CN101190251B - Rhodiola rosea chewable tablets and preparation method and application thereof - Google Patents
Rhodiola rosea chewable tablets and preparation method and application thereof Download PDFInfo
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- CN101190251B CN101190251B CN2006100223819A CN200610022381A CN101190251B CN 101190251 B CN101190251 B CN 101190251B CN 2006100223819 A CN2006100223819 A CN 2006100223819A CN 200610022381 A CN200610022381 A CN 200610022381A CN 101190251 B CN101190251 B CN 101190251B
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- 238000002360 preparation method Methods 0.000 title abstract description 16
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- 238000002156 mixing Methods 0.000 claims description 68
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Abstract
The invention belongs to the Chinese traditional medicine field, which mainly relates to an Integripetal rhodiola herb chewable tablet, the preparation method and the usage thereof. The rhubarb chewable tablet of the invention is prepared by taking Integripetal rhodiola herb as the main raw material and adding the conventional excipients or complementary components used in chewable tablet preparation. The Integripetal rhodiola herb chewable tablet of the invention is characterized by small volume, convenient carrying and taking ( no hot water is needed for taking the medicine), good taste and compliance, etc., which is suitable to be utilized in plateau and field. Experiments show that the Integripetal rhodiola herb chewable tablet has remarkable effect and excellent taste, thus the invention has promising market prospect.
Description
Technical field
The present invention relates to a kind of chewable tablet, particularly, it is to be the chewable tablet that effective ingredient preparation gets by Radix Rhodiolae.
Background technology
Radix Rhodiolae is meant the Crassulaceae Rhodida plant, have 90 in the world surplus kind, be distributed in the severe cold areas in the Northern Hemisphere more, great majority all are grown under the high mountain flowstone or scrub forest about height above sea level 3500-5000 rice.China has 73 kinds, mainly is distributed in the high mountain severe cold areas in China Tibet, and also there is the Radix Rhodiolae resource distribution in some areas in northeast, northwest, North China in addition.
Radix Rhodiolae is used for a long time in China's traditional medicine; The main medicinal part of Radix Rhodiolae is a rhizome; Mainly contain effective constituent and be rhodosin, rhodioloside with and glycoside unit (butyl alcohol) etc.; Contain starch, protein, fat, tannin, flavone compound, phenolic compound and micro-volatile oil in addition, also contain trace elements iron, aluminum, zinc, silver, cobalt, cadmium, titanium, molybdenum, manganese of biologically active etc., contain a small amount of biological alkali in leaf and the stem.The research that the pharmacological action that process is deep and the clinical right to use are used; Find its mainly contain have resisting fatigue, effect such as anti-hypoxia, antimutagenic and inhibition tumor; And itself and have no side effect (Rhodida plant chemical constituent such as Song Yueying and Pharmacological action study progress Chinese herbal medicine .2004,35 (2) .-235-236; Li Gang waits the pharmaceutical research of Tibetan medicine Radix Rhodiolae to make progress Chinese national medicine magazine .2004,10 (3) .-38-40; The Advance on Pharmacological Activities Chinese medicine journal .2003 of the flat pious Radix Rhodiolae of Wang Sheng of the bright Yan Ji of king family, 31 (4) .-57-59), therefore in the exploitation of medicine and health food, obtained using widely.
Compare with other dosage forms, it is good that chewable tablet has mouthfeel, taking convenience (not needing boiled water to take), characteristics such as volume is little, delicately packed, and is easy to carry, and the compliance of use is better.But, how to optimize the mouthfeel of chewable tablet, the difficult point that to strengthen its edible compliance be this area always, and Radix Rhodiolae extract itself also has heavier bitter taste is therefore more difficultly accomplished the unification of mouthfeel and drug effect.At present do not see with the Radix Rhodiolae to be the relevant report that primary raw material prepares chewable tablet as yet.
