droplets are in contact with hot air in the drying tower, the surface moisture is evaporated instantaneously, continuous drying is carried out to dehydrate and solidify the inclusion structure, and the inclusion panax notoginseng polysaccharide is formed.

[0048] In some embodiments, the coating is carried out by using a fluidized bed coating process, and the coating material of the coating is hydroxypropyl methyl cellulose (HPMC).

[0049] The fluidized bed coating process can be as follows: the coating material HPMC is dissolved in water to prepare a solution with a concentration of 3wt%; a fluidized bed is installed with a capture bag with a pore size of 10μm, connected with a peristaltic pump hose and a 1.5mm spray gun, the rotation speed of the peristaltic pump is 35±5rpm, and the atomization pressure is 1.0±0.5bar. The inclusion panax notoginseng polysaccharide is taken and introduced into the fluidized bed. The height of the flow guide cylinder is adjusted to the lowest position, the inlet air temperature is set to 50±5℃, the inlet air volume is set to 600±100m 3 / h, the bag shaking cycle interval is set to 5s, the bag is shaken 4 times to the left and right, the inlet air humidity is set to 5.5±1.0g / kg, the equipment is started and the dehumidification is turned on, when the inlet air volume reaches the set value, the height of the flow guide cylinder is adjusted to 50 values (recorded as the value), and the material preheating is started. When the preheating temperature reaches 35℃, the liquid spraying and granulation are started, and the granular pre-coated panax notoginseng polysaccharide is obtained. The spray drying conditions are as follows: the inlet air temperature is 65±5℃, the inlet air volume is 700±100m 3 / h, the inlet air humidity is 5.5±1.0g / kg, the final material temperature is 45℃, and the moisture content of the granules is ≤1.5%.

[0050] The present application also provides a panax notoginseng polysaccharide chewable tablet, which comprises the pre-coated panax notoginseng polysaccharide obtained by the panax notoginseng processing method, a flavoring agent, a filler and a lubricant.

[0051] The present application further adds a flavoring agent to the panax notoginseng polysaccharide chewable tablet, so that the taste of the panax notoginseng polysaccharide chewable tablet is improved.

[0052] In some embodiments, the weight percentage of pre-coated Codonopsis pilosula polysaccharide in the Codonopsis pilosula polysaccharide chewable tablets is 20-45%. For example, the weight percentage can be any value or any value between 20%, 25%, 30%, 35%, 40%, 45%, etc.

[0053] In some embodiments, the flavoring agent is selected from one or a combination of two or more of xylitol, blueberry powder, yogurt powder, citric acid and neotame;

[0054] The flavoring agent accounts for 40-60% of the weight of the Codonopsis pilosula polysaccharide chewable tablets. For example, the weight percentage can be any value or any value between 40%, 45%, 50%, 55%, 60%, etc.

[0055] In some embodiments, the filler accounts for 20-40% of the weight of the Codonopsis pilosula polysaccharide chewable tablets. For example, the weight percentage can be any value or any value between 20%, 25%, 30%, 35%, 40%, etc., and the filler can be sorbitol, mannitol, microcrystalline cellulose, etc.; the lubricant accounts for 0.5-1% of the weight of the Codonopsis pilosula polysaccharide chewable tablets. For example, the weight percentage can be any value or any value between 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, etc., and the lubricant can be magnesium stearate.

[0056] The preparation method of the Codonopsis pilosula polysaccharide chewable tablets of the present invention is not particularly limited. For example, one method is as follows: All raw materials of the Codonopsis pilosula polysaccharide chewable tablets, except for the lubricant, are mixed evenly, granulated with 75% alcohol, the granules are dried in a fluidized bed, and then the lubricant is added and mixed to obtain premixed granules. The premixed granules are compressed into tablets using a rotary tablet press, thus obtaining the Codonopsis pilosula polysaccharide chewable tablets. The hardness of the Codonopsis pilosula polysaccharide chewable tablets can be 50-80 N.

[0057] The technical solutions of the present invention will be further described and explained below with reference to various embodiments.

[0058] Preparation of Codonopsis pilosula micro powder

[0059] The raw material of *Codonopsis pilosula* is dried at 40-50℃ until the moisture content is <5%. After mechanical pulverization, it is passed through a 60-mesh sieve. The material remaining on the sieve is then pulverized again until all particles pass through the sieve, obtaining pre-pulverized granules. These pre-pulverized granules are then subjected to air jet milling (0.6-0.8 MPa pressure) for 15-20 minutes to achieve the desired D... 90 Particle size ≤15μm, to obtain Codonopsis pilosula micro powder.

[0060] Examples 1-12 and Comparative Example 1 compare the effects of different extraction methods on the extraction efficiency of Codonopsis pilosula polysaccharides.

