CN1723986A - Effervescent tablets contg. Astragalus root and fructus ligustric lucidi for strengthening the body resistance, and its prepn. art - Google Patents
Effervescent tablets contg. Astragalus root and fructus ligustric lucidi for strengthening the body resistance, and its prepn. art Download PDFInfo
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- CN1723986A CN1723986A CN 200510031693 CN200510031693A CN1723986A CN 1723986 A CN1723986 A CN 1723986A CN 200510031693 CN200510031693 CN 200510031693 CN 200510031693 A CN200510031693 A CN 200510031693A CN 1723986 A CN1723986 A CN 1723986A
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Abstract
A Chinese medicine in the form of effervescent tablet for strengthening human body resistance is proportionally prepared from the extracts of astragalus root and lucid ligustrum fruit, lactose, rebaudiose, tartaric acid, sodium dicarbonate, poly ethanediol and magnesium stearate. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to body resistance-strengthening Zhenqi effervescent tablet and preparation technology thereof.
Background technology
The like product of domestic production at present mainly contains ZHENQI FUZHENG KELI.ZHENQI FUZHENG KELI is made up of the Radix Astragali, Fructus Ligustri Lucidi, and the Radix Astragali is given birth to and used invigorating QI to consolidate the body surface resistance, diuresis toxin expelling, evacuation of pus, expelling pus and promoting granulation.The Fructus Ligustri Lucidi nourishing the liver and kidney, black hair makes eye bright.All medicines share boosting qi and nourishing yin.ZHENQI FUZHENG KELI is the kind of recording in the 20 of Ministry of Health of the People's Republic of China's " Chinese traditional patent formulation preparation "; The raising immune function of human body is arranged, protection bone marrow and adrenal cortex function; What be used for that various diseases causes is deficient; Cooperate operation, lonizing radiation, chemotherapy, promote the effect of the recovery of normal function.But ZHENQI FUZHENG KELI is because adjuvant is more, and dosage is big, and it is big that patient takes volume, carries and take inconvenience, and the sugar content height, and dissolving is slow, stores, transportation is also inconvenient.In addition, technical process that former preparation technology mentions is simple, and the technology that much helps improving the quality does not all provide out, thereby unfavorable product quality is stable.
Summary of the invention
It is better that purpose of the present invention aims to provide a kind of product quality, have that disintegration time is short, the medicine stripping rapidly, absorb fast, bioavailability is high, drug dose is accurate, takes, easy to carry, especially is fit to the body resistance-strengthening Zhenqi effervescent tablet that old people, child and dysphagia patients use.
It is more complete that another object of the present invention aims to provide a kind of preparation technology, more perfect, more helps the raising of product quality level, saves cost, can carry out the preparation technology of the body resistance-strengthening Zhenqi effervescent tablet of large-scale industrial production.
The objective of the invention is to realize by following manner:
Body resistance-strengthening Zhenqi effervescent tablet weight proportion of the present invention is: dried cream powder 900-970 part of the Radix Astragali, Fructus Ligustri Lucidi, lactose 430-490 part, steviosin 5-20 part, tartaric acid 200-280 part, sodium bicarbonate 200-240 part, polyethylene glycol 6000,80-120 part, magnesium stearate 8-12 part.
The present invention is in 1000, and preferable weight proportion is: the dried cream powder 945g of the Radix Astragali, Fructus Ligustri Lucidi, lactose 475g, steviosin 10g, tartaric acid 240g, sodium bicarbonate 220g, polyethylene glycol 6000,100g, magnesium stearate 10g.
The weight proportion of the Radix Astragali, Fructus Ligustri Lucidi is 2: 1.
