Fructus cannabis formula granules and preparation method thereof

Abstract

The invention discloses fructus cannabis formula granules and a preparation method thereof. The preparation method comprises the following steps: squeezing fructus cannabis decoction pieces, and separating fructus cannabis fatty oil and decoction dregs; decoction dregs are decocted twice, medicine liquid is combined and concentrated to flow paste, spray drying is performed after filtering and paste collecting, and dry paste powder of the fructus cannabis formula granules is obtained; weighing fatty oil according to the total fatty oil content requirement of the finished product of the fructus cannabis formula granules, and carrying out adsorption treatment by utilizing an adsorption accelerant to obtain a fatty oil inclusion compound; and mixing the fatty oil clathrate with the fructus cannabis formula granule dry paste powder, adding a filling agent to reach the total amount of the fructus cannabis formula granule finished product, and mixing and granulating to obtain the fructus cannabis formula granule. According to the method, the content of the fatty oil in the finished product of the fructus cannabis formula granules can be accurately controlled, and various adverse effects of the fatty oil on the production process are solved.

Description

Technical Field

[0001] The invention relates to Chinese medicine formula granules, in particular to hemp seed formula granules and a preparation method thereof. Background Art

[0002] Chinese medicine formula granules are Chinese medicine granules that can be used for clinical preparation by boiling, concentrating, separating, drying, granulating, and packaging Chinese medicine slices. Chinese medicine formula granules have the advantages of safety, effectiveness, and convenience of administration. The main components of hemp seed are lignanamides, steroid components, olefins, alkaloids, fatty acid esters, etc. Among them, hemp seed fatty oil, as one of the main active ingredients, contains a large amount of unsaturated fatty acids such as linoleic acid and -linolenic acid, and has the effects of lowering blood lipids, anti-oxidation, and improving memory. In the national standard for hemp seed formula granules, the content limit requirements for hemp seed fatty oil are set. The total fatty oil content in each 1g of hemp seed formula granules should be 70.0mg~180.0mg. The traditional preparation process of hemp seed formula granules is water extraction, vacuum concentration, fluid paste separation, drying (generally spray drying), mixing, granulation, and packaging. There are many problems in the conventional preparation process of hemp seed formula granules, mainly the following problems: 1. The loss of fatty oil in each process during the preparation process is relatively large; the main reason is that fatty oil is not easy to water, and will adhere to the surface of equipment, pipeline surface, medicinal material surface, etc., and the loss is large in the extraction, concentration, drying and other links; 2. The production is not smooth during the drying process (spray drying) because of the presence of fatty oil. The powder will stick to the surface of the equipment together with the fatty oil, resulting in the loss of the powder. The consumption is large; 3. The fluidity of the powder is not good, which affects the mixing uniformity of the powder and excipients in the preparation stage and the compressibility of the granulation. The main reason is that the surface of the powder contains fatty oil, which will deteriorate the fluidity of the powder, affecting the mixing uniformity of the powder during the preparation process; in addition, the compressibility of the granulation is not good. The pressed tablets contain fatty oil, and the hardness is not enough after crushing and granulation, and they are easy to loosen, resulting in the particle size not meeting the requirements of the granules; 4. The total amount of fatty oil in the finished product is uncontrollable, and the content is insufficient or exceeds the limit. The main reason is that the amount of fatty oil extracted, lost, and collected during the production process is uncontrollable, resulting in uncontrollable amount of fatty oil in the finished product. In general, the current conventional production process of hemp seed formula granules reflects unstable process and uncontrollable quality. Summary of the invention

[0003] The technical problem to be solved by the invention is to provide a method for preparing hemp seed formula granules with stable process and controllable fat oil content.

[0004] Another technical problem to be solved by the present invention is to provide a hemp seed formula granule with precise fatty oil content.

