CN113425687B - Traditional Chinese medicine formula granule and preparation method thereof - Google Patents
Traditional Chinese medicine formula granule and preparation method thereof Download PDFInfo
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- CN113425687B CN113425687B CN202110614684.4A CN202110614684A CN113425687B CN 113425687 B CN113425687 B CN 113425687B CN 202110614684 A CN202110614684 A CN 202110614684A CN 113425687 B CN113425687 B CN 113425687B
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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
- A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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Abstract
The invention discloses a traditional Chinese medicine formula granule and a preparation method thereof, the traditional Chinese medicine formula granule is obtained by dry granulation of raw materials comprising an oil inclusion compound and medicine ointment powder; the oil inclusion compound comprises raw materials including oil, cyclodextrin and an adhesive, wherein the mass ratio of the oil to the cyclodextrin to the adhesive in the raw materials is 1: 6-12: 1-5, and the oil inclusion rate is more than 70%. The traditional Chinese medicine formula particles adopt the oil inclusion compound with high inclusion rate, so that the dosage can be reduced, and medicinal materials can be saved.
Description
Technical Field
The invention relates to a traditional Chinese medicine formula granule and a preparation method thereof.
Background
The traditional Chinese medicine formula particle is a single medicine and is prepared by extracting, concentrating, drying and granulating medicinal materials with water. In the commonly used Chinese herbs, some herbs contain volatile oil and fat, such as peppermint, Schizonepeta tenuifolia, Cinnamomum cassia, forsythia fruit, etc. A few medicinal materials contain nonvolatile oil and fat components, such as fructus Cannabis, semen Pruni, and Coicis semen. When the medicinal materials are prepared into formula granules, the oil components are added during preparation. Generally, in order to avoid volatilization of volatile oil, volatile oil and fat components are included by beta-cyclodextrin to form an inclusion compound, and then the inclusion compound is added during granulation of the paste powder. Currently, the preparation of formulation granules has the following problems:
(1) the inclusion rate of the oil of the volatile oil inclusion compound is low, and the content of the oil included by the inclusion compound in unit mass is low, so that the content of the oil in the formula particles in unit mass is low, and the dosage is large;
(2) the inclusion rate of the non-volatile oil inclusion compound is low, so that the grease mixed in the inclusion compound is attached to the surface of the inclusion compound, and dry granulation cannot be performed in the later period;
(3) in order to improve the inclusion rate of the oil inclusion compound, the amount of oil is increased in the inclusion process, so that the waste of the oil is caused.
CN103751793A discloses a preparation method of a cyclodextrin inclusion compound, which comprises the steps of preparing hydroxypropyl betadex into an aqueous solution, adding povidone K29/32, uniformly mixing, heating to 30-50 ℃, adding ligustilide under the stirring condition, stirring for 1-6 hours at constant temperature, and removing an organic solvent through freeze drying or rotary evaporation. The obtained clathrate contains volatile oil ligustilide, hydroxypropyl betacyclodextrin and polyvidone K29/32, and has improved stability and prolonged shelf life. However, the oil inclusion rate of the inclusion compound obtained by the method is low and is only 30-45%.
Disclosure of Invention
In view of the above, an object of the present invention is to provide a traditional Chinese medicine formula granule, which has a high inclusion rate of an inclusion compound, and a high oil content of the inclusion compound in unit mass, and can reduce the dosage of the traditional Chinese medicine formula granule and save medicinal materials. The invention also aims to provide a preparation method of the traditional Chinese medicine formula granule.
On one hand, the traditional Chinese medicine formula granule provided by the invention is prepared by dry granulation of raw materials comprising an oil inclusion compound and medicine paste powder; the oil inclusion compound comprises raw materials including oil, cyclodextrin and an adhesive, wherein the mass ratio of the oil to the cyclodextrin to the adhesive in the raw materials is 1: 6-12: 1-5, and the oil inclusion rate is more than 70%.
According to the traditional Chinese medicine formula particle, preferably, the grease is volatile grease, and the inclusion rate of the grease is 80-90%.
