CN112315937A - Fibrauretine soft capsule and preparation method thereof - Google Patents
Fibrauretine soft capsule and preparation method thereof Download PDFInfo
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- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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Abstract
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a fibrauretine soft capsule and a preparation method thereof. The fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8-12 parts of fibrauretine extract, 12-16 parts of soybean oil, 0.4-0.6 part of beeswax, 0.2-0.4 part of polysorbate and 0.6-1 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3-1.6. The contents of the fibrauretine soft capsule are not easy to separate oil substances in the grinding process, are convenient to produce, improve the production efficiency, and have good use safety and longer quality guarantee period. The fibrauretine soft capsule has good therapeutic effect, stable quality, good safety, and long shelf life. The preparation method of the fibrauretine soft capsule has simple operation, convenient control and high production efficiency, and is beneficial to industrial production.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a fibrauretine soft capsule and a preparation method thereof.
Background
The fibrauretine is alkaloid extracted from dry caulis Fibraureae of Menispermaceae. At present, because the content of the fibrauretine extract in the market is high, the preparation of the fibrauretine soft capsule content in the grinding process causes serious oil-matter separation, causes poor material flow in pipelines and equipment, even blocks, cannot be ground, seriously influences production, has broad-spectrum antibacterial and antiviral effects, obviously increases multiple pharmacological effects of white blood cell phagocytosis bacteria, and has good anti-inflammatory and organism immunity enhancing effects; has effects in clearing away heat and toxic materials, and can be used for treating gynecological inflammation, bacillary dysentery, enteritis, respiratory tract and urinary tract infection, surgical infection, and conjunctivitis. Because the content of the fibrauretine extract on the current world is high, the preparation of the fibrauretine soft capsule content causes serious oil separation in the grinding process, causes bad material flow in pipelines and equipment, even blockage, and can not be ground, thus seriously affecting the production. The existing fibrauretine content is seriously adsorbed on the capsule shell, so that the uniformity of the content is influenced, the content detection in the content is influenced, the instability is caused, and the error is large.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention aims to provide the fibrauretine soft capsule, the content of the fibrauretine soft capsule is not easy to separate oil substances in the grinding process, the production is convenient, the production efficiency is improved, and the waste of materials is reduced; the medicine has the advantages of uniform content distribution, good treatment effect, stable quality, good use safety and long quality guarantee period.
The invention also aims to provide a preparation method of the fibrauretine soft capsule, which has the advantages of simple operation, convenient control and high production efficiency and is beneficial to industrial production.
The invention is realized by the following technical scheme: a fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8-12 parts of fibrauretine extract, 12-16 parts of soybean oil, 0.4-0.6 part of beeswax, 0.2-0.4 part of polysorbate and 0.6-1 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3-1.6.
The contents of the fibrauretine soft capsule are not easy to separate oil substances in the grinding process, so that the preparation method is convenient for production, improves the production efficiency and reduces the waste of materials; the medicine has the advantages of uniform content distribution, good treatment effect, stable quality, good use safety and long quality guarantee period. The soybean oil contains abundant microelements, is rich in nutrition, stable in chemical property as an oil phase, low in cost, strong in oxidation resistance, and capable of improving the stability of contents as a solvent, being rich in nutrition and improving the quality guarantee period and health care performance of capsules.
Further, the polysorbate is polysorbate 80.
Further, the polyethylene glycol is polyethylene glycol 400.
Furthermore, the purity of the fibrauretine in the fibrauretine extract is more than 98%.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 0.9-1.1 parts of gelatin, 0.3-0.5 parts of glycerol, 0.2-0.3 parts of mannitol and 0.8-1.2 parts of water.
