CN115501266A - Effervescence granule containing pseudostellaria root and production process thereof - Google Patents

Effervescence granule containing pseudostellaria root and production process thereof Download PDF

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CN115501266A
CN115501266A CN202211256127.0A CN202211256127A CN115501266A CN 115501266 A CN115501266 A CN 115501266A CN 202211256127 A CN202211256127 A CN 202211256127A CN 115501266 A CN115501266 A CN 115501266A
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parts
honey
preparation
erythritol
dextrin
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王颖芳
王惜泉
田悦昕
陆滨欣
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Guangdong Institute Of Good Taste And Nutrition
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Guangdong Institute Of Good Taste And Nutrition
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Abstract

The invention provides an effervescent granule containing radix pseudostellariae and a production process thereof, belonging to the technical field of preparation of traditional Chinese medicine granules, wherein the effervescent granule comprises the following raw materials: radix pseudostellariae, poria cocos, bighead atractylodes rhizome, honey-fried licorice root, erythritol, dextrin, sorbitol, honey, citric acid, PEG-6000 and sodium bicarbonate, and a preparation method of the effervescent granule is also provided; the prepared medicinal composition granule has the effects of nourishing yin, promoting the production of body fluid, invigorating spleen and replenishing qi; meanwhile, the product has good smell and mouthfeel, is easily accepted by young people, is convenient to carry, and can be drunk after being brewed at any time.

Description

Effervescence granule containing pseudostellaria root and production process thereof
Technical Field
The invention belongs to the technical field of preparation of traditional Chinese medicine granules, and relates to an effervescent granule containing radix pseudostellariae and a production process thereof.
Background
The traditional Chinese medicine with homology of medicine and food is a common component in health-care products, and a dietotherapy health-care formula and a prevention formula are developed by utilizing natural food with homology of medicine and food, so that the sub-health state of a human body can be improved. Understanding the development trend of the functional raw and auxiliary materials of traditional Chinese medicine and deeply researching the functional characteristics of the raw and auxiliary materials can bring new vitality into product innovation in the health care industry. Some health-care foods capable of strengthening spleen and stomach and enhancing immunity are available in the market, although the taste is still good, the selected medicinal materials and the adding mode thereof need to be studied, and the health-care foods usually contain certain chemical additives, so that the side effects still exist after long-term eating.
Chinese patent CN 102188498A discloses a Chinese medicinal composition for treating infantile hyperpyrexia and a preparation method thereof. It is mainly composed of radix pseudostellariae, radix tetrastigme, herba clematidis armandii, polygonum cuspidatum leaves and the like. The preparation method comprises weighing radix Pseudostellariae, radix Apioris Fortunei, herba Rorippae Fortunei, and folium Polygoni Cuspidati, decocting in water, concentrating, precipitating with ethanol, recovering ethanol, concentrating into extract, drying, sieving, granulating, and making into suitable preparation. The invention is characterized in that the medicine is a full natural medicine preparation, has the functions of tonifying spleen and lung, dispelling wind and eliminating phlegm, and clearing heat and detoxicating, and has particularly obvious effect on various children hyperpyrexia; the oral preparation is adopted, so that the use is convenient, the taste is good, and the oral preparation is easily accepted by patients; has good curative effect, short period, low price and no toxic or side effect in clinical use, and is a satisfactory medicament for clearing high fever of children. However, the addition of too much additive in the patent has certain side effects after long-term administration.
Chinese patent CN 110090282A discloses a traditional Chinese medicine composition for alleviating gastrointestinal toxic and side effects, which is prepared from the following traditional Chinese medicine materials in parts by weight for one day: 20-30 g of radix pseudostellariae, 10-15 g of poria cocos, 10-15 g of fried bighead atractylodes rhizome, 5-10 g of honey-fried licorice root, 6-10 g of costustoot, 6-10 g of fructus amomi, 5-10 g of ginger processed pinellia tuber, 5-15 g of dried orange peel, 10-20 g of chicken's gizzard-membrane, 10-20 g of fried medicated leaven, 10-20 g of fried malt, 10-20 g of fried hawthorn and 10-20 g of fried rice sprout. The Chinese medicinal composition can be made into granule, and can effectively relieve gastrointestinal toxic and side effects caused by chemotherapy, such as nausea, emesis, abdominal distention, anorexia, etc., improve life quality during chemotherapy, and improve chemotherapy completion rate. The ginseng, poria cocos and bighead atractylodes rhizome granules prepared by the method are special preparations for children patients, and are high in compliance of children taking medicines and remarkable in curative effect. However, the traditional Chinese medicine has a complex formula, and the traditional Chinese medicine has special smell and taste, so that the taste is difficult to change and is not easy to be accepted by young people.