Summary of the invention
Technical problem to be solved by this invention provides a kind of rhodiola rosea chewable tablets.This chewable tablet is prepared from the following weight proportion raw material: rhodioside content is 50～150 parts of 2～6% Radix Rhodiolae extract powders; Further; It is prepared from the following weight proportion raw material: rhodioside content is 80～120 parts of 2～6% Radix Rhodiolae extract powders, 21～63 parts of one or more in lactose, xylitol or the hydroxyl isomaltulose, 21～63 parts in mannitol; 8～26 parts of instant starch, CaCO
38～26 parts, 8～26 parts of citric acid, 0.08～0.24 part of steviosin, 0.7～2.0 part of Mentholum, 0.13～0.39 part of flavoring orange essence, 3.8～11.6 parts of Pulvis Talci and 3～15% polyvidone alcoholic solution are an amount of; The total amount of aloe-emodin, chrysophanic acid, emodin, chrysophanol and Radix Et Rhizoma Rhei methyl ether is 2～8% in the above-mentioned extractum rhei powder.
Further; It is prepared from the following weight proportion raw material: rhodioside content is that 2～6% rhodioside content is 80～120 parts of 2～6% Radix Rhodiolae extract powders; 21～63 parts of in lactose, xylitol or the hydroxyl isomaltulose one or more; 21～63 parts in mannitol, 8～26 parts of instant starch, CaCO
38～26 parts, 8～26 parts of citric acid, 0.8～0.24 part of steviosin, 0.7～2.0 part of Mentholum, 0.13～0.39 part of flavoring orange essence, 3.8～11.6 parts of Pulvis Talci, percentage by weight are that 3～15% polyvidone alcoholic solution are an amount of.
Further; The preferred weight proportioning of chewable tablet prescription of the present invention is: rhodioside content is that 2～6% rhodioside content is 100 parts of 2～6% Radix Rhodiolae extract powders; 42 parts of in lactose, xylitol or the hydroxyl isomaltulose one or more; 42 parts in mannitol, 17 parts of instant starch, CaCO
317 parts, 17 parts of citric acid, 0.16 part of steviosin, 1.3 parts of Mentholums, 0.26 part of flavoring orange essence, 7.7 parts of Pulvis Talci, percentage by weight are that 3～15% polyvidone alcoholic solution are an amount of.
The above-mentioned ethanol that is used to dissolve the polyvidone alcoholic solution of preparation 3～15% can use concentration commonly used at 30% to 100% ethanol, is preferably 60%～90% ethanol.
Another technical problem to be solved by this invention provides the method for preparing of chewable tablet of the present invention, and it comprises the steps:
A, get Radix Rhodiolae, through pulverizing, extract, after the filtration, it is concentrated filtrate, is dried to dried cream, pulverize extract powder; Maybe filtrating is concentrated into proportion 1.03～1.26, the spray drying extract powder.
B, measure Radix Rhodiolae extract powder and other adjuvant, in the Radix Rhodiolae extract powder, add in lactose, xylitol, the hydroxyl isomaltulose one or more, mixing by prescription; Add mannitol, mixing; Add instant starch, mixing; Add portion C aCO
3, mixing; Add citric acid, mixing; Add steviosin, mixing with the equivalent method of progressively increasing;
C, an amount of with 3～15% polyvidone alcoholic solution granulates at 8～40 orders, and 45～80 ℃ are dried to moisture less than 3～8%, 8～40 order granulate; Mentholum with dissolve with ethanol after with the residue CaCO
3Absorption joins in the above-mentioned granule mixing; Spray adds an amount of flavoring orange essence, mixing; Add Pulvis Talci, mixing; Tabletting promptly gets.
It should be noted that CaCO in the said method
3Should add at twice, after adding instant starch for the first time, add the CaCO of part amount
3, reserve The addition of C aCO
3Be used for behind granulate will be with the Mentholum solution absorbs of dissolve with ethanol to granule, the reservation amount should be confirmed according to the use amount of Mentholum.Generally should be about 8～12 times of Mentholum consumption.
Employed rhodioside content is that 2～6% Radix Rhodiolae extract powders can be to be raw material with the Radix Rhodiolae among the present invention, adopt common process to extract and obtain, and also can be the commercially available prod of buying from market.
These article are chewable tablet, and selected filler should be water solublity.In the adjuvant of this chewable tablet prescription, lactose, fructose, xylitol, hydroxyl isomaltulose, mannitol, instant starch is conventional adjuvant, plays filler and general correctives effect.CaCO
3, citric acid, steviosin, Mentholum though the amount of flavoring orange essence etc. is few, has but play a part very importantly, is the core adjuvant.CaCO wherein
3The fine hygroscopicity of improving this chewable tablet of ability is beneficial to preparations shaping; Citric acid can alleviate the bitterness of these article; Steviosin, Mentholum, flavoring orange essence can improve the mouthfeel of these article well.