[0005] In order to solve the above technical problems, the technical solution adopted in the present invention is a method for preparing hemp seed formula granules, comprising the following steps: 101) Pressing the hemp seed slices to separate the hemp seed fatty oil and the medicinal residue; 102) decocting the medicinal residue, combining the medicinal liquid after decocting twice, concentrating to a fluid paste, filtering the paste, and spray drying to obtain a dry paste powder of hemp seed formula granules; 103) According to the total amount of the prepared hemp seed formula granules, the fatty oil is weighed according to the requirements of the hemp seed formula granules standard, and adsorption treatment is performed using an adsorption promoter to obtain a fatty oil inclusion compound; 104) The fatty oil inclusion compound is mixed with the dry paste powder of the hemp seed formula granules, and a filler is added to reach the total amount of the finished hemp seed formula granules, and mixed and granulated to obtain the hemp seed formula granules.

[0006] In the above-mentioned preparation method, in step 101, the pressing process includes pressing oil through an oil press, collecting fatty oil and medicinal residues, and collecting pure fatty oil through sieve filtering.

[0007] The above preparation method comprises the following steps: in step 102, the medicinal residues are decocted, and according to the mass of the medicinal residues, 7 to 9 times of water are added for the first decoction, and the mixture is soaked for 0.3 to 0.7 hours and then heated to 100° C., and the mixture is kept slightly boiling and decocted for 0.3 to 0.7 hours, and the medicinal liquid of the first decoction is collected; 5 to 7 times of water are added for the second decoction, and the mixture is heated to 100° C., and the mixture is kept slightly boiling and decocted for 0.3 to 0.7 hours, and the medicinal liquid of the second decoction is collected; and the medicinal liquids of the two decoctions are combined and concentrated to a fluid paste density of 1.02 to 1.06 g / ml, the paste is filtered and collected, and the paste is spray-dried to obtain the dry paste powder of the hemp seed formula granules.

[0008] According to the preparation method described above, 100 parts by weight of hemp seed slices are processed in step 101 and step 102 to obtain 20 to 30 parts by weight of pure fatty oil and 14.5 to 21.5 parts by weight of hemp seed formula granule dry paste powder.

[0009] In the above-described preparation method, in step 103, the total amount of the finished hemp seed formula granules is 28.6 parts by mass, and the mass of the fatty oil weighed is 2.5 to 3.2 parts by mass; the adsorption promoter includes β-cyclodextrin and silicon dioxide, and in the step of adsorption treatment, the mass ratio of β-cyclodextrin to fatty oil is 2.8 to 3.2:1, and the silicon dioxide is 0.8 to 1.2 parts by mass.

[0010] In the above-described preparation method, in the step of mixing and granulating in step 104, the dry paste powder of the hemp seed formula granules is 14.5 to 21.5 parts by mass, and the balance is the filler. The filler is mixed with the dry paste powder of the hemp seed formula granules and the fatty oil inclusion compound to 28.6 parts by mass, and dry granulation and sieving are performed.

[0011] In the above-mentioned preparation method, the filler is maltodextrin.

[0012] A hemp seed formula granule, which is obtained by the above-mentioned preparation method.

[0013] The preparation method of the hemp seed formula granules of the present invention can accurately control the fatty oil content of the finished hemp seed formula granules and solve various adverse effects of the fatty oil on the production process. DETAILED DESCRIPTION