[0061] Comparative Example 1

[0062] Precisely weigh 10 g of micro-powder of Radix Pseudoginseng, add 400 ml of distilled water, and reflux extract for 1 h. Repeat the extraction of the residue for 2 times, combine the 3 times of filtrate, and concentrate to 100 ml by rotary evaporation. Add 300 ml of 95% ethanol, and stand still at 4°C overnight. Centrifuge at 4000 r / min for 10 min, discard the supernatant, and collect the precipitate. Add 100 ml of distilled water to the precipitate, and repeat the alcohol precipitation for 1 time. Collect the precipitate to obtain crude Radix Pseudoginseng polysaccharide, and then freeze-dry under vacuum at low temperature to obtain Radix Pseudoginseng polysaccharide freeze-dried powder.

[0063] The vacuum freeze-drying process of the present comparative example is shown in Table 1 below.

[0064] Table 1

[0065] Stage Temperature (°C) Rate of temperature decrease / increase (°C / h) Hold time (h) Vacuum (Pa) Pre-freezing -40 2 2 / Evacuation sublimation -5 1.5 10 10 Drying 35 1.5 6 25

[0066] Example 1

[0067] Precisely weigh 10 g of micro-powder of Radix Pseudoginseng, add 400 ml of distilled water, and reflux extract for 1 h. Repeat the extraction of the residue for 2 times, combine the 3 times of filtrate, and concentrate to 100 ml by rotary evaporation. Add 300 ml of 95% ethanol, and stand still at 4°C overnight. Centrifuge at 4000 r / min for 10 min, discard the supernatant, and collect the precipitate. Add 100 ml of distilled water to the precipitate, and repeat the alcohol precipitation for 1 time. Collect the precipitate to obtain crude Radix Pseudoginseng polysaccharide, and then freeze-dry under vacuum at low temperature to obtain Radix Pseudoginseng polysaccharide freeze-dried powder.

[0068] The vacuum freeze-drying process of the present example is the same as Comparative Example 1.

[0069] Example 2

[0070] The difference between the present example and Example 1 is that in Example 1, the amount of cellulase is adjusted from 0.5 g to 0 g, i.e., the extraction method only uses ultrasonic method without combining with enzymatic hydrolysis method. The remaining steps remain unchanged.

[0071] Example 3

[0072] The difference between the present example and Example 1 is that in Example 1, the amount of cellulase is adjusted from 0.5 g to 0.25 g. The remaining steps remain unchanged.

[0073] Example 4

[0074] The difference between the present example and Example 1 is that in Example 1, the amount of cellulase is adjusted from 0.5 g to 0.75 g. The remaining steps remain unchanged.

[0075] Example 5

[0076] The difference between this example and Example 1 is that the amount of cellulase in Example 1 is adjusted from 0.5 g to 1.00 g. The remaining steps remain unchanged.

[0077] Example 6

[0078] The difference between this example and Example 1 is that the ultrasonic power in Example 1 is adjusted from 350 W to 0, i.e., the extraction method only uses enzymatic hydrolysis without combining ultrasonic method. The remaining steps remain unchanged.

[0079] Example 7

[0080] The difference between this example and Example 1 is that the ultrasonic power in Example 1 is adjusted from 350 W to 200 W. The remaining steps remain unchanged.

[0081] Example 8

[0082] The difference between this example and Example 1 is that the ultrasonic power in Example 1 is adjusted from 350 W to 500 W. The remaining steps remain unchanged.

[0083] Example 9

[0084] The difference between this example and Example 1 is that the ultrasonic power in Example 1 is adjusted from 350 W to 700 W. The remaining steps remain unchanged.

[0085] Example 10

[0086] The difference between this example and Example 1 is that the enzymatic hydrolysis and ultrasonic treatment time in Example 1 is adjusted from 30 min to 15 min. The remaining steps remain unchanged.

[0087] Example 11

[0088] The difference between this example and Example 1 is that the enzymatic hydrolysis and ultrasonic treatment time in Example 1 is adjusted from 30 min to 45 min. The remaining steps remain unchanged.

[0089] Example 12

[0090] The difference between this example and Example 1 is that the enzymatic hydrolysis and ultrasonic treatment time in Example 1 is adjusted from 30 min to 60 min. The remaining steps remain unchanged.

[0091] Determination of the active ingredient content of the freeze-dried powder of Radix Pseudostellariae polysaccharides obtained in Comparative Example 1 and Examples 1-12.

[0092] I. Determination of Radix Pseudostellariae polysaccharide content

[0093] 1. Preparation of standard solution: After drying glucose at 105°C to constant weight, accurately weigh 10 mg of glucose, add distilled water to make up to 100 ml, and shake well to obtain a 0.1 mg / mL glucose standard solution.

[0094] 2. Preparation of sample solution: 10 mg of freeze-dried radix pseudoginseng polysaccharide was precisely weighed and dissolved in 100 ml of distilled water.

