CN100544758C - A kind of compound Taizi ginsen preparation and production method thereof - Google Patents
A kind of compound Taizi ginsen preparation and production method thereof Download PDFInfo
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- CN100544758C CN100544758C CNB2006100837079A CN200610083707A CN100544758C CN 100544758 C CN100544758 C CN 100544758C CN B2006100837079 A CNB2006100837079 A CN B2006100837079A CN 200610083707 A CN200610083707 A CN 200610083707A CN 100544758 C CN100544758 C CN 100544758C
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Abstract
The present invention discloses a kind of compound Taizi ginsen extract and pharmaceutical preparation and production method.Extract of the present invention carries out the precipitate with ethanol processing by adopting the suitable determining alcohol that contains, obtain the compound Taizi ginsen extract behind the purification, can effectively remove impurity wherein, can keep effective ingredient wherein simultaneously, keep the curative effect of medicine, and increased the stability of finished product.Extract of the present invention and preparation thereof have the function of the stomach of enhancing, can be used for treating diseases such as weakness of the spleen and stomach and dyspepsia.
Description
Technical field
The present invention relates to a kind of compound Taizi ginsen extract and pharmaceutical preparation and production method, especially relate to a kind of compound Taizi ginsen oral liquid preparation and production method thereof.Compound Taizi ginsen extract of the present invention and pharmaceutical preparation thereof have the function of the stomach of enhancing, can be used for treating diseases such as weakness of the spleen and stomach and dyspepsia.Belong to field of medicaments.
Background technology
Deficiency of spleen-QI and stomach-QI is the sign of clinical very common pilosity, is one of the spleen-stomach disease disease of seeing at most, is the insufficient one group of comprehensive syndrome of reaction body spleen and stomach function.By mass survey, its sickness rate nearly 40%.General diseases the syndrome of spleen-deficiency occurs in evolution the person reaches 87.9%.Some primary lesioies can not have the performance of syndrome of spleen-deficiency yet in gastral disease.Therefore, development safety, medicine effective, taking convenience are very important with the demand that satisfies the patient, and be significant.
The spleen-stomach disease is controlled from this dirty opinion of taste, is the most the most frequently used method of function of spleen and stomach regulating.Chinese medicine Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus and Fructus Crataegi, all based on function of spleen and stomach regulating, promoting digestion and removing stagnation is auxilliary, has to mend the double function of controlling that disappears.Radix Pseudostellariae is the tuber of the different false Herba stellariae mediae of pinkwort, and sweet and slightly bitter taste seven is flat, returns spleen, lung meridian.It has, and nourishing is strong, the function of QI invigorating, and body is had the effect of " adaptogen " sample, can strengthen substance metabolism in the human body.Clinically can be used for treating diseases such as insufficiency of the spleen stomach is weak, deficiency of stomach-Yin.The Chinese medicine Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange, and bitter in the mouth, suffering, temperature are returned lung, spleen channel.Modern pharmacology test shows that Pericarpium Citri Reticulatae has pair anti-acetylcholine effect, and the effect that Pericarpium Citri Reticulatae suppresses the isolated rabbit intestinal can resist by acetylcholine again, and the spastic contraction of intestinal tube to pilocarpine causes has antagonism.The decocting liquid of Pericarpium Citri Reticulatae can increase the rat gastric secretion, and city's total acidity and total acid output increase, and can promote salivary gland secretion amylase, thereby adjusts digestive function.Rhizoma Dioscoreae is the dry rhizome of potato Yam, and is sweet, flat, returns spleen, lung, kidney channel, tonifying the spleen and stomach arranged, the effect of the lung benefiting that promotes the production of body fluid.Modern pharmacological research shows that Rhizoma Dioscoreae can be improved the mice non-specific immunity.Rhizoma Dioscoreae contains compositions such as polysaccharide, potato Yam saponin, starch.Fructus Crataegi is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae or Fructus Crataegi, be used for strengthening the spleen and stomach, help digestion long-pending, especially dyspepsia, diarrhoea, abdominal distention etc.Modern study shows, can increase enzyme in the stomach, facilitating digestion after Fructus Crataegi is taken.Decocting liquid or the alcohol extract of Fructus Crataegi have obvious inhibitory action to the intestinal smooth muscle contraction that is caused by acetylcholine.Fructus Hordei Germinatus is the mature fruit of grass tree section Hordeum Fructus Hordei Vulgaris, makes through germination, and medicinal part comprises its plumelet, wheat grain and fibrous root, and sweet in the mouth, flat is returned spleen, stomach warp.Fructus Hordei Germinatus is as appetite-stimulating indigestion-relieving, and is with a long history in China.Modern study shows that Fructus Hordei Germinatus contains amylase, can help the starchiness food digestion.The decocting liquid of Fructus Hordei Germinatus, slightly gastric acid secretion increasing also has slight facilitation to pepsic secretion.The XIAOSHI PIAN of Shi Yonging is clinically made oral tablet for Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus and Fructus Crataegi decocting liquid after concentrating, and has functions of strengthening stomach and promoting digestion, is mainly used in treatment weakness of the spleen and stomach, dyspepsia.