Furthermore, each part of the capsule shell also comprises 0.18 to 0.22 part by weight of a synergistic additive, and the additive amount of each part of the synergistic additive is the following raw materials in parts by weight: 0.1 to 0.16 portion of sodium alginate, 0.015 to 0.02 portion of microcrystalline cellulose, 0.004 to 0.008 portion of nano titanium dioxide and 0.12 to 0.17 portion of glycine. Further, the preparation method of the synergistic auxiliary agent comprises the following steps: taking microcrystalline cellulose and nano titanium dioxide according to a certain proportion, carrying out ultrasonic dispersion, filtering and drying in water to prepare the synergistic auxiliary agent. The stability of the capsule shell can be better improved by adding the nano titanium dioxide, the disintegration performance of the capsule can also be improved by the microcrystalline cellulose, the nano titanium dioxide is dispersed on the surface of the microcrystalline cellulose in advance, the microcrystalline cellulose absorbs water and swells, the nano titanium dioxide can be easily discharged out of a human body along with the microcrystalline cellulose, the absorption efficiency of the human body on contents is improved, in addition, the ultraviolet shielding effect of the capsule shell can be improved by matching the microcrystalline cellulose, the nano titanium dioxide and sodium alginate, the absorption of the capsule shell on the contents can be reduced, the contents are not easily absorbed by the capsule shell, and when the contents in the capsule shell are detected, the effective detection on the content of active substances in the contents is facilitated, the detection precision is improved, and the product quality is monitored.
The invention also provides a preparation method of the fibrauretine soft capsule, which comprises the following steps:
a preparation method of the fibrauretine soft capsule comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring, grinding and mixing for 20-40min to obtain content, and standing for use;
(2) uniformly mixing gelatin, glycerol and purified water according to a certain proportion, heating and continuously stirring, then vacuumizing to prepare capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules.
Further, in the step (2), the mixture is heated to 60-75 ℃, and is kept warm for 30-60min and is continuously stirred.
The preparation method of the fibrauretine soft capsule has the advantages of simple operation, convenient control, high production efficiency and contribution to industrial production, and the content of the fibrauretine soft capsule is not easy to separate oil from matter in the grinding process during preparation, thereby facilitating production, improving production efficiency and reducing material waste; the content is not easy to be adsorbed by the capsule shell, and when the content in the capsule shell is detected, the content of active substances in the content can be effectively detected, the detection precision is improved, and the product quality is monitored; the product has good treatment effect, stable quality, good use safety and long shelf life.
The invention has the beneficial effects that: the contents of the fibrauretine soft capsule are not easy to separate oil substances in the grinding process, so that the preparation method is convenient for production, improves the production efficiency and reduces the waste of materials; the content is uniformly distributed, and the product has good use safety and long shelf life. The fibrauretine soft capsule can be used for treating gynecological inflammation, bacillary dysentery, enteritis, respiratory tract and urinary tract infection, surgical infection, conjunctivitis and the like, and has the advantages of good treatment effect, stable quality, good use safety, long shelf life and effective shelf life of 24 months. The preparation method of the fibrauretine soft capsule has simple operation, convenient control and high production efficiency, and is beneficial to industrial production.
Detailed Description
The present invention will be further described with reference to the following examples for facilitating understanding of those skilled in the art, and the description of the embodiments is not intended to limit the present invention.
In a typical embodiment of the invention, the fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8-12 parts of fibrauretine extract, 12-16 parts of soybean oil, 0.4-0.6 part of beeswax, 0.2-0.4 part of polysorbate and 0.6-1 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3-1.6.
Further, the polysorbate is polysorbate 80.
Further, the polyethylene glycol is polyethylene glycol 400.
Furthermore, the purity of the fibrauretine in the fibrauretine extract is more than 98%.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 0.9-1.1 parts of gelatin, 0.3-0.5 parts of glycerol, 0.2-0.3 parts of mannitol and 0.8-1.2 parts of water.
