CN115531511A - Novel biochemical particle and preparation method thereof - Google Patents
Novel biochemical particle and preparation method thereof Download PDFInfo
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- CN115531511A CN115531511A CN202211132270.9A CN202211132270A CN115531511A CN 115531511 A CN115531511 A CN 115531511A CN 202211132270 A CN202211132270 A CN 202211132270A CN 115531511 A CN115531511 A CN 115531511A
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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Abstract
The invention provides a new biochemical particle and a preparation method thereof. The preparation method comprises the following steps: extracting volatile oil from radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos with water by steam distillation, collecting volatile oil, and clathrating the volatile oil with beta-cyclodextrin to form clathrate; extracting volatile oil to obtain water solution; extracting the dregs after extracting the volatile oil with water to obtain an aqueous extract; combining the obtained water extract and the water solution after extracting the volatile oil, concentrating the mixture to an extract with the relative density of 1.05-1.15 at the temperature of 60 ℃, filtering the extract, and spray-drying the filtrate to obtain extract powder; mixing the obtained clathrate, the obtained extract powder and brown sugar, and performing dry granulation to obtain the final product. The preparation method shortens production cycle, greatly improves the content of ferulic acid, leonurine hydrochloride stachydrine hydrochloride, glycyrrhizin and glycyrrhizic acid in the new biochemical granules, integrally improves the quality of the new biochemical granule finished product, and improves the product curative effect of the new biochemical granules.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a new biochemical granule and a preparation method thereof.
Background
The new biochemical granules are used for treating postpartum lochiorrhea and lower abdominal pain, and can also be used for treating vaginal bleeding and menorrhagia caused by upper contraceptive ring.
According to the national medicine standard WS3-B-1056-91-2015 of the State food and drug administration, the preparation method of the new biochemical particles comprises the following steps: pulverizing the above seven materials into coarse powder, and extracting volatile oil. Collecting the distilled water solution in another container. Decocting the residue with water for 2 hr for the first time and 1.5 hr for the second time, mixing decoctions, filtering, mixing the filtrate with the above water solution, concentrating into soft extract, adding brown sugar, mixing, and granulating; drying at 60 deg.C, pulverizing, adding ethanol, granulating, and spraying volatile oil. The functions and indications are: promote blood circulation, dispel blood stasis and alleviate pain.
The newly-generated granules produced by the prior art are concentrated into thick paste, granulation is carried out twice, the process is complicated, and the loss of effective components is large.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides the new biochemical particles and the preparation method thereof, and the new biochemical particles have high content of effective components, so that the product curative effect of the new biochemical particles is improved.
Specifically, the invention provides the following technical scheme:
a preparation method of newly-formed granules comprises the following steps:
(1) Extracting volatile oil from radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos with water by steam distillation, collecting volatile oil, and clathrating the volatile oil with beta-cyclodextrin to form clathrate; extracting volatile oil to obtain water solution;
(2) Extracting the dregs of the decoction after the volatile oil is extracted in the step (1) with water to obtain an aqueous extract;
(3) Combining the water extract obtained in the step (2) with the water solution obtained after the volatile oil is extracted in the step (1), concentrating the mixture to an extract with the relative density of 1.05-1.15 at the temperature of 60 ℃, filtering the extract, and performing spray drying on the filtrate to obtain extract powder;
(4) And (2) mixing the inclusion compound obtained in the step (1), the paste powder obtained in the step (3) and brown sugar, and performing dry granulation to obtain the sugar-free eye cream.
Through a large amount of experiments, the inventor finds that the extract is instantly dried into extract powder by reducing the relative density of the concentrated extract and adopting a spray drying technology; mixing the extract powder, the volatile oil inclusion compound and the brown sugar powder uniformly, and performing dry granulation to greatly improve the effective components in the product, particularly the ferulic acid content, the leonurine hydrochloride content, the stachydrine hydrochloride content, the liquiritin content and the glycyrrhizic acid content, thereby integrally improving the curative effect of the newly-transformed granular product.