Therefore, the development of a granule which has healthy components, good taste, simple storage conditions and convenient eating method is needed.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides the radix pseudostellariae-containing effervescent granule which is healthy in components, good in taste, simple in storage condition and convenient and fast in eating method, and the production process thereof.
In order to realize the purpose, the technical scheme adopted by the invention is as follows:
firstly, an effervescent granule is provided, which comprises the following raw materials: radix pseudostellariae, poria cocos, bighead atractylodes rhizome, honey-fried licorice root, erythritol, dextrin, sorbitol, honey, citric acid, PEG-6000 and sodium bicarbonate.
Further, the effervescent granule comprises the following raw materials in parts by weight: 2-5 parts of radix pseudostellariae, 2-5 parts of poria cocos, 2-5 parts of bighead atractylodes rhizome, 1-4 parts of honey-fried licorice root, 14-16 parts of erythritol, 14-16 parts of dextrin, 2-4 parts of sorbitol, 2-4 parts of honey, 2-3 parts of citric acid, 1-3 parts of PEG-6000 and 0.01-2 parts of sodium bicarbonate.
Preferably, the effervescent granule comprises the following raw materials in parts by weight: 2-4 parts of radix pseudostellariae, 2-4 parts of poria cocos, 2-4 parts of bighead atractylodes rhizome, 1-3 parts of honey-fried licorice root, 14-16 parts of erythritol, 14-16 parts of dextrin, 2-4 parts of sorbitol, 2-4 parts of honey, 2-3 parts of citric acid, 1-2 parts of PEG-6000 and 0.01-1 part of sodium bicarbonate.
Secondly, a preparation method of the effervescent granule is provided, which comprises the following steps:
(1) Cleaning radix Pseudostellariae, poria, atractylodis rhizoma, and radix Glycyrrhizae Preparata, cutting into pieces, and soaking in distilled water;
(2) Boiling the medicinal materials treated in the step (1), and filtering to obtain a filtrate (1) and filter residues;
(3) Adding distilled water into the filter residue obtained in the step (2), boiling and filtering to obtain a filtrate (2); combining the filtrates (1) and (2) to obtain a total filtrate;
(4) Concentrating and centrifuging the total filtrate obtained in the step (3), and concentrating supernate to obtain an extract;
(5) Adding honey, sorbitol and citric acid into the extract obtained in the step (4), and uniformly stirring; adding erythritol and dextrin, and stirring to obtain dry extract;
(6) Taking the dry extract obtained in the step (5), dividing the dry extract into 2 equal parts, adding citric acid into the 1 st part, uniformly mixing by an equivalent incremental method, and adding absolute ethyl alcohol to prepare a soft acid material; adding PEG-6000-coated sodium bicarbonate into the second part, uniformly mixing by an equivalent incremental method, and adding absolute ethyl alcohol to prepare an alkali soft material; sieving the acid soft material and the alkali soft material to prepare acid and alkali granules;
(7) And (5) baking the granules obtained in the step (6) and then packaging to obtain the effervescent granule product.
The prepared acid and alkali particles contain the same medicaments and have the same effect; the acid and alkali particles only change the preparation form, and improve the dissolution effect.
Further, the dosage ratio of the total amount of the pseudostellaria root, the poria cocos, the bighead atractylodes rhizome and the honey-fried licorice root in the step (1) to the distilled water is 1-2g:7-9mL; in the step (3), the dosage ratio of the filter residue to the distilled water is 1-2g:6-7mL.
Further, in the step (4), the centrifugation temperature is 2-6 ℃, the rotation speed is 7500-8500r/min, the time is 8-12min, the medicine content of the extract is 1-2g/mL, and the medicine content refers to the total amount of radix pseudostellariae, poria cocos, bighead atractylodes rhizome and honey-fried licorice root.
