CN116077602A - Dai medicine composition, medicine preparation, preparation method and application thereof - Google Patents
Dai medicine composition, medicine preparation, preparation method and application thereof Download PDFInfo
- Publication number
- CN116077602A CN116077602A CN202111304630.4A CN202111304630A CN116077602A CN 116077602 A CN116077602 A CN 116077602A CN 202111304630 A CN202111304630 A CN 202111304630A CN 116077602 A CN116077602 A CN 116077602A
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- dai
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Classifications
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Abstract
The invention discloses a Dai medicine composition, a medicine preparation, a preparation method and application thereof. The Dai medicine composition comprises the following raw material components in parts by weight: 5-30 parts of glabrous greenbrier rhizome, 5-25 parts of clerodendranthus spicatus, 5-25 parts of mango leaf, 5-25 parts of vine tea, 5-25 parts of radix glehniae, 5-25 parts of astragalus membranaceus, 5-25 parts of rhizoma corydalis, 5-25 parts of Dai grass corktree root and 2-25 parts of eclipta. The Dai medicine composition disclosed by the invention can obviously reduce the blood uric acid level of mice with hyperuricemia and has an obvious effect of treating gout.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a Dai medicine composition, a medicinal preparation, a preparation method and application thereof.
Background
Gout is a group of heterogeneous diseases with increased blood uric acid caused by purine metabolic disorder and/or uric acid excretion disorder, and has the clinical characteristics that gouty acute arthritis repeatedly attacks to form tophus, gouty chronic arthritis and joint deformity, and interstitial nephritis and uric acid kidney stones are caused. With the improvement of living standard and the change of dietary structure, the incidence rate of the traditional Chinese medicine has been increased year by year and has a tendency of younger, and the traditional Chinese medicine has become the second most metabolic disease next to diabetes in China and seriously threatens the health of human beings.
At present, dai medicine is still blank in the field of treating gout caused by high uric acid, and on the basis of summarizing the experience of comprehensive treatment success and failure, the invention follows the modern Dai medicine theory, and a large number of experimental researches prove that the Dai medicine composition for effectively treating gout caused by high uric acid is found.
Disclosure of Invention
In view of the above problems in the prior art, the present invention aims to provide a Dai medicine composition, a pharmaceutical preparation, and a preparation method and application thereof, which are used for solving the problems in the prior art.
To achieve the above and other related objects, the present invention is achieved by the following technical means.
The invention aims at providing a Dai medicine composition, which comprises the following raw material components in parts by weight:
5 to 30 parts of glabrous greenbrier rhizome
5-25 parts of clerodendranthus spicatus
5-25 parts of mango leaves
5-25 parts of vine tea
5-25 parts of glehnia root
5 to 25 portions of astragalus
5-25 parts of corydalis tuber
Dai grass coronet root 5-25 parts
2-25 parts of eclipta.
Preferably, 20-30 parts of glabrous greenbrier rhizome. More preferably, the smilax glabra may be 20 to 24 parts, 23 to 27 parts, or 26 to 30 parts.
Preferably 15-25 parts of clerodendranthus spicatus. More preferably, the clerodendranthus spicatus may be 15-19 parts, 18-23 parts, or 20-25 parts.
Preferably, 5-15 parts of mango leaves. More preferably, the mango leaves may be 5 to 9 parts, 8 to 12 parts, or 11 to 15 parts.
Preferably, 10-20 parts of vine tea. More preferably, the vine tea may be 10 to 14 parts, 13 to 17 parts, or 16 to 20 parts.
Preferably, 5-15 parts of glehnia root. More preferably, the glehnia root can be 5-11 parts, or 9-15 parts.
Preferably, astragalus root is 5-15 parts. More preferably, the astragalus root may be 5-11 parts, or 9-15 parts.
Preferably, 10-20 parts of rhizoma corydalis. More preferably, the amount may be 10 to 14 parts, 13 to 17 parts, or 16 to 20 parts.
Preferably, the Dai grass coronet root is 5-15 parts. More preferably, the Dai grass coronet root can be 5-9 parts, 8-12 parts or 11-15 parts.
Preferably, 2-10 parts of eclipta. More preferably, the eclipta may be 2 to 6 parts, or 5 to 9 parts, or 6 to 10 parts.