According to the traditional Chinese medicine formula particle, preferably, the grease is non-volatile grease, and the inclusion rate of the grease is 70-75%.
Preferably, the binder is one or more selected from povidone, pregelatinized starch, dextrin and lactose.
On the other hand, the invention also provides a preparation method of the traditional Chinese medicine formula granule, which preferably comprises the following steps:
(1) preparing medicinal ointment powder;
(2) the oil inclusion compound is prepared by the following steps: mixing the grease, the cyclodextrin and the adhesive, stirring for the first time, and uniformly stirring to obtain a mixture; mixing the mixture with water, stirring for the second time, and uniformly stirring to obtain a paste powder aqueous solution; drying the paste powder aqueous solution to obtain a grease inclusion compound;
(3) mixing the oil inclusion compound and the medicinal extract powder uniformly, and performing dry granulation to obtain the medicinal composition.
According to the preparation method of the traditional Chinese medicine formula particle, preferably, in the step (2), the adhesive and the cyclodextrin are mixed and then pre-stirred, and after uniform stirring, grease is added for first stirring.
According to the preparation method of the traditional Chinese medicine formula particle, the mass ratio of the added water to the grease in the mixture in the step (2) is preferably 50-60: 1.
According to the preparation method of the traditional Chinese medicine formula particle, preferably, in the step (2), the second stirring speed is 50-100 r/min, the second stirring temperature is 10-30 ℃, and the stirring time of the second stirring is 1-3 h.
According to the preparation method of the traditional Chinese medicine formula granule, preferably, in the step (3), the mass ratio of the oil inclusion compound to the medicine ointment powder is 1: 3-8.
The invention has the beneficial effects that:
the traditional Chinese medicine formula particles adopt the oil inclusion compound with high inclusion rate, so that the dosage can be reduced, and medicinal materials can be saved;
the preparation method does not need to add cosolvents such as ethanol and the like, does not need heating, is simple and safer, and has low requirement on equipment.
Detailed Description
The present invention will be further described with reference to specific examples, but the scope of the present invention is not limited thereto.
< oil and fat Inclusion Compound >
The oil inclusion compound is prepared from raw materials including oil, cyclodextrin and an adhesive. The oil and fat includes volatile oil and non-volatile oil and fat. Preferably, the cyclodextrin is β -cyclodextrin; more preferably, the cyclodextrin is hydroxypropyl β -cyclodextrin.
In the invention, the volatile oil is selected from one or more of mint volatile oil, schizonepeta volatile oil, cinnamon volatile oil and forsythia volatile oil; preferably, the volatile oil is selected from one or more of peppermint volatile oil, catnip volatile oil and cinnamon volatile oil; more preferably, the volatile oil is selected from one of peppermint volatile oil or catnip volatile oil. The non-volatile oil is selected from one or more of hemp seed oil, Prunus humilis Bunge oil and Coix seed oil, preferably, the non-volatile oil is selected from one of hemp seed oil or Prunus humilis Bunge oil; more preferably, the non-volatile oil is hemp seed oil. The binder is one or more selected from polyvidone, lactose, pregelatinized starch and dextrin; preferably, the binder is selected from one of povidone and lactose; more preferably, the binder is povidone K30.
In the invention, the mass ratio of the grease to the cyclodextrin to the adhesive is 1: 6-12: 1-5. Preferably, when the grease is volatile grease, the mass ratio of the grease, the cyclodextrin and the adhesive is 1: 8-10: 1-4. Preferably, when the grease is a non-volatile grease, the mass ratio of the grease, the cyclodextrin and the binder is 1: 8-10: 1.5-3.5.
According to a specific embodiment of the invention, the grease is volatile grease, and the inclusion rate of the grease is 80-90%; preferably, the mass ratio of the grease to the cyclodextrin to the binder is 1: 8-10: 1-4, and the grease inclusion rate is 84-90%.
