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CN111110755A - A tablet containing fructus Lycii and arillus longan - Google Patents

A tablet containing fructus Lycii and arillus longan Download PDF

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CN111110755A
CN111110755A CN202010042117.1A CN202010042117A CN111110755A CN 111110755 A CN111110755 A CN 111110755A CN 202010042117 A CN202010042117 A CN 202010042117A CN 111110755 A CN111110755 A CN 111110755A
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weight
extract
parts
tablet
wolfberry fruit
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余建强
常晓婕
金卫洲
周茹
周雨慧
杨佳美
刘宁
马琳
张文晋
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Ningxia Medical University
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

本发明提供了一种含有枸杞子及龙眼肉的片剂,由枸杞子提取物、龙眼肉提取物、填充剂、矫味剂、食用香精以及润滑剂组成;本发明还提供了所述片剂的制备方法及其在制备抗疲劳保健品或药物中的用途。本发明提供的片剂口味独特,适应人群广,且具有抗疲劳、改善贫血等保健功效。

Figure 202010042117

The invention provides a tablet containing wolfberry fruit and longan meat, which is composed of wolfberry fruit extract, longan meat extract, filler, flavoring agent, edible essence and lubricant; the invention also provides the tablet The preparation method and its use in the preparation of anti-fatigue health care products or medicines. The tablet provided by the invention has a unique taste, is suitable for a wide range of people, and has health care effects such as anti-fatigue and anemia improvement.

Figure 202010042117

Description

A tablet containing fructus Lycii and arillus longan
Technical Field
The invention belongs to the field of health products and tablets, and particularly provides a tablet containing medlar and longan pulp, a corresponding preparation method and application thereof in preparing health products or medicines for relieving fatigue and improving anemia.
Background
The wolfberry fruit as the medicinal material in Ningxia dao has a long application history. Wolfberry fruit (Lycium barbarum L.) belongs to the solanaceae deciduous shrubs, has a fruit length of 1-2 cm, is a bright orange red ellipsoid berry, can be used as a medicine after fruits, leaves, seedlings and roots of the wolfberry fruit are harvested in 6-8 months, and is an important component of a traditional Chinese medicine formula. It was originally recorded in Shen nong Ben Cao Jing and listed as the top grade. The chemical components of the medlar comprise polysaccharide, organic acids, alkaloids, flavonoids, pigment, amino acids, trace elements, vitamins and inorganic salt, and the pharmacological effects comprise delaying senility, regulating nervous system, resisting tumor, enhancing immunity, protecting liver, reducing blood sugar, blood fat and blood pressure, preventing lens oxidative damage and the like. The lycium barbarum polysaccharide serving as a main active ingredient of lycium barbarum is a hot point for researching lycium barbarum in recent years, has the effects of resisting fatigue, oxidation and gastric ulcer, protecting retina and the like, and achieves excellent research results in a plurality of fields of medical treatment, health care, beauty treatment, food and the like. The modern research on fatigue resistance of the medlar proves that the lycium barbarum polysaccharide can remove free radicals, improve the oxidation resistance of an organism, reduce fatigue-causing substances of the organism, regulate the energy metabolism of the organism, and simultaneously improve the body function, thereby promoting the recovery of physical strength and relieving the fatigue state. The purified lycium barbarum polysaccharide is poured into the stomach of a mouse, and the result shows that the lycium barbarum polysaccharide can obviously increase the reserve amount of muscle glycogen and liver glycogen of the mouse, improve the total activity of blood lactate dehydrogenase before and after exercise, reduce the increase of blood urea nitrogen of the mouse after strenuous exercise, accelerate the removal rate of the blood urea nitrogen after exercise, and prompt that the lycium barbarum polysaccharide has very obvious effects on improving the adaptability of load exercise, resisting fatigue and accelerating the elimination of fatigue.