Summary of the invention
The object of the invention provides a kind of compound Taizi ginsen extract and pharmaceutical preparation thereof that is prepared from through scientific and rational pharmaceutical technology.
One of the present invention program provides a kind of compound Taizi ginsen extract, calculate by weight, form by medical materials such as 10 parts of 100 parts of Radix Pseudostellariaes, 75 parts of Rhizoma Dioscoreaes, 75 parts in Fructus Hordei Germinatus, 50 parts of Fructus Crataegis and Pericarpium Citri Reticulataes, above-mentioned medical material through water extract that water extraction obtains after ad hoc approach is handled and make, it is characterized in that described method is that described water extract adds ethanol and makes that to contain alcohol amount be 50%～75%, get supernatant after the placement, reclaim ethanol and be concentrated into an amount of.
Wherein, described Fructus Hordei Germinatus can parch, also can give birth to product.The preferred Fructus Hordei Germinatus (parched) that uses.
Wherein, as preferred embodiment, the above-mentioned described alcohol amount of containing is 60%.
Wherein, described water extraction can be general water extraction process, for example water boiling and extraction, the extraction of water logging bubble, the extraction of water percolation etc.As preferred embodiment, described water extraction is the medical material water boiling and extraction; More preferably water decocts second extraction, wherein, 2 hours for the first time, 1 hour for the second time, collecting decoction.
As preferred embodiment, above-mentioned described aqueous extract adds Ethanol Treatment again through the clear paste that obtains after suitably concentrating, and wherein said clear paste relative density can be 1.10～1.20, more preferably 1.15 (50 ℃ of heat are surveyed).
Another program of the present invention provides a kind of compound Taizi ginsen medicine, and it is made up of above-mentioned described compound Taizi ginsen extract and acceptable accessories as active component.
Wherein, described compound Taizi ginsen medicine can be oral liquid, if desired, can contain sucrose as adjuvant.
As one of preferred embodiment, the invention provides a kind of compound Taizi ginsen oral liquid, Radix Pseudostellariae 100 grams, Rhizoma Dioscoreae 75 grams, Fructus Hordei Germinatus 75 grams, Fructus Crataegi 50 grams, Pericarpium Citri Reticulatae 10 grams, its method through comprising following steps is prepared from: (1) above-mentioned five tastes medical material is through the extracting solution that water boiling and extraction obtains, and being concentrated into relative density is the clear paste of 1.15 (50 ℃ of heat are surveyed), and the resulting clear paste of (2) step (1) adds ethanol makes that to contain the alcohol amount be 60%, get supernatant after the placement, recovery ethanol also is concentrated in right amount, leaves standstill after-filtration, obtains filtrate, (3) the resulting filtrate of step (2), add an amount of sucrose adjuvant if desired, boil the back filtered while hot, put and add water to 1000 milliliters of total amounts after cold.
Wherein, above-mentioned described oral liquid if desired, can add an amount of antiseptic, for example benzoic acid or its esters, Buddhist nun's platinum class, sorbic acid etc.Wherein, more preferably use sodium benzoate as antiseptic.
Wherein, above-mentioned described water boiling and extraction is preferably decocting and boils secondary, and 2 hours for the first time, 1 hour for the second time.
Compound Taizi ginsen extract of the present invention and pharmaceutical preparation thereof have the effect that strengthens the stomach function, can be used for treating diseases such as weakness of the spleen and stomach or dyspepsia.
Medical material of the present invention adopts the prepared of water extraction Ethanol Treatment to form described compound Taizi ginsen extract.Adopt water as extracting solvent, technology is simple, and cost is low, and can extract the effective ingredient in the medical material effectively, for example compositions such as saponins, Pericarpium Citri Reticulatae glycosides and organic acid salt.But the water extraction process paste-forming rate is very high, and pigment, lymphatic temperament, natural gum or the like invalid components is also extracted in a large number in the medical material, not only causes dose big, and influences stability of formulation and outward appearance.Adopt general purifying process, when removing above-mentioned useless composition, also can remove compositions such as saponins, Pericarpium Citri Reticulatae glycoside simultaneously, thereby influence the drug effect of medicine.The present invention finds unexpectedly, by adopting the suitable determining alcohol that contains, handle described water extract, obtain the compound Taizi ginsen extract behind the purification, can effectively remove impurity wherein, can keep effective ingredient wherein simultaneously, keep the curative effect of medicine, and increased the stability of finished product, really play " removing crudely and store essence " unexpected invention effect.
