CN101125130B - Indian chrysanthemum effervescent preparation and preparation method thereof - Google Patents
Indian chrysanthemum effervescent preparation and preparation method thereof Download PDFInfo
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- CN101125130B CN101125130B CN200610109644XA CN200610109644A CN101125130B CN 101125130 B CN101125130 B CN 101125130B CN 200610109644X A CN200610109644X A CN 200610109644XA CN 200610109644 A CN200610109644 A CN 200610109644A CN 101125130 B CN101125130 B CN 101125130B
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Abstract
The present invention relates to a wild chrysanthemum effervescent preparation and the preparation method, the preparation has simple and convenient production method as well as the low cost. The preparation has rapid dissolution, good efficacy, simple technique and low cost.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly relate to a kind of effervescent formulation that contains the Flos Chrysanthemi Indici effective ingredient and preparation method thereof.
Background technology
In clinical, no matter be Chinese medicine or Western medicine, many different types of antipyretic and antidotal type medicines are all arranged.Western medicine costs an arm and a leg, and side reaction is many, and the clinical practice effect is not very good.Curative effect is comparatively satisfied and use more still based on Chinese medicine.
Flos Chrysanthemi Indici is clinical the most frequently used medicine always, has the effect of subduing swelling and detoxicating, wind and heat dispersing, infection, antiviral, and medicinal history among the people is long in China, and Chinese Pharmacopoeia also early records.Modern pharmacology proves: Flos Chrysanthemi Indici has effects such as broad-spectrum antiseptic, antiviral, blood pressure lowering, coronary blood flow increasing, removing oxygen-derived free radicals, and untoward reaction is few, action temperature and lasting, has higher medical value.
The chemical constituent that Flos Chrysanthemi Indici contains comprises terpenoid and volatile oil, is mainly monoterpenes, sesquiterpenoids and oxygen derivant thereof, triterpenoid compound, aliphatic compound etc.Also contain compositions such as flavone compound, chlorogenic acid and Glyceryl Behenate, Palmic acid, polysaccharide, beta-carotene, protein, aminoacid, purine, choline, stachydrine, tannin, vitamin, chlorophyll in addition.A kind of main active of Flos Chrysanthemi Indici is a chlorogenic acid, and the Sanitation Ministry medicine standard is included to have heat-clearing and toxic substances removing, 170 kinds of Chinese patent medicines of anti-inflammation all contain chlorogenic acid and be main component.
The Flos Chrysanthemi Indici in the different cultivars and the place of production all contains the various trace elements of needed by human, and the content of calcium, magnesium, ferrum is than the height in the Flos Chrysanthemi.The Flos Chrysanthemi Indici biological activity is various, delicate fragrance is pleasant, safe and reliable, simultaneously the medicine source is extensive, cheap, has wide development value in fields such as medicine, food, health product, cosmetics.
The present domestic common Flos Chrysanthemi Indici granule of having produced folk prescription, clinical practice prove, Flos Chrysanthemi Indici granule to furuncle swell and ache, conjunctival congestion and swelling pain, the dizzy therapeutic effect of headache be reliable, safe in utilization, is comparatively ideal medicine in the similar Chinese patent medicine, is subjected to the welcome of consumer deeply.
But existing Flos Chrysanthemi Indici granule preparation is mainly become to make for two kinds by Flos Chrysanthemi Indici and sucrose, and its dosage form is single, makes extensive patients have big limitation on selection of clinical.In addition, the shortcoming of existing common Flos Chrysanthemi Indici granule agent is that also brewing time is long, and solubility property is poor, needs when taking to melt granule with big water gaging, greatly reduces patient's compliance.Though patent of invention CN1586593A has mentioned a kind of preparation method of Wild chrysanthemum oral disintegration tablet, but in this method for the content of active ingredient chlorogenic acid in the finished product, the method that adopts is: will extract volatile oil with steam distillation through the Flos Chrysanthemi Indici that soaks earlier, the volatile oil that makes is made clathrate; Decocting liquid is filtered, last macroporous adsorbent resin gets extract with ethanol elution again; At last with the mixed oral cavity disintegration tablet that gets of clathrate, extract and pharmaceutic adjuvant.Above-mentioned complex process has increased production cost virtually, therefore press for that a kind of production technology of research and development is simple, with low cost, disintegrate rapidly, the residual newtype drug effervescent formulation of no dissolved residue, the clinical practice of being more convenient for.
