CN111249326B - Gynostemma pentaphylla vitamin E buccal tablet and preparation method thereof - Google Patents
Gynostemma pentaphylla vitamin E buccal tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of pharmaceutical preparations, and particularly discloses gynostemma pentaphylla vitamin E buccal tablets and a preparation method thereof. The gynostemma pentaphylla vitamin E buccal tablet is prepared by taking gynostemma pentaphylla extract and vitamin E as active ingredients and then adding auxiliary materials; the auxiliary materials comprise a diluent, a flavoring agent, an adhesive and a lubricant, wherein the diluent is mannitol, the flavoring agent is stevioside, and the adhesive is starch slurry. The gynostemma pentaphylla vitamin E buccal tablet disclosed by the invention has excellent performances such as appearance, mouthfeel, hardness, disintegration time limit and the like; and the forming process is reasonable, stable and feasible, and is suitable for large-scale industrial production.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to gynostemma pentaphylla vitamin E buccal tablets and a preparation method thereof.
Background
Gynostemma pentaphylla (Gynosta pentaphyllu (Thunb.) akino.) is a plant of the genus Gynostemma of the family Cucurbitaceae, namely a small herb, Gynostemma pentaphylla, Hemsleya macrosperma, Hemsleya amabilis, and is grown on the ground and rooted in roots all the time, and is listed as a health product by the Ministry of health in 3/5 of 2003. The main components of gynostemma pentaphylla include saponin, flavone, polysaccharide, amino acid, vitamins and trace elements, among which 201 kinds of saponin components are found. The gypenoside is the main active component of the gynostemma pentaphylla, and the aglycone part of the gypenoside is basically dammarane type tetracyclic triterpenes; it is a good antioxidant, and has effects of enhancing organism free radical scavenging ability, and improving organism antioxidant ability, thereby playing antioxidation role.
Vitamin E (vitamine E, VE), also known as tocopherol, an anti-infertility vitamin, is one of the first discovered vitamins and belongs to chroman derivatives. Vitamin E is known in nature in 8 kinds, of which alpha-tocopherol is the most physiologically active. Vitamin E is one of the most important antioxidants, exerting its antioxidant action on the one hand by directly scavenging peroxides or free radicals, and on the other hand by limiting the production and level of superoxide and the corresponding reactive oxygen or nitrogen compounds.
With the improvement of living standard of people, more and more people pay attention to the aspect of health care. In recent years, the appearance of antioxidant health care products on the market is endless; however, studies have shown that their antioxidant efficacy is marginal. Therefore, it is very important to research a Chinese medicinal preparation with an antioxidation effect.
The invention aims to develop a brand new antioxidant buccal tablet by taking gynostemma pentaphylla extract powder and vitamin E as antioxidant active ingredients. However, in the process of developing buccal tablets, the performance problems of appearance, taste, hardness, disintegration time limit, etc. of the buccal tablets must be solved. However, the appearance, taste, hardness, disintegration time limit and other properties of the buccal tablet are closely related to the selection of the types and the dosage proportion of the auxiliary materials such as the diluent, the flavoring agent, the adhesive, the lubricant and the like. However, at present, no research report exists on the preparation of buccal tablets by taking gynostemma pentaphylla extract powder and vitamin E as active ingredients, so that how to select auxiliary materials such as a diluent, a flavoring agent, an adhesive, a lubricant and the like needs to be studied in a large amount to prepare the gynostemma pentaphylla vitamin E buccal tablets with excellent appearance, taste, hardness, disintegration time limit and other properties.
Chinese patent 201110390559.6 and 201310403154.0 disclose gynostemma pentaphylla buccal tablets, but the buccal tablets are prepared by taking traditional Chinese medicine gynostemma pentaphylla powder as a raw material, and not by taking gynostemma pentaphylla extract powder as a raw material. The gynostemma pentaphylla extract powder has very different properties from the pure traditional Chinese medicine gynostemma pentaphylla powder, such as hygroscopicity, compressibility, fluidity, mouthfeel and the like. Therefore, the auxiliary materials adopted by the buccal tablet taking the traditional Chinese medicine gynostemma pentaphylla powder as the raw material have no reference significance for the preparation of the buccal tablet taking the gynostemma pentaphylla extract powder as the raw material.
