CN114099446B - Ginseng stem and leaf total saponin preparation and preparation method thereof - Google Patents
Ginseng stem and leaf total saponin preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a ginseng stem and leaf total saponin preparation which is prepared from the following raw materials in parts by weight: 10-20 parts of ginseng stem and leaf total saponins, 10-20 parts of beta-cyclodextrin, 20-40 parts of slow release material, 40-60 parts of diluent and 0.1-0.5 part of adhesive. The ginseng stem and leaf total saponin preparation has obvious slow release effect through specific components and dosage proportion, reduces the administration frequency, reduces the dosage, obviously increases the administration compliance, reduces the side effect of the medicine and has practical popularization and application value compared with the common preparation in the prior art.
Description
Technical Field
The invention particularly relates to a ginseng stem and leaf total saponin preparation and a preparation method thereof.
Background
The ginseng stem and leaf total saponin is prepared from dry stem and leaf of ginseng, and has slightly odor and bitter taste. The main components of the ginseng saponin comprise ginsenoside Rg1, re, rc, rb2, rd and the like, and the ginseng saponin has the functions of nourishing and strengthening, tranquillizing and improving intelligence and enhancing immunity.
Ginseng resources are precious, and researches on ginseng stems and leaves show that the ginseng stems and leaves contain a large amount of ginseng stem and leaf saponins (about 7% -16%), and researches show that the structure and composition of a saponin monomer are almost consistent with those of ginseng roots, pharmacological activity of the saponin monomer is basically similar to that of ginseng roots, and ginseng stem and leaf total saponins preparations are sold in the market at present, such as ginseng stem and leaf total saponins capsules and tablets, are used for preventing or treating diseases, and meanwhile, as the ginseng stem and leaf total saponins have strong pharmacological activity, the ginseng stem and leaf total saponins are prepared into veterinary drugs for enhancing the immunity of livestock and poultry. However, the preparations are common preparations, and no research report on a ginseng stem and leaf total saponin slow release preparation exists at present.
Disclosure of Invention
In order to solve the problems, the invention provides a ginseng stem and leaf total saponin preparation which is prepared from the following raw materials in parts by weight:
10-20 parts of ginseng stem and leaf total saponins, 10-20 parts of cyclodextrin, 20-40 parts of slow release material, 40-60 parts of diluent and 0.1-0.5 part of adhesive.
Further, the material is prepared from the following raw materials in parts by weight:
10 parts of ginseng stem and leaf total saponins, 10 parts of cyclodextrin, 30 parts of slow-release material, 50 parts of diluent and 0.3-0.4 part of adhesive.
Further, the cyclodextrin is α -cyclodextrin, β -cyclodextrin, γ -cyclodextrin, hydroxypropyl- β -cyclodextrin, preferably β -cyclodextrin.
Further, the slow release material is sodium carboxymethyl cellulose, gelatin, agar, carrageenan; carrageenan is preferred.
Further, the binder is maltodextrin, sucrose, povidone K30, povidone K17, sodium carboxymethyl cellulose, preferably sodium carboxymethyl cellulose.
Further, the diluent is sucrose, glucose, sorbitol, mannitol, maltodextrin, lactose, preferably sorbitol.
Further, the material is prepared from the following raw materials in parts by weight:
10 parts of ginseng stem and leaf total saponins, 10 parts of beta-cyclodextrin, 30 parts of carrageenan, 50 parts of sorbitol and 0.32 part of sodium carboxymethyl cellulose.
The invention also provides a preparation method of the ginseng stem and leaf total saponin preparation, which comprises the following steps:
1) Weighing the raw materials according to the proportion; taking beta-cyclodextrin, and adding water to prepare saturated beta-cyclodextrin solution; taking an adhesive, and adding water to prepare an adhesive solution with the concentration of 1-3%;
2) Dissolving total saponins of caulis et folium Ginseng in ethanol, adding saturated beta-cyclodextrin solution obtained in step 1), stirring until no ethanol exists, standing, collecting precipitate, and oven drying to obtain total saponins clathrate of caulis et folium Ginseng;
3) Mixing the total saponin clathrate of caulis et folium Ginseng obtained in step 2), herba Chenopodii gum and sorbitol, adding the binder solution obtained in step 1), stirring, granulating, sieving, and oven drying.
Further, the concentration of the binder solution was 2%.
Further, in the step 2), the mass volume ratio of the beta-cyclodextrin to the ethanol is 1g:50ml; the temperature of the saturated beta-cyclodextrin solution is 40 ℃; the stirring temperature is 40 ℃; the standing temperature is 0 ℃, and the time is when all the precipitate is separated out; the temperature of the drying is 60 ℃.