Another object of the present invention realizes by following manner: the Radix Astragali, Fructus Ligustri Lucidi, decoct with water three times, and add water 8-12 for the first time and doubly measure, decocted 2-3 hour; For the second time add water 6-10 and doubly measure, decocted 1-2 hour; Add water 6-10 for the third time and doubly measure, decocted 0.5-1 hour; Filter, merging filtrate is evaporated to relative density 1.08-1.10 (60 ℃ of surveys), and spray drying gets dry extract;
Get dried cream, add lactose, tartaric acid, steviosin, mix, be ground into fine powder,, granulate with ethanol system soft material, 60-65 ℃ of drying, granulate, standby; Taking polyethylene glycol-6000 fusion in addition adds sodium bicarbonate, stirs, and is ground into fine powder after the cooling, sieves, with above-mentioned granulates, magnesium stearate mixing, tabletting.
The preparation technology of the best of the present invention is:
The Radix Astragali, Fructus Ligustri Lucidi decoct with water three times, add 10 times of amounts of water for the first time, decoct 3 hours; For the second time add 8 times of amounts of water, decocted 2 hours; Add 8 times of amounts of water for the third time, decocted 1 hour; Filter, merging filtrate is evaporated to relative density 1.08-1.10 (60 ℃ of surveys), and spray drying gets dry extract;
Get dried cream, add lactose, tartaric acid, steviosin, mix, be ground into fine powder,, granulate with ethanol system soft material, 60-65 ℃ of drying, granulate, standby; Taking polyethylene glycol-6000 fusion in addition adds sodium bicarbonate, stirs, and is ground into fine powder after the cooling, sieves, with above-mentioned granulates, magnesium stearate mixing, tabletting.
Described concentrating under reduced pressure is at 60-65 ℃, and vacuum is to carry out under the 0.07-0.09Mpa.
The extraction process of former ZHENQI FUZHENG KELI is: get the Radix Astragali, Fructus Ligustri Lucidi decocts with water three times, collecting decoction filters, and filtrate concentrates clear paste.The water extraction process condition only has extraction time, decocting time, but lacks amount of water, and they are the key factors that influence extraction effect.Amount of water after the present invention not only clearly proposes to optimize, and can make technology more complete, extraction effect is better, not only save cost, and active ingredient is kept fully also.
Show that by test dry extract yield of the present invention can reach 21.5%, Radix Astragali active ingredient first glycosides extracted amount can reach 126.9mg.Can reach energy-saving and cost-reducing preferably, the effect of increasing work efficiency.In addition, the present invention is at 60-65 ℃, and vacuum is that drying under reduced pressure can reach the effective ingredient that does not as far as possible destroy in the medicinal liquid under the 0.07-0.09Mpa, with the effect of the quality that guarantees finished product.The present invention also adopts spray drying, thereby drying time is short, the drying efficiency height, and the dried cream of gained is crisp, of light color, and melting is good, the Astragaloside content height.Thereby improved end product quality, also saved the production time.
The present invention adopts sodium bicarbonate can make effervescent tablet disintegrate rapidly in water as alkali source, and the pH value of effervescent solution is lower.With sodium bicarbonate as alkali source after, because acid source has citric acid, tartaric acid, fumaric acid, malic acid etc., the present invention determines to adopt tartaric acid can be used as and is fit to best adjuvant of the present invention through multiple comparison test, at granulation, tabletting, all there is good effect aspects such as effervescent.The present invention adopts tartaric acid and medicated powder, lactose to mix granulation, do not lump in the time of can making drug particles dry, and good tabletting, effervescent is effective.The present invention adopts lactose both water-soluble, no hygroscopicity, and stable in properties again, and moisture resistance is good, does not chemically react with most drug, and the tablet surface of making is bright and clean attractive in appearance.