[0014] 1. Raw materials: Hemp seed slices, β-cyclodextrin (auxiliary material), silicon dioxide (auxiliary material), maltodextrin (auxiliary material) 2. Equipment: oil press, extraction tank, vacuum concentrator, spray dryer, mixer, dry granulator 3. Process steps: 1. Take 100g of hemp seed slices to make 28.6g of hemp seed formula granules. First, use an oil press to press the hemp seed slices, collect the fatty oil and the residue, filter the fatty oil through a 300-mesh sieve, and collect 20g to 30g of pure fatty oil; 2. Decoction the residue: decoct twice, add 8 times the amount of water for the first time, soak for 0.5 hours, then heat to 100°C, keep boiling for 0.5 hours, and collect the liquid medicine; add 6 times the amount of water for the second time, heat to 100°C, keep boiling for 0.5 hours, and collect the liquid medicine; combine the two liquid medicines, concentrate to a fluid paste density of 1.02-1.06 g / ml, filter with a 300-mesh filter cloth to collect the paste, spray dry, and obtain 14.5-21.5 g of powder; 3. Add fat oil according to the standard of hemp seed formula granules (YBZ-PFKL-2021067) containing 70mg to 180mg of total fat oil per gram of finished product: according to the total amount of finished product of 28.6g, each gram of finished product contains 90 to 120mg of total fat oil, weigh 2.57 to 3.4g of fat oil, first add β-cyclodextrin according to the ratio of oil to β-cyclodextrin = 1:2.8 to 3.2 to stir and mix the fat oil for adsorption, then add 1g (1% of the mass of the decoction piece) of silicon dioxide, stir, and pass through a 60-mesh sieve to obtain a hemp seed fatty oil inclusion compound with good fluidity; 4. Take an appropriate amount of maltodextrin, mix it with the hemp seed powder and the fatty oil inclusion compound to a total amount of 28.6 g, mix for 15 minutes, and then perform dry granulation to obtain hemp seed formula granules.

[0015] 5. Test the hemp seed formula granules according to the national standards for hemp seed formula granules, and summarize and analyze the test results.

[0016] The present invention firstly squeezes the hemp seed slices, squeezes out the fatty oil in the hemp seed slices as much as possible, separates the fatty oil, and collects by filtering to obtain pure hemp seed fatty oil and hemp seed dregs; the dregs can be extracted, concentrated, separated, and dried according to the conventional preparation process of the formula granules to obtain the dry paste powder of the hemp seed formula granules; the fatty oil is weighed according to the intermediate value of the finished product limit requirement (according to the standard requirements of the hemp seed formula granules, the fatty oil is added in an amount of 70mg to 180mg of total fatty oil per gram of the finished product), and the auxiliary materials silicon dioxide and beta-cyclodextrin are used for adsorption treatment, wherein the auxiliary material beta-cyclodextrin plays a role in adsorbing the fatty oil, and the auxiliary material silicon dioxide is added to improve the fluidity and compressibility of the fatty oil inclusion compound. Finally, the hemp seed fatty oil inclusion compound is mixed with the dry paste powder of the hemp seed formula granules, and a filler is added to reach the total amount of the finished hemp seed formula granules, and the mixture is granulated and packaged together to obtain the hemp seed formula granules.

[0017] Embodiment 1: Take 100g of hemp seed slices, first use an oil press to press oil from the hemp seed slices, collect fatty oil and medicinal residues, filter the fatty oil through a 300-mesh screen, collect 28.9g of pure fatty oil and 61g of medicinal residues, and set aside; Take 61g of medicinal residues, decoct twice, add 8 times the amount of water for the first time, soak for 0.5 hour, then heat to 100°C, keep boiling and decoct for 0.5 hour, and collect the medicinal liquid; add 6 times the amount of water for the second time, heat to 100°C, keep boiling and decoct for 0.5 hour, and collect the medicinal liquid; Combine the two medicinal liquids, concentrate to a flow paste density of 1.04g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 1 medicated powder 5.5g for standby; according to the total amount of finished product being 28.6g, each gram of finished product containing 90mg of total fatty oil, weigh 2.57g of fatty oil; according to the mass ratio, fatty oil: β-cyclodextrin = 1:3.2, add β-cyclodextrin, stir and mix for adsorption, then add 1g of silicon dioxide, stir, pass through a 60-mesh sieve, and obtain a hemp seed fatty oil inclusion compound with good fluidity for standby; Take an appropriate amount of maltodextrin, mix it with 15.5g of hemp seed powder and the fatty oil inclusion compound to a total amount of 28.6g, mix for 15 minutes, and then carry out dry granulation to obtain hemp seed formula granules, and detect it according to the national standard for hemp seed formula granules, and the results are as follows:

