CN110870897A - Cortex lycii radicis formula particle and preparation method and application thereof - Google Patents

Cortex lycii radicis formula particle and preparation method and application thereof Download PDF

Info

Publication number
CN110870897A
CN110870897A CN201811004871.5A CN201811004871A CN110870897A CN 110870897 A CN110870897 A CN 110870897A CN 201811004871 A CN201811004871 A CN 201811004871A CN 110870897 A CN110870897 A CN 110870897A
Authority
CN
China
Prior art keywords
cortex lycii
lycii radicis
formula
radicis
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201811004871.5A
Other languages
Chinese (zh)
Other versions
CN110870897B (en
Inventor
王伯綸
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hubei Xianglian Pharmaceutical Co Ltd
Original Assignee
Hubei Xianglian Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hubei Xianglian Pharmaceutical Co Ltd filed Critical Hubei Xianglian Pharmaceutical Co Ltd
Priority to CN201811004871.5A priority Critical patent/CN110870897B/en
Publication of CN110870897A publication Critical patent/CN110870897A/en
Application granted granted Critical
Publication of CN110870897B publication Critical patent/CN110870897B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against 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 cortex lycii radicis formula granules as well as a preparation method and application thereof. The formula particle comprises an active ingredient cortex lycii radicis and pharmaceutically acceptable auxiliary materials, wherein the content of the cortex lycii radicis is 250-800 mg/g, and the pharmaceutically acceptable auxiliary materials comprise one or more fillers. The formula particle is prepared by uniformly mixing and granulating a cortex lycii radicis formula particle intermediate and auxiliary materials. The invention adopts spray drying and dry granulation processes, strictly controls the process step parameters, improves the paste yield of the cortex lycii radicis decoction pieces, and the prepared formula granules have high content of effective components and small dosage. The quality of the finished granular product is excellent, and the product quality conforms to the regulation of Chinese pharmacopoeia: 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