Summary of the invention
Purpose of the present invention overcomes the deficiencies in the prior art exactly, provides that a kind of production technology is simple, with low cost, the disintegrate newtype drug effervescent formulation of Flos Chrysanthemi Indici rapidly, makes patient's selection more wide in range, with dashing with usefulness, convenient and swift, be fit to very much modern life rhythm, be more suitable for clinical practice.
An object of the present invention is to provide a kind of Flos Chrysanthemi Indici effervescent formulation.
Another object of the present invention provides the preparation method of described Flos Chrysanthemi Indici effervescent formulation.
The inventor is through a large amount of research and repetition test, develops quick dissolving, curative effect excellence, technology Flos Chrysanthemi Indici effervescent formulation easy, with low cost and preparation method thereof.
Flos Chrysanthemi Indici effervescent formulation of the present invention:
1) gets Flos Chrysanthemi Indici 50～10000g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (80 ℃), room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25 (80 ℃), drying under reduced pressure becomes dry extract (60～80 ℃);
2) with Flos Chrysanthemi Indici after extract powder is broken into fine powder, mix with following adjuvant,
Filler such as lactose 20～100g
Disintegrating agent such as carboxymethylstach sodium 100～150g
Disintegrating agent such as low-substituted hydroxypropyl cellulose 50～80g
Lubricant such as Macrogol 200～350g
Acid 10～50g
Alkali 5～60g
Correctives such as cyclamate 10～30g
Dehydrated alcohol is an amount of
Granulate with dehydrated alcohol, or substep granulates, carry out drying in 50 ℃～80 ℃, make the Flos Chrysanthemi Indici effervescent formulation.
The invention further relates to preparing such formulations.In the development of this method, carried out the screening operation of adjuvant in the prescription, determine to select for use the adjuvant of forming, wherein said acid is selected from: citric acid, tartaric acid, fumaric acid, adipic acid, malic acid, rare ore deposit acid (example hydrochloric acid), water-soluble amino acid, acid salt (citric acid hydrogen dipotassium, potassium hydrogen tartrate, fumaric acid sodium etc.); Wherein said alkali is selected from: sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate etc.; Spendable filler is selected from the said preparation: starch, Icing Sugar, dextrin, lactose, microcrystalline Cellulose, mannitol; Described disintegrating agent is selected from: carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose; Described lubricant is selected from: magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol; Described correctives is selected from: cyclamate, sucrose, stevioside, aspartame, xylitol.The sample of the side of Clicking here, process trial meets the requirement of quality standard through check.
The amount ratio of bronsted lowry acids and bases bronsted lowry is 0.6: 1～1: 1.2 in this prescription, and preferred proportioning is 0.8: 1～1: 1, and most preferred proportioning is 0.86: 1.
The consumption of preferred Flos Chrysanthemi Indici is 500～8000g in the Flos Chrysanthemi Indici effervescent tablet preparation of the present invention, is more preferably 1500～5000g, most preferably is 2500～4500g, for example is 3000g.
Disintegrating agent is preferably 120～140g as the consumption of carboxymethyl starch sodium, is more preferably 125～135g.In addition, the consumption of disintegrating agent such as low-substituted hydroxypropyl cellulose is 55～75g preferably, more preferably 60～70g, most preferably 62.5～65g.