Preferably, the active ingredients of the raw material components are extracted to form a fluid extract or extract powder.
More preferably, the relative density of the fluid extract is 1.15-1.30 at 55-65 ℃. The relative densities of the present application were measured using densitometers.
More preferably, the relative density of the fluid extract is 1.15-1.20 at 55-65 ℃.
More preferably, the particle size of the extract powder is: the sum of the passing of the No. five sieves is not less than 90 percent. In the application, the granularity of the extract powder is too large and too small, and the requirement of the granule cannot be obtained by granulating. The granularity of the extract powder in the application is detected according to the method for determining the illumination granularity and granularity distribution specified in the "pharmacopoeia of the people's republic of China" 2020 edition, wherein the aperture of the fifth sieve is 180+/-7.6 mu m, and the mesh number is 80 meshes.
The second purpose of the invention is to provide a preparation method of the Dai medicine composition, which comprises the following steps:
1) Mixing the raw material components according to a proportion to obtain a raw material mixture;
2) Preparing an extracting solution of the raw material mixture, and concentrating into clear paste.
Preferably, the preparation method further comprises the steps of drying, crushing and sieving the fluid extract to obtain extract powder.
The Dai medicine composition can be concentrated or purified conventionally to obtain the clear paste after extracting the effective components. Methods of concentration include, but are not limited to: atmospheric pressure evaporation, reduced pressure evaporation, thin film evaporation and multiple effect evaporation; methods of purification include, but are not limited to: salting out purification, macroporous resin adsorption purification, ethanol precipitation purification, ion exchange resin purification, flocculation precipitation purification, membrane separation purification, polyamide adsorption purification, silica gel adsorption chromatography purification and the like;
and drying the fluid extract to obtain extract powder. Methods of drying include, but are not limited to: drying, drum drying, belt drying, moisture absorption drying, boiling drying, spray drying, reduced pressure drying, freeze drying, infrared drying, microwave drying, vacuum drying, etc.
Preferably, the preparation method of the extracting solution of the raw material mixture is an alcohol extraction method.
More preferably, the alcohol extraction method is that the raw material mixture is soaked in an aqueous solution of 20-70wt% ethanol which is 6-15 times of the raw material mixture by weight for 1-3 hours, then the mixture is refluxed for 0.5-1.5 hours, and the mixture is filtered to obtain an extracting solution.
Further preferably, the filtered filter residue is repeatedly refluxed for 1 to 5 times, and is combined with the filtrate to obtain the extracting solution.
Still more preferably, the filter residue is repeatedly refluxed 3 times.
The invention further aims to provide a pharmaceutical preparation of the Dai medicine composition, which consists of the Dai medicine composition and pharmaceutically acceptable auxiliary materials.
Preferably, the preparation is decoction, mixture, oral liquid, capsule, tablet or granule.
The granule has the following advantages: 1) In the pharmaceutical aspect, the scattering property, the adhesiveness, the aggregation property and the hygroscopicity of the granule are very small, so that the dosage can be well divided; 2) The Dai medicine composition-containing granules can not only keep the basis of the traditional decoction and syrup, but also overcome the trouble of decoction and are convenient to take; 3) The granule can be dissolved or suspended in water, so that the medicine is absorbed in the body, the medicine can play a role in quick effect, and compared with a liquid preparation, the granule has more stable property, and has advantages in aspects of taking, carrying, storing and the like; 4) The granule can also be added with some additives to make the taste more acceptable.
More preferably, the particle size of the granule is: the sum of the passage through the first sieve and the passage through the fifth sieve is not more than 15%. The granularity of the granule in the application is detected according to the method for determining the granularity and the granularity distribution specified in the "pharmacopoeia of the people's republic of China" 2020 edition, wherein the aperture of the first sieve is 2000+/-70 mu m, and the mesh number is 10 mesh; the pore diameter of the fifth sieve is 180+/-7.6 mu m, and the mesh number is 80.
More preferably, the granule comprises the extract powder and a binder; the mass ratio of the extract powder to the binder is 25: (3-14).
Further preferably, the binder is selected from one or more of dextrin, hydroxypropyl cellulose, copovidone.