Cortex lycii radicis formula particle and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicine formula granules, and particularly relates to cortex lycii radicis formula granules as well as a preparation method and application thereof.
Background
Cortex Lycii is dried root bark of Lycium chinense Mill or Lycium barbarum L of Lycium barbarum of Solanaceae. Digging root in early spring or after autumn, cleaning, peeling root bark, and sun drying. Cortex Lycii has effects of cooling blood, removing heat, clearing lung-heat, and lowering fire; can be used for treating hectic fever due to yin deficiency, hectic fever, night sweat, cough due to lung heat, hemoptysis, epistaxis, internal heat, and diabetes.
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 cortex lycii radicis formula particle which comprises an active ingredient cortex lycii radicis and pharmaceutically acceptable auxiliary materials, wherein the content of the cortex lycii radicis is 250-800 mg/g, preferably 300-700 mg/g, and more preferably 300-600 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 granularity of the cortex lycii radicis formula particles is 10-100 meshes, such as 10-80 meshes and 30-50 meshes. Preferably, the total amount of the granules 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 moisture content of the cortex lycii radicis formula particles is between 4.0 and 5.5 wt%; for example, 4.5 to 5.2 wt%, 4.7 to 5.0 wt%.
According to the invention, the alcohol-soluble extract of the cortex lycii radicis formula granules is not less than 23.0 wt%; for example, not less than 24.0 wt%, not less than 26.0 wt%; preferably, the cortex lycii radicis formula particle has an alcohol-soluble extract content of 23.5-24.6 wt%.
According to the present invention, the cortex lycii radicis formulation granules further comprise a packaging bag or box, such as a composite film bag, containing the granules; illustratively, the composite film bag may be selected from composite aluminum foil bags.
According to the invention, the specification of the cortex lycii radicis formula particle is equivalent to 3g of cortex lycii radicis decoction pieces per 1g of formula particle.
According to the invention, the packaging specification of the cortex lycii radicis formulation granules may have various specifications, for example 1-20 g, exemplarily 1g, 2g, 3g, 5g, 6g, 9g, 10g, 12g, 15g, 20 g.
Further, the invention also provides a preparation method of the cortex lycii radicis formula particle, which comprises the following steps: and mixing the intermediate of the cortex lycii radicis formula particle with auxiliary materials, and granulating to obtain the cortex lycii radicis formula particle.
According to the preparation method, the cortex lycii radicis formula particle intermediate is obtained through the following steps: adding adjuvants into the fluid extract, mixing, and spray drying to obtain cortex Lycii granule intermediate.
According to the preparation method of the invention, the clear paste is obtained by the following steps: soaking cortex Lycii decoction pieces, decocting, filtering, and concentrating the filtrate to obtain fluid extract.
According to an embodiment of the present invention, the method for preparing the cortex lycii radicis formula particle specifically comprises the following steps:
(1) preparation of cortex lycii radicis formula particle intermediate: soaking cortex Lycii decoction pieces, decocting, filtering, concentrating the filtrate to obtain fluid extract, adding adjuvants into the fluid extract, mixing, and spray drying to obtain cortex Lycii granule intermediate;
(2) preparation of cortex lycii radicis 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), cortex lycii radicis decoction pieces are added into water during soaking, and the mass ratio of the cortex lycii radicis decoction pieces to the water is 1 (10-15); preferably, the mass ratio is 1 (10-12); illustratively, the mass ratio is 1: 12;
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 8-12 times, for example 10 times, of the mass of the cortex lycii radicis 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; for example, concentrating under reduced pressure until the relative density of the fluid extract is 1.05-1.25, preferably, the relative density is 1.10-1.15, 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 (1-2) to (1-2); for example 1:1.2, 1:1.6, 1.5: 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 of the invention, the moisture content of the cortex lycii radicis formula particle intermediate is not more than 8 wt%; for example, not more than 7 wt%, not more than 6 wt%; preferably, the moisture content is 4.7 to 5.7 wt%.
According to the preparation method, the content of alcohol-soluble extract of the cortex lycii radicis formula particle intermediate is not less than 33.0 wt%; for example, not less than 34.0 wt%, not less than 35.0 wt%; preferably, the content of alcohol-soluble extract of the cortex lycii radicis formula particle intermediate is 33.4-36.2%.
According to the preparation method, in the step (2), the mass ratio of the intermediate to the auxiliary materials is (3-9): (1-2); such as 4:1, 5: 2.
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.
The preparation method further comprises the step (3) of preparing a cortex lycii radicis standard decoction.
The step (3) specifically comprises the following operations: soaking cortex Lycii decoction pieces, decocting, filtering, concentrating the filtrate, and lyophilizing 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 may 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 cortex lycii radicis 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 cortex lycii radicis formula particles obtained by the preparation method.
Further, the present invention also provides a preparation comprising the above cortex lycii radicis formulation granules.
Furthermore, the invention also provides application of the cortex lycii radicis formula particle in preparing a compound medicine.
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 cortex lycii radicis decoction pieces is improved, and the prepared formula granules are high in effective component content and small in dosage.
2. The finished product quality of the cortex lycii radicis formula particle is excellent, and the product quality accords with the regulation of Chinese pharmacopoeia and 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 process for preparing a cortex lycii radicis formulation granule 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 cortex Lycii Standard decoction
Preparing a cortex lycii standard decoction: weighing three batches of cortex lycii radicis traditional Chinese medicine decoction pieces 200g each, adding 12 times of water to soak for 30 minutes, heating to boil, decocting for 30 minutes, filtering while hot (No. 6 sieve, 100 meshes), adding 10 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 the relative density of 1.20-1.25 (measured at 65 ℃) to obtain clear paste, and freeze-drying the clear paste (the temperature is-50-45 ℃ and the vacuum degree is 10Pa) to prepare freeze-dried powder serving as standard decoction samples (the 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 for 3 hours, cooling the three batches of standard decoction samples in a drier for 30 minutes, precisely weighing the three batches of standard decoction samples, calculating the cream yield and the standard deviation according to the formula (1), and determining the cream yield range of the cortex lycii standard decoction according to 70-130% of the average cream yield. The test results are shown in Table 1.
Figure BDA0001783778000000061
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 cortex Lycii standard decoction cream yield
Figure BDA0001783778000000071
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.
Figure BDA0001783778000000072
In the formula (2), W is the weight (g) of the freeze-dried powder, W1-dosage of decoction pieces (g).
TABLE 2 cortex Lycii Standard decoction lyophilized powder yield
Figure BDA0001783778000000073
Example 1