Further, the step (4) applies the technology of concentrating and settling the water decoction: after the decoction of the water decoction is finished, primarily filtering by adopting a reduced pressure filtration method to reduce precipitation; then, carrying out reduced pressure distillation by using a rotary evaporator, and concentrating the water decoction; concentrating to the extent of no wall build-up, centrifuging with a freezing high-speed centrifuge, collecting supernatant to obtain clear liquid, and concentrating with an evaporating dish to obtain extract.
Further, in the step (5), the weight ratio of the dry extract, dextrin and erythritol in the part 1 is 1-1.5:2-2.5:2-2.5; the weight ratio of the dry extract, the dextrin and the erythritol in the 2 nd part is 1-1.5:2-2.5:2-2.5; the purpose of adding the absolute ethyl alcohol is to ensure that the extract can be fully dissolved, and the addition amount is only required to ensure that the extract can be fully dissolved.
Finally, the application of the medicine composition particles or the medicine composition particles obtained by the preparation method in preparing the product for nourishing yin, promoting the production of body fluid, tonifying spleen and benefiting qi is provided.
In the raw materials of the effervescent granules provided herein:
radix pseudostellariae: the product is sweet in taste, slightly bitter and neutral, and has the effects of invigorating spleen and replenishing qi;
tuckahoe, poria cocos: has sweet, light and mild nature and taste, enters heart, lung and spleen channels, and has the effects of strengthening spleen and stomach, excreting dampness and promoting diuresis;
white atractylodes rhizome: bitter and sweet in taste, warm in nature, capable of invigorating spleen, replenishing qi, eliminating dampness and inducing diuresis; can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm and fluid retention, palpitation, and edema;
honey-fried licorice root: invigorating spleen and regulating stomach function, invigorating qi and recovering pulse, relieving spasm and removing toxic substance, and harmonizing various medicines; can be used for treating weakness of spleen and stomach, asthenia, palpitation, and intermittent pulse, and can relieve subsidiary toxicity;
erythritol: is applied to the development of novel zero-calorie and low-calorie beverages. The erythritol can increase sweetness, thickness and lubrication of the beverage, reduce bitterness, mask other odors and improve beverage flavor. Erythritol can also be used for refreshing solid beverages because erythritol absorbs a large amount of heat when dissolved. Erythritol can promote the combination of ethanol molecules and water molecules, and the alcoholic beverage can reduce the odor and the sensory stimulation of alcohol and effectively improve the quality of white spirit and wine. Erythritol can also obviously improve the bad odor of plant extracts, collagen, peptides and other substances;
and (3) citric acid: not only used for flavoring, but also used as a material for preparing an acidic soft material;
PEG-6000: in the preparation of the alkaline soft material, the sodium bicarbonate is used for wrapping to achieve a slow release effect.
In some embodiments, the method for preparing the pharmaceutical composition particles comprises the following steps:
(1) Cleaning radix Pseudostellariae, poria, atractylodis rhizoma and radix Glycyrrhizae Preparata, cutting into small pieces, adding distilled water, soaking for 30min; the dosage ratio of the total amount of the pseudostellaria root, the tuckahoe, the white atractylodes rhizome and the honey-fried licorice root to the distilled water is 1-2g:7-9mL;
(2) Boiling the medicinal materials treated in the step (1) with strong fire, and then slightly boiling for 1h with soft fire; filtering under reduced pressure while the solution is hot to obtain filtrate (1) and filter residue; adding distilled water again to immerse the filter residue, boiling with strong fire, boiling with slow fire for 40min, and filtering under reduced pressure to obtain filtrate (2); combining the filtrates of (1) and (2) to obtain a total filtrate; the dosage ratio of the filter residue to the distilled water is 1-2g:6-7mL;
(3) Distilling the total filtrate obtained in the step (2) under reduced pressure, concentrating to a degree of no wall built-up, centrifuging at 4 ℃ and 8000r/min for 10min, taking supernatant to obtain clear liquid, and performing final concentration (concentrating to a drug content of 1.46g/mL, wherein the drug content refers to the total amount of radix pseudostellariae, poria cocos, bighead atractylodes rhizome and radix glycyrrhizae preparata) by using an evaporation dish to obtain extract;