Further, in the step 3), the sieving is carried out by a No. 3 sieve, and the temperature of drying is 60 ℃.
The ginseng stem and leaf total saponin preparation has obvious slow release effect through specific components and dosage proportion, reduces the administration frequency, reduces the dosage, obviously increases the administration compliance, reduces the side effect of the medicine and has practical popularization and application value compared with the common preparation in the prior art.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Detailed Description
EXAMPLE 1 preparation of the medicament of the invention
The formula comprises the following components: 10g of ginseng stem and leaf total saponins, 10g of beta-cyclodextrin, 30g of carrageenan, 50g of sorbitol and 0.32g of sodium carboxymethyl cellulose.
The preparation method comprises the following steps:
1) Weighing the raw materials according to the proportion; adding water into beta-cyclodextrin to prepare saturated beta-cyclodextrin solution, and heating to 40 ℃ for standby; adding water into sodium carboxymethyl cellulose to prepare sodium carboxymethyl cellulose solution with the concentration of 2%;
2) Dissolving total saponins of caulis et folium Ginseng in 50 times v/w, ml/g of anhydrous ethanol, adding saturated beta-cyclodextrin solution of 40deg.C obtained in step 1), stirring at 40deg.C until no ethanol exists, standing at 40deg.C until precipitation is completely separated out, collecting precipitate, and oven drying at 60deg.C to obtain total saponins clathrate of caulis et folium Ginseng;
3) Mixing the total saponin clathrate of ginseng stem and leaf obtained in the step 2), cross vegetable gum and sorbitol, adding the sodium carboxymethyl cellulose solution obtained in the step 1), stirring, granulating, sieving with No. 3 sieve, and oven drying at 60deg.C.
EXAMPLE 2 preparation of the medicament of the invention
The formula comprises the following components: 20g of ginseng stem and leaf total saponins, 20g of beta-cyclodextrin, 40g of carrageenan, 60g of sorbitol and 0.5g of sodium carboxymethyl cellulose.
The preparation method comprises the following steps: same as in example 1
EXAMPLE 3 preparation of the medicament of the invention
The formula comprises the following components: 15g of ginseng stem and leaf total saponins, 15g of beta-cyclodextrin, 30g of carrageenan, 50g of sorbitol and 0.2g of sodium carboxymethyl cellulose.
The preparation method comprises the following steps: same as in example 1
EXAMPLE 4 preparation of the medicament of the invention
The formula comprises the following components: 10g of ginseng stem and leaf total saponins, 10g of beta-cyclodextrin, 20g of carrageenan, 40g of sorbitol and 0.1g of sodium carboxymethyl cellulose.
The preparation method comprises the following steps: same as in example 1
The advantageous effects of the present invention are described below by way of test examples.
Test example 1 study of Total saponins of Ginseng Stem and leaf sustained-release preparation
The ginseng stem leaf total saponin is prepared by processing dried stem leaves of ginseng of Araliaceae, and is prepared by cutting ginseng stem leaves into 1-2cm sections, decocting with water twice for 2 hr for the first time and 1.5 hr for the second time, filtering decoction, mixing filtrates, passing through D101 macroporous adsorption resin, eluting with water to colorless, eluting with 60% ethanol, collecting 60% ethanol eluate, concentrating filtrate to obtain fluid extract with relative density of 1.06-1.08 (80deg.C), drying, and pulverizing. Total saponins of ginseng stems and leaves can also be obtained by commercial purchase. The prepared or purchased total saponins of ginseng stem and leaf are yellow-white, light yellow or white amorphous powder; slightly stinky, bitter; has hygroscopicity, is soluble in methanol or ethanol, is soluble in water, and is hardly soluble in diethyl ether or petroleum ether. The main components of the ginseng saponin comprise ginsenoside Rg1, re, rc, rb2, rd and the like, and the ginseng saponin has the functions of nourishing and strengthening, tranquillizing and improving intelligence and enhancing immunity. The product is converted into veterinary drugs for enhancing the immunity of livestock and poultry. The slow release technology is widely applied to the aspects of pharmaceutical preparations and the like, but the literature report for the traditional Chinese medicine preparations is relatively few, so that the test is tried in the aspect of slow release of total saponins of ginseng stems and leaves.
1 Material
1.1 reagents
Total saponins of caulis et folium Ginseng with a content of 85.4%, and biological technology limited company of Shanxi, shanxi; ginseng saponin Re reference, chinese food and drug verification institute; beta-cyclodextrin, absolute ethanol, adult coumarone chemical company; sucrose, glucose, sorbitol, mannitol, maltodextrin, lactose, anhui mountain river pharmaceutical excipients Co.