Specifically, the binder is a mixture of dextrin and hydroxypropyl cellulose.
More specifically, the mass ratio of the dextrin to the hydroxypropyl cellulose is (2-10): 1.
Further preferably, the preparation method of the granule comprises the following steps: mixing the extract powder with a binder, and then carrying out dry extrusion granulation to obtain the granule.
Still more preferably, the rotation speed is 5 to 10rpm and the pressure is 8 to 10Mpa during extrusion granulation.
More preferably, the granule comprises the extract powder, excipient and wetting agent; the mass ratio of the extract powder to the excipient to the wetting agent is 25:20 (11-14).
Further preferably, the excipient is selected from one or both of dextrin and soluble starch.
Further preferably, the wetting agent is selected from ethanol.
Specifically, the concentration of the ethanol is 50-70 v/v%.
Further preferably, the preparation method of the granule comprises the following steps: and (3) carrying out wet granulation on the extract powder, the excipient and the wetting agent, and drying to obtain the granule.
The fourth object of the invention is to provide the use of the Dai medicine composition or the pharmaceutical preparation in preparing or as a medicine for treating gout.
Preferably, the Dai medicine composition of the invention is used in an amount selected from any one of the following:
1) Adding 10 times of water, soaking for 30min, decocting for three times, each time for 30min, mixing filtrates, concentrating to 600ml, and warm taking after meals;
2) Mixing the whole prescription, grinding the mixture into fine powder, orally taking 5-10 g each time, adding boiled water for oral taking three times a day;
3) Boiling the powder for 30 g/time, adding 200ml of boiled water, and boiling to obtain the tea beverage.
Preferably, for Dai medicine granules, the usage amount is as follows: the medicine is orally taken, 13g is taken each time, and 3 times a day.
Dai medicine composition and pharmaceutical preparation thereof in the application take 15 days as a treatment course.
The Dai medicine composition has remarkable treatment effect on gout caused by high uric acid in two aspects, and firstly, the Dai medicine composition has strong heat and dampness eliminating effect; secondly, gout is caused by excessive intake of thick paste of sorghum or high purine food of animal viscera, so that spleen and stomach functions are low, and transportation and transformation are not feasible, so that damp-producing patients need to be assisted with spleen-strengthening and stomach-benefiting medicines to strengthen body resistance and strengthen the root, and damp turbidity can be prevented from producing.
The Dai medicine composition takes glabrous greenbrier rhizome, clerodendranthus spicatus and mango leaves as main medicines, and the three medicines have the effects of tonifying earth, promoting diuresis, reducing acid, dredging three water channels, regulating and tonifying four towers, tonifying lung, spleen and kidney qi, reducing uric acid and relieving pain;
the vine tea, the astragalus root, the radix glehniae and the rhizoma corydalis are taken as auxiliary medicines, and are used for detoxifying and activating blood and assisting the main medicines to regulate qi and blood, so that the effects of promoting urination, dredging three channels and reducing uric acid are exerted;
dai grass coronet root is taken as a regulating medicine, has the effects of sexual temperature, entering a soil tower, tonifying soil, promoting diuresis, promoting qi circulation and relieving pain, and can also regulate the cold nature medicine in the prescription without damaging the soil tower;
eclipta as a drug primer is caused by the imbalance of water and fire towers, insufficient water towers and excessive fire towers, and has the effects of tonifying kidney, detoxifying and relieving pain, and can be introduced into the water towers to ensure that the drug has the maximum curative effect.
Compared with the prior art, the invention has the following beneficial effects:
(1) In clinical application, the Dai medicine composition has remarkable effects on limb joint redness, swelling, heat pain and deformation caused by uric acid increase, namely, chronic gouty arthritis.
(2) The Dai medicine composition prepared by the method is uniform in particles, high in forming rate and more convenient to use.
(3) The Dai medicine composition disclosed by the invention can obviously reduce the blood uric acid level of mice with hyperuricemia and has an obvious effect of treating gout.
(4) The Dai medicine composition contains main medicinal components such as polysaccharide, glycosides and flavonoid, the prepared extract powder is very easy to absorb moisture when placed in the air, dai medicine powder can be adhered to a rotating wheel of a granulator in the dry granulation process, the prepared Dai medicine powder has large hardness and long dissolution time, and multiple researches show that the granulating effect is relatively good when dextrin and hydroxypropyl cellulose are adopted as auxiliary materials.