[0018] Embodiment 2: Take 100g of hemp seed slices, first use an oil press to press oil from the hemp seed slices, collect fatty oil and medicinal residues, filter the fatty oil through a 300-mesh screen, collect 25.6g of pure fatty oil and 63.1g of medicinal residues for standby use; take 63.1g of medicinal residues, decoct twice, add 8 times the amount of water for the first time, soak for 0.5 hour, then heat to 100°C, keep boiling and decoct for 0.5 hour, and collect the medicinal liquid; add 6 times the amount of water for the second time, heat to 100°C, keep boiling and decoct for 0.5 hour, and collect the medicinal liquid; combine the two medicinal liquids,, concentrate to a fluid paste density of 1.05g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain a medicinal powder 15.9g is for standby; in addition, according to the total amount of finished product being 28.6g, each gram of finished product contains 100mg total fatty oil, weigh 2.86g of fatty oil, according to the mass ratio, fatty oil: β-cyclodextrin=1:3, add β-cyclodextrin, stir and mix for adsorption, then add 1g of silicon dioxide, stir, pass through a 60-mesh sieve, obtain a hemp seed fatty oil inclusion compound with good fluidity, for standby; Take an appropriate amount of maltodextrin, mix it with 15.9g of hemp seed powder and the fatty oil inclusion compound, to a total amount of 28.6g, mix for 15 minutes, then carry out dry granulation, sieve, obtain hemp seed formula granules, according to the national standard for hemp seed formula granules, detect, and the results are as follows:

[0019] Embodiment 3: Take 100g of hemp seed slices, first use an oil press to press oil from the hemp seed slices, collect fatty oil and medicinal residues, filter the fatty oil through a 300-mesh screen, collect 26.8g of pure fatty oil and 60.5g of medicinal residues for standby use; Take 60.5g of medicinal residues, decoct twice, add 8 times the amount of water for the first time, soak for 0.5 hour, then heat to 100°C, keep boiling for 0.5 hour, and collect the medicinal liquid; add 6 times the amount of water for the second time, heat to 100°C, keep boiling for 0.5 hour, and collect the medicinal liquid; Combine the two medicinal liquids, concentrate to a flow paste density of 1.04g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 1 medicated powder 5.2g is standby; in addition, according to the finished product total amount of 28.6g, every gram of finished product contains 110mg total fatty oil, weigh 3.14g of fatty oil, according to mass ratio, fatty oil: β-cyclodextrin=1:2.8, add β-cyclodextrin, stir and mix for adsorption, then add 1g of silicon dioxide, stir, pass 60 mesh sieve, obtain hemp seed fatty oil inclusion compound with good fluidity, standby; Take appropriate amount of maltodextrin, mix with hemp seed powder 15.2g and fatty oil inclusion compound, to a total amount of 28.6g, mix for 15 minutes, then carry out dry granulation, obtain hemp seed formula granules, according to the national standard of hemp seed formula granules, detect, the result is as follows:

[0020] Comparative Example: 100g of hemp seed slices were decocted twice, 8 times of water was added for the first time, soaked for 0.5 hour, then heated to 100°C, kept slightly boiling and decocted for 0.5 hour, and the medicinal liquid was collected; 6 times of water was added for the second time, heated to 100°C, kept slightly boiling and decocted for 0.5 hour, and the medicinal liquid was collected; the medicinal liquids were combined twice, concentrated to a flow paste density of 1.04g / ml, filtered through a 300 mesh filter cloth, and the paste was collected, spray-dried, and 20.2g of medicated powder was obtained. 8.4g of maltodextrin was taken, and 28.6g was mixed with hemp seed powder, mixed for 15 minutes, and then dry granulated to obtain hemp seed formula granules. According to the national standard for hemp seed formula granules, detection was performed, and the results were as follows:

[0021] The preparation method of the hemp seed formula granules of the above embodiment of the present invention has the following beneficial effects: 1. The quality problem of the finished product is solved. The fat oil content of the finished hemp seed formula granules produced by conventional process technology is uncontrollable, fluctuates, and cannot be accurately controlled. However, the production technology of the present invention is adopted, through the production process of oil pressing and auxiliary material adsorption of fat oil, the amount of fat oil added can be accurately controlled, thereby accurately controlling the fat oil content of the finished product.