Weighing three batches of Chinese medicinal decoction pieces of cortex lycii radicis 2000g each, adding 12 times of water to soak for 30 minutes, heating to boil, decocting for 30 minutes, filtering while hot (No. 6 sieve, 100 meshes), adding 10 times of water to decoction dregs, decocting for 30 minutes after boiling, filtering while hot (No. 6 sieve, 100 meshes), merging filtrates, concentrating under reduced pressure to obtain clear paste with relative density of 1.10-1.15 (measured at 65 ℃), adding 150g of dextrin, mixing uniformly, filtering (No. 6 sieve, 100 meshes), spray drying (air inlet temperature of 127 ℃, air outlet temperature of 90 ℃), obtaining spray drying powder (namely an intermediate, the alcohol-soluble extract content of the intermediate is 33.4-36.2 wt%, and the water content of 4.7-5.7 wt%), adding dextrin according to the mass ratio of 4:1 of the intermediate to the dextrin, mixing uniformly, and granulating by a dry method, (operation conditions are that the roller pressure is 2.5MPa, the tabletting frequency is highThe rate is 20Hz, the feeding frequency is 15Hz), the mixture is sieved by a 20-mesh sieve, and 1000g of granules (the batch number is marked as 1)#、2#、3#) And packaging to obtain the finished product.
The properties of the finished product of the cortex lycii radicis particle formula are as follows: light yellow to yellowish brown particles; light smell, slightly bitter taste.
The specification of the finished product of the cortex lycii radicis particle formula is as follows: each 1g of the formula granule is equivalent to 3g of decoction pieces.
Determination of the ointment yield of the cortex lycii radicis formula particle: referring to the procedure of preparation example 1, the extraction rate of the granules of cortex lycii radicis formulation was measured and calculated. The results are shown in Table 3.
TABLE 3 determination of the cream yield of the cortex Lycii granule formulation
Figure BDA0001783778000000081
As can be seen from the results in Table 3, the cream yield of the three batches of cortex Lycii granules is within the allowable range of the standard cream yield of the decoction.
Example 2
The particle size, moisture content, solubility and loading difference of the finished product of the cortex lycii radicis formula particle obtained in example 1 were tested according to the provisions of 0104 particle in the general rules of the four ministry of the Chinese pharmacopoeia 2015. And (3) detection results: the mass percentage sum of the cortex lycii radicis formula particle finished product which can not pass through the No. one sieve and can pass through the No. five sieve is 3.2-4.6%; the water content is 4.5-5.2%; the dissolubility is good; the loading difference is within +/-10%.
The heavy metals and harmful elements (including lead, cadmium, arsenic, mercury and copper) in the finished product of the cortex lycii radicis formula particle obtained in example 1 are measured according to the method for measuring lead, cadmium, arsenic, mercury and copper (the atomic absorption spectrophotometry or the inductively coupled plasma mass spectrometry of 2321 in the four ministry of communications in the pharmacopoeia of China 2015). And (3) detection results: the cortex lycii radicis formulation granules have a lead content below 5mg/kg (e.g. below 3mg/kg), a cadmium content below 0.3mg/kg (e.g. below 0.15mg/kg), an arsenic content below 2mg/kg (e.g. below 1mg/kg), a mercury content below 0.2mg/kg (e.g. below 0.1mg/kg) and a copper content below 20mg/kg (e.g. below 10 mg/kg).
The total number of aerobic bacteria, the total number of mold and yeast, and Escherichia coli in the finished product of the cortex lycii radicis formulation granules obtained in example 1 were measured according to the microbial limit test method (Chinese pharmacopoeia 2015, four Ministry of Japan, 1105, 1106, and 1107). And (3) detection results: in the finished product of the cortex lycii radicis formula particles, 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 product of the cortex lycii radicis granules obtained in example 1 was measured by a hot dipping method under the item of alcohol-soluble extract measurement method (national pharmacopoeia 2015, Ministry of the four departments, 2201). And (3) detection results: the content of alcohol-soluble extract in the finished product of the cortex lycii radicis formula particle is not less than 23.0 percent, for example, between 23.5 and 24.6 percent.
In summary, all indexes of the finished product of the cortex lycii radicis formula particle obtained in example 1 meet the regulation of 0104 particle under the item of the general rules of the four ministry of the ministry of health in the '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. The cortex lycii radicis formula particle is characterized by comprising an active ingredient cortex lycii radicis and pharmaceutically acceptable auxiliary materials, wherein the content of the cortex lycii radicis is 250-800 mg/g;
preferably, the pharmaceutically acceptable excipient comprises one, two or more fillers.
2. The cortex lycii radicis formulation granules according to claim 1, wherein the particle size of the cortex lycii radicis formulation granules is between 10 and 100 mesh;
preferably, the water content of the cortex lycii radicis formula particles is 4.0-5.5 wt%;
preferably, the cortex lycii radicis formulation particles have an alcohol soluble extract of not less than 23.0 wt%.
According to the invention, the specification of the cortex lycii radicis formula particle is equivalent to 3g of cortex lycii radicis decoction pieces per 1g of formula particle.
3. The cortex lycii radicis formulation granulate according to claim 1 or 2, further comprising a packaging bag or a box containing the granulate.
4. A method of preparing a cortex lycii radicis formulation granulate according to any of claims 1 to 3, characterised in that it comprises: mixing the intermediate of the cortex lycii radicis formula particle with auxiliary materials, and granulating to obtain cortex lycii radicis formula particles;
preferably, the preparation method of the cortex lycii radicis formula particle specifically comprises the following steps:
(1) preparation of cortex lycii radicis formula particle intermediate: soaking cortex Lycii decoction pieces, decocting, filtering, concentrating the filtrate to obtain fluid extract, adding adjuvants into the fluid extract, mixing, and spray drying to obtain cortex Lycii granule intermediate;
(2) preparation of cortex lycii radicis formula granules: and mixing the intermediate and auxiliary materials uniformly, and performing dry granulation to obtain a finished product.
5. The method of claim 4, wherein the moisture content of the intermediate of cortex Lycii granules is no more than 8 wt%;
preferably, the content of alcohol-soluble extract of cortex lycii radicis formula particle intermediate is not less than 33.0 wt%;
preferably, in the step (1), during soaking, cortex lycii radicis decoction pieces are added into water, and the mass ratio of the cortex lycii radicis decoction pieces to the water is 1 (10-15); 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 (1-2) to (1-2);
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 preparation method according to claim 4 or 5, wherein in the step (2), the mass ratio of the intermediate to the auxiliary materials is (3-9): 1-2); and sieving the uniformly mixed clear paste and auxiliary materials before spray drying, wherein the dry granulation can adopt the conventional operation in the field, firstly rolling, continuously compacting material blocks, and granulating and sieving to obtain the finished product of granules.
7. The method according to any one of claims 4 to 6, further comprising the step of (3) preparing a standard decoction of cortex Lycii: soaking cortex Lycii decoction pieces, decocting, filtering, concentrating the filtrate, and lyophilizing to obtain lyophilized powder as standard decoction.
8. The method for preparing a cosmetic composition according to any one of claims 4 to 7, further comprising the step of (4) packaging: and (3) hermetically packaging the cortex lycii radicis formula particles obtained in the step (2).
9. A formulation comprising the cortex lycii radicis formulation particles according to any one of claims 1 to 3.
10. Use of the cortex lycii radicis formulation granules according to any one of claims 1 to 3 for the preparation of a compound medicament.
CN201811004871.5A 2018-08-30 2018-08-30 Preparation method of cortex lycii radicis formula particles Active CN110870897B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201811004871.5A CN110870897B (en) 2018-08-30 2018-08-30 Preparation method of cortex lycii radicis formula particles