Although the Chinese patent 201110221340.3 discloses a buccal tablet using gynostemma pentaphylla extract powder as a raw material, the buccal tablet is only prepared simply, and the appearance, the taste, the hardness, the disintegration time limit and other properties of the buccal tablet are not studied deeply.
In conclusion, the gynostemma pentaphylla extract powder has important significance in providing the gynostemma pentaphylla buccal tablet with excellent appearance, taste, hardness, disintegration time limit and other performances for the raw materials.
Disclosure of Invention
The invention aims to solve the technical problem of providing gynostemma pentaphylla vitamin E buccal tablets and a preparation method thereof in order to overcome the defects of gynostemma pentaphylla extract powder and vitamin E which are used as raw materials in the prior art in the preparation process. The gynostemma pentaphylla vitamin E buccal tablet has excellent appearance, taste, hardness, disintegration time limit and other performances.
The technical problem to be solved by the invention is realized by the following technical scheme:
a Gynostemma pentaphyllum vitamin E buccal tablet is prepared by taking Gynostemma pentaphyllum extract and vitamin E as active ingredients, and then adding auxiliary materials; the auxiliary materials comprise a diluent, a flavoring agent, an adhesive and a lubricant, wherein the diluent is mannitol, the flavoring agent is stevioside, and the adhesive is starch slurry.
The inventor researches and discovers that when the gynostemma pentaphylla extract and the vitamin E are used as active ingredients to prepare the buccal tablet, excellent performances such as appearance, mouthfeel, hardness, disintegration time limit and the like are required to be obtained; this is closely related to the choice of diluents, flavoring agents, binders and lubricants. The types and the contents of the auxiliary materials are randomly selected, and although the buccal tablets can be prepared into export buccal tablets, the appearance, the taste, the hardness, the disintegration time limit and other properties of the buccal tablets are greatly reduced.
The inventor researches and discovers that the performances of the raw material gynostemma pentaphylla extract and gynostemma pentaphylla powder, such as hygroscopicity, compressibility, flowability and the like, are different; when the gynostemma pentaphylla extract and the vitamin E are used as active ingredients to prepare the buccal tablets, the diluent plays an important role in the taste, hardness, disintegration time limit and the like of the tablets; the inventor finds that the buccal tablet has the most excellent mouthfeel, hardness and disintegration time only by selecting mannitol through a large number of experiments and screens from a plurality of diluents. For example, conventional lactose, which is used as a diluent for gynostemma pentaphyllum extract and vitamin E, has the disadvantages of low hardness and short disintegration time, although it is suitable for the taste. The defect of low hardness also exists when xylitol is used as a diluent; when sorbitol is used as a diluent, the sorbitol has the defects of poor mouthfeel and poor disintegration time limit.
The inventor researches and discovers that the taste of the raw material gynostemma pentaphylla extract is completely different from that of gynostemma pentaphylla powder, and the raw material gynostemma pentaphylla extract has heavy astringent taste; therefore, how to select the flavoring agent is also a key problem, and the inventor finds that the stevioside serving as the flavoring agent has moderate sweetness in taste and can effectively cover the astringent taste of the extract powder through a large amount of experimental screening of a plurality of flavoring agents; and the astringent taste of the extract powder cannot be effectively covered by other flavoring agents. If aspartame and erythritol are selected to have the taste inferior to stevioside, the astringent taste is still obvious, and the granules feel; if the menthol and the cane sugar are selected to have common mouthfeel, the astringent taste is heavier, and the gritty feeling is heavier.