[0095] 3. Determination method: 0.1 ml, 0.2 ml, 0.4 ml, 0.8 ml, 1.0 ml and 1.6 ml of glucose standard solution and 0.5 ml of sample solution were precisely pipetted into test tubes with stoppers, respectively, and distilled water was added to make up to 2 ml. 1 ml of 5% phenol solution was added to each tube and shaken well, and then 5 ml of concentrated sulfuric acid was added dropwise and shaken well. After standing for 5 min, the tubes were placed in boiling water for 15 min, and then removed and cooled to room temperature. 2 ml of distilled water was treated in the same manner as above to serve as a blank control. The absorbance at 490 nm was determined. The standard curve was plotted with the concentration C (μg / ml) of glucose as the abscissa and the absorbance A as the ordinate. The content of radix pseudoginseng polysaccharide was calculated by using the standard curve regression equation.

[0096] II. Determination of ginsenoside content

[0097] 1. Preparation of standard solution: 10 mg of ginsenoside Rb1 was precisely weighed and dissolved in 100 ml of methanol to prepare a 0.1 mg / mL ginsenoside standard solution.

[0098] 2. Preparation of sample solution: 0.1 g of freeze-dried radix pseudoginseng polysaccharide was precisely weighed and dissolved in 100 ml of methanol and made up to the volume.

[0099] 3. Determination method: 0.1 ml, 0.2 ml, 0.4 ml, 0.8 ml and 1.6 ml of standard solution and 1.0 ml of sample solution were precisely pipetted into 10 ml test tubes with stoppers, respectively, and the solvent was evaporated on a boiling water bath. 0.2 ml of 5% vanillin glacial acetic acid solution (prepared immediately before use) and 0.8 ml of perchloric acid were precisely added and mixed well, the tubes were tightly stoppered, placed in a 60°C water bath for 15 min, removed, and cooled. Then 5 ml of glacial acetic acid was precisely added and shaken well. 1.0 ml of methanol was placed in a 10 ml test tube with a stopper, the solvent was evaporated on a boiling water bath, 0.2 ml of 5% vanillin glacial acetic acid solution (prepared immediately before use) and 0.8 ml of perchloric acid were precisely added and mixed well, the tube was tightly stoppered, placed in a 60°C water bath for 15 min, removed, and cooled with running water. Then 5 ml of glacial acetic acid was precisely added and shaken well to serve as a blank control. The absorbance was determined at 560 nm. The standard curve was plotted with the concentration C as the abscissa and the absorbance A as the ordinate, and the content of ginsenoside in the crude radix pseudoginseng polysaccharide was calculated.

[0100] Table 2. Contents of radix pseudoginseng polysaccharide and ginsenoside

[0101] No. Polysaccharide content (%) Saponin content (%) Comparative Example 1 41.9 3.100 Example 1 49.8 0.800 Example 2 25.2 0.723 Example 3 38.6 0.776 Example 4 53.1 0.824 Example 5 54.3 0.887 Example 6 36.7 0.654 Example 7 46.4 0.732 Example 8 52.1 0.875 Example 9 47.6 1.123 Example 10 44.2 0.698 Example 11 51.8 0.947 Example 12 48.3 1.214

[0102] From the data results of Table 2 above, it can be seen that the cellulase dosage, ultrasonic power and treatment time have effects on the contents of polysaccharides and saponins in the extract of Radix Pseudostellariae:

[0103] 1. Effect of cellulase dosage on the extraction rate: When the enzyme dosage is too low (0-0.25 g), the cell wall is not sufficiently destroyed, and the polysaccharide yield is low; when the enzyme dosage is increased to 0.75 g, the cell wall is sufficiently destroyed, and the polysaccharide yield is the highest; when the enzyme dosage reaches 1.0 g, the enzymolysis capacity is saturated, and the polysaccharide yield is slowly increased. The saponin yield is less affected by the enzyme dosage, and slightly increases with the increase of the degree of cell wall destruction.

[0104] 2. Effect of ultrasonic power on the extraction rate: When the power is too low (0-200 w), the mass transfer is weak, and the polysaccharide yield is low; when the power reaches 500 w, the cavitation effect is the strongest, and the polysaccharide yield is the highest; when the power is too high (700 w), the polysaccharide is degraded due to high temperature / mechanical force, and the yield is decreased. Under strong ultrasonic action, the organelles are destroyed, and the dissolution of saponins is significantly increased, and the yield is increased.

[0105] 3. Treatment time: When the time is too short (15 min), the extraction is insufficient, and the polysaccharide yield is low; when the time is 45 min, the polysaccharide is completely dissolved, and the yield is the highest; when the time is 60 min, the polysaccharide structure is excessively destroyed by ultrasonic, and the yield is decreased. Meanwhile, long-time treatment leads to the rupture of organelles, and the saponin yield is significantly increased.

[0106] Considering the contents of polysaccharides and saponins in the extract, the preferred scheme for extraction is: relative to 10 g of Radix Pseudostellariae micro-powder, cellulase 0.75 g, ultrasonic power 350 w, and treatment time 30 min, or cellulase 0.5 g, ultrasonic power 500 w, and treatment time 30 min, which takes into account the efficient extraction of Radix Pseudostellariae polysaccharides and the low dissolution of saponins, and is conducive to improving the quality of Radix Pseudostellariae polysaccharides and reducing the bitter taste.