In the step (3), if the extract is concentrated until the relative density of the extract is lower than 1.05, the defects of large extract amount and long working time of subsequent spray drying exist, and if the extract is concentrated until the relative density of the extract is higher than 1.15, the defects of large extract relative density and difficult atomization in the spray drying process exist.
Preferably, the safflower is safflower coarse powder.
Preferably, in the above method for preparing a novel biochemical particle, in step (1), the water addition is specifically: adding water with the weight 6-10 times of that of the raw materials.
Preferably, in the above method for preparing new biochemical particles, the distillation temperature for extracting volatile oil by steam distillation is 97-103 ℃.
Preferably, in the above method for preparing the novel biochemical particles, in step (1), the step of including the volatile oil with beta-cyclodextrin to form the inclusion compound comprises the specific steps of: firstly, uniformly mixing the volatile oil with 95% ethanol with equal volume; grinding beta-cyclodextrin with 2-3 times of water, gradually adding the mixture of volatile oil and 95% ethanol, grinding while adding, grinding into paste, refrigerating at 0-10 deg.C for 16-48 hr, filtering, drying at 40-60 deg.C, and pulverizing.
Preferably, in the above method for preparing a novel biochemical particle, in step (2), the water extraction is specifically: adding water with the weight 6-8 times of that of the decoction dregs to decoct and extract for 2 times, each time lasts for 1.0-2.5 hours, filtering to obtain filtrate, and combining the filtrates obtained by water extraction twice to obtain water extract.
Preferably, in the above method for preparing novel biochemical particles, in step (3), the inlet temperature of the spray drying is 130 to 180 ℃, and the outlet temperature is 70 to 120 ℃. Further preferably, the inlet temperature of the spray drying is 140-160 ℃, the outlet temperature is 75-95 ℃, and experiments show that under the conditions of the inlet temperature and the outlet temperature, an ideal drying effect can be achieved, and the effective components of the product can be retained to the maximum extent.
Preferably, in the above method for preparing the novel biochemical particles, the novel biochemical particles are prepared from the following components in parts by weight:
230 to 250 portions of angelica, 80 to 100 portions of Szechuan lovage rhizome, 20 to 30 portions of peach seed, 10 to 20 portions of liquoric root, 10 to 20 portions of dried ginger, 280 to 320 portions of motherwort and 10 to 20 portions of safflower.
The invention also provides a new biochemical particle, which is prepared according to the preparation method of the new biochemical particle.
The invention has the following beneficial effects:
the preparation method of the new biochemical particles shortens the production period, greatly improves the contents of ferulic acid, leonurine hydrochloride stachydrine hydrochloride, liquiritin and glycyrrhizic acid in the new biochemical particles, integrally improves the quality of finished new biochemical particles and improves the product curative effect of the new biochemical particles.
Detailed Description
The following examples are given to further illustrate embodiments of the present invention. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art, and the raw materials used are commercially available.
Example 1
This example provides a new biochemical granule formulated as follows: 80kg of angelica, 30kg of ligusticum wallichii, 8kg of peach kernel, 5kg of liquorice (roasted), 5kg of dried ginger (charcoal), 100kg of motherwort and 5kg of safflower.