According to another specific embodiment of the invention, the grease is schizonepeta volatile oil, the adhesive is povidone K30, the mass ratio of the grease to the cyclodextrin to the adhesive is 1: 8-10: 1-4, and the oil inclusion rate is 85-90%.
In the inclusion process, the proportion of the cyclodextrin and the adhesive is increased, so that the oil inclusion rate can be improved. But more cyclodextrin is adopted, so that the content of grease in the inclusion compound can be reduced; with more adhesive, wall sticking occurs when dry-process preparation of the formulation granules. The applicant finds in a large number of experiments that by adopting the component proportion range of the invention, the fat inclusion rate can be improved, the content of the fatty oil in the inclusion compound can be ensured, and the wall sticking phenomenon is avoided in the dry granulation process.
According to an embodiment of the invention, the grease is a non-volatile grease, and the inclusion rate of the grease is 70-75%.
According to a specific embodiment of the invention, the volatile oil is selected from schizonepeta volatile oil, the adhesive is selected from povidone K30, the mass ratio of the oil to the hydroxypropyl beta-cyclodextrin to the adhesive is 1: 8-12: 2-3, and the oil inclusion rate is 85-95%; the volatile oil is mint volatile oil, the adhesive is povidone K30, the mass ratio of the oil to the hydroxypropyl beta-cyclodextrin to the adhesive is 1: 10-12: 2-3, and the oil inclusion rate is 85-90%.
< granule of Chinese medicine >
The traditional Chinese medicine formula granule is prepared from raw materials including an oil inclusion compound and medicine paste powder through dry granulation. The mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 3-8; preferably, the mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 4-6; more preferably, the mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 5. In the present invention, the oil inclusion compound is the above-described oil inclusion compound, and details thereof are not repeated.
< preparation method of Chinese medicinal granule >
The preparation method comprises the following steps: (1) preparing medicinal ointment powder; (2) preparing a grease inclusion compound; (3) and (4) dry granulating.
Regarding step (1), the method for preparing the pharmaceutical ointment powder of the present invention is not limited, and may be any method for preparing pharmaceutical ointment powder in the prior art. Preferably, in the present invention, the prepared pharmaceutical ointment powder can be used in a dry granulation process.
Step (2), mixing the grease, the hydroxypropyl beta-cyclodextrin and the adhesive, stirring for the first time, and uniformly stirring to obtain a mixture; mixing the mixture with water, stirring for the second time, and uniformly stirring to obtain a paste powder aqueous solution; and drying the paste powder aqueous solution to obtain the grease inclusion compound.
By adopting the preparation method, the oil is encapsulated in the hydroxypropyl beta-cyclodextrin cavity structure under the condition of not adding solvents such as ethanol, water and the like, so that the oil inclusion rate can be greatly improved. The whole preparation process is only completed at normal temperature without heating, and the inclusion rate is improved compared with the prior art. In the inclusion compound, volatile oil which is not included can be volatilized in the drying process and directly wasted; the non-volatile oil which is not included can be adhered to the surface of the inclusion compound, so that the inclusion compound can not be granulated by a dry method. Therefore, the inclusion rate is improved, the waste of the volatile oil can be avoided, the non-volatile oil inclusion compound can be granulated by a dry method, and the significance is great.
In a specific embodiment of the invention, the adhesive and the hydroxypropyl beta-cyclodextrin are mixed and pre-stirred, and then the grease is added for the first stirring after the uniform stirring. Experiments prove that the oil inclusion rate can be further improved. Preferably, the first stirring temperature is 10-30 ℃, the first stirring speed is 30-50 r/min, and the first stirring time is 10-30 min.
In the invention, the mass ratio of the added water to the grease in the mixture is 50-60: 1.
As a specific embodiment of the invention, the second stirring temperature is 10-30 ℃, and the stirring time of the second stirring is 1-3 h; the second stirring speed is 50-100 r/min.
In the present invention, the drying method of the aqueous solution of the paste powder is not particularly limited, and conventional aqueous solution drying methods including, but not limited to, vacuum drying, spray drying, freeze drying, etc. may be selected and will not be described herein again.