The longan pulp is rich in nutrition, has the effects of tonifying heart and spleen, nourishing blood and tranquillizing, and building up body, and is a legal medicament in pharmacopoeia of the people's republic of China, and an ideal tonic. According to the traditional Chinese medicine, longan has sweet taste and warm nature. Enter heart and spleen meridians. Has effects in invigorating heart and spleen, nourishing blood, tranquilizing mind, invigorating spleen, relieving diarrhea, promoting urination, and relieving swelling. Is suitable for treating asthenia, blood deficiency, sallow complexion, deficiency of both qi and blood, neurasthenia, palpitation, amnesia, insomnia, etc. Longan has already been used as a medicine in the period of Han dynasty. Li shizhen says: "longan tonifies greatly", "litchi is a precious food, and longan is a good food. 'daily herbal medicine' for promoting intelligence and calming heart. According to the formula, longan is good for spleen and stomach, keeps heart blood, moistens five internal organs and treats palpitation. The ' Quanzhou materia medica ' considers that longan ' strengthens yang and tonifies qi and tonifies spleen and stomach. The 'Yi Yao Hua Yi' is recorded in the description of longan, Chinese angelica, nourishing liver and enriching blood. To date, longan is still an important medicine for enriching blood and soothing nerves. The longan pulp comprises chemical components including fats, volatile oils, saccharides, abundant proteins, vitamins, trace elements, retinol 3mg and retinol 0.14mg, and has pharmacological effects including stress resistance, aging resistance, anxiety resistance, endocrine influence and the like. In addition, experiments prove that the longan polysaccharide can achieve the anti-fatigue effect by enhancing the activity of antioxidant enzyme and removing oxygen free radicals.
With the advancement of science and technology and the development of society, the pace of life is faster and faster, the working pressure of people is gradually increased, and excessive pressure can certainly burden the body, so that a series of sub-health states are caused, wherein fatigue is one of the remarkable manifestations. Although the fatigue pair can not directly harm the life of people, long-term fatigue or over-fatigue still can bring serious health risks to people and even induce cancers. Long-term fatigue not only causes the immune function of the human body to be reduced, but also increases the risk of suffering from chronic diseases and can cause serious damage to the heart and brain, and the chronic fatigue not only can damage the organism, but also can accelerate the aging speed of the human body and shorten the normal life of the human body.
Disclosure of Invention
In order to solve the problems, the inventor fully utilizes the health care effects of the medlar and the longan pulp and develops a health food containing medicinal and edible congeners and having the function of relieving fatigue. The wolfberry fruit and the longan pulp used in the invention are both medicinal and edible, and are safe and reliable. Experiments prove that the raw materials are combined together after scientific and reasonable compatibility, and the Chinese medicinal composition has good effect on fatigue and anemia caused by deficiency of qi and blood.
The purpose of the invention is realized by the following technical scheme:
on one hand, the invention provides a tablet containing medlar and longan aril, which comprises the following components in parts by weight: 6.25 to 25 parts of medlar extract, 6.25 to 25 parts of longan pulp extract, 36.5 to 146 parts of filler, 0.25 to 1 part of flavoring agent, 0.5 to 2 parts of edible essence and 0.25 to 1 part of lubricant.
Further, the tablet comprises the following components in parts by weight: 10-20 parts of wolfberry extract, 10-20 parts of longan pulp extract, 58.4-116.8 parts of filler, 0.4-0.8 part of flavoring agent, 0.8-1.6 parts of edible essence and 0.4-0.8 part of lubricant.
Further, the tablet comprises the following components in parts by weight: 12.5 parts of medlar extract, 12.5 parts of longan pulp extract, 73 parts of filler, 0.5 part of flavoring agent, 1 part of edible essence and 0.5 part of lubricant.
Further, the filler is selected from: one or more of lactose, microcrystalline cellulose, mannitol, isomalt, corn starch, and dextrin.
Further, the filler is a mixture of lactose, microcrystalline cellulose and mannitol; the total amount of the three fillers is 73 parts by weight; more preferably, 18.25 parts by weight lactose, 18.25 parts by weight microcrystalline cellulose and 36.5 parts by weight mannitol.
Further, the flavoring agent is selected from one or more of DL-malic acid and citric acid; the essence is selected from one or more of fruit water and oil, milk, nuts, preserves and emulsion.
Further, the lubricant is selected from one or more of magnesium stearate, talcum powder and superfine silica gel powder.
Further, the medlar extract is prepared by cleaning medlar, drying, extracting with water as a solvent, concentrating and drying to obtain a medlar extract; the arillus longan extract is prepared by peeling and removing core of longan, drying to obtain arillus longan, extracting with water as solvent, concentrating, and drying.
Further, the wolfberry extract and the longan pulp extract can be in the form of completely dried powder or in the form of concentrated thick extract with a certain density.