Because Polyethylene Glycol in the moulding process of the present invention-6000 packing technology research is very big to the hardness influence of effervescent tablet, this technology if be provided with preferably, can cause effervescent tablet to be placed and lose efficacy.Therefore the inventor is therefore to wrapping up and not wrapping up the test of contrasting: if with sodium bicarbonate and the direct mixed pressuring plate of granulates, after placing a period of time, acid interacts with alkali, and slice, thin piece hardness is reduced, therefore need sodium bicarbonate is adopted Polyethylene Glycol-6000 parcel, soda acid is isolated.Parcel by Polyethylene Glycol-6000 that sodium bicarbonate is adopted with do not wrap up two kinds of technologies, respectively at the 0th day firmness change situation, determine whether to adopt the method for the parcel of Polyethylene Glycol-6000 with the 30th day investigation tablet.The results are shown in Table 10:
Table 10: the investigation result of Polyethylene Glycol-6000 packing technology
| Technology | Hardness (kg) | |
| The 0th day | The 30th day | |
| Wrap up | 8.57 8.62 | 8.45 7.38 |
The result shows: adopt the technology of Polyethylene Glycol-6000 parcel, place after 30 days hardness and do not have significant change.Can place the problem that lost efficacy thereby solve effervescent tablet effectively every acid source and alkali source so adopt the method for polyethylene glycol 6000 parcel.
Thereby Polyethylene Glycol-6000 packing technology that the present invention determines is: after Polyethylene Glycol-6000 fusion, add sodium bicarbonate, stir, pulverized 80 mesh sieves after the cooling, with granulates mixing in proportion, get final product before tabletting.
The present invention compares with the ZHENQI FUZHENG KELI agent, its dosage of original ZHENQI FUZHENG KELI 15g/ bag, one time one bag, every day 2 times, thereby for patient, its dose is obviously bigger, the sugar content height.And dosage 2.0g/ sheet of the present invention, one time 3, every day 2 times, it is little to have a volume of taking, good looking appearance, patient carries, taking convenience, be specially adapted to the patient of child, old people and dysphagia, the present invention has the advantage of tablet and liquid preparation concurrently, takes with the solution form because of it again, drug effect is rapid, the bioavailability height.And because technology of the present invention is more perfect, the quality standard of the product effervescent tablets of gained increases than former ZHENQI FUZHENG KELI agent.
ZHENQI FUZHENG KELI and the present invention are relatively
The above results shows: quality standard of the present invention increases than former dosage form, and the present invention also has advantages such as taking, carry more convenient, patient Geng Yi acceptance.
Finished product yield of the present invention is higher, quality controllable, is fit to industrialized great production.
The specific embodiment
Embodiment 1
Get Radix Astragali 3000g and Fructus Ligustri Lucidi 1500g, decoct with water three times, add 10 times of amounts of water for the first time, decocted 3 hours; For the second time add 8 times of amounts of water, decocted 2 hours; Add 8 times of amounts of water for the third time, decocted 1 hour; Filter, merging filtrate, at 60-65 ℃, vacuum is to be evaporated to relative density 1.08-1.10 (60 ℃ of surveys) under the 0.07-0.09Mpa, spray drying, about 945g gets dry extract.
Get dried cream 945g, add lactose 475g, tartaric acid 240g, steviosin 10g, mix, be ground into fine powder,, granulate then with ethanol system soft material, 60-65 ℃ of drying, granulate, standby.Taking polyethylene glycol-6000100g fusion in addition adds sodium bicarbonate 220g, stirs, and is ground into fine powder after the cooling, sieves, and with above-mentioned granulates, magnesium stearate 10g mixing, tabletting, makes 1000 approximately.
Embodiment 2
Get Radix Astragali 3000g and Fructus Ligustri Lucidi 1500g, decoct with water three times, add 8 times of amounts of water for the first time, decocted 2 hours; For the second time add 6 times of amounts of water, decocted 1 hour; Add 6 times of amounts of water for the third time, decocted 0.5 hour; Other step is with embodiment 1.
Embodiment 3
Get Radix Astragali 3000g and Fructus Ligustri Lucidi 1500g, decoct with water three times, add 12 times of amounts of water for the first time, decocted 3 hours; For the second time add 10 times of amounts of water, decocted 2 hours; Add 10 times of amounts of water for the third time, decocted 1 hour; Filter, merging filtrate, other step is with embodiment 1.