Mannitol dissolves in the oral cavity gives cooling feeling, to relax uncomfortable taste in the mouth, can be used as the filler (diluent) of chewable tablet.Single mobility of particle, poor compressibility with mannitol system, mannitol and lactose can form eutectic mixture, and these mixture have good flowability and compressibility, and simultaneously, the sugariness of mannitol and lactose all is about 70% of sucrose, can make preparation that mouthfeel is preferably arranged.So, can select the pairing of mannitol and lactose to use filler as these article.
Xylitol be a kind ofly from materials such as corn cob, bagasse, extract, the novel sweetener and the senior treatment of pure natural use food.Its flavor is sweet, the outward appearance crystal powder powder that is white in color, and sugariness is equivalent to sucrose.Xylitol is the intermediate of human body carbohydate metabolism, also extensively exists at occurring in nature, and especially content is abundant in edible fungi such as vegetable, fruit, natural mushroom.Lacking insulin at human body influences under the glycometabolic situation, need not insulin and promote, xylitol also can permeate through cell membranes by the tissue absorption utilization, and can promote liver glycogen synthetic, improve liver function, be diabetes and hepatitis train wreck's desirable product of replacing sugar.Simultaneously, this product is not produced carious tooth in the oral cavity bacterium utilizes, and can prevent carious tooth.So, can select the filler of xylitol as these article.
Hydroxyl isomaltulose is claimed Palatinitol again, claims isomalt abroad, is emerging in the world in recent years functional edible sugar alcohol, and sugariness is 42% of a sucrose, and sweet taste is pure, is a kind of ideal product of replacing sugar.Its unique physical and chemical properties, physiological function and edible safety have been tested abundant confirmation, are given food safety highest ranking " GRAS (generally recognized as safe) " by U.S. FDA, to its every day intake do not limit.Also can select the filler of hydroxyl isomaltulose as these article.
Chewable tablet of the present invention for different uses needs, can be selected different filleies in the preparation process, such as being used for being prone to dental caries crowd, obese people, diabetes patient's group time, should mainly use xylitol and hydroxyl isomaltulose; As the health food of field usage the time, then can mainly use mannitol and lactose, can be user certain energy is provided.
For improving the chewable tablet mouthfeel, remove and also should add suitable correctives with filler.The citric acid sour in the mouth can be benumbed taste bud; Mentholum and flavoring orange essence belong to natural perfume material, can be used as correctives equally and use.Though lactose or xylitol or hydroxyl isomaltulose etc. are arranged in the adjuvant, through trial, its sweet taste is not enough, also need add sweeting agent.We the are preferred again affixing sweetening agent of steviosin as these article.Steviosin has received people's favor as a kind of new type natural sweeting agent, and is applied.The sweet taste of steviosin is pure, after taking, is not absorbed by the body, and edible safety is reliable.For making mobility of particle better, and make tablet that outward appearance preferably arranged, should suitably add Pulvis Talci.
It is little, easy to carry that rhodiola rosea chewable tablets of the present invention has a volume, taking convenience (not needing boiled water to take), and characteristics such as mouthfeel is good, and compliance is good are adapted at using under plateau and the field condition.Take in the highlands, chew and ream weight to want the blood flow in brain district to significantly improve, improved the blood flow and the oxygen supply level in these brain districts, mutually promote with the drug effect of improving anoxybiotic symptom and these article.When containing mannitol and lactose in the adjuvant, on the plateau or open-air regional the use can also certain energy be provided as user.And when using xylitol and hydroxyl isomaltulose, the performance that is applicable to hyperlipidemia and diabetic population is arranged more then.Experiment shows that rhodiola rosea chewable tablets effect of the present invention is remarkable, and mouthfeel is fine, receives experimenter's consistent favorable comment, and the inventive method is simple, practical, controlled, has good market prospect.
