CN1768785A - Honey suckle and scutellaria root pill and preparation thereof - Google Patents
Honey suckle and scutellaria root pill and preparation thereof Download PDFInfo
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- CN1768785A CN1768785A CN 200510114569 CN200510114569A CN1768785A CN 1768785 A CN1768785 A CN 1768785A CN 200510114569 CN200510114569 CN 200510114569 CN 200510114569 A CN200510114569 A CN 200510114569A CN 1768785 A CN1768785 A CN 1768785A
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Abstract
The invention relates to drop pill and its preparing process, wherein the drop pill is prepared from honeysuckle flower extract 10g, baikal skullcap root extract 4g and polyethylene glycol 4000 35g.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, particularly relate to the modified form of YINHUANG PIAN, make Lonicera and scutellaria drip pill through technological transformation, this drop pill is by Flos Lonicerae extract 10g, Radix Scutellariae extract 4g, and Macrogol 4000 35g makes.
Background technology:
Lonicera and scutellaria drip pill is to come through changing dosage form on the basis of YINHUANG PIAN, and YINHUANG PIAN is recorded in the 6th in ministry standard Chinese traditional patent formulation preparation, standard numbering WS
3-B-1233-92 has heat clearing away, detoxifcation, the effect of antiinflammatory.Be used for the acute and chronic tonsillitis, acute and chronic pharyngitis, Treatment of Upper Respiratory Tract Infection.At present list marketing be that the dosage form of main component has ordinary tablet, capsule, freeze-dried powder and injection etc. with Flos Lonicerae extract, Radix Scutellariae extract.Bioavailability is low, onset waits problem slowly because common oral tablet preparation exists.And the injection prolonged application has all proposed very high requirement to stability of formulation, safety and patient's tolerance degree.And prior art processes and quality standard backwardness, for overcoming above defective, selected the dosage form of drop pill to carry out technological transformation, and its curative effect and quality have been studied, obtained beyond thought effect.Found a kind of efficient, bioavailability is high, the dosage form of taking convenience, can heighten the effect of a treatment and reduce patient's burden and reduce untoward reaction, better meet clinical practice needs, increase the compliance of kind clinical practice.Drop pill steady quality of the present invention, dosage are accurately, medicament contg difference is little, take, carry, transport, storage etc. is all more convenient, easily implements the big production of mechanization, and output is big, and cost is low.
Summary of the invention:
The invention provides a kind of Lonicera and scutellaria drip pill preparation, this drop pill is made by active constituents of medicine and excipient substance.
This drop pill is preferably write out a prescription as follows:
Prescription Flos Lonicerae extract 7.5-13.3g Radix Scutellariae extract 3-5.3g Macrogol 4000 26-47g makes 1000 balls
Most preferred prescription
Prescription Flos Lonicerae extract 10g Radix Scutellariae extract 4g Macrogol 4000 35g makes 1000 balls
Above extract is an active constituents of medicine.
Method for making
Taking polyethylene glycol 4000 adds Flos Lonicerae extract, Radix Scutellariae extract, mixing, be heated to 80-85 ℃, treat whole fusions after, mechanical high-speed stirs 10min to evenly, be transferred in the reservoir, 70～80 ℃ of insulations splash in the refrigerative simethicone of gradient, drip apart from 3～6cm, drip 30～40 droplets/minute of speed, make 1000 balls, promptly with the drop pill drop that forms to the greatest extent and wipe simethicone.
Above Flos Lonicerae extract, Radix Scutellariae extract can have been bought from the market, also can use Flos Lonicerae, Radix Scutellariae is that raw material obtains by extracting processing, extracting method can use any of prior art, as the technology in Chinese Pharmacopoeia or the drug standard, or patented technology, or the technology in the textbook.
Being prepared as follows of preferred Flos Lonicerae extract and Radix Scutellariae extract:
The preparation of Flos Lonicerae extract: extracting honeysuckle, decoct with water twice, add 12 times of amounts of water for the first time, for the second time add 10 times of amounts of water, each 2 hours, merge decoction liquor, filter, filtrate adds lime cream and regulates pH value to 10～12, leaves standstill, the leaching precipitation, it is an amount of to add water, regulates pH value to 6～7 with sulphuric acid, stir evenly, filter, filtrate is concentrated into the thick paste shape, and (relative density is 1.32,50 ℃ of surveys), oven dry, promptly.