Drawings
Fig. 1 is an external view showing granules prepared in example 2 of the present application.
Detailed Description
Further advantages and effects of the present invention will become apparent to those skilled in the art from the disclosure of the present invention, which is described by the following specific examples.
Before the embodiments of the invention are explained in further detail, it is to be understood that the invention is not limited in its scope to the particular embodiments described below; it is also to be understood that the terminology used in the examples of the invention is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the invention. The test methods in the following examples, in which specific conditions are not noted, are generally conducted under conventional conditions or under conditions recommended by the respective manufacturers.
Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In addition to the specific methods, devices, materials used in the embodiments, any methods, devices, and materials of the prior art similar or equivalent to those described in the embodiments of the present invention may be used to practice the present invention according to the knowledge of one skilled in the art and the description of the present invention.
In the embodiment of the application, the aperture of the first sieve is 2000+/-70 mu m, and the mesh number is 10 meshes; the pore diameter of the fifth sieve is 180+/-7.6 mu m, and the mesh number is 80.
Example 1
In this example, dai medicine composition was prepared, comprising the steps of:
1) The raw material components are mixed according to 5 parts of glabrous greenbrier rhizome, 5 parts of clerodendranthus spicatus, 5 parts of mango leaf, 5 parts of vine tea, 5 parts of radix glehniae, 5 parts of astragalus membranaceus, 5 parts of rhizoma corydalis, 5 parts of Dai semen amomum cardamomum root and 2 parts of eclipta, so as to obtain a raw material mixture.
2) Soaking the raw material mixture in ethanol with the concentration of 50wt% which is 10 times of the weight of the raw material mixture for 1h, refluxing for 1h, and filtering to obtain filtrate; the residue was then refluxed for 2 times repeatedly and the 3 filtrates were combined.
3) Concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.15 at 55-65deg.C, vacuum drying, pulverizing, and sieving with 80 mesh sieve to obtain extract powder.
Example 2
In this embodiment, the preparation of Dai medicine composition granules comprises the following steps:
the extract powder prepared in example 1, dextrin and hydroxypropyl cellulose are mixed according to the mass ratio of 25:10:4, mixing, adopting dry extrusion granulation, wherein the extrusion rotating speed is 5r/min, the extrusion pressure is 8Mpa, tabletting to obtain flaky solids, then finishing by a granulator, sieving, and obtaining the Dai medicine composition granules, wherein the sum of the granules and the powder which cannot pass through the No. 1 sieve and the No. 5 sieve cannot exceed 15%.
Example 3
In this example, pharmacodynamics evaluation was performed using the Dai medicine composition granules prepared in example 2
The granules of example 2 were ground into powder and then dissolved in water to form an injection.
The 48 mice are randomly divided into a blank group, a model group, a positive control group, a high-dose Dai medicine composition test group, a medium-dose Dai medicine composition test group and a low-dose Dai medicine composition test group, which are 6 groups. The blank group is injected with physiological saline solution by abdominal cavity, the rest 5 groups are molded by injecting potassium oxazinate by abdominal cavity, and the dosage of the potassium oxazinate is 300 mg.kg -1 Weight of the body. After molding for 1h, injecting physiological saline into the blank group and the model group through the abdominal cavity; the positive control group was intraperitoneally injected with allopurinol at a dose of 5 mg.kg -1 Weight of the body; the dosages of the high-dosage Dai medicine composition test group, the medium-dosage Dai medicine composition test group and the low-dosage Dai medicine composition test group are respectively 2.96 g.kg, 1.48 g.kg and 0.74 g.kg by intraperitoneal injection -1 Weight of the body.
Continuous administration for 7d, no water control was performed after 12h fasting before mice were sacrificed, blood was collected from cheeks 1h after administration on day 7, and the mass concentration of haematuria in serum of each group was measured according to uric acid kit (Nanjing institute of biological engineering 20180703) in mg.L -1 The results are shown in Table 1. Statistical analysis was performed using SPSS22.0 software, the measurement data were expressed as mean ± standard deviation, the t-test was used for the comparison of the mean of the two groups, and the results of the comparison of the effects of each group on hyperuricemia are shown in table 2.
