CN110870903A - Yam formula particle and preparation method and application thereof - Google Patents
Yam formula particle and preparation method and application thereof Download PDFInfo
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- CN110870903A CN110870903A CN201811004851.8A CN201811004851A CN110870903A CN 110870903 A CN110870903 A CN 110870903A CN 201811004851 A CN201811004851 A CN 201811004851A CN 110870903 A CN110870903 A CN 110870903A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention belongs to the technical field of traditional Chinese medicine formula granules, and discloses a Chinese yam formula granule as well as a preparation method and application thereof. The yam formula particle comprises an active ingredient yam and pharmaceutically acceptable auxiliary materials, wherein the content of the yam is 250-800 mg/g, and the pharmaceutically acceptable auxiliary materials comprise one, two or more fillers. The intermediate of the yam formula granule is evenly mixed with auxiliary materials and granulated to prepare the yam formula granule. The invention adopts spray drying and dry granulation processes, strictly controls the process step parameters, improves the cream yield of the yam decoction pieces, and has high content of effective components and small dosage in the prepared formula granules. The quality of the finished granular product is excellent, and the product quality conforms to the regulation of Chinese pharmacopoeia, which is specifically represented by the following steps: the granule has uniform particle size, high alcohol-soluble extract content, low content of impurities and fungi (aerobic bacteria, fungi and saccharomycetes, Escherichia coli, etc.), high product stability, and easy storage.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine formula granules, and particularly relates to a Chinese yam formula granule as well as a preparation method and application thereof.
Background
The rhizoma Dioscoreae is dried rhizome of Dioscorea opposita Thunb of Dioscoreaceae. Picking in winter after stem and leaf withering, cutting off root head, cleaning, removing outer skin and fibrous root, drying, or cutting into thick slices while it is fresh, and drying; optionally selecting dry rhizoma Dioscoreae, soaking in clear water until there is no dry core, sealing, cutting, rubbing with wood plate into cylinder, sun drying, and polishing, and is called "Dioscorea Opposita". The processing should meet the relevant regulations under the item of "processing" in the first part of the 2015 pharmacopoeia. The yam has the effects of tonifying spleen and nourishing stomach, promoting the production of body fluid and benefiting lung, and tonifying kidney and arresting seminal emission; can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, and diabetes due to deficiency heat.
The traditional Chinese medicine formula granule is a granule prepared by taking traditional Chinese medicine decoction pieces processed according to specifications as raw materials under the guidance of traditional Chinese medicine theory. The Chinese medicinal composition can be clinically and flexibly prepared and taken after being mixed with water, can also be used as an industrial raw material of a Chinese medicinal preparation, and provides a new way for clinical medication of Chinese medicaments. Compared with the traditional Chinese medicine decoction, the formula granules can be directly used for blending the traditional Chinese medicine clinical prescription, and the patient can directly take the formula granules with water according to the prescribed dosage of the prescription, so that the traditional Chinese medicine decoction is convenient to take, small in dosage, controllable in quality, easy to store and convenient to carry.
Disclosure of Invention
The invention provides a Chinese yam formula particle which comprises an active ingredient Chinese yam and pharmaceutically acceptable auxiliary materials, wherein the content of the Chinese yam is 250-800 mg/g, preferably 300-800 mg/g, and more preferably 400-600 mg/g.
According to the present invention, the pharmaceutically acceptable excipients include one, two or more fillers, for example, at least one selected from the group consisting of starch, dextrin, sucrose, lactose, mannitol, xylitol and a bifidobacterium; preferably, the filler is selected from starch, dextrin, sucrose or lactose; illustratively, the filler is selected from dextrins.
According to the invention, the particle size of the yam formula particles is 10-100 meshes, such as 10-80 meshes and 30-50 meshes. Preferably, the total amount of the yam formula particles which can not pass through a No. 1 sieve (10 meshes) and can pass through a No. 5 sieve (80 meshes) does not exceed 15 percent of the test amount; e.g., no more than 10%, 5%; preferably, between 3.2 and 4.6%.