[0107] Example 13

[0108] Preparation of Radix Pseudostellariae polysaccharide freeze-dried powder: 10 g of Radix Pseudostellariae micro-powder was precisely weighed, 400 ml of distilled water was added, 0.5 g of cellulase was added, and it was soaked at 40°C and treated by ultrasonic (500 w) for 30 min. The enzyme was inactivated by boiling for 10 minutes, and then filtered. The filtrate was repeated twice, and the filtrate was combined and concentrated to 100 ml under vacuum at 40°C. 300 ml of 95% ethanol was added, and it was placed at 4°C overnight. It was centrifuged at 4000 r / min for 10 min, the supernatant was discarded, and the precipitate was collected. 100 ml of distilled water was added to the precipitate, and the alcohol precipitation was repeated once. The precipitate was collected to obtain the crude Radix Pseudostellariae polysaccharide. After vacuum low-temperature freeze-drying, low-temperature freezing and crushing, and passing through a 50-mesh sieve, the Radix Pseudostellariae polysaccharide freeze-dried powder was obtained. The vacuum freeze-drying process of this example is the same as that of Comparative Example 1.

[0109] Inclusion of saponins in the freeze-dried powder of polysaccharides from Radix Pseudostellariae: 10 g of the freeze-dried powder of polysaccharides from Radix Pseudostellariae obtained above was added to a methyl-β-cyclodextrin aqueous solution with a concentration of 700 g / L, and stirred at 300 rpm and 30°C for 4 h to form an inclusion compound.

[0110] Freeze-dried granules of cyclodextrin-included polysaccharides from Radix Pseudostellariae: The solution of the inclusion compound was concentrated to a relative density of 1.25, and degassed in vacuum (-0.08 MPa, 30 min) to remove air bubbles. A pressure atomizer was used to break the mixture into micron-sized droplets with a size of 10-200 μm at an atomization pressure of 15 MPa. The inlet air temperature was controlled at 120°C, the outlet air temperature at 80°C, and the feeding rate at 7 mL / min. The droplets were brought into contact with hot air in a drying tower, and the surface water was instantaneously evaporated. Continuous drying was used to dehydrate and solidify the inclusion structure, and freeze-dried granules of cyclodextrin-included polysaccharides from Radix Pseudostellariae were obtained.

[0111] Example 14

[0112] The difference between this example and Example 13 is that in Example 13, the concentration of the methyl-β-cyclodextrin aqueous solution was adjusted from 700 g / L to 350 g / L. The other steps remained unchanged.

[0113] Example 15

[0114] The difference between this example and Example 13 is that in Example 13, the concentration of the methyl-β-cyclodextrin aqueous solution was adjusted from 700 g / L to 600 g / L. The other steps remained unchanged.

[0115] Example 16

[0116] The difference between this example and Example 13 is that in Example 13, the concentration of the methyl-β-cyclodextrin aqueous solution was adjusted from 700 g / L to 850 g / L. The other steps remained unchanged.

[0117] Example 17

[0118] The difference between this example and Example 13 is that in Example 13, the inclusion temperature was adjusted from 30°C to 25°C. The other steps remained unchanged.

[0119] Example 18

[0120] The difference between this example and Example 13 is that in Example 13, the inclusion temperature was adjusted from 30°C to 45°C. The other steps remained unchanged.

[0121] Example 19

[0122] The difference between this example and Example 13 is that in Example 13, the inclusion temperature was adjusted from 30°C to 60°C. The other steps remained unchanged.

[0123] Example 20

[0124] The difference between this embodiment and embodiment 13 is that the inclusion time in embodiment 13 is adjusted from 4h to 2h. The remaining steps remain unchanged.

[0125] Example 21

[0126] The difference between this embodiment and embodiment 13 is that the inclusion time in embodiment 13 is adjusted from 4h to 6h. The remaining steps remain unchanged.

[0127] Example 22

[0128] The difference between this embodiment and embodiment 13 is that the inclusion time in embodiment 13 is adjusted from 4h to 8h. The remaining steps remain unchanged.

[0129] Determination of the effects of different conditions in examples 13-22 on the inclusion rate of saponins and the inclusion rate of polysaccharides in Radix Pseudostellariae.

[0130] III. Inclusion rate determination

[0131] Precisely weigh the Radix Pseudostellariae polysaccharide freeze-dried powder before inclusion with cyclodextrin and the Radix Pseudostellariae polysaccharide freeze-dried granules after inclusion, and prepare sample solutions according to the Radix Pseudostellariae polysaccharide and saponin content determination method. Centrifuge the inclusion compound solution at 8000 rpm for 10 min, take the supernatant, and determine the contents of saponins and polysaccharides, respectively, to calculate the inclusion rate.