TABLE 1
TABLE 2
Note that: compare 1) P <0.001 to the blank; comparison to model group 2) P <0.001,3) P <0.01.
From tables 1 and 2, the mass concentration of blood uric acid was significantly increased in the mice of the model group compared to the blank group (P < 0.001). Compared with the model group, the Dai medicine composition test groups with high dose, medium dose and low dose can obviously reduce the blood uric acid level (P < 0.001) in serum of hyperuricemia mice. The Dai medicine composition can obviously reduce the blood uric acid concentration of mice with hyperuricemia.
Example 4
In this example, dai medicine composition was prepared, comprising the steps of:
1) The raw material components are mixed according to 30 parts of glabrous greenbrier rhizome, 25 parts of clerodendranthus spicatus, 25 parts of mango leaf, 25 parts of vine tea, 25 parts of radix glehniae, 25 parts of astragalus membranaceus, 25 parts of rhizoma corydalis, 25 parts of Dai semen amomi rotundus root and 25 parts of eclipta alba to obtain a raw material mixture.
2) Soaking the raw material mixture in ethanol with the concentration of 50wt% and the weight of 10 times of the raw material mixture for 1h, refluxing for 1h, and filtering to obtain filtrate; the residue was then refluxed for 2 times. The filtrates were combined 3 times.
3) Concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.15 at 55-65deg.C, vacuum drying, and pulverizing into 80 mesh fine powder to obtain extract powder.
Example 5
In this example, dai medicine composition was prepared, comprising the steps of:
1) The raw material components are mixed according to 18 parts of glabrous greenbrier rhizome, 15 parts of clerodendranthus spicatus, 15 parts of mango leaf, 15 parts of vine tea, 15 parts of radix glehniae, 10 parts of astragalus membranaceus, 12 parts of rhizoma corydalis, 13 parts of Dai semen amomi rotundus root and 12 parts of eclipta alba to obtain a raw material mixture.
2) Soaking the raw material mixture in ethanol with the concentration of 50wt% and the weight of 10 times of the raw material mixture for 1h, refluxing for 1h, and filtering to obtain filtrate; the residue was then refluxed for 2 times. The filtrates were combined 3 times.
3) Concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.15 at 55-65deg.C, vacuum drying, and pulverizing into 80 mesh fine powder to obtain extract powder.
Example 6
In this embodiment, the Dai medicine composition granules are prepared by wet granulation, and are examined from three aspects of auxiliary material proportion, wetting agent screening and wetting agent dosage, and the method comprises the following steps:
in the embodiment of the present application, the extract powder obtained in the embodiment 1 is used as a raw material.
Inspection of extract powder, excipient and wetting agent
Mixing 25g of extract powder with 20g of excipient, then mixing with 70wt% ethanol water solution to prepare soft material, sieving with 16 mesh sieve, drying, and sieving with 16 mesh sieve to obtain Dai medicine composition granule. Wherein the excipient is dextrin, soluble starch and mixture of dextrin and soluble starch respectively.
The results were recorded using the ease of granulation, the state of granulation and the rate of granule formation as indicators. The results are shown in Table 3.
TABLE 3 Table 3
As is clear from Table 3, when wet granulation is carried out using dextrin alone or soluble starch alone as an excipient, the granule state is good and the granule forming rate is high.
(II) investigation of the wetting agent concentration
The excipient is dextrin and soluble starch respectively, 25g of extract and 20g of excipient are mixed uniformly, ethanol with concentration of 60wt%, 70wt% and 80wt% is used as wetting agent respectively to prepare soft materials, the soft materials are sieved by a 16-mesh sieve, and the soft materials are dried and sieved by the 16-mesh sieve to obtain the Dai medicine composition granules.
The results were recorded using the ease of granulation and the rate of granule formation as evaluation indicators. The results are shown in tables 4 and 5.
TABLE 4 Table 4
TABLE 5
As is clear from tables 4 and 5, 70wt% ethanol was used as a wetting agent, and the pellet state was good and the pellet forming rate was high.