Below through the specific embodiment the present invention is described further; But this is not a limitation of the present invention, and those skilled in the art can make various modification or improvement according to basic thought of the present invention; Only otherwise break away from basic thought of the present invention, all within scope of the present invention.
The specific embodiment
The preparation of embodiment 1 rhodiola rosea chewable tablets of the present invention
Get rhodioside content and be 4% commercially available Radix Rhodiolae extract powder 150kg, add hydroxyl isomaltulose 15kg, mixing; Add lactose 20kg, mixing; Add xylitol 20kg, mixing; Add mannitol 51kg, mixing; Add instant starch 21kg, mixing; Add CaCO
33kg, mixing; Add citric acid 19kg, mixing; The equivalent method of progressively increasing adds steviosin 0.21kg, mixing; An amount of with 15% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution (concentration of alcohol is 75%), 40 orders are granulated 80 ℃ and are dried to moisture less than 8%, 40 order granulate; Mentholum 1.7kg is with ethanol 5L dissolving, and alcoholic solution is used CaCO
316kg absorption joins in the above-mentioned granule mixing; Spray adds flavoring orange essence 0.32kg, mixing; Add Pulvis Talci 8.1kg, mixing; Tabletting, the bag film-coat promptly gets.
The preparation of embodiment 2 rhodiola rosea chewable tablets of the present invention
Get rhodioside content and be 4% commercially available Radix Rhodiolae extract powder 80kg, add hydroxyl isomaltulose 23kg, mixing; Add lactose 20kg, mixing; Add mannitol 43kg, mixing; Add instant starch 17kg, mixing; Add CaCO
32kg, mixing; Add citric acid 17kg, mixing; The equivalent method of progressively increasing adds steviosin 0.17kg, mixing; An amount of with 15% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution (concentration of alcohol is 75%), 40 orders are granulated, and 45 ℃ are dried to moisture less than 8%, 40 order granulate; Mentholum 1.5kg is with ethanol 5L dissolving, and alcoholic solution is used CaCO
314kg absorption joins in the above-mentioned granule mixing; Spray adds flavoring orange essence 0.27kg, mixing; Add Pulvis Talci 7.6kg, mixing; Tabletting, the bag film-coat promptly gets.
The preparation of embodiment 3 rhodiola rosea chewable tablets of the present invention
Get rhodioside content and be 4% commercially available Radix Rhodiolae extract powder 120kg, add hydroxyl isomaltulose 20kg, mixing; Add xylitol 25kg, mixing; Add mannitol 41kg, mixing; Add instant starch 16kg, mixing; Add CaCO
33kg, mixing; Add citric acid 15kg, mixing; The equivalent method of progressively increasing adds steviosin 0.16kg, mixing; An amount of with 15% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution (concentration of alcohol is 75%), 40 orders are granulated, and 60 ℃ are dried to moisture less than 8%, 40 order granulate; Mentholum 1.3kg is with ethanol 5L dissolving, and alcoholic solution is used CaCO
312kg absorption joins in the above-mentioned granule mixing; Spray adds flavoring orange essence 0.25kg, mixing; Add Pulvis Talci 7.8kg, mixing; Tabletting, the bag film-coat promptly gets.
The preparation of embodiment 4 rhodiola rosea chewable tablets of the present invention
Get Radix Rhodiolae, use water extraction, extracting solution is concentrated into proportion 1.03～1.26, and it is 4% extract powder that spray drying gets rhodioside content.Get Radix Rhodiolae extract powder 50kg, add hydroxyl isomaltulose 21kg, mixing; Add mannitol 21kg, mixing; Add instant starch 8kg, mixing; Add CaCO
31kg, mixing; Add citric acid 8kg, mixing; The equivalent method of progressively increasing adds steviosin 0.08kg, mixing; An amount of with 15% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution (concentration of alcohol is 75%), 40 orders are granulated, and 70 ℃ are dried to moisture less than 8%, 40 order granulate; Mentholum 0.7kg is with ethanol 3L dissolving, and alcoholic solution is used CaCO
37kg absorption joins in the above-mentioned granule mixing; Spray adds flavoring orange essence 0.13kg, mixing; Add Pulvis Talci 3.8kg, mixing; Tabletting, the bag film-coat promptly gets.