In a typical embodiment of the invention, each part of the capsule shell further comprises 0.18-0.22 part by weight of a synergistic additive, and the addition amount of each part of the synergistic additive is the following raw materials in parts by weight: 0.1 to 0.16 portion of sodium alginate, 0.015 to 0.02 portion of microcrystalline cellulose, 0.004 to 0.008 portion of nano titanium dioxide and 0.12 to 0.17 portion of glycine. Further, the preparation method of the synergistic auxiliary agent comprises the following steps: taking microcrystalline cellulose and nano titanium dioxide according to a certain proportion, carrying out ultrasonic dispersion, filtering and drying in water to prepare the synergistic auxiliary agent.
In a typical embodiment of the present invention, the preparation method of the fibrauretine soft capsule comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring, grinding and mixing for 20-40min to obtain content, and standing for use;
(2) uniformly mixing gelatin, glycerol and purified water according to a certain proportion, heating and continuously stirring, then vacuumizing to prepare capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules.
Further, in the step (2), the mixture is heated to 60-75 ℃, and is kept warm for 30-60min and is continuously stirred.
Example 1
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 10 parts of fibrauretine extract, 14 parts of soybean oil, 0.5 part of beeswax, 0.3 part of polysorbate and 0.8 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.5.
Further, the polysorbate is polysorbate 80.
Further, the polyethylene glycol is polyethylene glycol 400.
Furthermore, the purity of the fibrauretine in the fibrauretine extract is more than 98%.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 1 part of gelatin, 0.4 part of glycerol, 0.25 part of mannitol and 0.9 part of water.
The preparation method of the fibrauretine soft capsule comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring well, grinding and mixing for 30min to obtain a content, and standing for later use;
(2) uniformly mixing gelatin, glycerol and purified water in proportion, heating and continuously stirring, vacuumizing at 45 ℃ to obtain capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules. The content is yellow viscous liquid, has light smell and bitter taste.
Further, in the step (2), the temperature is heated to 65 ℃, and the temperature is kept for 45min and the stirring is continuously carried out.
Example 2
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8 parts of fibrauretine extract, 12 parts of soybean oil, 0.4 part of beeswax, 0.2-part of polysorbate and 0.6 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 0.9 part of gelatin, 0.3 part of glycerol, 0.2 part of mannitol and 0.8 part of water.
The preparation method of the fibrauretine soft capsule comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring well, grinding and mixing for 20min to obtain a content, and standing for later use;
(2) uniformly mixing gelatin, glycerol and purified water according to a certain proportion, heating and continuously stirring, then vacuumizing to prepare capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules.
Further, in the step (2), the mixture is heated to 60 ℃, and is kept warm for 60min and is continuously stirred.
The rest of this embodiment is the same as embodiment 1, and is not described herein again.
Example 3
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 12 parts of fibrauretine extract, 16 parts of soybean oil, 0.6 part of beeswax, 0.4 part of polysorbate and 1 part of polyethylene glycol; the weight ratio of the capsule shell to the contents is 1: 1.6.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 1.1 parts of gelatin, 0.5 part of glycerol, 0.3 part of mannitol and 1.2 parts of water.
The preparation method of the fibrauretine soft capsule comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring well, grinding and mixing for 40min to obtain a content, and standing for later use;
(2) uniformly mixing gelatin, glycerol and purified water according to a certain proportion, heating and continuously stirring, then vacuumizing to prepare capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules.
Further, in the step (2), the temperature is heated to 75 ℃, the temperature is kept for 30min, and the stirring is continuously carried out.
The rest of this embodiment is the same as embodiment 1, and is not described herein again.
Example 4
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 10 parts of fibrauretine extract, 14 parts of soybean oil, 0.5 part of beeswax, 0.3 part of polysorbate and 0.8 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.5.
Further, the polysorbate is polysorbate 80.
Further, the polyethylene glycol is polyethylene glycol 400.
Furthermore, the purity of the fibrauretine in the fibrauretine extract is more than 98%.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 1 part of gelatin, 0.4 part of glycerol, 0.25 part of mannitol and 0.9 part of water.