Embodiment 4
Other step is got the dried cream powder 900g of the Radix Astragali, Fructus Ligustri Lucidi with embodiment 1, lactose 430g, steviosin 5g, tartaric acid 200g, sodium bicarbonate 200g, polyethylene glycol 6000 80g, magnesium stearate 8g.
Embodiment 5
The dried cream powder 970g of the Radix Astragali, Fructus Ligustri Lucidi, lactose 490g, steviosin 20g, tartaric acid 280g, sodium bicarbonate 240g, polyethylene glycol 6000 120g, magnesium stearate 12g.
Claims (7)
1, body resistance-strengthening Zhenqi effervescent tablet is characterized in that: its weight proportion is: dried cream powder 900-970 part of the Radix Astragali, Fructus Ligustri Lucidi, lactose 430-490 part, steviosin 5-20 part, tartaric acid 200-280 part, sodium bicarbonate 200-240 part, polyethylene glycol 6000 80-120 part, magnesium stearate 8-12 part.
2, body resistance-strengthening Zhenqi effervescent tablet according to claim 1 is characterized in that: in 1000, weight proportion is: the dried cream powder 945g of the Radix Astragali, Fructus Ligustri Lucidi, lactose 475g, steviosin 10g, tartaric acid 240g, sodium bicarbonate 220g, polyethylene glycol 6000 100g, magnesium stearate 10g.
3, body resistance-strengthening Zhenqi effervescent tablet according to claim 1 and 2 is characterized in that: the weight proportion of the Radix Astragali, Fructus Ligustri Lucidi is 2: 1.
4, the technology of the described body resistance-strengthening Zhenqi effervescent tablet of preparation claim 1 is characterized in that: the Radix Astragali, Fructus Ligustri Lucidi, decoct with water three times, and add water 8-12 for the first time and doubly measure, decocted 2-3 hour; For the second time add water 6-10 and doubly measure, decocted 1-2 hour; Add water 6-10 for the third time and doubly measure, decocted 0.5-1 hour; Filter, merging filtrate is evaporated to relative density 1.08-1.10 (60 ℃ of surveys), and spray drying gets dry extract; Get dried cream, add lactose, tartaric acid, steviosin, mix, be ground into fine powder,, granulate with ethanol system soft material, 60-65 ℃ of drying, granulate, standby; Taking polyethylene glycol-6000 fusion in addition adds sodium bicarbonate, stirs, and is ground into fine powder after the cooling, sieves, with above-mentioned granulates, magnesium stearate mixing, tabletting.
5, the preparation technology of body resistance-strengthening Zhenqi effervescent tablet according to claim 4 is characterized in that: the Radix Astragali, Fructus Ligustri Lucidi, decoct with water three times, and add 10 times of amounts of water for the first time, decocted 3 hours; For the second time add 8 times of amounts of water, decocted 2 hours; Add 8 times of amounts of water for the third time, decocted 1 hour; Filter, merging filtrate is evaporated to relative density 1.08-1.10 (60 ℃ of surveys), and spray drying gets dry extract; Get dried cream, add lactose, tartaric acid, steviosin, mix, be ground into fine powder,, granulate with ethanol system soft material, 60-65 ℃ of drying, granulate, standby; Taking polyethylene glycol-6000 fusion in addition adds sodium bicarbonate, stirs, and is ground into fine powder after the cooling, sieves, with above-mentioned granulates, magnesium stearate mixing, tabletting.
6, the preparation technology of body resistance-strengthening Zhenqi effervescent tablet according to claim 4 is characterized in that: described concentrating under reduced pressure is at 60-65 ℃, and vacuum is to carry out under the 0.07-0.09Mpa.