This product contains chlorogenic acid (C
16H
18O
9), must not be less than 2.4%.
The preparation of Radix Scutellariae extract: get Radix Scutellariae, add to and decoct twice in the boiling water, add 12 times of amounts of water at every turn and decocted 1 hour, merge decoction liquor, filter, filtrate adds sulphuric acid and regulates pH value to 2, leaves standstill, and the leaching precipitation, after an amount of washing of ethanol, drying, promptly.
More than prescription form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be a unit with gram or milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Drop pill of the present invention, contain the medicine acceptable auxiliary, this adjuvant is any excipient substance that is fit to make drop pill, as: Polyethylene Glycol, stearic acid, glyceryl monostearate, poloxamer, gelatin, the hydrogenated vegetable wet goods that can be molecular weight 400-20000, wherein Macrogol 4000 is a most preferred substrate adjuvant of the present invention, the utilization of this adjuvant obtains through science screening, proves that it has excellent characteristic.Its screening process is as follows:
1, substrate is selected according to bibliographical information, selects drop pill substrate Macrogol 4000 and polyethylene glycol 6000 commonly used to compare test.The Polyethylene Glycol of different model is put in the small beaker, add medicated powder (Flos Lonicerae extract and Radix Scutellariae extract form by 10: 4 mixed, and be as follows), mixing, be heated to 80-85 ℃, after treating whole fusions, investigate the fusion situation of substrate and medicated powder, select fusion situation dripping system (the system condition: expect warm 75 ℃ of writing out a prescription preferably, coolant is a simethicone, drip apart from 4cm, drip 30～40 droplets/minute of speed), the results are shown in Table 1.
Result of the test shows that Macrogol 4000 is as substrate, and is big to the medicine saturation, the good fluidity of medicinal liquid, and drug loading is bigger, the drop pill good moldability, smooth in appearance, mellow and full attractive in appearance, the ball method of double differences is different little, and molten loosing comparatively fast is so select Macrogol 4000 as this product substrate.
The fusion situation of table 1 substrate and principal agent relatively
| The prescription number | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Medicated powder (g) | 14 | 14 | 14 | 14 | 14 | 14 | 14 | 14 |
| Macrogol 4000 (g) | 14 | 28 | 42 | 56 | -------- | ------ | ------- | ------ |
| Polyethylene glycol 6000 (g) | ----- | ------- | ------ | ------- | 14 | 28 | 42 | 56 |
| Principal agent: substrate | 1∶1 | 1∶2 | 1∶3 | 1∶4 | 1∶1 | 1∶2 | 1∶3 | 1∶4 |
| The fusion situation of principal agent and substrate | Principal agent can merge with substrate, but system does not have flowability | Principal agent can merge with substrate, and system is better mobile | Principal agent can merge with substrate, and the system flowability is fine | Principal agent can merge with substrate, and the system flowability is fine | Principal agent and substrate merge relatively poor | Principal agent can merge with substrate, but system does not have flowability | Principal agent can merge with substrate, and the system flowability is relatively poor | Principal agent can merge with substrate, and system is better mobile |
| The drop pill outward appearance | ----- | Roundness is poor, hangover | Smooth, roundness is good | Smooth, roundness is good | ------ | ------- | Roundness is poor, hangover | Roundness is poor slightly, and hangover is arranged slightly |
| Drop pill hardness | ----------- | Hardness is better | Hardness is better | Hardness is better | -------- | --------- | Hardness is better | Hardness is better |
| The ball method of double differences is different | ----------- | 15％ | 6.0％ | 6.2％ | ---------- | ------------ | 25％ | 20％ |
| Dissolve scattered time limit (min) | ----- | 6～8 | 8～10 | 8～10 | ------ | ------- | 11～13 | 11～13 |
2, substrates quantity selects afore-mentioned test to determine with the substrate of Macrogol 4000 as this product, does not determine concrete consumption.The ball that substrates quantity directly has influence on this product heavily reaches dose, production cost etc.The substrate ratio is low excessively, and then the medicinal liquid flowability is bad, production equipment is required also high, can cause and drip that system difficulty, ball shape are poor, ball heavily differs greatly.The substrate ratio is excessive, then can cause production cost to increase, and causes the patient to take too much adjuvant.Thereby the ratio to substrate is further screened on the basis of afore-mentioned test, thereby determines optimal proportion.