(4) Adding honey, sorbitol and citric acid into the extract obtained in the step (3), and uniformly stirring; adding erythritol and dextrin (erythritol and dextrin are dried at low temperature before use, and sieved with No. 5 sieve), and stirring to obtain dry extract;
(5) Taking the dry extract obtained in the step (4), dividing the dry extract into 2 equal parts, adding citric acid into the 1 st part, uniformly mixing by an equivalent incremental method, and adding absolute ethyl alcohol to prepare an acid soft material; adding PEG-6000 sodium bicarbonate in the second part, mixing by equivalent incremental method, adding anhydrous ethanol, and making into soft alkaline material; soft material standard: holding with hand to form a ball, and slightly pressing to disperse; extruding the soft material through a No. 5 screen to form uniform granules (laboratory preparation, mass production using a swing granulator or a rotary granulator); wherein, the process of wrapping the sodium bicarbonate by the PEG-6000 specifically comprises the following steps: placing PEG-6000 in a beaker, heating in water bath at 60-80 deg.C to melt, adding sodium bicarbonate, stirring, cooling, and pulverizing into fine powder;
(6) Uniformly spreading the particles obtained in the step (5) on a tray, putting the tray into a preheated oven, drying for 90min at the temperature below 40 ℃ (acid-base particles cannot resist high temperature), and turning the surface once every 30min in the drying process (generally controlling the water content within 2%); using a No. 1 sieve and a No. 5 sieve to carry out granulation, wherein the total amount of the granules with the particle size larger than the No. 1 sieve and smaller than the No. 5 sieve is not more than 15 percent, and obtaining uniform granules;
(7) And (3) uniformly mixing the acidic granules and the alkaline granules obtained in the step (6) (the number ratio of the acidic granules to the alkaline granules is 1.
Compared with the prior art, the invention has the following beneficial effects:
(1) The effervescent granule provided by the invention has the effects of nourishing yin, promoting the production of body fluid, tonifying spleen and benefiting qi;
(2) The effervescent granule provided by the invention inherits the advantages of low toxicity and no preservative of a traditional Chinese medicine water decoction, and effectively solves the problem of low stability;
(3) The effervescent granule provided by the invention has good smell and mouthfeel, is easily accepted by young people, is convenient to carry, and can be drunk after being brewed at any time; the requirement on the storage condition is lower, and the method is more suitable for students and office workers;
(4) The preparation method provided by the invention applies a novel technology for removing the sediment of the traditional Chinese medicine water decoction.
Detailed Description
It should be noted that the raw materials used in the present invention are all common commercial products, and the sources thereof are not particularly limited.
A process for the preparation of effervescent granules comprising the steps of:
(1) Cleaning radix Pseudostellariae, poria, atractylodis rhizoma and radix Glycyrrhizae Preparata, cutting into small pieces, adding distilled water to submerge the medicinal materials, and soaking for 30min; the dosage ratio of the total amount of the radix pseudostellariae, the tuckahoe, the white atractylodes rhizome and the honey-fried licorice root to the distilled water is 1-2g:7-9mL;
(2) Boiling the medicinal materials treated in the step (1) with strong fire, and then slightly boiling for 1h with small fire; filtering under reduced pressure while the solution is hot to obtain filtrate (1) and filter residue; adding distilled water again to immerse the filter residue, boiling with strong fire, boiling with slow fire for 40min, and filtering under reduced pressure to obtain filtrate (2); combining the filtrates of (1) and (2) to obtain a total filtrate; the dosage ratio of the filter residue to the distilled water is 1-2g:6-7mL;
(3) Distilling the total filtrate obtained in the step (2) under reduced pressure, concentrating to a degree of no wall built-up, centrifuging at 4 ℃ and 8000r/min for 10min, taking supernatant to obtain clear liquid, and performing final concentration (concentrating to a drug content of 1.46g/mL, wherein the drug content refers to the total amount of radix pseudostellariae, poria cocos, bighead atractylodes rhizome and radix glycyrrhizae preparata) by using an evaporation dish to obtain extract;
(4) Adding honey, sorbitol and citric acid into the extract obtained in the step (3), and uniformly stirring; adding erythritol and dextrin (erythritol and dextrin are dried at low temperature before use, and sieved with No. 5 sieve), and stirring to obtain dry extract;