Further, the tablet containing the medlar and the longan pulp is in the form of chewable tablets, buccal tablets, sublingual tablets, buccal patches, dispersible tablets, effervescent tablets, quick-release or sustained-release or controlled-release tablets and enteric-coated tablets or other pharmaceutically/food acceptable oral preparation forms, and the chewable tablet form is preferred.
Further, the tablet further comprises an effervescent agent, a disintegrating agent or a foaming agent; the effervescent agent is prepared from citric acid: the proportion of sodium bicarbonate is 1:1, preferably 18.75 parts by weight; the foaming agent is composed of citric acid and sodium bicarbonate with the proportion of 1:1, and preferably 3.6 parts by weight; the disintegrant consists of MCC to L-HPC in a ratio of 8: 1, preferably 54 parts by weight.
In another aspect, the present invention further provides a method for preparing the tablet containing wolfberry fruit and longan pulp, wherein the preparation method comprises: mixing fructus Lycii extract and arillus longan extract with filler, correctant and essence, making into soft mass, sieving, granulating, drying, adding lubricant, mixing, tabletting with single tablet machine, and packaging.
Further, the wolfberry fruit extract and the longan pulp extract are prepared by the following methods: adding fructus Lycii and arillus longan into 5-20 times of purified water, extracting for 1-3 times (each for 0.5-2.5 hr), mixing filtrates, concentrating or concentrating, and drying.
Further, the amount of the extraction and purification water is 10 to 15 times, preferably 15 times.
Further, the number of extraction times is preferably 2.
Further, the extraction time is preferably 1.5 hours per time.
Further, cleaning and drying fructus Lycii, extracting with water as solvent, concentrating and drying to obtain fructus Lycii extract; the arillus longan extract is prepared by peeling and removing core of longan, drying to obtain arillus longan, extracting with water as solvent, concentrating, and drying.
Further, the preparation process of the tablet comprises the following specific steps:
(1) adding fructus Lycii and arillus longan into 15 times of purified water, extracting for 2 times (each time for 1.5 hr), mixing all filtrates, filtering, removing residue, and concentrating the filtrate under reduced pressure to density of 1.30(25 deg.C) to obtain soft extract;
(2) uniformly mixing 12.5 parts of a wolfberry fruit extract, 12.5 parts of a longan pulp extract, 18.25 parts of lactose, 18.25 parts of microcrystalline cellulose, 36.5 parts of mannitol, 0.5 part of DL-malic acid and 1 part of essence to prepare a soft material, sieving with a 14-mesh sieve for granulation, drying in an oven at 50 ℃ for 2 hours, granulating, adding 0.5 part of magnesium stearate, uniformly mixing, tabletting and packaging to obtain the traditional Chinese medicine composition.
In a third aspect, the invention also provides application of the tablet in preparing health care products or medicines for relieving fatigue.
Further, the fatigue relief includes mental fatigue and physical fatigue, and improvement of serum urea nitrogen (BUN), serum lactic acid (LD), and Liver Glycogen (LG), etc.
In a fourth aspect, the invention also provides the application of the tablet in preparing health products or medicines for improving anemia.
Further, the improvement of anemia includes improvement of hemoglobin level, free protoporphyrin content in red blood cells and the like.
The raw materials of the medlar and the arillus longan in the application can adopt products of various producing areas and varieties which meet the requirements of national food/medicine, for example, the medlar can be medlar in Ningxia, medlar in Xinjiang and medlar in Gansu, and the arillus longan can be produced in Guangdong, Fujian, Taiwan, Guangxi, Yunnan, Guizhou, Sichuan and the like.
The tablets of the present application may further comprise various food/pharmaceutical acceptable excipients according to the form/dosage form requirement, including but not limited to coating materials, solvents, solubilizers, binders, stabilizers, antioxidants, pH adjusters, flavors, and these excipient ingredients can be selected by those skilled in the art according to the common general knowledge in food/pharmaceutical science.
The tablets of the present application may also be supplemented with or in communication with various known or unknown fatigue-relieving, anemia-ameliorating drug/extract/food raw material ingredients, including, but not limited to, natural antioxidants, saponins, amino acid activated carbons, octacosanol, L-carnitine, caffeine, chalybeate, folic acid, ginseng, American ginseng, donkey-hide gelatin, angelica, and the like, as desired.
Drawings
Figure 1 is a graph of dextran standards.