Can adopt acid in the effervescent formulation of the present invention, wherein the preferred 15～45g of Suan consumption more selects 15～40g, most preferably 20～30g, for example 25g.Used alkali is sodium bicarbonate, sodium carbonate for example, and the consumption of alkali is 10～50g preferably, more preferably 20～40g, 25～35g most preferably, 29g for example, 34g.
The preparation method of Flos Chrysanthemi Indici effervescent formulation of the present invention comprises the following steps:
1. get Flos Chrysanthemi Indici and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (80 ℃), room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25 (80 ℃), drying under reduced pressure becomes dry extract (60～80 ℃);
2. after Flos Chrysanthemi Indici dry extract being ground into fine powder, mix, granulate, or substep granulates, carry out drying in 50 ℃～80 ℃, promptly with dehydrated alcohol with appropriate amount of auxiliary materials;
3. the method for substep granulation is for to granulate acid, alkali respectively, and dry again, mixing gets final product.
The formulation method of this product adopts preparation means conventional in the pharmaceutical field, and those skilled in the art can granulate according to this area Professional knowledge.
When this preparation carries out quality research, consider that Flos Chrysanthemi Indici belongs to monarch drug in this preparation, and prescription has only this medical material simply entirely, so decision is studied Flos Chrysanthemi Indici.Chlorogenic acid with Flos Chrysanthemi Indici is the assay index, and adopts the HPLC method to quantize examination.Methodological study is the result show, uses the content linear relationship of this method mensuration this product good, and repeatability, precision and response rate height have proved that this method mensuration this product content has feasibility.Test agent is all up to specification in the three batches of lab scales and three batches.
By drafting method the chlorogenic acid in the test agent in three batches of lab scale samples and three batches is carried out assay, all more than the 2.30mg/ bag, with reference to officinal standard formulation method, so content limit is denoted as: this product contains chlorogenic acid for every bag must not be less than 2.30mg to the result.
The method of assay is to investigate by linear test, stability test, precision test, recovery test etc., proves that this method is used for measuring content, and method is feasible, and is quality controllable, meets the pharmacopeia regulation.
In stability study.Test agent is pressed commercially available back in three batches, has carried out 12 months test under 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% condition, and the result shows that every detection index all meets set quality standard and pharmacopeia regulation.Explanation under this terms of packing, preparation stabilization.
The specific embodiment
Following examples are in order further to describe the present invention for example, rather than limit the present invention by any way.
Embodiment 1:
1. get Flos Chrysanthemi Indici 3000g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (80 ℃), room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25 (80 ℃), drying under reduced pressure becomes dry extract (60～80 ℃);
2. after Flocdrysanthemi being ground into fine powder, mix with lactose 50g, carboxymethylstach sodium 125g, low-substituted hydroxypropyl cellulose 62.5g, Polyethylene Glycol 250g, cyclamate 25g, tartaric acid 25g, sodium bicarbonate 29g, granulate in right amount with dehydrated alcohol, carry out drying in 50 ℃～80 ℃, promptly.
Embodiment 2:
1. get Flos Chrysanthemi Indici 50g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (80 ℃), room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.25 (80 ℃), drying under reduced pressure becomes dry extract (60～80 ℃);
2. after Flocdrysanthemi being ground into fine powder, mix with lactose 20g, carboxymethylstach sodium 135g, low-substituted hydroxypropyl cellulose 55g, magnesium stearate 200g, cyclamate 25g, citric acid 50g, sodium carbonate 60g, granulate in right amount with dehydrated alcohol, carry out drying in 50 ℃～80 ℃, promptly.
Embodiment 3:
1. according to embodiment 1 preparation Flocdrysanthemi, wherein the consumption of Flos Chrysanthemi Indici is 9800g,
2. the half with above-mentioned Flocdrysanthemi powder mixes with 100g carboxymethylstach sodium, 10g tartaric acid, 350g Pulvis Talci, with dehydrated alcohol system soft material, and oven dry in about 50 ℃;
3. remaining Flocdrysanthemi powder and 8g sodium bicarbonate, 65g low-substituted hydroxypropyl cellulose, an amount of cyclamate are mixed, with dehydrated alcohol system soft material, oven dry in about 50 ℃;
4. two kinds of granules are mixed, granulate, promptly.