The inventor researches and discovers that the performances of the raw material gynostemma pentaphylla extract and gynostemma pentaphylla powder, such as hygroscopicity, compressibility, flowability and the like, are different; when the gynostemma pentaphylla extract and the vitamin E are used as active ingredients to prepare the buccal tablets, the diluent plays an important role in the hardness, disintegration time limit and the like of the tablets; the inventor finds that the buccal tablet prepared only by selecting starch slurry as the adhesive has the most moderate hardness and the most appropriate disintegration time through a large number of experiments and screens from a plurality of adhesives. For example, when 5% PVP water is selected as the adhesive, the hardness of the buccal tablet is not satisfactory.
Preferably, the lubricant is selected from magnesium stearate.
The inventor researches and discovers that when the gynostemma pentaphylla extract and the vitamin E are used as active ingredients to prepare the buccal tablet, the buccal tablet prepared by using the magnesium stearate as the lubricant has smooth surface and does not influence the taste and the disintegration time limit; the buccal tablets prepared by selecting other lubricants, such as talcum powder and micro silica gel powder, have common taste, slightly sand feeling, rough two surfaces, uneven color and serious rupture phenomenon; meanwhile, the disintegration time of the micropowder silica gel does not meet the specification of tablets.
In conclusion, when the gynostemma pentaphylla extract and the vitamin E are used as active ingredients to prepare the buccal tablet, factors such as the diluent, the flavoring agent, the adhesive, the lubricant and the like play a complementary role in the appearance, the taste, the hardness, the disintegration time limit and other properties of the buccal tablet, and the types of the diluent, the flavoring agent, the adhesive and the lubricant must be selected well at the same time to obtain excellent appearance, taste, hardness and disintegration time limit; improper selection of either will affect the overall performance of the buccal tablet.
Preferably, the weight ratio of mannitol to gynostemma pentaphylla extract powder is 5-7: 1.
most preferably, the weight ratio of the mannitol to the gynostemma pentaphyllum extract powder is 7: 1.
preferably, the weight ratio of stevioside to gynostemma pentaphylla extract powder is 7-9: 20.
most preferably, the weight ratio of the stevioside to the gynostemma pentaphylla extract powder is 7: 20.
preferably, the concentration of the starch slurry is 10-12%.
Most preferably, the concentration of the starch slurry is 11%.
Research shows that when the concentration of the starch slurry is 15%, the hardness of the buccal tablet is too high and is not in accordance with requirements; when the concentration of the starch slurry is 5% and 8%, the buccal tablet has poor appearance and short disintegration time limit; when the concentration of the starch slurry is 11-12%, the buccal tablet has smooth appearance, uniform color, moderate hardness and proper disintegration time limit.
Preferably, the weight ratio of the gynostemma pentaphylla extract to the vitamin E is 10: 1-5.
The inventor further researches and discovers that the dosage ratios of the diluent, the flavoring agent, the binding agent and the lubricant also play an important role in the appearance, the taste, the hardness, the disintegration time limit and other properties of the buccal tablet, and the inventor discovers that the oral tablet with the most excellent appearance, taste, hardness, disintegration time limit and other properties can be obtained only by the components within the dosage ratio range through a great amount of experimental researches.
Preferably, the weight parts of the raw materials are as follows:
10-15 parts of gynostemma pentaphylla extract powder; 1-5 parts of vitamin E; 50-70 parts of mannitol; 3-5 parts of stevioside; 4-6 parts of starch slurry; 1-3 parts of magnesium stearate; 5-10 parts of ethanol.
Further preferably, the weight parts of the raw materials are as follows:
10 parts of gynostemma pentaphylla extract powder; 1-3 parts of vitamin E; 60-70 parts of mannitol; 3-4 parts of stevioside; 5-6 parts of starch slurry; 2-3 parts of magnesium stearate; 7-9 parts of ethanol.
Most preferably, the weight parts of the raw materials are as follows:
10 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 70 parts of mannitol; 3.5 parts of stevioside; 5.5 parts of starch slurry; 2 parts of magnesium stearate; 8 parts of ethanol.
The preparation method of the gynostemma pentaphylla vitamin E buccal tablet comprises the following steps:
(1) mixing herba Gynostemmatis extract powder with mannitol and stevioside;
(2) then adding vitamin E dissolved in ethanol;
(3) adding starch slurry to obtain soft material, sieving, granulating, drying, and grading to obtain granule;
(4) adding the granules into magnesium stearate, mixing, and tabletting.