Detailed Description
The present invention will be described in detail with reference to specific examples, but the scope of the present invention is not limited to the following examples.
Example 1
Mixing fructus Lycii extract and arillus longan extract 12.5g, lactose 18.25g, microcrystalline cellulose 18.25g, mannitol 36.5g, DL-malic acid 0.5g, and essence 1.0g, granulating by wet method, drying for 2 hr, adding magnesium stearate 0.5g, tabletting with single-punch tablet press, and packaging.
Example 2
Mixing fructus Lycii extract and arillus longan extract 6.25g, lactose 9.13g, microcrystalline cellulose 9.13g, mannitol 18.25g, DL-malic acid 0.25g, and essence 0.5g, granulating by wet method, drying for 1 hr, adding magnesium stearate 0.25g, tabletting with single-punch tablet press, and packaging.
Example 3
Mixing fructus Lycii extract and arillus longan extract 25g, lactose 36.5g, microcrystalline cellulose 36.5g, mannitol 73g, DL-malic acid 1.0g, and essence 2.0g, granulating by wet method, drying for 3 hr, adding magnesium stearate 1.0g, tabletting with single punch tablet press, and packaging.
Example 4
Mixing fructus Lycii extract and arillus longan extract 10g, lactose 14.6g, microcrystalline cellulose 14.6g, mannitol 29.2g, DL-malic acid 0.4g, and essence 0.8g, granulating by wet method, drying for 1.5 hr, adding magnesium stearate 0.4g, tabletting with single-punch tablet press, and packaging.
The fructus Lycii extract and arillus longan extract are respectively added into purified water 15 times of the weight of the fructus Lycii extract and arillus longan extract, extracted for 2 times, each time for 1.5 hr, the filtrates are combined, concentrated and dried to obtain the final product.
Example 5
Respectively mixing fructus Lycii extract and arillus longan extract 15g, lactose 21.9g, microcrystalline cellulose 21.9g, mannitol 43.8g, DL-malic acid 0.6g, and essence 1.2g, wet granulating, drying in different dishes for 1.5 hr, adding magnesium stearate 0.6g, tabletting with single punch tablet press, and packaging.
The fructus Lycii extract and arillus longan extract are prepared by respectively adding into 10 times of purified water, extracting for 3 times, each time for 1 hr, mixing filtrates, concentrating, and drying.
Example 6
Respectively mixing fructus Lycii extract and arillus longan extract 20g, lactose 29.2g, microcrystalline cellulose 29.2g, mannitol 58.4g, DL-malic acid 0.8g, and essence 1.6g, wet granulating, drying in different discs for 2 hr, adding magnesium stearate 0.8g, tabletting with single punch tablet press, and packaging.
The fructus Lycii extract and arillus longan extract are respectively added into purified water 20 times of the weight of the fructus Lycii extract and arillus longan extract, extracted for 2 times, each time extracted for 2.5 hr, the filtrates are combined, concentrated and dried to obtain the final product.
Example 7
Uniformly mixing 12.5g of each of the wolfberry extract and the longan pulp extract, 18.25g of lactose, 18.25g of microcrystalline cellulose, 36.5g of mannitol, 0.5g of DL-malic acid and 1g of essence, granulating by a wet method, drying in a tray, drying for 2 hours, adding 0.5g of magnesium stearate after finishing granules, tabletting by a single-punch tablet press, and packaging to obtain the traditional Chinese medicine composition.
The wolfberry fruit extract and the longan pulp extract are respectively added into purified water with the weight 15 times of that of the wolfberry fruit extract and the longan pulp extract, extracted for 2 times, each time extracted for 1.5 hours, and the filtrates are combined and concentrated into thick extract with the density of 1.30.
Example 8
Mixing fructus Lycii extract and arillus longan extract 6.25g, lactose 9.13g, microcrystalline cellulose 9.13g, mannitol 18.25g, DL-malic acid 0.25g, and essence 0.5g, granulating by wet method, drying for 1 hr, adding magnesium stearate 0.25g, tabletting with single-punch tablet press, and packaging.
The wolfberry fruit extract and the longan pulp extract are respectively added into purified water with the weight of 20 times of that of the wolfberry fruit extract and the longan pulp extract, extracted for 2 times, each time extracted for 1.5 hours, and the filtrates are combined and concentrated into thick extract with the density of 1.30.