(III) investigation of the amount of wetting agent
The preparation method comprises the steps of respectively taking dextrin and soluble starch as excipients, uniformly mixing 25g of extract powder and 20g of excipients, respectively taking ethanol with different mass concentrations of 70% as a wetting agent, preparing a soft material, sieving with a 16-mesh sieve, drying at the temperature of below 80 ℃, and sieving with a 16-mesh sieve to obtain the Dai medicine composition granules.
The results were recorded using the ease of granulation and the rate of granule formation as evaluation indicators. The results are shown in tables 6 and 7.
TABLE 6
TABLE 7
As can be seen from tables 6 and 7, the mass ratio of the extract powder to the dextrin was 25g:20g, and 13g of 70wt% ethanol as wetting agent; the mass ratio of the extract powder to the soluble starch is 25g:20g and 14g of 70wt% ethanol are used as wetting agents, and the granule forming rate is high when wet granulation is carried out.
From this example, the mass ratio of the extract powder to the dextrin was 25g:20g and 13g of 70wt% ethanol as wetting agent, drying by blowing at 80 ℃, and sieving with a 16-mesh sieve to obtain the Dai medicine composition granules with good appearance and molding rate. Alternatively, the mass ratio of the extract powder to the soluble starch is 25g:20g and 14g of 70wt% ethanol as wetting agent, drying by blowing at 80 ℃ and sieving with a 16-mesh sieve, wherein the prepared Dai medicine composition granules have good appearance and molding rate.
Example 7
In this example, the granulation of Dai medicine composition by fluidized spray method was examined from the two aspects of granulating the mixture of the water side spray extract powder and the excipient, and granulating the thick paste diluent side spray excipient, respectively, and comprises the following steps:
preparing extract powder:
the procedure is as in example 1.
Preparation of thick paste:
step 1) and step 2) are the same as in example 1.
The step 3) is as follows: concentrating the filtrate under reduced pressure to obtain a thick paste with relative density of 1.25-1.30 at 60 ℃.
Granulating the mixture of the water side spray extract powder and the excipient
100g of extract powder and 80g of excipient (dextrin and soluble starch respectively) are placed in a one-step granulator to be uniformly mixed, preheated, so that materials are in a boiling state in equipment, the frequency of a fan, the air inlet temperature, the opening degree of an air door, the atomization pressure and the liquid supply speed are regulated, when the temperature of the extract powder and the excipient reaches 50 ℃, purified water is sprayed on the side, and the extract powder and the excipient are dried, cooled to 35 ℃, discharged, sieved and granulated.
The results of the evaluation of the ease of granulation and the granule forming rate are shown in Table 8.
TABLE 8
As is clear from Table 8, the collapse phenomenon occurred during the test, which resulted in uneven particles and low particle formation rate. Since the molding rate of the excipient particles is higher by using dextrin as an excipient, the test is further carried out by using dextrin as an excipient and adjusting the process parameters.
100g of extract powder and 80g of dextrin are placed in a one-step granulator and uniformly mixed, and the steps are the same. The results are shown in Table 9.
TABLE 9
As is clear from Table 9, the collapse phenomenon still occurred after the parameters were adjusted, the particles were not uniform, and the particle forming rate was low.
Granulating the thick paste diluent by spraying excipient at side
A thick paste corresponding to 200g of extract powder was taken, and then diluted with water to give a mixture having a relative density of (1) 1.05 to 1.10 (60 ℃), (2) 1.10 to 1.15 (60 ℃), and (3) 1.15 to 1.20 (60 ℃), respectively, which was then sprayed onto 160g of excipient by side spraying. The temperature of the air inlet is regulated to 70 ℃, and the mixture is boiled, dried and granulated. The results are shown in Table 10.
Table 10
As can be seen from Table 10, the granulation process was not smooth and the granulation state was poor, and the granule forming rate was low by adjusting the relative densities.
In this example, the Dai medicine composition was found to have poor granule state and low granule forming rate when fluidized spray granulation was used. It is probably because the Dai medicine composition of the application has strong hygroscopicity, and the excipient and the Dai medicine composition are difficult to be mixed uniformly, so that fluidization spray granulation is not suitable.
Example 8
In the embodiment, the Dai medicine composition granules are prepared by adopting dry extrusion, and are examined from the three aspects of the types of the binders, the proportions of the binders and the granulating and forming process, and the Dai medicine composition granules comprise the following steps:
the extract powder obtained in example 1 was used as the raw material of the granule.