[0022] 2. Improve the production process, make it smoother, and reduce product losses. Under conventional process conditions, the spray-dried powder contains a certain amount of fatty oil in the liquid medicine during the spray-drying process, which causes the powder to contain fatty oil on its surface and easily adhere to the surface of the equipment, causing serious product losses. In the subsequent mixing process, the powder is prone to agglomeration due to the presence of oil on its surface, and the powder has poor fluidity and is not easy to mix evenly, which does not meet the process control requirements. 3. During the granulation process, the powder contains fatty oil, which results in insufficient hardness of the pressed tablets. After crushing and granulation, the obtained granules are easily loose and have insufficient particle size, which does not meet the particle size requirements of granules. The present invention can solve the problems arising in the above process through the production process of pressing and adsorbing fatty oil by auxiliary materials, and can preferentially separate the fatty oil in the medicinal materials. By adsorbing by auxiliary materials, various adverse effects of fatty oil on the production process can be well solved.

Claims

1. A method for preparing hemp seed formula granules, characterized in that: The following steps are involved: 101) Pressing the hemp seed slices to separate the hemp seed fatty oil and the residue; 102) decocting the medicinal residue, combining the medicinal liquid after decocting twice, concentrating to a fluid paste, filtering the paste, and spray drying to obtain a dry paste powder of hemp seed formula granules; 103) According to the total amount of the prepared hemp seed formula granules, the fatty oil is weighed according to the requirements of the hemp seed formula granules standard, and adsorption treatment is performed using an adsorption promoter to obtain a fatty oil inclusion compound; 104) The fatty oil inclusion compound is mixed with the dry paste powder of the hemp seed formula granules, and a filler is added to reach the total amount of the finished hemp seed formula granules, and mixed and granulated to obtain the hemp seed formula granules.

2. The preparation method according to claim 1, characterized in that: In step 101, the pressing process includes pressing oil through an oil press, collecting fatty oil and medicinal residues, and collecting pure fatty oil through sieve filtering.

3. The preparation method according to claim 2, characterized in that: In step 102, the medicinal residue is decocted, and according to the weight of the medicinal residue, 7 to 9 times the amount of water is added for the first decoction, and the mixture is soaked for 0.3 to 0.7 hours, heated to 100° C., and kept slightly boiling for 0.3 to 0.7 hours, and the medicinal liquid of the first decoction is collected; 5 to 7 times the amount of water is added for the second decoction, heated to 100° C., and kept slightly boiling for 0.3 to 0.7 hours, and the medicinal liquid of the second decoction is collected; the medicinal liquids of the two decoctions are combined and concentrated to a fluid paste density of 1.02 to 1.06 g / ml, filtered to collect the paste, and spray-dried to obtain the hemp seed formula granule dry paste powder.

4. The preparation method according to claim 1, characterized in that: 100 parts by weight of hemp seed slices are processed in step 101 and step 102 to obtain 20 to 30 parts by weight of pure fatty oil and 15 to 16 parts by weight of hemp seed formula granule dry paste powder.

5. The preparation method according to claim 1, characterized in that: In step 103, the total amount of the finished hemp seed formula granules is 28.6 parts by mass, and the mass of the fatty oil weighed is 2.5 to 3.2 parts by mass; the adsorption promoter includes β-cyclodextrin and silicon dioxide, and in the step of adsorption treatment, the mass ratio of β-cyclodextrin to fatty oil is 2.8 to 3.2:1, and the silicon dioxide is 0.8 to 1.2 parts by mass.

6. The preparation method according to claim 5, characterized in that: In step 104 of mixing and granulating, the dry powder of hemp seed formula granules is 15 to 16 parts by mass, and the balance is the filler. The filler is mixed with the dry powder of hemp seed formula granules and the fatty oil inclusion compound to 28.6 parts by mass, and dry granulation is performed.

7. The preparation method according to claim 6, characterized in that: The filler is maltodextrin.

8. A hemp seed formula granule, characterized in that: The hemp seed formula granules are obtained by the preparation method described in any one of claims 1 to 7.

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