According to the invention, the water content of the yam formula particles is 4.0-10.0 wt%; for example, 4.5 to 9.0 wt%, 4.8 to 8.0 wt%.
According to the invention, the alcohol-soluble extract of the yam formula particle is not less than 9.0 wt%; for example, not less than 9.5 wt%, not less than 10.0 wt%, not less than 11.0 wt%. Preferably, the content of the alcohol-soluble extract is 9.2-10.8 wt%.
According to the invention, the yam formula granule further comprises a packaging bag or a packaging box for containing the granule, such as a composite film bag; illustratively, the composite film bag may be selected from composite aluminum foil bags.
According to the invention, the specification of the yam prescription granule is that every 1g of prescription granule is equivalent to 5g of yam decoction pieces.
According to the invention, the packaging specification of the yam formula granules can have various specifications, such as 1-20 g, and exemplarily, the specifications are 1g, 2g, 3g, 5g, 6g, 10g, 12g, 15g and 20 g.
Further, the invention also provides a preparation method of the yam formula particle, which comprises the following steps: and mixing the intermediate of the yam formula particle with auxiliary materials, and granulating to obtain the yam formula particle.
According to the preparation method, the intermediate of the yam formula particle is obtained through the following steps: adding adjuvants into the fluid extract, mixing, and spray drying to obtain rhizoma Dioscoreae granule intermediate.
According to the preparation method of the invention, the clear paste is obtained by the following steps: soaking rhizoma Dioscoreae pieces, decocting, filtering, and concentrating the filtrate to obtain fluid extract.
According to the embodiment of the invention, the preparation method of the yam formula particle specifically comprises the following steps:
(1) preparing an intermediate of the yam formula particle: soaking rhizoma Dioscoreae pieces, decocting, filtering, concentrating the filtrate to obtain fluid extract, adding adjuvants into the fluid extract, mixing, and spray drying to obtain rhizoma Dioscoreae granule intermediate;
(2) preparing the yam formula granules: and mixing the intermediate and auxiliary materials uniformly, and performing dry granulation to obtain a finished product.
According to the preparation method, in the step (1), Chinese yam decoction pieces are added into water during soaking, and the mass ratio of the Chinese yam decoction pieces to the water is 1 (8-15); preferably, the mass ratio is 1 (8-12); illustratively, the mass ratio is 1: 10;
the soaking time is 20-40 minutes, preferably 25-35 minutes, and exemplarily 30 minutes;
the water is preferably purified water, such as distilled water, deionized water or pharmaceutical water prepared by reverse osmosis.
According to the preparation method of the present invention, in the step (1), the decoction and filtration are performed at least twice cyclically, for example, twice, three times or more cyclically; before decocting, heating water to boil, and then decocting with slow fire;
illustratively, when the decoction and filtration are circularly operated twice, the first decoction is carried out for 20-40 minutes, preferably 25-35 minutes, illustratively 30 minutes, and then filtration is carried out to obtain a filtrate I and a residue I; in the second decoction, water is added into the first decoction dregs, wherein the amount of the water is 7-10 times, for example 8 times, the weight of the yam decoction pieces, the decoction is carried out for 20-40 minutes, preferably 25-35 minutes, for example 30 minutes, and then the filtration is carried out to obtain a second filtrate and second decoction dregs.
According to the preparation method, in the step (1), the hot filtering is carried out, preferably, the hot filtering is carried out by using a 80-120-mesh sieve, for example, a 80-mesh sieve, a 100-mesh sieve and a 120-mesh sieve.
According to the preparation method of the invention, in the step (1), the filtrate is a combination of filtrates obtained by multiple times of filtration, for example, a combination of filtrate one and filtrate two.
According to the preparation method of the invention, in the step (1), the concentration mode can adopt reduced pressure concentration; preferably, concentrating until the relative density of the clear paste is 1.05-1.25; preferably, the relative density is 1.10 to 1.15, such as 1.10, 1.12, 1.15; the relative density of the clear paste is measured at the temperature of 60-70 ℃, preferably at the temperature of 65 ℃.