The preparation method comprises the following steps:
(1) Pulverizing radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos into coarse powder, adding water 10 times the weight of the raw materials, extracting volatile oil by steam distillation at 100 deg.C, collecting volatile oil 354mL, and clathrating the volatile oil with beta-cyclodextrin to form 0.8kg of clathrate (the specific method for forming clathrate comprises mixing volatile oil with 95% ethanol at equal volume, adding 2 times the weight of water into 1kg of beta-cyclodextrin, grinding, gradually adding the mixture of volatile oil and 95% ethanol, grinding while adding, grinding into paste, refrigerating at 0-10 deg.C for 16-48 hr, filtering, drying at 40-60 deg.C, and pulverizing); extracting volatile oil to obtain water solution;
(2) Carrying out water extraction on the dregs of the decoction after the volatile oil is extracted in the step (1) to obtain an aqueous extract; the water extraction is specifically as follows: adding water with the weight 8 times of that of the decoction dregs, decocting and extracting for 2 times, the first time is 2 hours, the second time is 1.5 hours, filtering to obtain filtrate, and combining the filtrate obtained by the two water extractions to obtain water extract;
(3) Combining the water extract obtained in the step (2) with the water solution obtained after the volatile oil is extracted in the step (1), concentrating to obtain 271.2kg of extract with the relative density of 1.12 at the temperature of 60 ℃, filtering, and performing spray drying on the filtrate to obtain 40.4kg of extract powder (the inlet temperature of spray drying is 140 ℃, and the outlet temperature is 76 ℃);
(4) Drying and crushing a proper amount of brown sugar into fine powder;
(5) And (3) mixing the inclusion compound obtained in the step (1), the paste powder obtained in the step (3) and 114.1kg of brown sugar fine powder, adding into a dry granulating machine, and granulating to obtain the sugar-free sugar-containing granule.
The amount of granules prepared in example 1 was 153.3kg, the theoretical number of bags (6 g/bag) was 25888, the actual number of bags was 25495, and the pass rate was 98.5%; the ferulic acid content of the prepared newly-generated granule is 0.90mg/g; the content of leonurine hydrochloride is 0.32mg/g; the content of the stachydrine hydrochloride is 7.01mg/g; the content of liquiritin is 0.22mg/g; the content of glycyrrhizic acid is 0.85mg/g.
Example 2
This example provides a new biochemical particle, formulated as follows: 80kg of angelica, 30kg of ligusticum wallichii, 8kg of peach kernel, 5kg of liquorice (roasted), 5kg of dried ginger (charcoal), 100kg of motherwort and 5kg of safflower.
The preparation method comprises the following steps:
(1) Pulverizing radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos into coarse powder, adding water 10 times the weight of the raw materials, extracting volatile oil by steam distillation at 100 deg.C, collecting 352mL of volatile oil, and clathrating the volatile oil with beta-cyclodextrin to form 0.8kg of clathrate (the specific method for forming clathrate comprises mixing the volatile oil with 95% ethanol at equal volume, adding 2 times the weight of water into 1kg of beta-cyclodextrin, grinding, gradually adding the mixture of volatile oil and 95% ethanol, grinding while adding, grinding into paste, refrigerating at 0-10 deg.C for 16-48 hr, filtering, drying at 40-60 deg.C, and pulverizing); extracting volatile oil to obtain water solution;
(2) Carrying out water extraction on the dregs of the decoction after the volatile oil is extracted in the step (1) to obtain an aqueous extract; the water extraction is specifically as follows: adding water with the weight 8 times of that of the decoction dregs, decocting and extracting for 2 times, the first time is 2 hours, the second time is 1.5 hours, filtering to obtain filtrate, and combining the filtrates obtained by water extraction twice to obtain water extract;
(3) Combining the water extract obtained in the step (2) and the water solution obtained after the volatile oil is extracted in the step (1), concentrating to 268.3kg of extract with the relative density of 1.12 at 60 ℃, filtering, and spray-drying the filtrate to obtain 40.1kg of extract powder (the inlet temperature of spray-drying is 150 ℃, and the outlet temperature is 85 ℃);
(4) Drying and crushing a proper amount of brown sugar into fine powder;
(5) And (3) mixing the inclusion compound obtained in the step (1), the paste powder obtained in the step (3) and 114.4kg of brown sugar fine powder, adding into a dry granulating machine, and granulating to obtain the sugar-free sugar-containing granule.