(5) Taking the dry extract obtained in the step (4), dividing the dry extract into 2 equal parts, adding citric acid into the 1 st part, uniformly mixing by an equivalent incremental method, and adding absolute ethyl alcohol to prepare an acid soft material; adding PEG-6000 sodium bicarbonate in the second part, mixing by equivalent incremental method, adding anhydrous ethanol, and making into soft alkaline material; soft material standard: holding into a ball, and lightly pressing to disperse; the soft material is extruded through a No. 5 screen to form uniform granules (laboratory preparation, mass production can use a swing granulator or a rotary granulator); wherein, the process of wrapping the sodium bicarbonate by the PEG-6000 specifically comprises the following steps: placing PEG-6000 in a beaker, heating in water bath at 60-80 deg.C to melt, adding sodium bicarbonate, stirring, cooling, and pulverizing into fine powder;
(6) Uniformly spreading the particles obtained in the step (5) on a tray, putting the tray into a preheated oven, drying the tray for 90min at the temperature of below 40 ℃, and turning the surface of the tray once every 30min (generally controlling the water content of the tray to be within 2%) in the drying process; using a No. 1 sieve and a No. 5 sieve to carry out granulation, wherein the total amount of the granules with the particle size larger than the No. 1 sieve and smaller than the No. 5 sieve is not more than 15 percent, and obtaining uniform granules;
(7) And (3) uniformly mixing the acidic particles and the alkaline particles obtained in the step (6) (the number ratio of the acidic particles to the alkaline particles is 1.
Examples 1 to 4, comparative example 1
The formulation of the granules of the pharmaceutical compositions of examples 1 to 4 and comparative example 1 is shown in Table 1, and the total amount of the drug (herein, the total drug refers to the total amount of Pseudostellaria root, poria cocos, atractylodes macrocephala and prepared licorice root) is guaranteed at 11g in each example.
TABLE 1
Figure BDA0003889618660000061
Note: the formulations given in the above tables are in parts by weight.
The effect test was performed on the effervescent granules prepared in examples 1 to 4 and comparative example 1 above.
Examples of the experiments
1. High temperature test
The granules obtained in examples 1-4 and comparative example 1 (thickness <5mm, mixed acid and alkali granules) were spread at 60 ℃ and sampled for detection of properties, particle size, and solubility for 0 day, 5 days, and 10 days, respectively.
1.1 detection of traits
Sensory and shape evaluation
The evaluation method comprises the following steps: the granules are evaluated for sense and shape by an evaluation group consisting of 10 screened and trained professional sense evaluators, wherein the sense evaluation criteria are shown in table 3, and the evaluation score results for sense and shape are shown in tables 4 and 5. Sensory evaluation was carried out directly after the product was prepared.
Sensory evaluation criteria: see table 3.
TABLE 3
Figure BDA0003889618660000071
TABLE 4
Figure BDA0003889618660000072
Note: the calculation formula of the percentage content (taking the odor index, class 1 as an example): the odor index belongs to the number of particles of category 1/total number of particles tested in each example x 100%, and the data in the table above is the average of the results of evaluation by 10 evaluators.
TABLE 5
Figure BDA0003889618660000081
1.2 particle size detection
The particle size detection is determined according to a double screening method of particle size and particle size distribution determination method of ' pharmacopoeia of the people's republic of China ' 2020 edition, taking particles M1=30g of examples 1-4 and comparative example 1, respectively passing through a No. 1 screen and a No. 5 screen, and recording that the sum of the particles which can not pass through the No. 1 screen and can pass through the No. 5 screen is M2, and the particles M2/M1 multiplied by 100% is not more than 15% to be qualified. The test results are shown in Table 6.
TABLE 6
Figure BDA0003889618660000082
1.3 dissolution testing
Dissolution test the dissolution is determined according to soluble granule inspection method of 2020 edition pharmacopoeia of the people's republic of China, taking 10g of granules of examples 1-4 and comparative example 1, respectively adding 200ml of hot water, stirring for 5min, immediately observing, and completely dissolving or suspending. All particles were completely dissolved, allowing slight cloudiness; the suspended particles should be able to suspend uniformly to be qualified. The test results are shown in Table 7.