According to the preparation method, in the step (1), the mass ratio of the clear paste to the auxiliary materials is (1-4): 1; for example 1:1, 2:1, 3:1, 4: 1.
According to the preparation method of the invention, in the step (1), the temperature of the spray drying is as follows: the air inlet temperature is 115-130 ℃, and the air outlet temperature is 80-95 ℃; preferably, the air inlet temperature is 120-130 ℃, and the air outlet temperature is 85-95 ℃; illustratively, the inlet air temperature is 127 ℃ and the outlet air temperature is 90 ℃.
According to the preparation method, the moisture content of the intermediate of the yam formula particle is not more than 8.0 wt%; for example, not more than 5 wt%; preferably, the moisture content is 4.2 to 4.8 wt%.
According to the preparation method, the content of alcohol-soluble extract of the intermediate of the yam formula particle is not lower than 15 wt%; for example, not less than 16 wt%; preferably, the content of the alcohol-soluble extract is 16.0-18.2 wt%.
According to the preparation method, in the step (2), the mass ratio of the intermediate to the auxiliary materials is (1-4): 1; for example 1:1, 2:1, 3:1, 4: 1.
According to the preparation method of the invention, in the step (2), the uniformly mixed clear paste and the auxiliary materials are sieved before spray drying, preferably, the sieved clear paste and the auxiliary materials are sieved by a sieve of 80-120 meshes, for example, a sieve of 80 meshes, a sieve of 100 meshes and a sieve of 120 meshes.
According to the preparation method of the invention, in the step (2), the dry granulation can adopt the conventional operation in the field, firstly, the material block is continuously compacted by rolling, and the finished product of the granules is obtained after the material block is sized and sieved;
wherein, the operation conditions of the dry granulation are as follows: the roller pressure is 2-3 MPa, the tabletting frequency is 16-25 Hz, and the feeding frequency is 12-18 Hz. For example, the roller pressure is 2.3-2.7 MPa, the tabletting frequency is 18-22 Hz, and the feeding frequency is 13-16 Hz. Illustratively, the roll pressure is 2.5MPa, the sheeting frequency is 20Hz, and the feed frequency is 15 Hz.
Wherein the sieving is to sieve by a sieve of 10-30 meshes; preferably through a 20 mesh screen.
According to the preparation method, the method also comprises the step (3) of preparing the yam standard decoction.
The step (3) specifically comprises the following operations: soaking rhizoma Dioscoreae pieces, decocting, filtering, concentrating the filtrate, and freeze drying to obtain lyophilized powder as standard decoction;
wherein the operations of soaking, decocting and filtering are the same as the operations in the step (1);
wherein the filtrate is concentrated to a relative density of 1.10-1.25; preferably, the relative density is 1.12-1.15, 1.20-1.25, such as 1.11, 1.13, 1.15; the relative density is measured at a temperature of 60 to 70 ℃, preferably at a temperature of 65 ℃. Preferably, the concentration can be performed by low-temperature reduced-pressure concentration.
Wherein the freeze-drying conditions are as follows: the temperature is minus 50 ℃ to 45 ℃, and the vacuum degree is 5 Pa to 50 Pa; preferably, the temperature is-40 ℃ to 15 ℃, and the vacuum degree is 10Pa to 30 Pa; illustratively, the temperature is-25 ℃ and the vacuum is 10 Pa.
According to the preparation method of the invention, the method further comprises the following steps (4) of packaging: sealing and packaging the yam formula particles obtained in the step (2); preferably, the packaging may use a packaging bag or box, such as a composite film bag; illustratively, the composite film bag may be selected from composite aluminum foil bags.
Further, the invention also provides the yam formula granules prepared by the preparation method.
Furthermore, the invention also provides a preparation which comprises the yam formula particles.
Furthermore, the invention also provides application of the yam formula particles in preparation of compound medicines.
The invention has the beneficial effects that:
1. the spray drying and dry granulation processes are adopted, the process step parameters are strictly controlled, the paste yield of the yam decoction pieces is improved, and the prepared formula particles have high content of effective components and small dosage.