Regarding step (3), the dry granulation method is not limited, and any method of the existing dry granulation may be employed. Preferably, the mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 3-8. Preferably, the mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 4-6. More preferably, the mass ratio of the oil inclusion compound to the medicinal ointment powder is 1: 5.
The experimental method comprises the following steps:
volatile oil content determination method
The content (ml) of volatile oil in the paste powder is determined according to a method 2204A method of the general rule of China pharmacopoeia 2020 edition, and the weight is converted according to the density of the volatile oil.
Method for measuring content of non-volatile oil (fatty oil)
Taking 10g of inclusion compound, precisely weighing, placing in a Soxhlet extractor, adding a proper amount of petroleum ether (60-90 ℃), heating and refluxing for extraction (about 5h) until the non-volatile oil is completely extracted, collecting the extract, placing in an evaporation pan which is dried to constant weight, evaporating on a water bath at low temperature, drying for 1h at 100 ℃, moving in a dryer, cooling for 30min, precisely weighing, and calculating to obtain the content of the non-volatile oil in the inclusion compound.
The inclusion rate calculation method is as follows:
the inclusion rate is [ total oil content kg/oil input kg ]. times.100%
Wherein, the total oil content of the inclusion compound is [ the total amount of the inclusion compound/the amount of the inclusion compound weighed when the inclusion rate is measured ] × the oil content of the inclusion compound when the inclusion rate is measured; and (4) carrying out equal proportion calculation.
Examples 1 to 15
Preparation examples 1 to 15 cyclodextrin oil inclusion compounds were prepared by the following preparation steps, and the mass of the materials in each example is shown in table 1:
(1) mixing hydroxypropyl beta-cyclodextrin with an adhesive, pre-stirring, adding grease after pre-stirring uniformly, and stirring for the first time at a stirring speed of 30-50 revolutions per minute for 30min to obtain a mixture.
(2) Adding water into the mixture for secondary stirring, wherein the stirring speed is 50-100 r/min, and the stirring time is 2 hours, so as to obtain a paste powder aqueous solution; wherein the mass ratio of the added water to the grease in the mixture is 55: 1.
(3) And (4) drying the paste powder aqueous solution in vacuum to obtain the cyclodextrin oil inclusion compound.
TABLE 1
Taking 10g of cyclodextrin oil inclusion compound prepared in each of examples 1-15, measuring the oil content of the cyclodextrin oil inclusion compound according to the experimental method, and calculating the oil inclusion rate, wherein the results are shown in the following table 2:
TABLE 2
| Serial number | Inclusion rate/%) |
| Example 1 | 82.5 |
| Example 2 | 86.5 |
| Example 3 | 88.0 |
| Example 4 | 91.0 |
| Example 5 | 91.5 |
| Example 6 | 83.8 |
| Example 7 | 84.5 |
| Example 8 | 85.4 |
| Example 9 | 88.9 |
| Example 10 | 87.7 |
| Example 11 | 70.2 |
| Example 12 | 73.8 |
| Example 13 | 75.2 |
| Example 14 | 74.5 |
| Example 15 | 73.1 |
Examples 16 to 18
In examples 16 to 18, the cyclodextrin oil inclusion compound was prepared by the following preparation steps, and the mass of the materials in each example is shown in table 3:
(1) mixing hydroxypropyl beta-cyclodextrin, an adhesive and grease, and stirring at the stirring speed of 30-50 r/min for 30min to obtain a mixture.
(2) Adding water into the mixture, and stirring again at the stirring speed of 50-100 revolutions per minute for 2 hours to obtain a paste powder aqueous solution; wherein the mass ratio of the added water to the grease in the mixture is 55: 1.
(3) And (4) drying the paste powder aqueous solution in vacuum to obtain the cyclodextrin oil inclusion compound.