Has the advantages that: the invention provides a brand-new gynostemma pentaphylla vitamin E buccal tablet; the buccal tablet has excellent appearance, taste, hardness, disintegration time limit and other properties; and the forming process is reasonable, stable and feasible, and is suitable for large-scale industrial production.
Detailed Description
The present invention is further explained below with reference to specific examples, but the scope of the present invention is not limited to the examples.
The buccal tablet of the embodiment has the following performance tests:
appearance: randomly drawing the buccal tablets, flatly paving the buccal tablets on a tray, investigating whether the surface smoothness and color of the buccal tablets are uniform or not, and giving scores according to the following scoring standard.
The mouthfeel is as follows: 1 buccal tablet is taken and put into the mouth, and the mouth feel is given with scores according to the following scoring standard.
Disintegration time limit inspection method: under the condition of water temperature of 37 +/-1 ℃, 6 test samples are taken and respectively placed in hanging basket glass tubes, an instrument is started, and the complete disintegration time is recorded.
Hardness: the hardness of 6 buccal tablets prepared according to each prescription is measured by a hardness tester, and the average value is obtained.
The specific scoring criteria are shown in table 1 below:
TABLE 1 quality score of Gynostemma pentaphyllum vitamin E buccal tablet
Example 1 preparation of Gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 70 parts of mannitol; 3.5 parts of stevioside; 5.5 parts of starch slurry (the mass fraction is 11%); 2 parts of magnesium stearate; 8 parts of ethanol.
The gynostemma pentaphylla extract powder is prepared by the following method: taking dry whole plant of gynostemma pentaphylla, carrying out reflux extraction for 3 times by using 10 times of ethanol with volume fraction of 95% by weight, extracting for 45min each time, combining three filtrates, carrying out suction filtration, concentration, drying and grinding into powder to obtain gynostemma pentaphylla extract powder.
The preparation method comprises the following steps:
(1) mixing herba Gynostemmatis extract powder with mannitol and stevioside;
(2) then adding vitamin E dissolved in ethanol;
(3) adding starch slurry to prepare soft material, sieving with 10 mesh sieve, granulating, drying in 60 deg.C drying oven for 3 hr, turning over once every 0.5 hr, sieving with 12 mesh sieve, and grading to obtain granule;
(4) adding the granules into magnesium stearate, mixing, and tabletting.
The evaluation showed that example 1 had an appearance score of 3 points, a mouth feel of 2 points, a hardness of 3 points, and a disintegration time of 3 points.
Example 2 preparation of Gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 12 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 60 parts of mannitol; 5 parts of stevioside; 3 parts of starch slurry (mass fraction is 11%); 1 part of magnesium stearate; 8 parts of ethanol.
The rest of the preparation method is the same as example 1.
The evaluation showed that example 2 had an appearance score of 3 points, a mouth feel of 2 points, a hardness of 2 points, and a disintegration time of 2 points.
Example 3 preparation of Gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 5 parts of vitamin E; 50 parts of mannitol; 5 parts of stevioside; 4 parts of starch slurry (mass fraction is 11%); 3 parts of magnesium stearate; 8 parts of ethanol.
The rest of the preparation method is the same as example 1.
The appearance score of example 3 was evaluated as 3 points, mouthfeel 2 points, hardness 2 points, and disintegration time 2 points.
Comparative example 1 preparation of gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 70 parts of lactose; 3.5 parts of stevioside; 5.5 parts of PVP water (the mass fraction is 5%); 2 parts of magnesium stearate; 8 parts of ethanol.
The rest of the preparation method is the same as example 1. Comparative example 1 differs from example 1 in that the diluent is lactose and the binder is PVP water.
The comparative example 1 was evaluated to have an appearance score of 2 points, a mouth feel of 2 points, a hardness of 0 point, and a disintegration time of 1 point.