2. The finished product quality of the yam formula granule is excellent, and the product quality accords with the regulation of Chinese pharmacopoeia, which is specifically shown in the following steps: the granule has uniform particle size, high alcohol-soluble extract content, low content of impurities and fungi (aerobic bacteria, fungi and saccharomycetes, Escherichia coli, etc.), high product stability, and easy storage.
3. The method has simple and reasonable process and is suitable for popularization to large-scale production.
Drawings
Fig. 1 is a flow chart of a preparation process of yam granules according to example 1 of the present invention.
Detailed Description
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. After reading the disclosure of the present invention, one skilled in the art can make various changes or modifications to the invention, and such equivalents fall within the scope of the invention.
Unless otherwise indicated, the starting materials, substrates or reagents in the following examples are all commercially available products. They may, if appropriate, also be prepared by methods known in the art.
Instrument information:
bamboo Shuixi FT-30H type full-automatic decocting pot (Shenzhen Zhengyun science and technology Limited);
RE-5205 rotary evaporator (Shanghai Yangrong Biochemical Instrument factory);
SCIENTZ-50F lyophilizer (Ningbo Xinzhi Biotech Co., Ltd.);
a multifunctional extraction testing machine (Hangzhou Chunjiang automation research institute);
LPG-8 spray dryer (okay drying equipment ltd, yozhou);
JSG-20 dry granulator (Wuyi gold stone pharmaceutical machinery Co., Ltd.).
Preparation example 1 preparation and measurement of yam standard decoction
Preparing a Chinese yam standard decoction: weighing three batches of Chinese yam traditional Chinese medicine decoction pieces, respectively weighing 200g, adding 10 times of water, soaking for 30 minutes, heating to boiling, decocting for 30 minutes, filtering while hot (No. 6 sieve, 100 meshes), adding 8 times of water into dregs of a decoction, decocting for 30 minutes after boiling, filtering while hot (No. 6 sieve, 100 meshes), combining two filtrates (determining the paste rate), concentrating at low temperature under reduced pressure to obtain clear paste with relative density of 1.20-1.25 (measured at 65 ℃), freeze-drying (temperature-50-45 ℃ and vacuum degree of 10Pa) to obtain freeze-dried powder, and taking the freeze-dried powder as a standard decoction sample (batch numbers are marked as 1, 2 and 3) for later use.
And (3) measuring the cream yield of the standard decoction: precisely sucking 10ml of each of the three batches of standard decoction samples, drying the three batches of standard decoction samples in an evaporation dish after constant weight in a water bath, drying the three batches of standard decoction samples for 3 hours at 105 ℃, placing the three batches of standard decoction samples in a dryer for cooling for 30 minutes, precisely weighing the three batches of standard decoction samples, calculating the cream yield and the standard deviation according to a formula (1), and determining the cream yield range of the yam standard decoction according to 70-130% of the average cream yield. The test results are shown in Table 1.
In the formula (1), W-is called the clear paste net weight (g), V-is the clear paste volume (ml), 10-the liquid medicine dosage (ml) is measured, W1-dosage of decoction pieces (g).
TABLE 1 determination of the cream yield of the yam standard decoction
Yield of standard decoction lyophilized powder: the weight of the freeze-dried powder of the standard decoction obtained by freeze drying is weighed, and the yield is calculated according to the following formula. The test results are shown in Table 2.
In the formula (2), W is the weight (g) of the freeze-dried powder, W1-dosage of decoction pieces (g).