Investigation of the type of Binder
The mass ratio of the extract powder to the dextrin to the hydroxypropyl cellulose is 25:10:2, the mass ratio of the extract powder to the soluble starch to the hydroxypropyl cellulose is 25:10:2, the mass ratio of the extract powder to the dextrin to the copovidone S-630 is 25:10:2, the mass ratio of the extract powder to the soluble starch to the copovidone S-630 is 25:10:2, mixing, granulating by using a dry granulator, and granulating by using a granulator.
The results were recorded using the ease of granulation, the state of granulation and the rate of granule formation as indicators. The results are shown in Table 11.
TABLE 11 list of preferred results for adjuvants
As is clear from Table 11, when dextrin and hydroxypropyl cellulose were used as binders, the granulation was smooth, the granular state was uniform, and the molding rate was high.
Investigation of the proportion of Binder
The mass ratio of the extract powder to the dextrin to the hydroxypropyl cellulose is 50:20:8, the mass ratio of the extract powder to the dextrin to the hydroxypropyl cellulose is 50:20:4, respectively mixing, granulating by using a dry-method granulator, and granulating by using a granulator.
The mixture ratio of dextrin, hydroxypropyl cellulose and extract powder is screened by taking the granule forming rate and solubility as indexes. The results are shown in Table 12.
TABLE 12 influence of different excipients on granules
As can be seen from table 12, when the mass ratio of the extract powder, dextrin and hydroxypropyl cellulose is 25:10:2, the granulation result is better.
(II) screening of granulation and molding processes
The granule forming process was examined from the extrusion pressure and extrusion rate. Under the condition that the rotating speed of the fixed roller is 5r/min, the influence of different extrusion pressures on the molding rate is examined, and the result is shown in a table 13; the effect of different extrusion rates on the molding rate was examined under an extrusion pressure of 8Mpa, and the results are shown in table 14.
TABLE 13
TABLE 14
As can be seen from tables 13 and 14, the mass ratio of the extract powder, dextrin and hydroxypropyl cellulose was 25:10:2, after being mixed uniformly, adding the mixture into a dry granulator, adjusting the extrusion speed to be 5rpm, extruding the mixture under the pressure of 8Mpa, tabletting to obtain flaky solids, carrying out granulation by using a granulator, and finally sieving the flaky solids, wherein the sum of the granules and the powder which cannot pass through a No. 1 sieve and the granules and the powder which can pass through a No. 5 sieve is less than 15%, thus obtaining the Dai medicine composition granules.
On the basis of the results of the pilot study, an amplification study was performed to further verify the feasibility of the formulation process, and samples were prepared for quality and stability studies. The sample preparation is shown in Table 15.
Table 15 particle preparation
As shown in Table 15, the yield of the granules was over 90%, which proves that the forming process of the granules was stable and feasible.
Example 9
In this embodiment, a decoction of Dai medicine composition is prepared, including the following:
20 parts of glabrous greenbrier rhizome, 15 parts of clerodendranthus spicatus, 5 parts of mango leaf, 10 parts of vine tea, 5 parts of radix glehniae, 5 parts of astragalus membranaceus, 10 parts of rhizoma corydalis, 5 parts of Dai grass cardamom root and 2 parts of eclipta, adding 10 times of water, decocting for three times, each time for 30 minutes, combining the water decoctions, concentrating to 600ml, dividing into three times in the morning, the evening, and taking after meal.
Example 10
In this example, the mixture for preparing the Dai medicine composition comprises the following components:
1) 30 parts of glabrous greenbrier rhizome, 15 parts of clerodendranthus spicatus, 5 parts of mango leaf, 10 parts of vine tea, 15 parts of radix glehniae, 5 parts of astragalus membranaceus, 20 parts of rhizoma corydalis, 5 parts of Dai grass corktree root and 2 parts of eclipta alba are mixed to obtain a raw material mixture.
2) Soaking the raw material mixture in ethanol with the concentration of 50wt% which is 10 times of the weight of the raw material mixture for 1h, refluxing for 1h, and filtering to obtain filtrate; the residue was then refluxed for 2 times repeatedly and the 3 filtrates were combined.
3) Concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.15 at 55-65deg.C, and packaging to obtain mixture.
Example 11
In this embodiment, an oral liquid of Dai medicine composition is prepared, which includes the following steps:
mixing the fluid extract obtained in example 1 with water, filtering to remove impurities, filling with 15ml bottle, and sterilizing to obtain oral liquid.
Example 12
In this embodiment, the preparation of the Dai medicine composition capsule comprises the following steps:
and (3) filling capsules by using the granules in the embodiment 2 by using a capsule filling machine to obtain capsules.
Example 13
In this example, a tablet of Dai medicine composition was prepared, comprising the following:
the extract powder in example 1 was mixed with starch and magnesium stearate, and then tableted with a tablet press to obtain tablets.
The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.
Claims (10)
1. The Dai medicine composition is characterized by comprising the following raw material components in parts by weight:
5 to 30 parts of glabrous greenbrier rhizome
5-25 parts of clerodendranthus spicatus
5-25 parts of mango leaves
5-25 parts of vine tea
5-25 parts of glehnia root
5 to 25 portions of astragalus
5-25 parts of corydalis tuber
Dai grass coronet root 5-25 parts
2-25 parts of eclipta.
2. The Dai medicine composition according to claim 1, wherein the active ingredients of the raw material components are extracted to form a fluid extract or extract powder.
3. The Dai medicine composition according to claim 2, wherein the relative density of the said fluid extract is 1.15-1.30 at 55-65 ℃;
and/or, the granularity of the extract powder is as follows: the sum of the passing of the No. five sieves is not less than 90 percent.
4. A method for preparing a Dai medicine composition according to any one of the claims 1 to 3, wherein,
1) Mixing the raw material components according to a proportion to obtain a raw material mixture;
2) Preparing an extracting solution of the raw material mixture, and concentrating into clear paste.
5. The method according to claim 4, wherein the method for producing the extract of the raw material mixture is an alcohol extraction method;
and/or, the preparation method further comprises the steps of drying, crushing and sieving the clear paste to obtain extract powder.
6. A pharmaceutical preparation of a Dai medicine composition, which is characterized by comprising the Dai medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable auxiliary materials.
7. The pharmaceutical formulation of claim 6, wherein the formulation is a decoction, a mixture, an oral liquid, a capsule, a tablet, or a granule.
8. The pharmaceutical formulation of claim 7, wherein the granule comprises the extract powder of claim 2 and a binder; the mass ratio of the extract powder to the binder is 25: (3-14);
and/or the granule comprises the extract powder, excipient and wetting agent of claim 2; the mass ratio of the extract powder to the excipient to the wetting agent is 25:20 (11-14).
9. The pharmaceutical formulation of claim 8, wherein the granule has a particle size of: the sum of the first sieve and the fifth sieve is not more than 15%;
and/or the binder is selected from one or more of dextrin, hydroxypropyl cellulose and copovidone;
and/or the excipient is selected from one or two of dextrin and soluble starch;
and/or the wetting agent is selected from ethanol.
10. Use of a Dai medicine composition according to any one of claims 1 to 3 or a pharmaceutical formulation according to any one of claims 6 to 9 for the manufacture or use as a medicament for the treatment of gout.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920450A (en) * | 2016-05-04 | 2016-09-07 | 王维娜 | Traditional Chinese medicinal composition for treating gout and preparation method of traditional Chinese medicinal composition |
| CN109045229A (en) * | 2018-11-08 | 2018-12-21 | 黄闰月 | The Chinese medicine composition and preparation method thereof for treating urarthritis |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920450A (en) * | 2016-05-04 | 2016-09-07 | 王维娜 | Traditional Chinese medicinal composition for treating gout and preparation method of traditional Chinese medicinal composition |
| CN109045229A (en) * | 2018-11-08 | 2018-12-21 | 黄闰月 | The Chinese medicine composition and preparation method thereof for treating urarthritis |
Non-Patent Citations (1)
| Title |
|---|
| 张媛;徐红;: "复方芪苓配方颗粒对尿酸性肾病模型大鼠作用机制研究", 浙江中西医结合杂志, no. 05, pages 375 - 379 * |
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