Further, each part of the capsule shell also comprises 0.02 part by weight of synergistic additive, and the additive amount of each part of the synergistic additive is the following raw materials in parts by weight: 0.13 part of sodium alginate, 0.017 part of microcrystalline cellulose, 0.006 part of nano titanium dioxide and 0.15 part of glycine. Further, the preparation method of the synergistic auxiliary agent comprises the following steps: taking microcrystalline cellulose and nano titanium dioxide according to a certain proportion, carrying out ultrasonic dispersion, filtering and drying in water to prepare the synergistic auxiliary agent.
The rest of this embodiment is the same as embodiment 1, and is not described herein again.
Example 5
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8 parts of fibrauretine extract, 12 parts of soybean oil, 0.4 part of beeswax, 0.2-part of polysorbate and 0.6 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 0.9 part of gelatin, 0.3 part of glycerol, 0.2 part of mannitol and 0.8 part of water.
Further, each part of the capsule shell also comprises 0.18 part of synergistic additive in parts by weight, and the additive amount of each part of the synergistic additive is the following raw materials in parts by weight: 0.1 part of sodium alginate, 0.015 part of microcrystalline cellulose and 0.004 part of nano titanium dioxide. Further, the preparation method of the synergistic auxiliary agent comprises the following steps: taking microcrystalline cellulose and nano titanium dioxide according to a certain proportion, carrying out ultrasonic dispersion, filtering and drying in water to prepare the synergistic auxiliary agent.
The rest of this embodiment is the same as embodiment 2, and is not described again here.
Example 6
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 12 parts of fibrauretine extract, 16 parts of soybean oil, 0.6 part of beeswax, 0.4 part of polysorbate and 1 part of polyethylene glycol; the weight ratio of the capsule shell to the contents is 1: 1.6.
Further, each part of the capsule shell comprises the following raw materials in parts by weight: 1.1 parts of gelatin, 0.5 part of glycerol, 0.3 part of mannitol and 1.2 parts of water.
Further, each part of the capsule shell also comprises 0.22 part by weight of synergistic additive, and the additive amount of each part of the synergistic additive is the following raw materials in parts by weight: 0.16 part of sodium alginate, 0.02 part of microcrystalline cellulose, 0.008 part of nano titanium dioxide and 0.0.17 parts of glycine. Further, the preparation method of the synergistic auxiliary agent comprises the following steps: taking microcrystalline cellulose and nano titanium dioxide according to a certain proportion, carrying out ultrasonic dispersion, filtering and drying in water to prepare the synergistic auxiliary agent.
The rest of this embodiment is the same as embodiment 3, and is not described herein again.
Comparative example 1
A fibrauretine soft capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 10 parts of fibrauretine extract, 14 parts of soybean oil, 0.5 part of beeswax and 0.3 part of polysorbate; the weight ratio of the capsule shell to the content is 1: 1.5.
The rest of this embodiment is the same as embodiment 1, and is not described herein again.
The fibrauretine capsules of examples 1-6 were allowed to stand for six months in an accelerated test (75% relative humidity, 40 ℃) and showed no significant change in appearance, disintegration time, and content.
Sensory requirements, physicochemical indexes, microbial indexes and functional component indexes of the samples of examples 1 to 6 are tested, and all the tests meet the following index requirements:
1.1 sensory requirements
1.2 physical and chemical indexes
| Item | Index (I) | Detection method |
| Acid value, mg/g | ≤3.0 | GB 5009.229 |
| Peroxide number, g/100g | ≤0.25 | GB 5009.227 |
| Disintegration time limit, min | ≤60 | Pharmacopoeia of the people's republic of China |
| Ash content% | ≤5.0 | GB 5009.4 |
| Aflatoxin B1，μg/kg | ≤10 | GB 5009.22 |
| Lead, mg/kg | ≤2.0 | GB 5009.12 |
| Total arsenic in mg/kg | ≤1.0 | GB 5009.11 |
| Total mercury, mg/kg | ≤0.3 | GB 5009.17 |
1.3 microbiological index
The contents of 20 capsules prepared in examples 1 and 4 and comparative example 1 were naturally poured out from the capsule shells, and the proportions of the weight of the poured contents to the theoretical weight were weighed to 84%, 91% and 79%, respectively. The contents of examples 1 and 4 and comparative example 1 were observed to separate oil during colloid milling, and it can be seen that the separation of oil in comparative example 1 was most severe.