[0132]

[0133] Table 3 Inclusion rate of Radix Pseudostellariae polysaccharides and saponins

[0134] No. Saponin inclusion rate (%) Prince sengen polysaccharide inclusion rate (%) Example 13 71.3 6.7 Example 14 49.1 4.3 Example 15 68.5 9.8 Example 16 62.7 6.4 Example 17 53.6 7.9 Example 18 71.8 5.6 Example 19 65.4 2.1 Example 20 48.9 4.7 Example 21 70.2 6.9 Example 22 69.3 5.1

[0135] From the data results in Table 3 above, it can be seen that the concentration of methyl-β-cyclodextrin aqueous solution, the inclusion temperature and the inclusion time have effects on the inclusion rate of polysaccharides and saponins in Radix Pseudostellariae extract:

[0136] 1. Concentration of methyl-β-cyclodextrin aqueous solution: When the concentration of cyclodextrin is too low (such as 350g / L), the number of cavity molecules is insufficient, and the inclusion rate of saponins is low. When the concentration increases, saponins enter the cyclodextrin cavity through hydrophobic interaction, and the inclusion rate increases significantly. When the concentration is too high (such as 850g / L), the viscosity of the system increases, the mass transfer resistance increases, and there is a supersaturation situation, and the inclusion rate of saponins decreases.

[0137] 2. Inclusion temperature: When the temperature is low (25℃), the molecular thermal motion is weak, and the inclusion efficiency is low. Therefore, increasing the temperature is beneficial to improving the inclusion rate. However, when the temperature is too high (60℃), the stability of the inclusion compound is destroyed, resulting in a slight decrease in the inclusion rate.

[0138] 3. Inclusion time: the inclusion reaction did not reach equilibrium due to insufficient time; prolonging the time was beneficial to the inclusion equilibrium, which tended to be stable after 4 h, and long-time stirring after that did not help to improve the inclusion rate.

[0139] 4. After comprehensive consideration, the preferred scheme for inclusion was as follows: the concentration of methyl-β-cyclodextrin aqueous solution was 600-700 g / L, the inclusion temperature was 30-45 ℃, and the inclusion time was 4 h, which was beneficial to improving the saponin inclusion rate.

[0140] Example 23

[0141] The freeze-dried granules of the inclusion of the polysaccharide from Radix Pseudoginseng in cyclodextrin were subjected to fluidized bed coating treatment, and flavoring agents were added to further improve the taste and avoid the aggregation of the polysaccharide from Radix Pseudoginseng due to moisture absorption, thereby improving the preparation performance of the chewable tablets. The specific steps are shown as follows.

[0142] Preparation of the freeze-dried powder of the polysaccharide from Radix Pseudoginseng: 10 g of Radix Pseudoginseng micro-powder was precisely weighed, 400 ml of distilled water was added, 0.5 g of cellulase was added, and the mixture was soaked at 40 ℃ and treated by ultrasonic (500 w) for 30 min. The enzyme was inactivated by boiling for 10 min, and then filtered. The residue was extracted twice, and the filtrates were combined and concentrated to 100 ml under vacuum at 40 ℃. 300 ml of 95% ethanol was added, and the mixture was allowed to stand at 4 ℃ overnight. The mixture was centrifuged at 4000 r / min for 10 min, the supernatant was discarded, and the precipitate was collected. 100 ml of distilled water was added to the precipitate, and the alcohol precipitation was repeated once. The precipitate was collected to obtain the crude polysaccharide from Radix Pseudoginseng. The crude polysaccharide was subjected to vacuum low-temperature freeze-drying, low-temperature freeze-pulverization, and filtration through a 50-mesh sieve to obtain the freeze-dried powder of the polysaccharide from Radix Pseudoginseng. The vacuum freeze-drying process of this example was the same as that of Comparative Example 1.

[0143] Inclusion of the freeze-dried powder of the polysaccharide from Radix Pseudoginseng: 10 g of the freeze-dried powder of the polysaccharide from Radix Pseudoginseng obtained above was added to a methyl-β-cyclodextrin aqueous solution with a concentration of 700 g / L, and the mixture was stirred at 300 rpm and 30 ℃ for 4 h to form an inclusion complex solution. The inclusion complex solution was concentrated to a relative density of 1.25, and the gas bubbles were removed by vacuum degassing (-0.08 MPa, 30 min). A pressure atomizer was used, and the atomizing pressure was 15 MPa to break the mixture into micron-sized droplets with a size of 10-200 μm. The inlet air temperature was controlled at 120 ℃, the outlet air temperature was 80 ℃, and the feeding rate was 7 mL / min. The droplets were brought into contact with the hot air in the drying tower, the surface moisture was instantaneously evaporated, and the inclusion structure was dehydrated and solidified by continuous drying. The freeze-dried granules of the polysaccharide from Radix Pseudoginseng included in cyclodextrin were formed.