Example 9
Respectively mixing fructus Lycii extract and arillus longan extract 15g, lactose 21.9g, microcrystalline cellulose 21.9g, mannitol 43.8g, DL-malic acid 0.6g, and essence 1.2g, wet granulating, drying in different dishes for 1.5 hr, adding magnesium stearate 0.6g after finishing, and tabletting with single punch tablet press to obtain chewable tablet.
The wolfberry fruit extract and the longan pulp extract are respectively added into purified water with the weight 10 times of that of the wolfberry fruit extract and the longan pulp extract, extracted for 3 times, each time extracted for 1.5 hours, and the filtrates are combined and concentrated into thick extract with the density of 1.30.
Example 10
Mixing fructus Lycii extract and arillus longan extract 12.5g, lactose 9.375g, microcrystalline cellulose 9.375g, mannitol 18.75g, effervescent 18.75g (ratio of citric acid to sodium bicarbonate is 1:1), DL-malic acid 0.5g, and essence 1g, wet granulating, drying for 2 hr, adding magnesium stearate 0.5g, and tabletting with single-punch tablet press to obtain effervescent tablet.
The fructus Lycii extract and arillus longan extract are prepared by respectively adding into 15 times of purified water, extracting for 2 times, each time for 1.5 hr, mixing filtrates, concentrating, and spray drying.
Example 11
Respectively 15g of medlar extract and longan pulp extract, 30g of lactose, 54g of disintegrating agent (the ratio of MCC to L-HPC is 8: 1), 3.6g of foaming agent (the ratio of citric acid to sodium bicarbonate is 1:1), 0.6g of DL-malic acid and 1.2g of essence are uniformly mixed, 30% ethanol is used as a binder for wet granulation, drying is carried out for 1h, 0.6g of magnesium stearate is added after granule finishing, and the orally disintegrating tablet is obtained by a single-punch tablet press.
The fructus Lycii extract and arillus longan extract are prepared by respectively adding into 15 times of purified water, extracting for 3 times, each time for 1 hr, mixing filtrates, concentrating, and spray drying.
Example 12
The example relates to the content determination of the polysaccharide as an effective component in the tablet, and the specific determination method is as follows:
the effective components of the barbary wolfberry fruit and the arillus longan in the tablet for relieving fatigue and improving anemia are plant polysaccharides, the polysaccharide with the molecular weight of more than 10000 daltons is precipitated by 80% ethanol, an alkaline copper reagent is added to selectively precipitate glucan from other high molecular substances, the precipitated part reacts with phenol-H2 SO4 to generate a colored substance, and the absorbance value of the colored substance is in direct proportion to the concentration of the glucan under the condition of 485 nm. The method can eliminate the interference of auxiliary materials.
(1) Sample processing
Sample extraction: weighing 3g of sample, adding 10ml of water, heating in a boiling water bath for 1h, cooling to room temperature, mixing uniformly, filtering, discarding the primary filtrate, and collecting the rest filtrate.
And (3) precipitating high molecular substances: accurately sucking 2ml of the filtrate, placing in a 15ml centrifuge tube, adding 8ml of absolute ethanol, placing in a refrigerator at 4 ℃ for refrigeration for 4h, taking 1.5ml of the mixed solution, centrifuging at 3000rpm for 10min, discarding the supernatant, washing the residue with 80% ethanol for 3 times, and allowing the residue to be used for precipitating glucan.
And (3) precipitating glucan: dissolving the residue with water, diluting to 0.5ml, adding 2.5mol/L NaOH (10g NaOH is diluted to 100ml by adding distilled water, and solid anhydrous sodium sulfate is added to saturation) 0.5ml, adding Cu application solution (0.3 g CuSO 4.5H 2O is weighed, 3.0g sodium citrate is added with water and dissolved to 100ml to prepare copper storage solution, then taking 50ml of copper storage solution, adding 50ml of water and mixing uniformly, then adding 12.5g anhydrous sodium sulfate, using fresh solution) 0.5ml, boiling in boiling water bath for 2 mm, cooling, centrifuging at 5000rpm for 10min, discarding supernatant, washing the residue with washing solution (taking 50ml water, adding 10ml copper application solution, 10ml 2.5mol/L NaOH solution, mixing uniformly), 3 times, and using the residue for determining glucan.