The soft capsules of example 1 and example 4 were measured for disintegration time by the four disintegration time limit inspection method 0921 according to the chinese pharmacopoeia 2015 edition, in which the disintegration medium was purified water, and subjected to an accelerated test (relative humidity 75%, 40 ℃) for six months to measure the disintegration time, and the results are shown in the following table:
the contents of the fibrauretine soft capsule are not easy to separate oil substances in the grinding process, so that the preparation method is convenient for production, improves the production efficiency and reduces the waste of materials; the content is uniformly distributed, and the product has good use safety and long shelf life. The fibrauretine soft capsule can be used for treating gynecological inflammation, bacillary dysentery, enteritis, respiratory tract and urinary tract infection, surgical infection, conjunctivitis and the like, and has the advantages of good treatment effect, stable quality, good use safety, long shelf life and effective shelf life of 24 months. The preparation method of the fibrauretine soft capsule has simple operation, convenient control and high production efficiency, and is beneficial to industrial production.
The above-described embodiments are preferred implementations of the present invention, and the present invention may be implemented in other ways without departing from the spirit of the present invention.
Claims (8)
1. A fibrauretine soft capsule is characterized in that: the capsule comprises a capsule shell and contents, wherein the contents comprise the following raw materials in parts by weight: 8-12 parts of fibrauretine extract, 12-16 parts of soybean oil, 0.4-0.6 part of beeswax, 0.2-0.4 part of polysorbate and 0.6-1 part of polyethylene glycol; the weight ratio of the capsule shell to the content is 1: 1.3-1.6.
2. The fibrauretine soft capsule of claim 1, characterized in that: the polysorbate is polysorbate 80.
3. The fibrauretine soft capsule of claim 1, characterized in that: the polyethylene glycol is polyethylene glycol 400.
4. The fibrauretine soft capsule of claim 1, characterized in that: each part of the capsule shell comprises the following raw materials in parts by weight: 0.9-1.1 parts of gelatin, 0.3-0.5 parts of glycerol, 0.2-0.3 parts of mannitol and 0.8-1.2 parts of water.
5. The fibrauretine soft capsule of claim 1, characterized in that: the purity of the fibrauretine in the fibrauretine extract is more than 98%.
6. A process for the preparation of the fibrauretine soft capsules according to any one of claims 1-5, characterized in that: the method comprises the following steps:
(1) taking fibrauretine and polyethylene glycol according to a certain proportion, adding fibrauretine into polyethylene glycol, stirring, grinding and mixing for 20-40min to obtain content, and standing for use;
(2) uniformly mixing gelatin, glycerol and purified water according to a certain proportion, heating and continuously stirring, then vacuumizing to prepare capsule shell mixed liquid, and standing for later use;
(3) and pressing the content and the capsule shell mixed solution into soft capsules in a soft capsule forming machine to obtain the fibrauretine soft capsules.
7. The method for preparing the fibrauretine soft capsule according to claim 6, which is characterized in that: in the step (1), a colloid mill is adopted for grinding.
8. The method for preparing the fibrauretine soft capsule according to claim 6, which is characterized in that: heating to 60-75 ℃ in the step (2), preserving heat for 30-60min and continuously stirring.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114948897A (en) * | 2022-07-20 | 2022-08-30 | 广东广发制药有限公司 | Chinese patent medicine soft capsule content and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1729979A (en) * | 2005-08-02 | 2006-02-08 | 浙江万联药业有限公司 | Soft capsule of fibrauretine composition |
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| CN114948897A (en) * | 2022-07-20 | 2022-08-30 | 广东广发制药有限公司 | Chinese patent medicine soft capsule content and preparation method thereof |
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