The specific embodiment
Following specific embodiment is to set forth content of the present invention for further, and should be understood that claim protection domain of the present invention is construed as limiting effect.
Embodiment 1
Radix Pseudostellariae 80 grams, Rhizoma Dioscoreae 60 grams, Fructus Hordei Germinatus (stir-fry) 60 grams, Fructus Crataegi 40 grams, Pericarpium Citri Reticulatae 8 grams.Above five tastes medical material decocts with water secondary, and 2 hours for the first time, 1 hour for the second time, merge decoction liquor, filter, it is 1.15 (50 ℃ of heat are surveyed) that filtrate is concentrated into relative density, obtains clear paste A.
Get an amount of above-mentioned resulting clear paste A, add ethanol and make that to contain the alcohol amount be 60%, after stirring evenly, cold preservation was placed 48 hours, got supernatant, behind the decompression recycling ethanol, was concentrated in right amount, obtained clear paste B.
1, the mensuration of content of hesperidin among clear paste A and the B
Adopt high effective liquid chromatography for measuring.Chromatographic condition is: being filler with the octadecylsilane chemically bonded silica, is mobile phase with methanol-0.5% glacial acetic acid solution (40:60), and the detection wavelength is 283nm, and number of theoretical plate calculates by the Hesperidin peak should be not less than 2000.Qinghuo reagent A and B test sample are an amount of respectively, and the fixed back of accurate title adds methanol 20ml, claims to decide weight, place in the water-bath reflux 1 hour, and put coldly, claim to decide weight again, supply the weight of minimizing with methanol, shake up, filter, precision is measured subsequent filtrate 5ml, place the 10ml measuring bottle, thin up shakes up to scale, filter, get subsequent filtrate and promptly get need testing solution.It is an amount of that other gets the Hesperidin reference substance, and accurate the title decides, and places measuring bottle, adds methanol and make dissolving and be diluted to scale, shakes up, and promptly gets reference substance solution.Accurate respectively reference substance solution and each 20 microlitre of need testing solution drawn inject chromatograph of liquid, measure.
According to the method described above, repeat 8 tests.Result such as following table 1.
Content of hesperidin changed before and after table 1 precipitate with ethanol was handled
By last table explanation, compound Taizi ginsen extract of the present invention is after precipitate with ethanol is refining, the loss rate average out to 5.65 ± 2.26% of Hesperidin, the water extraction group is compared t=0.676 with the water extract-alcohol precipitation group, P＞0.05, illustrate that technology of the present invention is reasonable, behind the precipitate with ethanol, can effectively remove impurity wherein, effective ingredient wherein be can keep simultaneously, active constituents of medicine and curative effect of medication do not influenced.
Embodiment 2
Radix Pseudostellariae 100 grams, Rhizoma Dioscoreae 75 grams, Fructus Hordei Germinatus (stir-fry) 75 grams, Fructus Crataegi 50 grams, Pericarpium Citri Reticulatae 10 grams.Above five tastes medical material decocts with water secondary, and 2 hours for the first time, 1 hour for the second time, merge decoction liquor, filter, it is 1.15 (50 ℃ of heat are surveyed) that filtrate is concentrated into relative density, obtains clear paste.Get above-mentioned resulting clear paste, add ethanol and make that to contain the alcohol amount be 60%, after stirring evenly, placed 24 hours, and got supernatant, behind the decompression recycling ethanol, be concentrated in right amount, cold putting 48 hours filters, filtrate restrains with sucrose 200 grams and sodium benzoate 1, after boiling, and filtered while hot, put coldly, add water to total amount 1000ml, stir evenly, leave standstill, filter, obtain oral liquid.Prepared oral liquid has good taste, has advantage rapid-action, that absorption is fast, and through study on the stability, after long-term the placement, liquid is clear and bright, has good stability.
Embodiment 3
Medicine of the present invention is to the influence test of mice gastric emptying.
Get 50 of mouselets, arranging in pairs or groups at random by body weight and sex is divided into five groups, and first three groups is equivalent to 50 times, 25 times and 12.5 times of (6.2g/kg of adult's consumption respectively as the high, medium and low three kinds of dosed administration groups of medicine of the present invention (embodiment 1 extractum B), 3.1g/kg, 1.55g/kg); The 4th group for not passing through medicine (the embodiment 1 extractum A) matched group of precipitate with ethanol step process; The 5th group as distilled water blank group.After the last administration 12 hours, measure the methyl orange residual quantity.The results are shown in following table 2.