The amount of the prepared granules in example 2 is 152.8kg, the theoretical number of bags (6 g/bag) is 25888, the actual number of bags is 25408, and the qualification rate is 98.1%; the ferulic acid content of the prepared newly-generated granule is 0.88mg/g; the content of the leonurine hydrochloride is 0.33mg/g; the content of the stachydrine hydrochloride is 6.98mg/g; the content of liquiritin is 0.23mg/g; the content of glycyrrhizic acid is 0.83mg/g.
Example 3
This example provides a new biochemical granule formulated as follows: 80kg of angelica, 30kg of ligusticum wallichii, 8kg of peach kernel, 5kg of liquorice (roasted), 5kg of dried ginger (charcoal), 100kg of motherwort and 5kg of safflower.
The preparation method comprises the following steps:
(1) Pulverizing radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos into coarse powder, adding water 10 times the weight of the raw materials, extracting volatile oil by steam distillation at 100 deg.C, collecting volatile oil 355mL, and clathrating the volatile oil with beta-cyclodextrin to form 0.8kg of clathrate (the specific method for forming clathrate comprises mixing volatile oil with 95% ethanol at equal volume, adding 2 times the weight of water into 1kg of beta-cyclodextrin, grinding, gradually adding the mixture of volatile oil and 95% ethanol, grinding while adding, grinding into paste, refrigerating at 0-10 deg.C for 16-48 hr, filtering, drying at 40-60 deg.C, and pulverizing); extracting volatile oil to obtain water solution;
(2) Carrying out water extraction on the dregs of the decoction after the volatile oil is extracted in the step (1) to obtain an aqueous extract; the water extraction is specifically as follows: adding water with the weight 8 times of that of the decoction dregs, decocting and extracting for 2 times, the first time is 2 hours, the second time is 1.5 hours, filtering to obtain filtrate, and combining the filtrate obtained by the two water extractions to obtain water extract;
(3) Combining the water extract obtained in the step (2) with the water solution obtained after the volatile oil is extracted in the step (1), concentrating to obtain 271.9kg of extract with the relative density of 1.12 at 60 ℃, filtering, and performing spray drying on the filtrate to obtain 40.5kg of extract powder (the inlet temperature of spray drying is 160 ℃, and the outlet temperature is 91 ℃);
(4) Drying and crushing a proper amount of brown sugar into fine powder;
(5) And (3) mixing the inclusion compound obtained in the step (1), the paste powder obtained in the step (3) and 114.0kg of brown sugar fine powder, adding into a dry granulating machine, and granulating to obtain the sugar-free sugar-containing granule.
The amount of the prepared granules in example 3 is 153.1kg, the theoretical number of bags (6 g/bag) is 25888, the actual number of bags is 25454, and the qualification rate is 98.3%; the ferulic acid content of the prepared newly-generated granule is 0.86mg/g; the content of the leonurine hydrochloride is 0.33mg/g; the content of the stachydrine hydrochloride is 6.85mg/g; the content of liquiritin is 0.21mg/g; the content of glycyrrhizic acid is 0.84mg/g.
The results of examples 1-3 show that: 3 batches of production processes all meet the design requirements. Indicating that the mass production process is stable.
Comparative example 1
The newly-formed granule of comparative example 1 is prepared according to national food and drug administration national drug Standard WS 3-B-1056-91-2015: 120kg of angelica, 45kg of ligusticum wallichii, 12kg of peach kernel, 7.5kg of liquorice (roasted), 7.5kg of dried ginger (charcoal), 150kg of motherwort and 7.5kg of safflower, and the seven ingredients are crushed into coarse powder to extract volatile oil. Collecting the distilled water solution in another container. And adding water into the dregs of a decoction, decocting for two times, the first time is 2 hours, the second time is 1.5 hours, combining the decoction, filtering, combining the filtrate with the aqueous solution, concentrating into thick paste with the relative density of 1.25-1.30, adding a proper amount of brown sugar, uniformly mixing, preparing into granules, drying at 60 ℃, crushing, adding ethanol to prepare into granules, and spraying the volatile oil to obtain the traditional Chinese medicine composition.