In the official relevant solubility property test, Flos Chrysanthemi Indici effervescence granular preparation 300mg of the present invention only need or not stir and can all dissolve in 300 seconds with 30ml water, the plain particles preparation needs 150ml water, and constantly stirs down, needs the granule residue of dissolving in 300 seconds and residual 20%.
Existing Flos Chrysanthemi Indici granule preparation is made 1000 granular preparations by 333 gram Flos Chrysanthemi Indicis and 960 gram sucrose, and granular preparation of the present invention can be made by 3000 grams and about 600 gram effervescent adjuvants, this shows that the present invention contains several times (about 7～10 times) in the Flos Chrysanthemi Indici active component of plain particles preparation in the preparation of equal in quality, thereby reduced the required drug administration amount of patient, improved curative effect.In addition, because effervescent formulation solubility property of the present invention is good and the consumption minimizing, facilitates patients more and carry.
Claims (6)
1. the preparation method of a Flos Chrysanthemi Indici effervescent formulation, this method may further comprise the steps:
1) gets Flos Chrysanthemi Indici 50～10000g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and relative density was 1.15 clear paste when filtrate was concentrated into 80 ℃, room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, relative density is 1.25 clear paste when being concentrated into 80 ℃, becomes dry extract in 60～80 ℃ of drying under reduced pressure;
2) Flos Chrysanthemi Indici dry extract is ground into fine powder after, mix with following adjuvant,
Lactose 20～100g
Carboxymethylstach sodium 100～150g
Low-substituted hydroxypropyl cellulose 50～80g
Macrogol 200～350g
Tartaric acid 10～50g
Sodium bicarbonate 5～60g
Cyclamate 10～30g
Granulate with dehydrated alcohol, carry out drying in 50 ℃～80 ℃, promptly; Wherein the amount ratio of bronsted lowry acids and bases bronsted lowry is 0.86: 1.
2. Flos Chrysanthemi Indici effervescent formulation is characterized in that:
1) gets Flos Chrysanthemi Indici 50～10000g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and relative density was 1.15 clear paste when filtrate was concentrated into 80 ℃, room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, relative density is 1.25 clear paste when being concentrated into 80 ℃, becomes dry extract in 60～80 ℃ of drying under reduced pressure;
2) Flos Chrysanthemi Indici dry extract is ground into fine powder after, mix with following adjuvant,
Lactose 20～100g
Carboxymethylstach sodium 100～150g
Low-substituted hydroxypropyl cellulose 50～80g
Macrogol 200～350g
Tartaric acid 10～50g
Sodium bicarbonate 5～60g
Cyclamate 10～30g
Granulate with dehydrated alcohol, carry out drying in 50 ℃～80 ℃, make the Flos Chrysanthemi Indici effervescent formulation, wherein the amount ratio of bronsted lowry acids and bases bronsted lowry is 0.86: 1.
3. Flos Chrysanthemi Indici effervescent formulation as claimed in claim 2, wherein the consumption of Flos Chrysanthemi Indici is 2500～4500g, the consumption of disintegrating agent carboxymethyl base Starch Sodium is 125～135g, the consumption of disintegrating agent low-substituted hydroxypropyl cellulose is 62.5～65g, tartaric consumption is 20～30g, and the consumption of sodium bicarbonate is 25～35g.
4. as claim 2 or 3 described Flos Chrysanthemi Indici effervescent formulations, wherein sodium bicarbonate is replaced by sodium carbonate, and tartaric acid is replaced by citric acid.