The influence of methyl orange residual rate in the table 2 pair mice stomach (x ± SD)
Result of the test further specifies, medicine of the present invention, and after the processing of suitable concn alcohol precipitation process, active constituents of medicine is unaffected, and curative effect of medication is also unaffected.
Embodiment 4
Influence to gastric secretion
Get 40 of rat, male and female half and half, body weight 240g ± 20g, arranging in pairs or groups at random by body weight and sex is divided into four groups, and 10 every group, (dosage is respectively 6.2g/kg as the high and low two kinds of dosed administration groups of medicine of the present invention (embodiment 2) respectively, 3.1g/kg, be equivalent to 50 times and 25 times of the clinical consumption of adult respectively) and medicine matched group (commercially available XIAOSHI PIAN does not contain the precipitate with ethanol step in the technology) (adult's consumption 25 times), the 4th group as blank group (giving distilled water).Every treated animal is irritated stomach and give once every day, and for three days on end, the administration volume is the 1ml/100g body weight.Fasting is 24 hours after the last administration, ligation pylorus under the narcotism, then at duodenal administration 1ml/100g, collect gastric juice after 5 hours, get supernatant respectively and carry out gastric analysis, the result shows that each dosage group of medicine of the present invention has no significant effect rat gastric juice amount, but can increase rat total acidity gastric juice stomach function regulating acid output by highly significant, and along with dosage increase effect strengthens, medicine of the present invention can also highly significant improves peptic activity of stomach and pepsin output, and along with dosage increase effect strengthens.No significance difference on medicine of the present invention and the control drug drug effect.The results are shown in Table 3.
The influence of table 3 pair gastric secretion
The present invention is described according to preferred embodiment.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (3)
1. the production method of a compound Taizi ginsen oral liquid, described compound Taizi ginsen oral liquid is by Radix Pseudostellariae 100 grams, Rhizoma Dioscoreae 75 grams, Fructus Hordei Germinatus 75 grams, Fructus Crataegi 50 grams and Pericarpium Citri Reticulatae 10 gram medical materials are made, it is characterized in that comprising following steps: the extracting solution that (1) above-mentioned five tastes medical material obtains through water boiling and extraction, being concentrated into relative density is that 50 ℃ of heat are surveyed 1.15 clear paste, (2) the resulting clear paste of step (1) adds ethanol and makes that to contain alcohol amount be 60%, get supernatant after the placement, reclaim ethanol and be concentrated into an amount of, leave standstill after-filtration, obtain filtrate, (3) the resulting filtrate of step (2), add an amount of sucrose adjuvant if desired, boil the back filtered while hot, put and add water to 1000 milliliters of total amounts after cold.
2. production method according to claim 1 wherein, if desired, adds an amount of preservative sodium benzoate.
3. production method according to claim 1 and 2, wherein, described water boiling and extraction is that decocting boils secondary, 2 hours for the first time, 1 hour for the second time.
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| CN102138608A (en) * | 2010-11-16 | 2011-08-03 | 苏州市天灵中药饮片有限公司 | Stomach-invigorating and digestion-promoting tea |
| CN103055128A (en) * | 2013-02-01 | 2013-04-24 | 山东华信制药集团股份有限公司 | Preparation process of stomach invigorating and digestion helping tablet |
| CN103845523A (en) * | 2014-03-13 | 2014-06-11 | 山东省千佛山医院 | Chinese medicinal preparation for treating dyspepsia |
| CN104585282A (en) * | 2014-12-31 | 2015-05-06 | 无限极（中国）有限公司 | Biscuit and preparation method thereof |
| CN105362285B (en) * | 2015-10-22 | 2017-12-29 | 南昌大学 | It is a kind of that there is the preparation method of complex polysaccharide for promoting gastric emptying and the application of complex polysaccharide |
| CN115944695A (en) * | 2022-12-28 | 2023-04-11 | 广东好味鲜菜品与营养研究所 | Composition with functions of soothing nerves, tonifying spleen and nourishing stomach and preparation method of granules of composition |
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Non-Patent Citations (3)
| Title |
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| 中华人民共和国卫生部药品标准中药成方制剂第2册. 中华人民共和国卫生部药典委员会，209. 1990 * |
| 中华人民共和国卫生部药品标准中药成方制第二册. 中华人民共和国卫生部药典委员会，209. 1990 中华人民共和国卫生部药品标准中药成方制剂第2册. 中华人民共和国卫生部药典委员会，209. 1990 |
| 中华人民共和国卫生部药品标准中药成方制第二册. 中华人民共和国卫生部药典委员会，209. 1990 * |
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