Test method:, add the Macrogol 4000 of different proportion respectively with reference to above-mentioned result of the test, the powder of getting it filled, mixing is heated to 80-85 ℃, treat whole fusions after, observation medicinal liquid flowability is transferred in the reservoir, 70～80 ℃ of insulations, splash in the simethicone, drip apart from 4cm, drip 30～40 droplets/minute of speed, to the greatest extent and wipe simethicone the drop pill drop that forms, investigate the outward appearance and the weight differential of gained drop pill, result of the test sees Table 2
Table 2 substrates quantity is selected
| Medicated powder: substrate | The medicinal liquid flowability | The drop pill outward appearance | Theoretical ball heavy (mg) | The ball method of double differences is different |
| 1∶2.2 1∶2.5 1∶2.8 | The poor slightly flowability of flowability is better better mobile | Shaped degree is poor slightly, and it is smooth slightly to trail, and roundness is good smooth, and roundness is good | 44.8 49 53.2 | 11.2％ 6.5％ 6.3％ |
By result in the table as can be known, when the ratio of medicated powder and substrate was 1: 2.5, medicinal liquid was better mobile, the drop pill smooth in appearance, and roundness is good, different the meeting the requirements of the drop pill ball method of double differences, supplementary product consumption is less, is 1: 2.5 so select the ratio of medicated powder and substrate.
3. pill prescription is determined
According to above-mentioned result of study, this product substrate is defined as Macrogol 4000, and consumption is 2.5 times of medicated powder, because medicated powder is preparation in 10: 4 according to Flos Lonicerae extract and Radix Scutellariae extract ratio, this product prescription is defined as:
Flos Lonicerae extract 10g Radix Scutellariae extract 4g Macrogol 4000 35g makes 1000 balls
The most preferred prescription of the present invention forms and method for making is seen embodiment 1.
The present invention also provides the method for quality control of drop pill of the present invention, comprises the step of discriminating, inspection, assay, wherein: and the assay of chlorogenic acid in the Flos Lonicerae extract, use the HPLC method to measure the method for chlorogenic acid content.
Adopt the chlorogenic acid reference substance to be contrast, acetonitrile-0.4% phosphoric acid solution (13: 87) is a mobile phase; The detection wavelength is 327nm, and the HPLC method is measured chlorogenic acid contents in this product preparation, and repeatability, the response rate are good as a result, and RSD% is all less than 2%.
Concrete operations are as follows:
We adopt the HPLC method to measure chlorogenic acid contents in the Lonicera and scutellaria drip pill, and this method is easy, accurate, and is highly sensitive, but the inherent quality of better controlled preparation.Measure according to high performance liquid chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.4% phosphoric acid solution (13: 87) is a mobile phase; The detection wavelength is 327nm, and number of theoretical plate is pressed the chlorogenic acid peak and calculated, and should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, puts in the brown measuring bottle, adds 50% dissolve with methanol and make the solution that every 1ml contains 18ug, promptly gets (preserving below 10 ℃).
This product under the weight differential item is got in the preparation of need testing solution, and porphyrize is got 0.5g, and accurate the title decides, put in the tool plug conical flask, the accurate 50% methanol 20ml that adds claims to decide weight, supersound process (power 250W, frequency 40KHz) 30 minutes, put and be chilled to room temperature, claim to decide weight again, supply the weight that subtracts mistake with 50% methanol, shake up, filter, precision is measured subsequent filtrate 1ml, puts in the brown measuring bottle of 10ml, adds 50% methanol to scale, shake up, filter with microporous filter membrane (0.45 μ m), promptly.
Accurate reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Drop pill of the present invention has been carried out stability test, adopted to simulate commercially available back reserved sample observing under room temperature condition,, carried out 6 months by a definite date accelerated tests and the investigation that kept sample for a long time in 12 months the project and the method for three batch samples according to the quality standard draft specifies.The result shows that drop pill of the present invention is investigated under above-mentioned experimental condition, every index does not have significant change, has good stability.