7, the preparation technology of body resistance-strengthening Zhenqi effervescent tablet according to claim 4 is characterized in that: get Radix Astragali 3000g and Fructus Ligustri Lucidi 1500g, decoct with water three times, add 10 times of amounts of water for the first time, decocted 3 hours; For the second time add 8 times of amounts of water, decocted 2 hours; Add 8 times of amounts of water for the third time, decocted 1 hour; Filter, merging filtrate, at 60-65 ℃, vacuum is to be evaporated to relative density 1.08-1.10 (60 ℃ of surveys) under the 0.07-0.09Mpa, spray drying, about 945g gets dry extract; Get dried cream 945g, add lactose 475g, tartaric acid 240g, steviosin 10g, mix, be ground into fine powder,, granulate then with ethanol system soft material, 60-65 ℃ of drying, granulate, standby.Taking polyethylene glycol-6000 100g fusion in addition adds sodium bicarbonate 220g, stirs, and is ground into fine powder after the cooling, sieves, and with above-mentioned granulates, magnesium stearate 10g mixing, tabletting, makes 1000.
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| CNB2005100316931A CN100337643C (en) | 2005-06-10 | 2005-06-10 | Effervescent tablets contg. Astragalus root and fructus ligustric lucidi for strengthening the body resistance, and its prepn. art |
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| CNB2005100316931A CN100337643C (en) | 2005-06-10 | 2005-06-10 | Effervescent tablets contg. Astragalus root and fructus ligustric lucidi for strengthening the body resistance, and its prepn. art |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103585281A (en) * | 2013-11-21 | 2014-02-19 | 贵州信邦制药股份有限公司 | Zhenqi chewable tablets and preparation method thereof |
| CN103655726A (en) * | 2013-12-09 | 2014-03-26 | 贵州信邦制药股份有限公司 | Syrup prepared from ligustrum lucidum and radix astragali and capable of reinforcing healthy qi, and preparation method thereof |
| CN103655727A (en) * | 2013-12-09 | 2014-03-26 | 贵州信邦制药股份有限公司 | Condensed pill prepared from ligustrum lucidum and radix astragali and capable of reinforcing healthy qi, and preparation method thereof |
| CN103720770A (en) * | 2013-12-20 | 2014-04-16 | 贵州信邦制药股份有限公司 | Glossy privet fruit-astragalus membranaceus effervescent preparation and preparation method thereof |
| CN104096204A (en) * | 2014-07-23 | 2014-10-15 | 重庆大学 | Children lung cough effervescent tablet and preparation method thereof |
| CN110339238A (en) * | 2019-07-29 | 2019-10-18 | 江西旭虹药业有限公司 | The preparation method of particle is exempted from a kind of stilbene chastity increasing |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1456234A (en) * | 2003-02-12 | 2003-11-19 | 毛友昌 | Preparation of weidakang effervescent tablets |
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2005
- 2005-06-10 CN CNB2005100316931A patent/CN100337643C/en active Active
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103585281A (en) * | 2013-11-21 | 2014-02-19 | 贵州信邦制药股份有限公司 | Zhenqi chewable tablets and preparation method thereof |
| CN103655726A (en) * | 2013-12-09 | 2014-03-26 | 贵州信邦制药股份有限公司 | Syrup prepared from ligustrum lucidum and radix astragali and capable of reinforcing healthy qi, and preparation method thereof |
| CN103655727A (en) * | 2013-12-09 | 2014-03-26 | 贵州信邦制药股份有限公司 | Condensed pill prepared from ligustrum lucidum and radix astragali and capable of reinforcing healthy qi, and preparation method thereof |
| CN103720770A (en) * | 2013-12-20 | 2014-04-16 | 贵州信邦制药股份有限公司 | Glossy privet fruit-astragalus membranaceus effervescent preparation and preparation method thereof |
| CN104096204A (en) * | 2014-07-23 | 2014-10-15 | 重庆大学 | Children lung cough effervescent tablet and preparation method thereof |
| CN104096204B (en) * | 2014-07-23 | 2017-10-13 | 重庆大学 | Lungs of Children coughs effervescent tablet and preparation method thereof |
| CN110339238A (en) * | 2019-07-29 | 2019-10-18 | 江西旭虹药业有限公司 | The preparation method of particle is exempted from a kind of stilbene chastity increasing |
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| CN100337643C (en) | 2007-09-19 |
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