And (3) testing glucan: dissolving the residue with 2.0ml of water, placing the solution in a 25ml colorimetric tube, adding 1.0ml of phenol solution and 10ml of concentrated sulfuric acid, boiling in a boiling water bath for 2 minutes, and cooling for color comparison. Checking the corresponding content from the standard curve, and calculating the content of the crude polysaccharide.
(2) Preparation of the Standard Curve
Dextran standard application liquid: taking 10g of dextran standard substance, adding into a volumetric flask to reach a constant volume of 100ml, wherein the final concentration of dextran is 0.1 mg/ml.
Accurately sucking 0.10, 0.20, 0.40, 0.60, 0.80, 1.00, 1.50, 2.00mL (respectively equivalent to 0.01, 0.02, 0.04, 0.06, 0.08, 0.10, 0.15, 0.20mg of glucan) of standard application solution, supplementing water to 2.0mL, adding 1.0mL of phenol solution and 5mL of concentrated sulfuric acid, uniformly mixing, boiling in a water bath for 2 minutes, cooling, measuring an absorbance value (A) by using a spectrophotometer at a 485nm wavelength and taking a reagent blank solution as a reference, and drawing a standard curve by taking the concentration of the glucan as an abscissa and the A as an ordinate. As shown in fig. 1.
(3) Determination of content
The polysaccharide content of the tablets was determined according to the above method, under which conditions the polysaccharide content of the tablets of example 7 was determined to be 4.78 mg/g.
Example 13
In the tablet containing wolfberry fruit and longan pulp according to the present embodiment, the maximum tolerance safety test of animals was performed on the product prepared in example 7.
20 male and female mice are screened, and the male and female mice with the weight range of 18-22 g are bred in cages. According to the disposable maximum gavage method, the mice are placed in an experimental environment to adapt for 2-3 days. Before the experiment, the mice are fasted for 12 hours, and are subjected to maximum intragastric gavage volume (0.2mL/10g) once by using a solution prepared by using the solid beverage containing the celery root with the maximum solubility, the weight, the hair, whether poisoning and death conditions of the mice are recorded by continuously observing for one week.
The experimental results are as follows: the tablets containing wolfberry fruit and longan aril were given to mice at maximum solubility and gavage, one week later: the weight change of the mice is in a normal range, the hair and the food intake are normal, the poisoning and death phenomena are not seen, and the obvious abnormal change does not exist after the examination of each major organ, which indicates that the product has high safety.
Example 14
Fatigue test
Take 48 healthy adult ICR male mice, weight range 20 + -2 g. After adaptive feeding, the animals were randomly divided into 4 groups, namely a blank control group, a low dose group, a medium dose group and a high dose group (experimental drugs were prepared from the product prepared in example 7). The four groups of mice were gavaged once a day with a gavage amount of 0.2ml/10g for 30 days. Wherein, the blank control group was perfused with normal saline.
After 30min of the last administration, a weight swimming test was performed. After 30min of the last intraperitoneal injection, the mice with 10% weight lead skin loaded on the tail root are placed in a swimming box. The water depth of the swimming box is about 30cm, the water temperature is 25 +/-1 ℃, the time from the beginning of swimming to the time when the head is completely immersed in water for 8s and cannot float out of the water surface and the time when the head is placed on a plane and cannot complete righting reflection is taken as the judgment standard of mouse exhaustion, and the time is taken as the mouse exhaustion swimming time.