[0144] Fluidized bed coating: a 3% hydroxypropyl methylcellulose (HPMC) solution was prepared; a capture bag with a pore size of 10 μm was installed on the fluidized bed, a peristaltic pump hose and a 1.5 mm spray gun were connected, and the freeze-dried granules of the polysaccharide from Radix Pseudoginseng included in cyclodextrin were introduced into the fluidized bed. The height of the flow guide cylinder was adjusted to the lowest position, the inlet air temperature was set to 50 ℃, the inlet air volume was 600 L / min, the spray gun was set to 0.2 mL / min, and the coating was carried out for 30 min.3 / h, set the bag-shaking cycle interval 5s, shake the bag 4 times, set the inlet humidity 5.5g / kg, start the equipment and open the dehumidifier, when the inlet air volume reaches the set value, increase the height of the flow guide cylinder by 50 values (record the displayed value), and start the material preheating. When the preheating temperature reaches 35℃, start the liquid spraying granulation to obtain the coated ginseng polysaccharide granules. The peristaltic pump speed is 35rpm, and the atomization pressure is 1.0bar. Drying: inlet air temperature 65℃, inlet air volume 700m 3 / h, inlet humidity 5.5g / kg, final material temperature 45℃, and the moisture content of the granules ≤1.5%.

[0145] Direct powder compression: citric acid and microcrystalline cellulose (particle size less than 30um) are premixed by equal amount addition method, and then the coated ginseng polysaccharide granules and blueberry powder are added and premixed for 5min, and then magnesium stearate is added and mixed for 5min. The total mixed powder is compressed into tablets by a rotary tablet press to obtain the ginseng polysaccharide chewable tablets. The tablet hardness is 50-80N.

[0146] The formula of the ginseng polysaccharide chewable tablets of the present example is shown in Table 4 below.

[0147] Table 4

[0148]

[0149] Example 24

[0150] The difference between the present example and Example 23 is that, in Example 23, the direct powder compression is replaced by granulation followed by tablet compression, and the specific steps are as follows: citric acid and microcrystalline cellulose are premixed by equal amount addition method, and then the coated ginseng polysaccharide granules and blueberry powder are added and premixed for 5min, and then granulation is performed using 75% alcohol, and the granules are dried in a fluidized bed, and then magnesium stearate is added and mixed for 5min. The total mixed granules are compressed into tablets by a rotary tablet press. The tablet hardness is 50-80N.

[0151] Example 25

[0152] The difference between the present example and Example 24 is that, in Example 24, the ginseng polysaccharide granules used for granulation are not subjected to fluidized bed coating, i.e. the step of coating the ginseng polysaccharide freeze-dried powder is omitted. The remaining steps remain unchanged.

[0153] Example 26

[0154] The difference between the present example and Example 23 is that, in Example 23, the ginseng polysaccharide granules used for fluidized bed coating are not subjected to cyclodextrin inclusion, i.e. the step of coating the ginseng polysaccharide freeze-dried powder is omitted. The remaining steps remain unchanged.

[0155] Comparative Example 2

[0156] Preparation of the chewable tablets of P. notoginseng polysaccharides: the freeze-dried powder of P. notoginseng polysaccharides obtained in Comparative Example 1 was used. Lemon acid and microcrystalline cellulose were premixed by the equal amount addition method, and the coated P. notoginseng polysaccharide granules and blueberry powder were added in turn and mixed for 5 min, and then magnesium stearate was added and mixed for 5 min. The total mixture was compressed into tablets by a rotary tablet press. The hardness of the tablets was 50-80 N.

[0157] The chewable tablets of P. notoginseng polysaccharides obtained in Examples 23-26 and Comparative Example 2 were evaluated for taste and preparation performance.

[0158] IV. Appearance and taste evaluation

[0159] The chewable tablets of P. notoginseng polysaccharides prepared by different methods were placed on white paper, and the appearance of the tablets was observed. Ten trained volunteers tasted and evaluated the taste. The comprehensive scores of each group are shown in Table 5.

[0160] Table 5

[0161]

[0162] From the data in Table 5, it can be seen that, compared with Example 23, the granulation process was optimized in Example 24, the flowability of the granules was improved, the tablets were more uniform, the cracks were reduced, the appearance was smoother, and the grittiness was reduced, making the taste more delicate.

[0163] The combination of cyclodextrin inclusion and HPMC coating is beneficial to masking the bitterness of saponins and reducing hygroscopic cracks through coating technology, and the comprehensive scores of the appearance and taste of the chewable tablets are improved.

[0164] Compared with Comparative Example 2, the polysaccharides obtained by enzymatic hydrolysis and ultrasonic extraction have higher purity, less odor impurities, and better taste.