TABLE 3
Taking 10g of the cyclodextrin oil inclusion compound prepared in each of the above examples 16 to 18, measuring the oil content according to the above method, and then calculating the oil inclusion rate, the results are shown in table 4 below:
TABLE 4
| Serial number | Inclusion rate/%) |
| Example 16 | 88.7 |
| Example 17 | 84.0 |
| Example 18 | 71.2 |
Comparative examples 1 to 3
Comparative examples 1 to 3 cyclodextrin oil inclusion compounds were prepared by the following preparation steps, and the mass of the materials in each comparative example is shown in table 5:
(1) mixing hydroxypropyl beta-cyclodextrin and grease, and stirring at the stirring speed of 30-50 revolutions per minute for 30min to obtain a mixture.
(2) Adding water into the mixture, and stirring again at the stirring speed of 50-100 revolutions per minute for 2 hours to obtain a paste powder aqueous solution; wherein the mass ratio of the added water to the grease in the mixture is 55: 1.
(3) And (4) drying the paste powder aqueous solution in vacuum to obtain the cyclodextrin oil inclusion compound.
TABLE 5
10g of cyclodextrin oil inclusion compound prepared in each of comparative examples 1 to 3 was taken, the oil content was measured according to the above experimental method, and then the oil inclusion rate was calculated, and the results are shown in table 6 below:
TABLE 6
| Serial number | Inclusion rate/%) |
| Comparative example 1 | 74.2 |
| Comparative example 2 | 70.5 |
| Comparative example 3 | 50.8 |
Comparative example 4
Comparative example 4 a cyclodextrin oil-and-fat clathrate was prepared by the following preparation steps:
(1) adding 1kg of schizonepeta volatile oil into 95 wt% ethanol water solution with the same volume as the schizonepeta volatile oil, and fully stirring and dissolving to obtain oil water solution; and adding 12kg of beta-cyclodextrin into water with the mass of 10 times of that of the beta-cyclodextrin, and uniformly stirring to obtain a cyclodextrin water solution.
(2) Slowly dripping the grease aqueous solution into the cyclodextrin aqueous solution, simultaneously starting stirring, heating to 40 ℃, and continuously stirring for 2 hours at constant temperature; an aqueous solution of the paste powder was obtained.
(3) And (4) drying the paste powder aqueous solution in vacuum to obtain the grease inclusion compound.
Taking 10g of cyclodextrin oil inclusion compound prepared in comparative example 4, the oil content was measured according to the above experimental method, and then the oil inclusion rate was calculated, the results are shown in table 7 below:
TABLE 7
| Serial number | Inclusion rate/%) |
| Comparative example 4 | 65.0 |
Comparative example 5
Comparative example 5 a cyclodextrin oil and fat clathrate was prepared by the following preparation steps:
(1) dissolving 5kg of hydroxypropyl beta-cyclodextrin in 5kg of water, stirring uniformly, adding 1.5kg of povidone K29/32, stirring uniformly, and adding 4kg of water for dilution to obtain a cyclodextrin water solution.
(2) Adding 1kg ligustilide into cyclodextrin water solution, stirring, and adding 9.5kg water for dilution; an aqueous solution of the paste powder was obtained.
(3) And (4) freeze-drying the paste powder aqueous solution to obtain the grease inclusion compound.
Taking 10g of cyclodextrin oil inclusion compound prepared in comparative example 5, the oil content was measured according to the above experimental method, and then the oil inclusion rate was calculated, the results are shown in table 8 below:
TABLE 8
| Serial number | Inclusion rate/%) |
| Comparative example 5 | 32.4 |
Comparative example 6
Comparative example 6 a cyclodextrin oil-and-fat clathrate was prepared by the following preparation steps:
(1) dissolving 5kg of hydroxypropyl beta-cyclodextrin in 5kg of water, stirring uniformly, adding 1.5kg of povidone K29/32, stirring uniformly, and adding 4kg of water for dilution to obtain a cyclodextrin water solution.
(2) Adding 1kg of hemp seed oil into a cyclodextrin water solution, stirring, and adding 9.5kg of water for dilution; an aqueous solution of the paste powder was obtained.