1.2 instruments
UV-1800PC type ultraviolet spectrophotometer, shanghai Meinada instruments Co., ltd; a Sidoris analytical balance, sidoris China; tablet four-purpose instrument, shanghai yellow sea drug testing equipment limited company; ultrasonic apparatus, shanghai Kunshan instruments Co., ltd.
2 methods and results
2.1 method for measuring total saponins content of ginseng stem and leaf
Preparing reference solution, precisely weighing appropriate amount of ginsenoside Re reference, and adding methanol to obtain solution containing 1mg per 1 ml.
Preparation of a standard curve, precisely sucking 20 μl, 40 μl, 80 μl, 120 μl, 160 μl and 200 μl of the reference solution, respectively placing into test tubes with plugs, volatilizing the solvent at low temperature, adding 0.5ml of 1% vanillin perchloric acid test solution, placing into a 60 ℃ constant temperature water bath, fully mixing, heating for 15 min, immediately cooling with ice water for 2 min, adding 5ml of 77% sulfuric acid solution, and shaking; the absorbance was measured at 540nm wavelength by ultraviolet-visible spectrophotometry with the corresponding reagent as blank, and the absorbance as ordinate and the concentration as abscissa to draw a standard curve.
The measuring method is to take about 50mg of total saponins of ginseng stem and leaf, precisely weigh, put into a 25ml measuring flask, add a proper amount of methanol to dissolve and dilute to scale, shake uniformly, precisely measure 50ml, and operate according to the method under the standard curve preparation item from 'putting into a test tube with a plug', measure absorbance, read out the amount of ginsenoside Re in the test sample solution from the standard curve, multiply the calculated result by 0.84, and obtain the ginseng stem and leaf total saponins.
The sample contains ginsenoside Re (C) 48 H 82 O 18 ) The meter should be
The actual measurement value of the total saponin raw material content of ginseng stem and leaf in the experiment is 85.2%.
2.2 preparation of the Total saponins clathrate of Ginseng Stem and leaf
2.2.1 inclusion method 1
Weighing 1g of ginseng stem leaf total saponins, adding into a 200ml beaker, adding 50ml of absolute ethyl alcohol to dissolve, raising the temperature to 40 ℃, slowly dripping a saturated beta-cyclodextrin solution at 40 ℃ in the stirring process, keeping the solution clear, keeping the temperature and stirring until no ethanol smell exists, collecting the solution, placing the solution into a refrigerator at 0 ℃, standing the solution in the refrigerator until the beta-cyclodextrin is separated out, collecting and drying the precipitate (60 ℃) until the precipitate is dried to obtain ginseng stem leaf total saponins inclusion compound, filtering the solution to measure the content of ginseng stem leaf total saponins, and recording the difference between the content of ginseng stem leaf total saponins and the added content as the included ginseng stem leaf total saponins. As a result, it was found that the solution was saturated when about 3.5% (g/v) of beta-cyclodextrin was added to water at 40℃as shown in Table 1.
2.2.2 inclusion method 2
Weighing 1g of beta-cyclodextrin, adding into a 200ml beaker, adding a proper amount of water, raising the temperature to 60 ℃ to dissolve, slowly dripping a ginseng stem and leaf total saponin solution at 60 ℃ in the stirring process, collecting the solution, placing into a refrigerator at 0 ℃, collecting precipitate, drying the precipitate (60 ℃) to obtain a ginseng stem and leaf total saponin inclusion compound, filtering out the solution, determining the content of ginseng stem and leaf total saponins, and recording the difference between the content of ginseng stem and leaf total saponins and the added content as the included ginseng stem and leaf total saponins. The results are shown in Table 1.
TABLE 1 preparation of clathrate
From Table 1, it can be seen that the inclusion ratio of total saponins of ginseng stem and leaf and beta-cyclodextrin is not greatly different after 1:1, so that in the subsequent experiment, the ratio of total saponins of ginseng stem and leaf to beta-cyclodextrin is 1:1, and the inclusion ratio of method 1 is higher than that of method 2.
2.3 preparation of sustained release particles
2.3.1 diluent selection
The sucrose, glucose, sorbitol, mannitol, maltodextrin, lactose and total saponins of ginseng stem and leaf inclusion compound are respectively mixed uniformly according to the proportion of 98:2, 1g of the mixture is respectively added into 100ml of water (28 ℃), the mixture is placed into a stirrer to be stirred until the mixture is dissolved, the time for completely dissolving the various mixtures is recorded, and as a result, the dissolution speed of other diluents except sorbitol is not greatly different, but the dissolution speed of the sucrose, glucose and maltodextrin is relatively fast, and as the aim of the test is to prepare slow release granules, the sorbitol is selected as the diluent, and the result is shown in table 2.