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201811004871.5A CN110870897B (en) 2018-08-30 2018-08-30 Preparation method of cortex lycii radicis formula particles

Publications (2)

Publication Number Publication Date
CN110870897A true CN110870897A (en) 2020-03-10
CN110870897B CN110870897B (en) 2022-03-25

Family

ID=69715042

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201811004871.5A Active CN110870897B (en) 2018-08-30 2018-08-30 Preparation method of cortex lycii radicis formula particles

Country Status (1)

Country Link
CN (1) CN110870897B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
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

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101167970A (en) * 2007-10-10 2008-04-30 江阴天江药业有限公司 Method for preparing gastrodia tuber dispensing granule
CN102204935A (en) * 2011-06-07 2011-10-05 江苏省中医药研究院 Preparation method of single Chinese medicinal formula tablets
CN103099788A (en) * 2013-01-25 2013-05-15 康美药业股份有限公司 Traditional Chinese medicine composite decoration from powder, preparation and decoction methods and dosage relation thereof
CN103405505A (en) * 2013-07-09 2013-11-27 安徽济人药业有限公司 Mulberry bark formula granules, and preparation method and quality control method thereof
CN104225206A (en) * 2014-07-23 2014-12-24 江苏七O七天然制药有限公司 Sugar-free Changchun longevity granules and preparation method thereof
CN104720067A (en) * 2013-12-22 2015-06-24 陈永如 Chinese medicinal herb essence granular drink and packaging method thereof
CN105456241A (en) * 2014-08-15 2016-04-06 安利(中国)植物研发中心有限公司 Composition comprising kukoamine A and / or kukoamine B and application method thereof
CN106074700A (en) * 2016-06-20 2016-11-09 广东方制药有限公司 A kind of Radix Scutellariae granule and Chinese medicine preparation thereof
CN106324174A (en) * 2015-06-18 2017-01-11 天津市药品检验所 Quality standard for traditional Chinese medicine formula granules