(3) And (4) freeze-drying the paste powder aqueous solution to obtain the grease inclusion compound.
The oil content of the cyclodextrin oil inclusion compound prepared in comparative example 6 was measured by the above experimental method, and then the oil inclusion rate was calculated, and the results are shown in table 9 below:
TABLE 9
| Serial number | Inclusion rate/%) |
| Comparative example 6 | 42.0 |
Comparative example 7
Comparative example 7 a cyclodextrin oil and fat clathrate was prepared by the following preparation steps:
(1) adding 1kg of hemp seed oil into 100ml of Tween 80 solution, and fully stirring and dissolving to obtain a hemp seed oil solution; 10kg of hydroxypropyl beta-cyclodextrin is dissolved in water with the mass of 10 times of that of the hydroxypropyl beta-cyclodextrin, and the mixture is uniformly stirred to obtain a cyclodextrin solution.
(2) Slowly dripping the hemp seed oil solution into the cyclodextrin solution, simultaneously starting stirring, heating to 40 ℃, and stirring for 2.5 hours at constant temperature to obtain a paste powder aqueous solution.
(3) And (4) drying the paste powder aqueous solution in vacuum to obtain the grease inclusion compound.
Taking 10g of cyclodextrin oil inclusion compound prepared in comparative example 7, the oil content was measured according to the above experimental method, and then the oil inclusion rate was calculated, the results are shown in table 10 below:
watch 10
| Serial number | Inclusion rate/%) |
| Comparative example 7 | 25.0 |
The oil inclusion compound and the corresponding medicinal ointment powder in the embodiments and the comparative examples are subjected to dry granulation according to the following steps:
a. pouring the medicine ointment powder and the high-quality inclusion compound into a mixer according to the mass ratio of 5:1, and uniformly mixing to obtain a mixture; wherein the rotating speed is 10-15 r/min, and the mixing time is 45 min;
b. adding the mixture into a hopper of a dry granulating machine through a pipeline for granulation to obtain a granulated crude product; wherein the spiral feeding speed is 25-120 r/min; the rotating speed of the extrusion press roll is 8-28 r/min; the hydraulic pressure is 50-180 bar; the thickness of the sheet is 0.3-1.3 mm; the whole grain rotating speed is 80-200 r/min; the temperature of the compression roller is not more than 40 ℃;
c. and (4) sieving the granulated crude product through an 14/40-mesh sieve, and collecting granules on the 40-mesh sieve to obtain a formula granular product.
The granulation rate was calculated as follows:
the granulation rate is 100 percent of the quality of the formula granule product/the quality of the medicinal ointment powder
The results are given in Table 11 below:
TABLE 11
| Serial number | Granulation Rate/%) | Serial number | Granulation Rate/%) |
| Example 1 | 82.0 | Example 13 | 80.2 |
| Example 2 | 84.0 | Example 14 | 79.4 |
| Example 3 | 85.3 | Example 15 | 77.9 |
| Example 4 | 86.7 | Example 16 | 86.1 |
| Example 5 | 88.5 | Example 17 | 86.5 |
| Example 6 | 83.4 | Example 18 | 76.5 |
| Example 7 | 85.5 | Comparative example 1 | 72.4 |
| Example 8 | 86.9 | Comparative example 2 | 71.8 |
| Example 9 | 88.7 | Comparative example 3 | 50.5 |
| Example 10 | 87.9 | Comparative example 4 | 70.5 |
| Example 11 | 75.4 | Comparative example 5 | 74.2 |
| Example 12 | 78.5 | Comparative example 6 | 51.4 |
As can be seen from table 11, the granulation rate of the traditional Chinese medicine formula granules prepared by the preparation method of the present invention is significantly improved; the oil inclusion compound adopted by the formula particles has high content of effective components, so that the cost can be reduced, and the dosage can be reduced.
The present invention is not limited to the above-described embodiments, and any variations, modifications, and substitutions which may occur to those skilled in the art may be made without departing from the spirit of the invention.