The preparation of embodiment 5 rhodiola rosea chewable tablets of the present invention
Get rhodioside content and be 4% commercially available Radix Rhodiolae extract powder 100kg, add hydroxyl isomaltulose 21kg, mixing; Add lactose 21kg, mixing; Add mannitol 42kg, mixing; Add instant starch 17kg, mixing; Add CaCO
34kg, mixing; Add citric acid 17kg, mixing; The equivalent method of progressively increasing adds steviosin 0.16kg, mixing; An amount of with 15% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution (concentration of alcohol is 75%), 40 orders are granulated, and 70 ℃ are dried to moisture less than 8%, 40 order granulate; Mentholum 1.3kg is with ethanol 3L dissolving, and alcoholic solution is used CaCO
313kg absorption joins in the above-mentioned granule mixing; Spray adds flavoring orange essence 0.26kg, mixing; Add Pulvis Talci 7.7kg, mixing; Tabletting, the bag film-coat promptly gets.
The screening test of Test Example one Radix Rhodiolae consumption of the present invention
According to previous preparations shaping trial test; When being about (1: 1～1.5), the part by weight of principal agent (leaching the weight of dry) and adjuvant can take into account preparations shaping property and the less relatively demand of supplementary product consumption, thus the best proportion of principal agent and adjuvant is confirmed as 1: 1～1.5.
Use embodiment one to five identical prescription and method, but not adding citric acid, Mentholum, flavoring orange essence and steviosin prepares chewable tablet A, B, C, D, E, with the consumption of screening Radix Rhodiolae.
1, the test of pesticide effectiveness
Sample preparation: get each 1g of chewable tablet that various embodiments of the present invention make, add water 150ml grinding and be made into suspension.
Test method: get 60 of healthy male Kunming mouses, body weight 17～23g, mice is divided into 6 groups (each embodiment group and blank control group), 10 every group at random by body weight.Each embodiment group is irritated 1 0.5ml of each embodiment sample of stomach (be equivalent to human body RD 3 times) every day; The blank group waits the capacity distilled water to irritate stomach.After the administration 7 days, mice is put into the wide mouthed bottle that fills the 10g sodica calx, each wide mouthed bottle is put a mice, smears bottleneck airtight (air tight) with vaseline, picks up counting immediately.Stopping with mouse breathing is index, the record mouse diing time.
Table 1 mice anoxia enduring experimental result (s, x ± s)
| A | B | ?C | D | E | The blank group | |
| Time-to-live | 1054.6±96.3 * | 945.1±105.8 * | ?940.7±114.9 * | 1008.3±112.3 * | 1028.5±108.2 * | 878.5±121.8 |
*: compare p＜0.01 with the blank group.
This experimental result shows that each embodiment sample all has tangible curative effect, and effect increases progressively with the increase of Radix Rhodiolae consumption.
2, mouthfeel experiment
Choose each 20 people of men and women totally 40 people participation.Everyone is difficult to stand (2 minutes) by standing (1 minute) reluctantly, can't stand (3 minutes) Three Estate really and respectively the mouthfeel kimonos marked with compliance, calculates total points (result sees table 4) then.
Table 2 mouthfeel experimental result
| A | B | C | D | E | |
| The mouthfeel total points | 82 | 108 | 92 | 51 | 113 |
This experimental result shows that selected sample mouthfeel is all bad, and mouthfeel is poor more with the increase of Radix Rhodiolae consumption.
Can be known that by above experimental result the effect of A, B, C, D, E can be accepted, but take all factors into consideration curative effect and mouthfeel and disintegration time, the E effect is best.
The mouthfeel test of Test Example two rhodiola rosea chewable tablets of the present invention
According to the experimental result of experimental example one, get the prescription and the method for experimental example five, only do not add citric acid, Mentholum, flavoring orange essence, steviosin or calcium carbonate respectively, process chewable tablet F, G, H, I, J, the product for preparing with embodiment five carries out the mouthfeel experiment.Each 20 people of men and women totally 40 people participation is chosen in the mouthfeel experiment.Everyone presses bad (1 minute), and good (2 minutes), fine (3 minutes) Three Estate is marked with compliance to the mouthfeel kimonos respectively, calculates total points (result sees table 4) then.