TABLE 2 Freeze-dried powder yield of rhizoma Dioscoreae standard decoction
Example 1
Weighing three batches of Chinese yam prepared in decoction pieces, adding 2000g of each Chinese yam prepared in a manner of adding 10 times of water into each batch of Chinese yam, soaking for 30 minutes, heating to boil, decocting for 30 minutes, filtering while hot (6 meshes, 100 meshes), adding 8 times of water into dregs of a decoction, decocting for 30 minutes after boiling, filtering while hot (6 meshes, 100 meshes), merging filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10-1.15 (measured at 65 ℃), adding 60g of dextrin, uniformly mixing, filtering (6 meshes, 100 meshes), spray drying (inlet air temperature of 127 ℃, outlet air temperature of 90 ℃), and obtaining spray drying powder (namely an intermediate with the moisture content of 4.2-4.8 wt% and the alcohol-soluble extract content of 16.0-18.2 wt%), according to the mass ratio of the intermediate to the dextrin4:1, adding dextrin, mixing, granulating by dry method (operating conditions: roller pressure 2.5MPa, tabletting frequency 20Hz, feeding frequency 15Hz), sieving with 20 mesh sieve, and making into granule 400g (batch number 1)#、2#、3#) And packaging to obtain the finished product.
The properties of the finished yam formula granule product are as follows: light yellow to brown yellow particles; light smell, light taste, slightly sour.
The specification of the finished yam formula granule product is as follows: each 1g of the formula granule is equivalent to 5g of decoction pieces.
Determination of the cream yield of the yam formula granules: then, referring to the procedure of preparation example 1, the cream yield of yam formula granules was measured and calculated. The results are shown in Table 3.
TABLE 3 determination of the cream yield of yam formula granules
The results in Table 3 show that the cream yield of the three batches of yam formula granules is within the allowable range of the standard decoction cream yield.
Example 2
The particle size, moisture, solubility and loading difference of the finished yam formula particle obtained in example 1 were measured according to the provisions of 0104 particle in the general rules of the four ministry of the pharmacopoeia of China 2015 edition. And (3) detection results: the sum of the mass percentages of the finished yam formula granules which can not pass through the first sieve and the fifth sieve is 3.2-4.6%; the water content is between 4.8 and 8.0wt percent (for example, between 5.2 and 6.4wt percent); the dissolubility is good; the loading difference is within +/-10%.
Heavy metals and harmful elements (including lead, cadmium, arsenic, mercury and copper) in the yam formula particle finished product obtained in example 1 are measured according to a lead, cadmium, arsenic, mercury and copper measuring method (2321 atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry in the four ministry of pharmacopoeia 2015). And (3) detection results: the yam formula granule finished product has lead content lower than 5mg/kg (such as lower than 3mg/kg), cadmium content lower than 0.3mg/kg (such as lower than 0.15mg/kg), arsenic content lower than 2mg/kg (such as lower than 1mg/kg), mercury content lower than 0.2mg/kg (such as lower than 0.1mg/kg), and copper content lower than 20mg/kg (such as lower than 10 mg/kg).
The total number of aerobic bacteria, the total number of mold and yeast, and the total number of Escherichia coli in the finished yam formula granules obtained in example 1 were measured according to the microbial limit test method (the "Chinese pharmacopoeia" 2015 edition of general rules for four departments 1105, 1106, and 1107). And (3) detection results: in the finished product of the yam formula granule, the total number of aerobic bacteria is less than or equal to 1000cfu/g (such as less than or equal to 700cfu/g), the total number of mould and microzyme is less than or equal to 100cfu/g (such as less than or equal to 60cfu/g), and the escherichia coli is not detected.
The finished yam granules obtained in example 1 were measured by a hot dipping method according to the alcohol-soluble extract measurement method (2201 in the general rules of the four departments of the national pharmacopoeia 2015). And (3) detection results: the extract content of rhizoma Dioscoreae granule is not less than 12.0%, for example, batch 1#The extract content is 12.5-14.6%, batch 2#And 3#The extract content is 13.1-14.8%.
In summary, all indexes of the finished yam formula particle product obtained in example 1 meet the regulation of 0104 particle in the four ministry of general regulations in chinese pharmacopoeia 2015 edition.
The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A yam formula particle comprises an active ingredient yam and pharmaceutically acceptable auxiliary materials, wherein the content of the yam is 250-800 mg/g;
preferably, the pharmaceutically acceptable excipient comprises one, two or more fillers.