5. Flos Chrysanthemi Indici effervescent formulation is characterized in that:
1) gets Flos Chrysanthemi Indici 3000g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and relative density was 1.15 clear paste when filtrate was concentrated into 80 ℃, room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, relative density is 1.25 clear paste when being concentrated into 80 ℃, becomes dry extract in 60～80 ℃ of drying under reduced pressure;
2) Flos Chrysanthemi Indici dry extract is ground into fine powder after, with lactose 50g, carboxymethylstach sodium 125g, low-substituted hydroxypropyl cellulose 62.5g, Polyethylene Glycol 250g, cyclamate 25g, tartaric acid 25g, sodium bicarbonate 29g, granulate in right amount with dehydrated alcohol, carry out drying in 50 ℃～80 ℃, promptly.
6. Flos Chrysanthemi Indici effervescent formulation is characterized in that:
1) gets Flos Chrysanthemi Indici 9800g and added water retting 3 hours, decoct 3 times, each 1 hour of first and second time; 0.5 hour for the third time; Collecting decoction filters, and relative density was 1.15 clear paste when filtrate was concentrated into 80 ℃, room temperature to be chilled to, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, relative density is 1.25 clear paste when being concentrated into 80 ℃, becomes dry extract in 60～80 ℃ of drying under reduced pressure;
2) after the half of getting above-mentioned Flos Chrysanthemi Indici dry extract is ground into fine powder, mix with carboxymethylstach sodium 100g, tartaric acid 10g, Pulvis Talci 350g, with dehydrated alcohol system soft material, in 50 ℃ of oven dry;
3) remaining Flocdrysanthemi powder and sodium bicarbonate 8g, low-substituted hydroxypropyl cellulose 65g, an amount of cyclamate are mixed, with dehydrated alcohol system soft material, oven dry in about 50 ℃;
4) two kinds of granules are mixed, granulate, promptly.
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| MD4061B1 (en) * | 2009-02-20 | 2010-07-31 | Николае Павел КОВАЛЕНКО | Cooler for luminaire with light-emitting diodes |
| CN102188469A (en) * | 2011-05-27 | 2011-09-21 | 河南大学 | Chrysanthemum morifolium extractive with live protection function, extraction method and applications thereof |
| CN106265833A (en) * | 2016-08-01 | 2017-01-04 | 遵义医学院 | A kind of Flos Lonicerae effervescent tablet and preparation method thereof |
| CN107242556B (en) * | 2017-05-25 | 2021-03-23 | 四川农业大学 | Dual-purpose chrysanthemum morifolium ramat buccal tablets and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1425413A (en) * | 2002-12-27 | 2003-06-25 | 中山大学 | Xiasangju effervescent tablet and its preparing process |
| CN1586593A (en) * | 2004-07-23 | 2005-03-02 | 张晴龙 | Wild chrysanthemum oral disintegration tablet and its preparing method |
| CN1698663A (en) * | 2004-05-21 | 2005-11-23 | 江西本草天工科技有限责任公司 | Ring form effervescence dosage and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1425413A (en) * | 2002-12-27 | 2003-06-25 | 中山大学 | Xiasangju effervescent tablet and its preparing process |
| CN1698663A (en) * | 2004-05-21 | 2005-11-23 | 江西本草天工科技有限责任公司 | Ring form effervescence dosage and preparation method thereof |
| CN1586593A (en) * | 2004-07-23 | 2005-03-02 | 张晴龙 | Wild chrysanthemum oral disintegration tablet and its preparing method |
Non-Patent Citations (2)
| Title |
|---|
| 万红波.玉菊泡腾片的制备工艺及质量标准研究.中国优秀博硕士学位论文全文数据库（硕士）工程科技I辑 1.2005,(1),1-50. |
| 万红波.玉菊泡腾片的制备工艺及质量标准研究.中国优秀博硕士学位论文全文数据库(硕士)工程科技I辑 1.2005,(1),1-50. * |
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