The content of ferulic acid in the newly-formed granules prepared in comparative example 1 was 0.19mg/g; the content of leonurine hydrochloride is 0.17mg/g; the content of the stachydrine hydrochloride is 2.19mg/g; the content of liquiritin is 0.15mg/g; the content of glycyrrhizic acid is 0.32mg/g.
Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, it is intended that all such modifications and alterations be included within the scope of this invention as defined in the appended claims.
Claims (8)
1. A method for preparing newly formed particles is characterized by comprising the following steps:
(1) Extracting volatile oil from radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, semen Persicae, glycyrrhrizae radix, zingiberis rhizoma, herba Leonuri, and Carthami flos with water by steam distillation, collecting volatile oil, and clathrating the volatile oil with beta-cyclodextrin to form clathrate; extracting volatile oil to obtain water solution;
(2) Carrying out water extraction on the dregs of the decoction after the volatile oil is extracted in the step (1) to obtain an aqueous extract;
(3) Combining the water extract obtained in the step (2) with the water solution obtained after the volatile oil is extracted in the step (1), concentrating the mixture to an extract with the relative density of 1.05-1.15 at the temperature of 60 ℃, filtering the extract, and performing spray drying on the filtrate to obtain extract powder;
(4) And (3) mixing the inclusion compound obtained in the step (1), the paste powder obtained in the step (3) and brown sugar, and performing dry granulation to obtain the sugar-free tea.
2. The method for preparing newly formed particles according to claim 1, wherein in step (1), the water is added as follows: adding water in 6-10 times the weight of the material.
3. The method for preparing newborn granules according to claim 1 or 2, wherein the distillation temperature for extracting volatile oil by steam distillation is 97-103 ℃.
4. The method for preparing newborn biochemical particles according to any one of claims 1 to 3, wherein in the step (1), the specific steps of including the volatile oil with beta cyclodextrin to form an inclusion compound are as follows: firstly, uniformly mixing the volatile oil with 95% ethanol with equal volume; grinding beta-cyclodextrin with 2-3 times of water, gradually adding the mixture of volatile oil and 95% ethanol, grinding while adding, grinding into paste, refrigerating at 0-10 deg.C for 16-48 hr, filtering, drying at 40-60 deg.C, and pulverizing.
5. The method for preparing newborn granules according to any one of claims 1 to 4, wherein in the step (2), the water extraction is specifically: adding water with the weight 6-8 times of that of the decoction dregs to decoct and extract for 2 times, each time lasts for 1.0-2.5 hours, filtering to obtain filtrate, and combining the filtrates obtained by water extraction twice to obtain water extract.
6. The method for preparing newly formed particles according to any one of claims 1 to 5, wherein in the step (3), the inlet temperature of the spray drying is 130 to 180 ℃ and the outlet temperature is 70 to 120 ℃.
7. The method for preparing the new biochemical particles according to any one of claims 1 to 6, wherein the new biochemical particles are prepared from the following components in parts by weight:
230 to 250 portions of angelica, 80 to 100 portions of Szechuan lovage rhizome, 20 to 30 portions of peach seed, 10 to 20 portions of liquoric root, 10 to 20 portions of dried ginger, 280 to 320 portions of motherwort and 10 to 20 portions of safflower.
8. A new biochemical particle produced by the production method of a new biochemical particle according to any one of claims 1 to 7.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362975A (en) * | 2014-08-29 | 2016-03-02 | 江苏仁寿药业有限公司 | Traditional Chinese medicine granule for treating postpartum lochiorrhea and lesser-abdominal pain and preparation method thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362975A (en) * | 2014-08-29 | 2016-03-02 | 江苏仁寿药业有限公司 | Traditional Chinese medicine granule for treating postpartum lochiorrhea and lesser-abdominal pain and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药典委员会编: "《卫生部颁药品标准（中药成方制剂第五册）》", pages: 194 * |
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