Example 2 preparation of Gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 70 parts of xylitol; 3.5 parts of stevioside; 5.5 parts of starch slurry (the mass fraction is 11%); 2 parts of talcum powder; 8 parts of ethanol.
The rest of the preparation method is the same as example 1. Comparative example 2 differs from example 1 in that the diluent is xylitol and the lubricant is talc.
The comparative example 2 was evaluated to have an appearance score of 0, a mouth feel of 1, a hardness of 0 and a disintegration time of 1.
Comparative example 3 preparation of gynostemma pentaphyllum vitamin E buccal tablet
The weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1 parts of vitamin E; 70 parts of sorbitol; 3.5 parts of cane sugar; 5.5 parts of starch slurry (the mass fraction is 11%); 2 parts of magnesium stearate; 8 parts of ethanol.
The rest of the preparation method is the same as example 1. Comparative example 3 differs from example 1 in that sorbitol is used as the diluent; the sweetener is sucrose.
The comparative example 3 was evaluated to have an appearance score of 1 point, a mouth feel of 0 point, a hardness of 2 points, and a disintegration time of 0 point.
Claims (10)
1. A Gynostemma pentaphyllum vitamin E buccal tablet is prepared by taking Gynostemma pentaphyllum extract and vitamin E as active ingredients, and then adding auxiliary materials; the auxiliary materials comprise a diluent, a flavoring agent, an adhesive and a lubricant, and are characterized in that the diluent is mannitol, the flavoring agent is stevioside, and the adhesive is starch slurry;
wherein the weight ratio of mannitol to gynostemma pentaphylla extract powder is 5-7: 1; the weight ratio of stevioside to gynostemma pentaphylla extract powder is 7-9: 20; the weight ratio of the gynostemma pentaphylla extract to the vitamin E is 10: 1-5.
2. The gynostemma pentaphyllum vitamin E buccal tablet according to claim 1, wherein the lubricant is selected from magnesium stearate.
3. The gynostemma pentaphylla vitamin E buccal tablet according to claim 1, wherein the weight ratio of mannitol to gynostemma pentaphylla extract powder is 7: 1.
4. the gynostemma pentaphylla vitamin E buccal tablet according to claim 1, wherein the weight ratio of stevioside to gynostemma pentaphylla extract powder is 7: 20.
5. the gynostemma pentaphyllum vitamin E buccal tablet according to claim 1, wherein the concentration of starch slurry is 10-12%.
6. The gynostemma pentaphyllum vitamin E buccal tablet according to claim 5, wherein the concentration of the starch slurry is 11%.
7. The gynostemma pentaphylla vitamin E buccal tablet according to claim 1, wherein the weight parts of the raw materials are as follows: 10-15 parts of gynostemma pentaphylla extract powder; 1-5 parts of vitamin E; 50-70 parts of mannitol; 3-5 parts of stevioside; 4-6 parts of starch slurry; 1-3 parts of magnesium stearate; 5-10 parts of ethanol.
8. The gynostemma pentaphyllum vitamin E buccal tablet according to claim 7, wherein the weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1-3 parts of vitamin E; 60-70 parts of mannitol; 3-4 parts of stevioside; 5-6 parts of starch slurry; 2-3 parts of magnesium stearate; 7-9 parts of ethanol.
9. The gynostemma pentaphyllum vitamin E buccal tablet according to claim 8, wherein the weight parts of the raw materials are as follows: 10 parts of gynostemma pentaphylla extract powder; 1 part of vitamin E; 70 parts of mannitol; 3.5 parts of stevioside; 5.5 parts of starch slurry; 2 parts of magnesium stearate; 8 parts of ethanol.
10. The preparation method of gynostemma pentaphylla vitamin E buccal tablet according to any one of claims 1 to 9, which is characterized by comprising the following steps:
(1) mixing herba Gynostemmatis extract powder with mannitol and stevioside;
(2) then adding vitamin E dissolved in ethanol;
(3) adding starch slurry to obtain soft material, sieving, granulating, drying, and grading to obtain granule;
(4) adding the granules into magnesium stearate, mixing, and tabletting.
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