2. The yam formula particle of claim 1, wherein the yam formula particle has a particle size of 10-100 mesh;
preferably, the water content of the yam formula particles is 4.0-10.0 wt%;
preferably, the alcohol soluble extract of the yam formula particle is not less than 9.0 wt%;
preferably, the specification of the yam prescription granule is that every 1g of prescription granule is equivalent to 5g of yam decoction pieces.
3. The yam formulation of claim 1, further comprising a packaging bag or box for holding the pellets.
4. A method of preparing a yam formulation according to any one of claims 1 to 3, comprising: mixing the intermediate of the rhizoma Dioscoreae granule with adjuvants, and granulating to obtain rhizoma Dioscoreae granule;
preferably, the preparation method of the yam formula particle specifically comprises the following steps:
(1) preparing an intermediate of the yam formula particle: soaking rhizoma Dioscoreae pieces, decocting, filtering, concentrating the filtrate to obtain fluid extract, adding adjuvants into the fluid extract, mixing, and spray drying to obtain rhizoma Dioscoreae granule intermediate;
(2) preparing the yam formula granules: and mixing the intermediate and auxiliary materials uniformly, and performing dry granulation to obtain a finished product.
5. The preparation method of claim 4, wherein in the step (1), the yam pieces are added into water during soaking, the mass ratio of the yam pieces to the water is 1 (8-15), and the soaking time is 20-40 minutes;
preferably, the relative density of the clear paste is 1.05-1.25;
preferably, the mass ratio of the clear paste to the auxiliary materials is (1-4) to 1;
preferably, the temperature of the spray drying is: the air inlet temperature is 115-130 ℃, and the air outlet temperature is 80-95 ℃.
6. The method of claim 4 or 5, wherein the intermediate yam formulation granule has a moisture content of no more than 8.0 wt%;
preferably, the content of alcohol-soluble extract of the intermediate of yam formula granule is not less than 15 wt%.
7. The preparation method according to claim 5 or 6, wherein in the step (2), the mass ratio of the intermediate to the auxiliary materials is (1-4): 1;
preferably, the dry granulation can adopt the conventional operation in the field, firstly roll pressing, continuously compacting the material blocks, granulating and sieving to obtain the finished product of granules;
preferably, the operating conditions of the dry granulation are: the roller pressure is 2-3 MPa, the tabletting frequency is 16-25 Hz, and the feeding frequency is 12-18 Hz.
8. The preparation method according to any one of claims 4 to 7, further comprising the step (3) of preparing a yam standard decoction: soaking rhizoma Dioscoreae pieces, decocting, filtering, concentrating the filtrate, and freeze drying to obtain lyophilized powder as standard decoction;
preferably, the method further comprises the step (4) of packaging: and (3) sealing and packaging the yam formula particles obtained in the step (2).
9. A formulation comprising a yam formulation according to any one of claims 1 to 3.
10. Use of the yam dispensing granule of any one of claims 1-3 for the preparation of a compound medicament.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113368061A (en) * | 2021-05-28 | 2021-09-10 | 河北红日药都药业有限公司 | Method for improving extract of sugar-containing formula particles |
| CN114594222A (en) * | 2022-03-29 | 2022-06-07 | 四川浦华中药科技有限公司 | Decoction piece detection method based on traditional Chinese medicine formula granules |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474333A (en) * | 2007-12-18 | 2009-07-08 | 北京康仁堂药业有限公司 | Yam dispensing granule as well as preparation method and quality control method thereof |
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| CN101474333A (en) * | 2007-12-18 | 2009-07-08 | 北京康仁堂药业有限公司 | Yam dispensing granule as well as preparation method and quality control method thereof |
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| CN113368061A (en) * | 2021-05-28 | 2021-09-10 | 河北红日药都药业有限公司 | Method for improving extract of sugar-containing formula particles |
| CN114594222A (en) * | 2022-03-29 | 2022-06-07 | 四川浦华中药科技有限公司 | Decoction piece detection method based on traditional Chinese medicine formula granules |
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