TABLE 2 diluent selection
| Type of diluent | Dissolution time (min) |
| Sucrose | 1.4 |
| Glucose | 1.4 |
| Sorbitol | 2.8 |
| Mannitol (mannitol) | 1.6 |
| Maltodextrin | 1.4 |
| Lactose and lactose | 1.6 |
2.3.2 Water addition selection
Taking 100g of sorbitol, taking 2g (2%) as a gradient, adding and stirring the sorbitol to particles from 10g, drying the sorbitol, measuring the sorbitol according to a particle size detection method carried in Chinese animal pharmacopoeia, recording the particle size passing through a 10-mesh screen and a 65-mesh screen, and selecting the water adding amount with the smallest particle size as the water adding amount of the test, wherein the water adding amount is 16% as shown in Table 3.
TABLE 3 selection of Water addition
| Water addition (%) | Particle size (%) |
| 12 | 33 |
| 14 | 31 |
| 16 | 26 |
| 18 | Difficult granulation (strip) |
| 20 | Cannot be granulated |
2.3.3 selection of adhesive
As the ginseng stem and leaf total saponin particles are considered to be water-soluble particles, maltodextrin, sucrose, povidone K30, povidone K17, sodium carboxymethyl cellulose and other water-soluble binders are selected as binders for the test, 2g of ginseng stem and leaf total saponin inclusion compound and 96g of sorbitol are uniformly mixed, 16g of water is added into 2g of binder (except sodium carboxymethyl cellulose) to prepare pulp, the pulp is stirred into particles, the particles are dried, the solubility (water temperature 27 ℃) and the particle size of the particles are measured, and as a result, the sodium carboxymethyl cellulose is the slowest to dissolve as the particles prepared by the binder, and the particle size of the particles is optimal, so that the sodium carboxymethyl cellulose is selected as the binder for the test, and the dosage is optimized, so that the addition amount of the test is 2.0%, which is shown in tables 4-5.
Table 4 adhesive selection
TABLE 5 selection of sodium carboxymethylcellulose addition
2.3.4 sustained Release Material selection
The test uses simple and easily obtained materials of carboxymethyl cellulose sodium, gelatin, agar and carrageenan which are taken into consideration as alternative materials, 10% of the materials are respectively added into and prepared into granules, 2% of carboxymethyl cellulose sodium is used as an adhesive, 2% of total saponins of ginseng stems and leaves are used as sorbitol, the other materials are used as sorbitol, the water addition amount is 16% of the materials are prepared into granules, the granules are dried and the release degree is measured according to the method of loading in Chinese pharmacopoeia, in order to control the detection limit of total saponins of ginseng stems and leaves, 0.1mol/L hydrochloric acid solution is adjusted to 100ml, sampling is carried out every 1 hour, continuous sampling is carried out for 12 hours, and the slow release material with the release degree of more than 80% and the longest time within 12 hours is selected as the slow release material of the test, and the slow release material is shown in Table 6.
Table 6 sustained release material selection
| Sustained release material | Releasing more than 80% of the time (h) |
| Sodium carboxymethyl cellulose | 5 |
| Gelatin | 4 |
| Agar-agar | 4 |
| Carrageenan gum | 6 |
| Blank control | 3 |
As can be seen from Table 6, the carrageenan was the best for this test, and the amount of carrageenan added was 30% by the amount optimization test, as shown in Table 7.
TABLE 7 selection of carrageenan dosage
2.4 verification test
2.4.1 particle preparation
2.4.1.1 preparing the slow-release granules, taking 20g of ginseng stem and leaf total saponin inclusion compound (approximately equivalent to 10g of ginseng stem and leaf total saponin), 30g of cross vegetable gum and 50g of sorbitol, uniformly stirring for standby, taking 16ml of 2% sodium carboxymethylcellulose, adding into uniformly mixed powder, stirring to prepare granules, sieving with a No. 3 sieve, and drying at 60 ℃ to obtain the ginseng stem and leaf total saponin inclusion compound.
2.4.1.2 the preparation method comprises mixing 10g of total saponins of caulis et folium Ginseng with 90g of sorbitol, stirring, adding 16ml of 2% sodium carboxymethylcellulose into the mixed powder, stirring, sieving with No. 3 sieve, and oven drying at 60deg.C.