Drop pill of the present invention is guaranteeing under the constant condition of clinical usage and consumption, overcome the defective of other agent, make outward appearance bright and clean, attractive in appearance, be easy to carry and take, disperse fast, good absorbing in oral cavity and gastrointestinal, the bioavailability height has overcome the problem of moisture absorption simultaneously, make preparation stabilization, side effect reduces.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
Prescription Flos Lonicerae extract 10g Radix Scutellariae extract 4g Macrogol 4000 35g makes 1000 balls
Method for making
Taking polyethylene glycol 4000 adds Flos Lonicerae extract, Radix Scutellariae extract, mixing, be heated to 80-85 ℃, treat whole fusions after, mechanical high-speed stirs 10min to evenly, be transferred in the reservoir, 70～80 ℃ of insulations splash in the refrigerative simethicone of gradient, drip apart from 3～6cm, drip 30～40 droplets/minute of speed, make 1000 balls, promptly with the drop pill drop that forms to the greatest extent and wipe simethicone.
Embodiment 2
Prescription Flos Lonicerae extract 7.5g Radix Scutellariae extract 3g Macrogol 4000 26g makes 1000 balls
Method for making
Taking polyethylene glycol 4000 adds Flos Lonicerae extract, Radix Scutellariae extract, mixing, be heated to 80-85 ℃, treat whole fusions after, mechanical high-speed stirs 10min to evenly, be transferred in the reservoir, 70～80 ℃ of insulations splash in the refrigerative simethicone of gradient, drip apart from 3～6cm, drip 30～40 droplets/minute of speed, make 1000 balls, promptly with the drop pill drop that forms to the greatest extent and wipe simethicone.
Embodiment 3
Prescription Flos Lonicerae extract 13.3g Radix Scutellariae extract 5.3g Macrogol 4000 47g makes 1000 balls
Method for making
Taking polyethylene glycol 4000 adds Flos Lonicerae extract, Radix Scutellariae extract, mixing, be heated to 80-85 ℃, treat whole fusions after, mechanical high-speed stirs 10min to evenly, be transferred in the reservoir, 70～80 ℃ of insulations splash in the refrigerative simethicone of gradient, drip apart from 3～6cm, drip 30～40 droplets/minute of speed, make 1000 balls, promptly with the drop pill drop that forms to the greatest extent and wipe simethicone.
Claims (9)
1, plant the Lonicera and scutellaria drip pill preparation, this drop pill is made by active constituents of medicine and excipient substance, and described active constituents of medicine is Flos Lonicerae extract and Radix Scutellariae extract.
2, the dropping pill formulation of claim 1 is characterized in that, this dropping pill formulation is by Flos Lonicerae extract 7.5-13.3g, Radix Scutellariae extract 3-5.3g, and Macrogol 4000 26-47g makes.
3, the dropping pill formulation of claim 1 is characterized in that, this dropping pill formulation is by Flos Lonicerae extract 10g, Radix Scutellariae extract 4g, and Macrogol 4000 35g makes.
4, the dropping pill formulation of claim 1 is characterized in that, by raw material of Chinese medicine is processed through extracting, making pharmaceutically active substance, subsequently, is raw material with this pharmaceutically active substance, add the medicine acceptable auxiliary, make dropping pill formulation according to the routine techniques of galenic pharmacy.
5, the dropping pill formulation of claim 3, it is characterized in that, described active substance is to obtain by extracting raw material of Chinese medicine respectively, or obtain by the co-extracted raw material of Chinese medicine, as by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain.
6, the dropping pill formulation of claim 4 is characterized in that, wherein said active substance is the material of extractum form.
7, the preparation method of the dropping pill formulation of claim 3: it is characterized in that,, add Flos Lonicerae extract, Radix Scutellariae extract through following steps taking polyethylene glycol 4000, mixing is heated to 80-85 ℃, treat whole fusions after, mechanical high-speed stirs 10min to evenly, is transferred in the reservoir 70～80 ℃ of insulations, splash in the refrigerative simethicone of gradient, drip apart from 3～6cm, drip 30～40 droplets/minute of speed, to the greatest extent and wipe simethicone the drop pill drop that forms, make 1000 balls, promptly.
8, the method for quality control of the dropping pill formulation of claim 6 is characterized in that, process following steps: the assay of product discriminating, product examination, product.