The experimental result shows that the weight-bearing swimming time of mice in the low, medium and high dose groups is obviously improved (P is less than 0.01) compared with that in the blank control group, and the difference between the dose groups of the product has no statistical significance.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (16)

1.一种含有枸杞子及龙眼肉的片剂,其特征在于,包括以下重量份的组分:枸杞子提取物6.25-25重量份,龙眼肉提取物6.25-25重量份,填充剂36.5-146重量份,矫味剂0.25-1重量份,食用香精0.5-2重量份,润滑剂0.25-1重量份。1. a tablet containing wolfberry fruit and longan meat, is characterized in that, comprises the following components by weight: wolfberry fruit extract 6.25-25 weight parts, longan meat extract 6.25-25 weight parts, filler 36.5- 146 parts by weight, 0.25-1 part by weight of flavoring agent, 0.5-2 part by weight of edible essence, and 0.25-1 part by weight of lubricant. 2.根据权利要求1所述的片剂,其特征在于,包括以下重量份的组分:枸杞子提取物10-20重量份,龙眼肉提取物10-20重量份,填充剂58.4-116.8重量份,矫味剂0.4-0.8重量份,食用香精0.8-1.6重量份,润滑剂0.4-0.8重量份。2. The tablet according to claim 1, characterized in that it comprises the following components in parts by weight: 10-20 parts by weight of wolfberry fruit extract, 10-20 parts by weight of longan meat extract, 58.4-116.8 parts by weight of filler 0.4-0.8 parts by weight of flavoring agent, 0.8-1.6 part by weight of edible essence, and 0.4-0.8 part by weight of lubricant. 3.根据权利要求2所述的片剂,其特征在于,包括以下重量份的组分:枸杞子提取物12.5重量份,龙眼肉提取物12.5重量份,填充剂73重量份,矫味剂0.5重量份,食用香精1重量份,润滑剂0.5重量份。3. The tablet according to claim 2, characterized in that it comprises the following components by weight: 12.5 parts by weight of wolfberry fruit extract, 12.5 parts by weight of longan meat extract, 73 parts by weight of filler, 0.5 parts by weight of corrective agent parts by weight, 1 part by weight of edible essence, and 0.5 part by weight of lubricant. 4.根据权利要求1-3任一所述的片剂,其特征在于,所述填充剂选自:乳糖、微晶纤维素、甘露醇、异麦芽酮糖醇、玉米淀粉、糊精中的一种或一种以上。4. The tablet according to any one of claims 1-3, wherein the filler is selected from the group consisting of lactose, microcrystalline cellulose, mannitol, isomalt, corn starch, and dextrin. one or more. 5.根据权利要求4所述的片剂,其特征在于,所述填充剂为乳糖、微晶纤维素及甘露醇的混合;优选地,三种填充剂的总量为73重量份;更优地,乳糖为18.25重量份,微晶纤维素为18.25重量份,甘露醇为36.5重量份。5. The tablet according to claim 4, wherein the filler is a mixture of lactose, microcrystalline cellulose and mannitol; preferably, the total amount of the three fillers is 73 parts by weight; more preferably Specifically, lactose was 18.25 parts by weight, microcrystalline cellulose was 18.25 parts by weight, and mannitol was 36.5 parts by weight. 6.根据权利要求1-3任一所述的片剂,其特征在于,所述矫味剂选自DL-苹果酸、柠檬酸中的一种或一种以上;所述香精选自水果类水质和油质、奶类、坚果类、蜜饯类、乳化类中的一种或一种以上。6. according to the arbitrary described tablet of claim 1-3, it is characterized in that, described flavoring agent is selected from one or more in DL-malic acid, citric acid; Described flavoring is selected from fruit One or more of the water quality and oil quality, milk, nuts, preserves, and emulsification. 7.根据权利要求1-3任一所述的片剂,其特征在于,所述润滑剂选自硬脂酸镁、滑石粉、微粉硅胶中一种或一种以上。7. The tablet according to any one of claims 1-3, wherein the lubricant is selected from one or more of magnesium stearate, talc, and micropowder silica gel. 8.根据权利要求1-3任一所述的片剂,其特征在于,所述枸杞子提取物是将枸杞子洗净干燥后,用水为溶剂进行提取,浓缩干燥后得到枸杞子提取物;龙眼肉提取物是将龙眼去皮去核后干燥得到龙眼肉,用水为溶剂进行提取,浓缩干燥后而得。8. The tablet according to any one of claims 1-3, wherein the wolfberry fruit extract is obtained by washing and drying the wolfberry fruit, extracting with water as a solvent, and concentrating and drying to obtain the wolfberry fruit extract; The extract of longan meat is obtained by peeling and denucleating longan, then drying to obtain longan meat, extracting with water as a solvent, and concentrating and drying. 9.根据权利要求8所述的片剂,其特征在于,所述枸杞子提取物、龙眼肉提取物形态可以为完全干燥后的粉末形式,也可以为浓缩到一定密度的稠浸膏形式。