[0165] V. Determination of the content of P. notoginseng polysaccharides in the chewable tablets

[0166] Sample treatment: The P. notoginseng polysaccharide chewable tablets prepared by different methods were ground into powder. 0.1 g of the chewable tablet powder was accurately weighed, 20 ml of purified water was added, and ultrasonic extraction was performed for 30 minutes. The supernatant was obtained by centrifugation (8000 rpm, 10 min). 4 times the volume of anhydrous ethanol was added to precipitate the polysaccharides, which were allowed to stand overnight at 4°C. The precipitate was collected by centrifugation at 4000 r / min for 10 min, and the supernatant was discarded. The precipitate was redissolved in water. 0.5 mL of the sample solution was taken and placed in a test tube with a stopper, and purified water was added to make up to 2 ml. 1 ml of 5% phenol solution was added to each tube and shaken well. Concentrated sulfuric acid 5 ml was added dropwise, shaken well, and allowed to stand for 5 min. It was placed in a boiling water bath for 15 min and then cooled to room temperature. The absorbance was measured at 490 nm, and the content of polysaccharides in the chewable tablets was calculated by substituting the glucose standard curve. The chewable tablets of each method were tested in triplicate, and the results were averaged.

[0167] Table 6

[0168] No. Polysaccharide content in chewable tablets (%) Example 23 12.8±0.8 Example 24 14.5±0.4 Example 25 13.2±0.5 Example 26 11.7±0.6 Comparative Example 2 10.3±1.0

[0169] As shown by the data results of Table 6 above, the least loss of polysaccharide of Radix Pseudoginseng occurs in the Radix Pseudoginseng polysaccharide chewable tablets prepared after HPMC coating and granulation, and the polysaccharide content in the chewable tablets reaches 14.5%. The water extraction and alcohol precipitation method has many impurities, and direct compression leads to polysaccharide degradation and adsorption loss, and the polysaccharide content is only 10.3%.

[0170] Six, Disintegration Time Determination

[0171] The disintegration time of the Radix Pseudoginseng polysaccharide chewable tablets was determined by using an ascending and descending disintegration tester. The medium was distilled water, and the temperature was 37°C. The disintegration tester was started, and the time required for complete disintegration of the chewable tablets (no hard core, granules passing through the screen) was observed. The chewable tablets of each method were tested in parallel for 3 times, and the average value was taken as the result.

[0172] Table 7

[0173] No. Disintegration time (min) Example 23 2.8±0.5 Example 24 0.9±0.2 Example 25 2.5±0.4 Example 26 2.8±0.3 Comparative Example 2 3.0±06

[0174] As shown by the data results of Table 7 above, powder direct compression usually has poor flowability, weak inter-particle bonding force, and is easy to disintegrate. Granulation and compression are beneficial to improve the flowability and compressibility of the granules, and the disintegration rate is reduced compared to direct compression. However, for Example 24, after HPMC coating, HPMC as a hydrophilic coating material can promote disintegration by rapid water absorption and swelling, so the disintegration time is only slightly prolonged.

[0175] Seven, Dissolution Determination

[0176] The dissolution was determined by using the slurry method. The dissolution medium was hydrochloric acid solution (9 mL→1000 mL), the volume was 900 mL, the rotation speed was set to 75 revolutions / minute, and the temperature was 37°C. At different time points, the polysaccharide content of each group of Radix Pseudoginseng was determined by referring to the polysaccharide content determination method in the chewable tablets above. The chewable tablets of each method were tested in parallel for 3 times, and the average value was taken as the result. The results are shown in Table 8 below.

[0177] Table 8

[0178] No. 5 min 10 min 15 min 30 min 45 min 60 min Example 23 28.5±3.5 28.5±3.5 53.6±2.8 72.8±2.1 86.4±1.5 92.1±1.2 Example 24 35.2±2.1 65.3±1.8 84.7±1.5 94.5±0.9 97.8±0.7 98.5±0.5 Example 25 32.6±3.2 32.6±3.2 60.4±2.7 79.8±1.9 90.1±1.3 95.2±1.1 Example 26 25.7±3.0 25.7±3.0 48.9±2.6 68.3±2.2 82.6±1.7 89.5±1.4 Comparative Example 2 18.3±4.1 40.5±3.5 55.6±3.0 72.9±2.5 82.4±2.2 87.6±1.8

[0179] As shown by the results of Table 8 above, Example 24 (enzymatic hydrolysis + ultrasonic extraction, saponin inclusion with cyclodextrin + HPMC coating, granulation and compression) is the optimal formulation, with significantly better dissolution rate and completeness than other groups. The granulation process improves particle uniformity and flowability, combined with the controlled release effect of HPMC coating, forming a rapidly water-swelling barrier in hydrochloric acid medium, promoting tablet disintegration. Cyclodextrin inclusion effectively masks the bitterness of saponins, while not hindering the dissolution of polysaccharides. Dissolution data shows that Example 24 has a dissolution rate of 84.7 ± 1.5% at 15 minutes, 97.8 ± 0.7% at 45 minutes, and the lowest standard deviation (≤ 2.1%), indicating excellent process stability and reproducibility. Compared to other groups, the dissolution curve of Example 24 has a higher slope and reaches the plateau earlier, meeting the dual requirements of rapid release and high bioavailability of chewable tablets.