Table 4 mouthfeel experimental result
| F | G | H | I | J | Embodiment five | |
| The mouthfeel total points | 61 | 72 | 79 | 56 | 95 | 112 |
| Take the compliance total points | 70 | 85 | 87 | 68 | 91 | 105 |
Score by this experimental result embodiment five contrasts group apparently higher than all the other.
Can know by this above-mentioned instance, rhodiola rosea chewable tablets determined curative effect of the present invention, characteristics such as mouthfeel is good, and compliance is good are adapted at using under plateau and the field condition; The inventive method is simple, controlled, cost is low, has good market prospect.
Claims (4)
1. rhodiola rosea chewable tablets; It is characterized in that; It is prepared from the following weight proportion raw material: rhodioside content is 50～150 parts of 2～6% Radix Rhodiolae extract powders, 21～63 parts of one or more in lactose, xylitol or the hydroxyl isomaltulose, 21～63 parts in mannitol; 8～26 parts of instant starch, CaCO
38～26 parts, 8～26 parts of citric acid, 0.8～0.24 part of steviosin, 0.7～2.0 part of Mentholum, 0.13～0.39 part of flavoring orange essence, 3.8～11.6 parts of Pulvis Talci, percentage by weight are that 3～15% polyvidone alcoholic solution are an amount of.
2. rhodiola rosea chewable tablets according to claim 1; It is characterized in that; It is prepared from the following weight proportion raw material: rhodioside content is 80～120 parts of 2～6% Radix Rhodiolae extract powders, 21～63 parts of one or more in lactose, xylitol or the hydroxyl isomaltulose, 21～63 parts in mannitol; 8～26 parts of instant starch, CaCO
38～26 parts, 8～26 parts of citric acid, 0.8～0.24 part of steviosin, 0.7～2.0 part of Mentholum, 0.13～0.39 part of flavoring orange essence, 3.8～11.6 parts of Pulvis Talci, percentage by weight are that 3～15% polyvidone alcoholic solution are an amount of.
3. rhodiola rosea chewable tablets according to claim 2; It is characterized in that; It is prepared from the following weight proportion raw material: rhodioside content is 100 parts of 2～6% Radix Rhodiolae extract powders, 42 parts of one or more in lactose, xylitol or the hydroxyl isomaltulose, 42 parts in mannitol; 17 parts of instant starch, CaCO
317 parts, 17 parts of citric acid, 0.16 part of steviosin, 1.3 parts of Mentholums, 0.26 part of flavoring orange essence, 7.7 parts of Pulvis Talci, percentage by weight are that 3～15% polyvidone alcoholic solution are an amount of.
4. method for preparing each described rhodiola rosea chewable tablets of claim 1～3, it comprises the steps:
A, get Radix Rhodiolae, through pulverizing, extract, after the filtration, it is concentrated filtrate, is dried to dried cream, pulverize extract powder; Maybe filtrating is concentrated into proportion 1.03～1.26, spray drying gets extract powder;
B, measure Radix Rhodiolae extractum, in extract powder, press formula ratio and add in lactose, xylitol, the hydroxyl isomaltulose one or more, mixing by prescription; Add mannitol, mixing; Add instant starch, mixing; Add portion C aCO
3, mixing; Add citric acid, mixing; Add steviosin, mixing with the equivalent method of progressively increasing;
C, an amount of with 3～15% polyvidone alcoholic solution granulates at 8～40 orders, and 45～80 ℃ are dried to moisture less than 3～8%, 8～40 order granulate; Mentholum with dissolve with ethanol after with the residue CaCO
3Absorption joins in the above-mentioned granule mixing; Spray adds an amount of flavoring orange essence, mixing; Add Pulvis Talci, mixing; Tabletting promptly gets.
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| CN1183295A (en) * | 1997-12-10 | 1998-06-03 | 周国柱 | Buccal tablet of Radix Rhodiolae preparation and preparing method thereof |
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| CN1183295A (en) * | 1997-12-10 | 1998-06-03 | 周国柱 | Buccal tablet of Radix Rhodiolae preparation and preparing method thereof |
| CN1729999A (en) * | 2004-08-04 | 2006-02-08 | 浙江可立思安制药有限公司 | Lactein chewing tablet and its preparing process |
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