9 . The tablet according to claim 8 , wherein the wolfberry fruit extract and the longan meat extract can be in the form of powder after being completely dried, or in the form of a thick extract concentrated to a certain density. 10 . 10.据权利要求1-3任一项所述的片剂,其特征在于,所述片剂还包括泡腾剂、崩解剂或发泡剂。10. The tablet according to any one of claims 1-3, wherein the tablet further comprises an effervescent agent, a disintegrating agent or a foaming agent. 11.根据权利要求1-3任一项所述的片剂,其特征在于,所述片剂类型可为咀嚼片、口含片、舌下片、口腔崩解片、分散片、泡腾片、速释或缓释或控释片与肠溶片或其他药学/食品上可接受的口服剂形式。11. The tablet according to any one of claims 1-3, wherein the tablet type can be chewable tablet, buccal tablet, sublingual tablet, orally disintegrating tablet, dispersible tablet, effervescent tablet , immediate-release or sustained-release or controlled-release tablets and enteric-coated tablets or other pharmaceutically/food acceptable oral dosage forms. 12.根据权利要求1-11所述的含有枸杞子及龙眼肉的片剂的制备方法,其特征在于,所述制备过程包括:将枸杞子提取物、龙眼肉提取物与填充剂、矫味剂、香精混合均匀后制软材,随后过筛制粒,干燥整粒,加入润滑剂混合均匀后,以单片式压片机压片,包装即得。12. The preparation method of the tablet containing wolfberry fruit and longan meat according to claim 1-11, characterized in that, the preparation process comprises: combining wolfberry fruit extract, longan meat extract with filler, flavoring The agent and essence are mixed evenly to make soft material, then sieved and granulated, dried and granulated, added with lubricant and mixed evenly, compressed with a single-tablet tablet press, and packaged. 13.根据权利要求12所述的片剂的制备方法,其特征在于,所述枸杞子提取物、龙眼肉提取物由以下方法制备:将枸杞子、龙眼肉分别加入其重量5-20倍的纯化水中,提取1-3次,每次提取1-2.5小时,合并滤液,浓缩或浓缩后干燥。13. The preparation method of the tablet according to claim 12, wherein the wolfberry fruit extract and the longan meat extract are prepared by the following methods: adding the wolfberry fruit and the longan meat respectively to 5-20 times their weight Purified water, extracted 1-3 times for 1-2.5 hours each time, combined the filtrates, concentrated or concentrated and then dried. 14.根据权利要求12所述的片剂的制备方法,其特征在于,所述制备过程具体步骤为:14. The preparation method of the tablet according to claim 12, wherein the specific steps of the preparation process are: (1)将枸杞子、龙眼肉分别加入其重量15倍的纯化水中,提取2次,每次提取1.5小时,将所有滤液合并后过滤,除去滤渣,将滤液减压浓缩到密度为1.30(25℃),得到稠浸膏;(1) add wolfberry fruit and longan meat respectively into purified water of 15 times its weight, extract 2 times, extract 1.5 hours each time, filter after all filtrates are combined, remove the filter residue, and concentrate the filtrate under reduced pressure to a density of 1.30 (25 ℃) to obtain a thick extract; (2)取枸杞子提取物12.5份,龙眼肉提取物12.5份,乳糖18.25份,微晶纤维素18.25份,甘露醇36.5份,DL-苹果酸0.5份,香精1份混合均匀,制得软材,过14目筛制粒,放入50℃烘箱中干燥2小时,整粒,加入硬脂酸镁0.5份,混合均匀后压片,包装即得。(2) Take 12.5 parts of wolfberry fruit extract, 12.5 parts of longan meat extract, 18.25 parts of lactose, 18.25 parts of microcrystalline cellulose, 36.5 parts of mannitol, 0.5 part of DL-malic acid, and 1 part of essence and mix them evenly to make soft The material was passed through a 14-mesh sieve to granulate, dried in an oven at 50°C for 2 hours, granulated, added with 0.5 part of magnesium stearate, mixed evenly, pressed into tablets, and packaged. 15.根据权利要求1-11所述含有枸杞子及龙眼肉的片剂在制备抗疲劳保健品或药物中的用途。15. The use of the tablet containing wolfberry fruit and longan meat according to claims 1-11 in the preparation of anti-fatigue health care products or medicines. 16.根据权利要求1-11所述含有枸杞子及龙眼肉的片剂在制备改善贫血保健品或药物中的用途。16. The use of the tablet containing wolfberry fruit and longan meat according to claims 1-11 in the preparation of anemia-improving health care products or medicines.
CN202010042117.1A 2020-01-15 2020-01-15 A tablet containing fructus Lycii and arillus longan Pending CN111110755A (en)

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