Claims (7)
1. A traditional Chinese medicine formula granule is characterized in that the traditional Chinese medicine formula granule is obtained by dry granulation of raw materials comprising an oil inclusion compound and medicine paste powder; the oil inclusion compound comprises raw materials including oil, cyclodextrin and an adhesive, wherein the mass ratio of the oil to the cyclodextrin to the adhesive in the raw materials is 1: 6-12: 1-5, and the oil inclusion rate is more than 70%;
the preparation method of the traditional Chinese medicine formula granule comprises the following steps:
(1) preparing medicinal ointment powder;
(2) the oil inclusion compound is prepared by the following steps: firstly, mixing the adhesive and cyclodextrin, then pre-stirring, adding grease after uniformly stirring, and stirring for the first time to obtain a mixture after uniformly stirring; mixing the mixture with water, stirring for the second time, and uniformly stirring to obtain a paste powder aqueous solution; drying the paste powder aqueous solution to obtain a grease inclusion compound;
(3) mixing the oil inclusion compound and the medicinal ointment powder uniformly, and performing dry granulation to obtain the medicinal ointment;
the oil comprises volatile oil and non-volatile oil, wherein the volatile oil is one or more of mint volatile oil, schizonepeta volatile oil, cinnamon volatile oil and forsythia volatile oil, and the non-volatile oil is non-volatile fatty oil;
wherein the binder is selected from one or more of povidone, pregelatinized starch, and lactose.
2. The traditional Chinese medicine formula particle as claimed in claim 1, wherein the oil is volatile oil, and the oil inclusion rate is 80-90%.
3. The traditional Chinese medicine formula particle according to claim 1, wherein the oil is a non-volatile oil, and the oil inclusion rate is 70-75%.
4. The method of any one of claims 1-3, wherein the method comprises the steps of:
(1) preparing medicinal ointment powder;
(2) the oil inclusion compound is prepared by the following steps: firstly, mixing the adhesive and cyclodextrin, then pre-stirring, adding grease after uniformly stirring, and stirring for the first time to obtain a mixture after uniformly stirring; mixing the mixture with water, stirring for the second time, and uniformly stirring to obtain a paste powder aqueous solution; drying the paste powder aqueous solution to obtain a grease inclusion compound;
(3) mixing the oil inclusion compound and the medicinal extract powder uniformly, and performing dry granulation to obtain the medicinal composition.
5. The preparation method of the traditional Chinese medicine formula particle according to claim 4, wherein in the step (2), the mass ratio of the added water to the grease in the mixture is 50-60: 1.
6. The method for preparing a Chinese medicinal granule according to claim 4, wherein in the step (2), the second stirring speed is 50-100 r/min, the second stirring temperature is 10-30 ℃, and the second stirring time is 1-3 h.
7. The preparation method of the traditional Chinese medicine formula particle according to claim 4, wherein in the step (3), the mass ratio of the oil inclusion compound to the medicine ointment powder is 1: 3-8.
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| WO2005117899A1 (en) * | 2004-06-02 | 2005-12-15 | Cipla Limited | Pharmaceutical composition comprising tibolone and process for procuding the same |
| CN102078349A (en) * | 2009-11-26 | 2011-06-01 | 上海中邦斯瑞生物药业技术有限公司 | Cyclodextrin inclusion compound containing angelica volatile oil |
| CN104800481A (en) * | 2013-09-13 | 2015-07-29 | 孙彩娟 | Preparation method and application of essential oil inclusion compound |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005117899A1 (en) * | 2004-06-02 | 2005-12-15 | Cipla Limited | Pharmaceutical composition comprising tibolone and process for procuding the same |
| CN102078349A (en) * | 2009-11-26 | 2011-06-01 | 上海中邦斯瑞生物药业技术有限公司 | Cyclodextrin inclusion compound containing angelica volatile oil |
| CN104800481A (en) * | 2013-09-13 | 2015-07-29 | 孙彩娟 | Preparation method and application of essential oil inclusion compound |
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