TABLE 7
Figure BDA0003889618660000083
2. Experiment of mouse anti-fatigue action
Subjects: 90 Kunming mice were used for the experiment, male, body weight (20.01 + -0.07) g. The mice were randomly divided into control and experimental groups of 15 mice each.
The experimental method comprises the following steps:
the feeding process comprises the following steps: the mice all eat normally, and at the specified time, the experimental group is fed with 10 g/(kg. D) of the products of the examples and the comparative examples (diluted by warm boiled water at 50-60 ℃), and the control group is fed with the placebo with the same dose and fed continuously for 30 days;
mouse pole climbing experiment: after 2h of last feeding, the mice are respectively placed on an organic glass rod, the time of the mice falling from the glass rod due to fatigue is recorded, the experiment is stopped when the mice fall for the 3 rd time, and the time of 3 times is accumulated and recorded as the rod climbing time(s) of the mice.
Mouse organ assay: mice were sacrificed by cervical dislocation, dissected, spleens were removed, peripheral blood was wiped dry with filter paper, weighed, and spleen organ index was calculated: organ index = organ (mg)/body weight (g).
And (4) counting results: the experimental data are expressed as mean ± standard deviation, and the experimental results are shown in table 8.
TABLE 8
Group of Time to climb the pole(s) Spleen index (mg/g)
Control group 1017.54±111.54 5.29±0.02
Example 1 1635.12±127.52 5.99±0.01
Example 2 1598.55±125.67 5.88±0.03
Example 3 1578.32±113.24 5.85±0.02
Example 4 1511.46±129.47 5.77±0.04
Comparative example 1 1034.38±108.35 5.35±0.02
According to the experimental results, 30 days after the products prepared in the embodiments 1-4 are given to the mice, compared with a control group, the rod climbing time of the mice in an experimental group is obviously increased, and the anti-fatigue capability is improved; the spleen index is increased, which shows that the spleen quality of mouse lymph organ can be increased after the test object is taken, thereby effectively promoting the transformation function of mouse spleen lymphocyte.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.

Claims (10)

1. An effervescent granule, characterized by comprising the following raw materials: radix pseudostellariae, poria cocos, bighead atractylodes rhizome, honey-fried licorice root, erythritol, dextrin, sorbitol, honey, citric acid, PEG-6000 and sodium bicarbonate.
2. The effervescent granule as claimed in claim 1, comprising the following raw materials in parts by weight: 2-5 parts of radix pseudostellariae, 2-5 parts of poria cocos, 2-5 parts of bighead atractylodes rhizome, 1-4 parts of honey-fried licorice root, 14-16 parts of erythritol, 14-16 parts of dextrin, 2-4 parts of sorbitol, 2-4 parts of honey, 2-3 parts of citric acid, 1-3 parts of PEG-6000 and 0.01-2 parts of sodium bicarbonate.
3. The effervescent granule as claimed in claim 2, characterized by comprising the following raw materials in parts by weight: 2-4 parts of radix pseudostellariae, 2-4 parts of poria cocos, 2-4 parts of bighead atractylodes rhizome, 1-3 parts of honey-fried licorice root, 14-16 parts of erythritol, 14-16 parts of dextrin, 2-4 parts of sorbitol, 2-4 parts of honey, 2-3 parts of citric acid, 1-2 parts of PEG-6000 and 0.01-1 part of sodium bicarbonate.
4. A process for the preparation of an effervescent granule as claimed in any one of claims 1 to 3, characterised by the steps of:
(1) Cleaning radix Pseudostellariae, poria, atractylodis rhizoma, and radix Glycyrrhizae Preparata, cutting into pieces, and soaking in distilled water;
(2) Boiling the medicinal materials treated in the step (1), and filtering to obtain a filtrate (1) and filter residues;
(3) Adding distilled water into the filter residue obtained in the step (2), boiling and filtering to obtain a filtrate (2); combining the filtrates (1) and (2) to obtain a total filtrate;
(4) Concentrating and centrifuging the total filtrate obtained in the step (3), and concentrating the supernatant to obtain an extract;
(5) Adding honey, sorbitol and citric acid into the extract obtained in the step (4), and uniformly stirring; adding erythritol and dextrin, and stirring to obtain dry extract;
(6) Taking the dry extract obtained in the step (5), dividing the dry extract into 2 equal parts, adding citric acid into the 1 st part, uniformly mixing by an equivalent incremental method, and adding absolute ethyl alcohol to prepare an acid soft material; adding PEG-6000 sodium bicarbonate in the second part, mixing by equivalent incremental method, adding anhydrous ethanol, and making into soft alkaline material; sieving the acid soft material and the alkali soft material, and granulating;
(7) And (5) baking the granules obtained in the step (6) and then packaging to obtain the effervescent granule product.