[0180] Eight, stability investigation

[0181] The stability of the Radix Pseudoginseng polysaccharide chewable tablets was investigated using accelerated testing. The test samples were placed at a temperature of 40 ± 2 °C and a relative humidity of 75 ± 5% for 6 months. The appearance and taste of the chewable tablets were evaluated at different times, and the polysaccharide content was determined. The results are shown in Table 9 below. A score of 10 indicates no change, and a score of 0 indicates a very significant change. The chewable tablets were tested in triplicate for each method, and the results were averaged.

[0182] Table 9

[0183]

[0184]

[0185] As shown by the results of Table 9 above, under accelerated conditions (40 ± 2 °C, RH 75 ± 5%), the Radix Pseudoginseng polysaccharide chewable tablets prepared by the method of Example 24 (enzymatic hydrolysis + ultrasonic extraction → saponin inclusion with cyclodextrin + HPMC coating → granulation and compression) exhibit the best stability: the Radix Pseudoginseng polysaccharide retention rate is 92.4% ± 2.2% after 6 months, and the appearance score (8.5 / 10) and taste score (8.0 / 10) are significantly higher than those of other groups. The HPMC coating effectively blocks moisture penetration, the granulation process reduces particle porosity, and the cyclodextrin inclusion inhibits the release of saponin bitterness, resulting in a better taste. In contrast, the direct compression group (Example 23, Comparative Example 2) causes moisture absorption and clumping due to the loose particles, and the content of polysaccharides decreases to 83.6% and 68.4% respectively after 6 months; the uncoated group (Example 25) lacks HPMC protection, and moisture absorption accelerates the appearance of yellowing and bitter taste. The traditional water extraction method (Comparative Example 2) intensifies impurity residues and microbial contamination, with the worst stability, with the tablets softening and sticking together after 6 months, and the degradation rate of Radix Pseudoginseng polysaccharides reaching 31.6%.

[0186] The basic principles, main features and advantages of the present application have been shown and described above. It should be understood by those skilled in the art that the present application is not limited by the above-described embodiments, which are merely preferred embodiments of the present application, and the scope of the present application is not limited by the above-described embodiments. Equivalent changes and modifications made in accordance with the scope of the present application and the content of the specification should still be within the scope of the present application. The scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A processing method of Radix Pseudostellariae, characterized in that, Comprise in sequence: The freeze-dried powder of P. notoginseng polysaccharide is extracted from P. notoginseng; The freeze-dried powder of P. notoginseng polysaccharide is packaged with cyclodextrin to obtain packaged P. notoginseng polysaccharide; The packaged P. notoginseng polysaccharide is coated to obtain pre-coated P. notoginseng polysaccharide.

2. The processing method of radix of Bupleurum as claimed in claim 1, characterized in that, The radix pseudostellariae is pre-crushed into D 90 Radix pseudostellariae micro-powder with a particle size of ≤20 μm.

3. The processing method of radix of Bupleurum as claimed in claim 1, characterized in that, The extraction is carried out by enzymatic hydrolysis combined with ultrasonic method; The crude product after extraction is subjected to vacuum freeze-drying to obtain the freeze-dried powder of P. notoginseng polysaccharide.

4. The processing method of radix of Bupleurum as claimed in claim 1, characterized in that, The packaging is that the cyclodextrin is prepared into a cyclodextrin aqueous solution and mixed uniformly with the freeze-dried powder of P. notoginseng polysaccharide to obtain a packaging solution; The packaging solution is subjected to spray drying to obtain the packaged P. notoginseng polysaccharide.

5. The processing method of radix of Bupleurum as claimed in claim 4, characterized in that, The concentration of the cyclodextrin aqueous solution is 500-900 g / L; The weight ratio of the cyclodextrin aqueous solution to the freeze-dried powder of P. notoginseng polysaccharide is 50-100:

1.

6. The processing method of radix of Bupleurum as claimed in claim 1, characterized in that, The coating is carried out by fluidized bed coating process, and the coating material of the coating is hydroxypropyl methyl cellulose.

7. A Radix Pseudostellariae polysaccharide chewable tablet, characterized in that, The raw material composition comprises: pre-coated P. notoginseng polysaccharide obtained by the P. notoginseng processing method of any one of claims 1-6, flavoring agent, filler and lubricant.

8. The Radix Pseudoginseng polysaccharide chewable tablet according to claim 7, characterized in that, The weight ratio of the pre-coated P. notoginseng polysaccharide in the P. notoginseng polysaccharide chewable tablet is 20-45%. 9.The Radix Pseudoginseng polysaccharide chewable tablet of claim 7, characterized in that, The flavoring agent is selected from one or more of the following: xylitol, blueberry powder, yogurt powder, citric acid and neotame, and a combination of two or more thereof; The weight ratio of the flavoring agent in the P. notoginseng polysaccharide chewable tablet is 40-60%.

10. The Radix Pseudoginseng polysaccharide chewable tablet according to claim 7, characterized in that, The weight ratio of the filler in the P. notoginseng polysaccharide chewable tablet is 20-40%, and the weight ratio of the lubricant in the P. notoginseng polysaccharide chewable tablet is 0.5-1%.

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