2.4.2 verification of sustained Release Effect
2.4.2.1 preparation of feed for test
Pulverizing the feed, mixing with total saponin granules of ginseng stem and leaf (1:1) uniformly, and pressing into tablet with the same hardness as the original pellet feed for later use.
2.4.2.2 test of Effect of 2 on spleen factor of mice
Taking 30 mice, namely, male and female mice, wherein the weight of the mice is 28-24g, and the mice are divided into 3 groups, namely, 10 mice in each group, namely, male and female mice, a slow-release granule group, a common granule group and a control group, wherein the common granule group is fed with a feed containing total saponins of ginseng stems and leaves; the slow-release particles are alternately used with common feed containing total saponins of ginseng stem and leaf slow-release particles at intervals of one day; the control group is continuously fed with common feed for 7 days, water and feed are cut off 3 hours before the mice are killed on the 8 th day, spleen and the weight of the mice are weighed after the mice are killed, the ratio of the weight of the spleen to the weight of the mice is the spleen coefficient, the average spleen coefficient of the common particle group is more than or equal to 2 times of that of the control group, the test data are valid, the result test shows that the average spleen coefficient (2.31+/-0.21) of the common particle group is 2.06 times of that of the control group (1.12+/-0.11), the average spleen coefficient (2.47+/-0.17) of the slow release particle group is slightly better than that of the common particle group (2.31+/-0.21) and is 2.12+/-0.11) of that of the control group, but the dosage of the slow release particles is 50% of that of the common particle, and therefore, the particles prepared by the invention can slow release the ginseng stem leaf total saponins, and achieve the slow release effect, as shown in table 8.
Table 8 verification of sustained release effect
In conclusion, the total saponins of ginseng stem and leaf have obvious slow-release effect through specific components and dosage proportion, compared with the common preparation, the administration frequency is reduced, the administration dosage is also reduced, the administration compliance is obviously improved, the side effect of the medicine is reduced, and the invention has practical popularization and application value.
Claims (6)
1. A ginseng stem and leaf total saponin preparation is characterized in that: the material is prepared from the following raw materials in parts by weight:
10 parts of ginseng stem and leaf total saponins, 10 parts of cyclodextrin, 30 parts of slow-release material, 50 parts of diluent and 0.3-0.4 part of adhesive;
the cyclodextrin is beta-cyclodextrin;
the slow release material is carrageenan;
the adhesive is sodium carboxymethyl cellulose;
the diluent is sorbitol.
2. The ginseng stem and leaf total saponin preparation according to claim 1, wherein: the material is prepared from the following raw materials in parts by weight:
10 parts of ginseng stem and leaf total saponins, 10 parts of beta-cyclodextrin, 30 parts of carrageenan, 50 parts of sorbitol and 0.32 part of sodium carboxymethyl cellulose.
3. A method for preparing the ginseng stem and leaf total saponin preparation as defined in claim 1 or 2, which is characterized in that: it comprises the following steps:
1) Weighing the raw materials according to the proportion of claim 1; taking beta-cyclodextrin, and adding water to prepare saturated beta-cyclodextrin solution; taking an adhesive, and adding water to prepare an adhesive solution with the concentration of 1-3%;
2) Dissolving total saponins of caulis et folium Ginseng in ethanol, adding saturated beta-cyclodextrin solution obtained in step 1), stirring until no ethanol exists, standing, collecting precipitate, and oven drying to obtain total saponins clathrate of caulis et folium Ginseng;
3) Mixing the total saponin clathrate of caulis et folium Ginseng obtained in step 2), herba Chenopodii gum and sorbitol, adding the binder solution obtained in step 1), stirring, granulating, sieving, and oven drying.
4. A method of preparation according to claim 3, characterized in that: the concentration of the binder solution was 2%.
5. A method of preparation according to claim 3, characterized in that: the mass volume ratio of the beta-cyclodextrin to the ethanol in the step 2) is 1g:50ml; the temperature of the saturated beta-cyclodextrin solution is 40 ℃; the stirring temperature is 40 ℃; the standing temperature is 0 ℃, and the time is when all the precipitate is separated out; the temperature of the drying is 60 ℃.
6. A method of preparation according to claim 3, characterized in that: and 3) sieving the mixture in the step 3) to obtain a No. 3 sieve, wherein the temperature of drying is 60 ℃.
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Denomination of invention: A Panax ginseng stem and leaf total saponin preparation and its preparation method Effective date of registration: 20230629 Granted publication date: 20230523 Pledgee: Wenjiang Branch of Bank of China Ltd. Pledgor: CHENGDU QIANKUN VETERINARY PHARMACEUTICAL CO.,LTD. Registration number: Y2023980046898 |