5. The preparation method according to claim 4, wherein the ratio of the total amount of the radix pseudostellariae, the poria cocos, the bighead atractylodes rhizome and the honey-fried licorice root in the step (1) to the amount of the distilled water is 1-2g:7-9mL.
6. The preparation method according to claim 4, wherein the use amount ratio of the filter residue to the distilled water in the step (3) is 1-2g:6-7mL.
7. The preparation method according to claim 4, wherein the centrifugation in step (4) is carried out at 2-6 ℃, the rotation speed is 7500-8500r/min, the time is 8-12min, and the drug content of the extract is 1-2g/mL.
8. The preparation method according to claim 4, wherein the weight ratio of the dry extract, dextrin and erythritol in the 1 st part in the step (5) is 1-1.5:2-2.5:2-2.5.
9. The preparation method according to claim 4, wherein the weight ratio of the dry extract, dextrin and erythritol in the 2 nd part in the step (5) is 1-1.5:2-2.5:2-2.5.
10. Use of the pharmaceutical composition granule of any one of claims 1 to 3 or the pharmaceutical composition granule obtained by the preparation method of any one of claims 4 to 9 in the preparation of a product for nourishing yin, promoting the production of body fluid, and invigorating spleen and qi.
CN202211256127.0A 2022-10-13 2022-10-13 Effervescence granule containing pseudostellaria root and production process thereof Pending CN115501266A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115944695A (en) * 2022-12-28 2023-04-11 广东好味鲜菜品与营养研究所 Composition with functions of soothing nerves, tonifying spleen and nourishing stomach and preparation method of granules of composition

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100998787A (en) * 2006-01-12 2007-07-18 广州王老吉药业股份有限公司 Traditional Chinese medicine effervescent tablets for treating gastrointestinal disease and its preparing method
CN105582077A (en) * 2016-02-19 2016-05-18 承德天原药业股份有限公司 Trollius chinensis bunge effervescent granules and preparation method thereof
CN106538922A (en) * 2016-10-12 2017-03-29 广东艾时代生物科技有限责任公司 A kind of Folium Artemisiae Argyi effervescent tablet and preparation method thereof
WO2019007237A1 (en) * 2017-07-04 2019-01-10 青海睿元药物研究所有限责任公司 Lycium ruthenicum effervescent tablet and preparation method therefor
CN110141623A (en) * 2019-03-27 2019-08-20 中国中医科学院西苑医院 For mitigating the Chinese medicine composition of gastrointestinal tract toxicity caused by chemotherapy

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100998787A (en) * 2006-01-12 2007-07-18 广州王老吉药业股份有限公司 Traditional Chinese medicine effervescent tablets for treating gastrointestinal disease and its preparing method
CN105582077A (en) * 2016-02-19 2016-05-18 承德天原药业股份有限公司 Trollius chinensis bunge effervescent granules and preparation method thereof
CN106538922A (en) * 2016-10-12 2017-03-29 广东艾时代生物科技有限责任公司 A kind of Folium Artemisiae Argyi effervescent tablet and preparation method thereof
WO2019007237A1 (en) * 2017-07-04 2019-01-10 青海睿元药物研究所有限责任公司 Lycium ruthenicum effervescent tablet and preparation method therefor
CN110141623A (en) * 2019-03-27 2019-08-20 中国中医科学院西苑医院 For mitigating the Chinese medicine composition of gastrointestinal tract toxicity caused by chemotherapy

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
李向中: "《中医学基础第2版》", 31 October 1978, 人民卫生出版社, pages: 245 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115944695A (en) * 2022-12-28 2023-04-11 广东好味鲜菜品与营养研究所 Composition with functions of soothing nerves, tonifying spleen and nourishing stomach and preparation method of granules of composition

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