9, the method for quality control of claim 8 is characterized in that, wherein said assay process following steps:
Adopt the HPLC method to measure chlorogenic acid contents in the Lonicera and scutellaria drip pill,
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.4% phosphoric acid solution is a mobile phase; The detection wavelength is 327nm, and number of theoretical plate is pressed the chlorogenic acid peak and calculated, and should be not less than 3000;
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, puts in the brown measuring bottle, adds 50% dissolve with methanol and make the solution that every 1ml contains 18ug, promptly;
This product under the weight differential item is got in the preparation of need testing solution, and porphyrize is got 0.5g, and accurate the title decides, and puts in the tool plug conical flask, and the accurate 50% methanol 20ml that adds claims to decide weight, supersound process; 0 minute, put and be chilled to room temperature, claim again to decide weight, supply the weight that subtracts mistake with 50% methanol, shake up, filter, precision is measured subsequent filtrate 1ml, puts in the brown measuring bottle of 10ml, adds 50% methanol to scale, shakes up, and uses microporous filter membrane, mistake, promptly;
Accurate reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.The algoscopy precision is measured reference substance solution and each 3ml of need testing solution, put respectively in the 100ml measuring bottle, the accurate 0.3% Phen solution 2ml that adds, with the dissolving of acetic acid-sodium-acetate buffer and be diluted to scale, shake up, be blank with the reagent corresponding, according to spectrophotography, wavelength place at 509nm measures trap, calculates, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510114569 CN1768785A (en) | 2005-10-25 | 2005-10-25 | Honey suckle and scutellaria root pill and preparation thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510114569 CN1768785A (en) | 2005-10-25 | 2005-10-25 | Honey suckle and scutellaria root pill and preparation thereof |
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| CN1768785A true CN1768785A (en) | 2006-05-10 |
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| CN 200510114569 Pending CN1768785A (en) | 2005-10-25 | 2005-10-25 | Honey suckle and scutellaria root pill and preparation thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101293012B (en) * | 2008-06-20 | 2010-12-01 | 吉林省通化振国药业有限公司 | Antiviral honeysuckle flower Chinese medicine compound preparation and preparation technique |
| CN101744883B (en) * | 2008-12-19 | 2011-12-07 | 北京亚东生物制药有限公司 | Chinese medicinal composition preparation and preparation method thereof and quality control method |
| CN102746153A (en) * | 2012-07-10 | 2012-10-24 | 浙江维康药业有限公司 | Chlorogenic acid compound and pharmaceutical composition thereof |
| CN109223863A (en) * | 2018-10-26 | 2019-01-18 | 浙江维康药业股份有限公司 | A kind of stomach dissolution type Lonicera and scutellaria drip pill agent resistant to high temperature and preparation method thereof |
| CN109288804A (en) * | 2018-10-23 | 2019-02-01 | 浙江维康药业股份有限公司 | A kind of Lonicera and scutellaria drip pill and preparation method thereof with drug slow release function |
-
2005
- 2005-10-25 CN CN 200510114569 patent/CN1768785A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101293012B (en) * | 2008-06-20 | 2010-12-01 | 吉林省通化振国药业有限公司 | Antiviral honeysuckle flower Chinese medicine compound preparation and preparation technique |
| CN101744883B (en) * | 2008-12-19 | 2011-12-07 | 北京亚东生物制药有限公司 | Chinese medicinal composition preparation and preparation method thereof and quality control method |
| CN102746153A (en) * | 2012-07-10 | 2012-10-24 | 浙江维康药业有限公司 | Chlorogenic acid compound and pharmaceutical composition thereof |
| CN102746153B (en) * | 2012-07-10 | 2013-04-17 | 浙江维康药业有限公司 | Chlorogenic acid compound and pharmaceutical composition thereof |
| CN109288804A (en) * | 2018-10-23 | 2019-02-01 | 浙江维康药业股份有限公司 | A kind of Lonicera and scutellaria drip pill and preparation method thereof with drug slow release function |
| CN109288804B (en) * | 2018-10-23 | 2020-12-29 | 浙江维康药业股份有限公司 | A dripping pill containing flos Lonicerae and Scutellariae radix with sustained release effect, and its preparation method |
| CN109223863A (en) * | 2018-10-26 | 2019-01-18 | 浙江维康药业股份有限公司 | A kind of stomach dissolution type Lonicera and scutellaria drip pill agent resistant to high temperature and preparation method thereof |
| CN109223863B (en) * | 2018-10-26 | 2021-10-12 | 浙江维康药业股份有限公司 | High-temperature-resistant stomach-soluble type honeysuckle and scutellaria baicalensis dropping pill and preparation method thereof |
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Open date: 20060510 |