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101167970A (en) * 2007-10-10 2008-04-30 江阴天江药业有限公司 Method for preparing gastrodia tuber dispensing granule
CN102204935A (en) * 2011-06-07 2011-10-05 江苏省中医药研究院 Preparation method of single Chinese medicinal formula tablets
CN103099788A (en) * 2013-01-25 2013-05-15 康美药业股份有限公司 Traditional Chinese medicine composite decoration from powder, preparation and decoction methods and dosage relation thereof
CN103405505A (en) * 2013-07-09 2013-11-27 安徽济人药业有限公司 Mulberry bark formula granules, and preparation method and quality control method thereof
CN104720067A (en) * 2013-12-22 2015-06-24 陈永如 Chinese medicinal herb essence granular drink and packaging method thereof
CN104225206A (en) * 2014-07-23 2014-12-24 江苏七O七天然制药有限公司 Sugar-free Changchun longevity granules and preparation method thereof
CN105456241A (en) * 2014-08-15 2016-04-06 安利(中国)植物研发中心有限公司 Composition comprising kukoamine A and / or kukoamine B and application method thereof
CN106324174A (en) * 2015-06-18 2017-01-11 天津市药品检验所 Quality standard for traditional Chinese medicine formula granules
CN106074700A (en) * 2016-06-20 2016-11-09 广东方制药有限公司 A kind of Radix Scutellariae granule and Chinese medicine preparation thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
广西壮族自治区食品药品监督管理局: "《广西壮族自治区中药配方颗粒质量标准第一卷》", 30 November 2016 *
徐天予: "中药配方颗粒应用的前景分析", 《大理学院学报》 *
涂瑶生,等: "《中药配方颗粒质量分析》", 30 May 2011, 广东科技出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
CN110870897B (en) 2022-03-25

Similar Documents

Publication Publication Date Title
JP2009514960A (en) Herbal extract powder and its preparation and use
CN105535033A (en) Method for extracting truffle polysaccharides from truffles
CN110870903A (en) Yam formula particle and preparation method and application thereof
CN110870897B (en) Preparation method of cortex lycii radicis formula particles
CN104224858B (en) Cordyceps militaris microcapsules, preparation and preparation method thereof
CN110870890A (en) Uncaria formula granules and preparation method and application thereof
CN110870883A (en) Bighead atractylodes rhizome formula particle and preparation method and application thereof
CN109289032B (en) Wind-cold common cold granules and preparation method thereof
CN106109569A (en) A kind of production method of Spica Prunellae beverage particles
CN110870888A (en) Coptis prescription granule and preparation method and application thereof
CN110115731B (en) Preparation method of fresh rehmannia root powder and fresh rehmannia root powder decoction pieces
WO2020119255A1 (en) Dioscorea alata formula granules and preparation method therefor
CN112603973A (en) Improved preparation method of pharmaceutical composition for treating lung cough
CN112957435A (en) Formula of granules for treating gout and production process thereof
CN112618627A (en) Improved Chinese mahonia stem internal heat-reducing medicine composition preparation method
CN112402515A (en) Chinese medicinal extract containing insect medicine and preparation method of preparation thereof
CN105535032A (en) Extraction method of truffle polysaccharides and health-care truffle product
CN111588750A (en) Preparation method of traditional Chinese medicine granules for treating wind-heat type common cold of pigs
CN111991446B (en) Glossy privet fruit flavone tablet and preparation method thereof
CN103181978B (en) Freeze-dried solanum septemlobum bunge for treating cancers
CN107638535A (en) A kind of compound oldenlandia diffusa granule and preparation method thereof
KR101645078B1 (en) Method for Making Red Ginseng Extract Powder Having Exellent Physical Properties and Economic Efficiency
CN106692230A (en) Preparation method of herba lysimachiae granules
CN107737235B (en) Pulse-activating granule and preparation method thereof
CN105769939A (en) Ganoderma spore wall breaking method and ganoderma spore powder health care product

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant