CN100473394C - Compound preparation of baikal skullcap root - Google Patents
Compound preparation of baikal skullcap root Download PDFInfo
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- CN100473394C CN100473394C CNB2005100341581A CN200510034158A CN100473394C CN 100473394 C CN100473394 C CN 100473394C CN B2005100341581 A CNB2005100341581 A CN B2005100341581A CN 200510034158 A CN200510034158 A CN 200510034158A CN 100473394 C CN100473394 C CN 100473394C
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Abstract
Disclosed is a compound preparation of baikal skullcap root for treating throat pains, which is prepared from baikal skullcap root, giant knotweed rhizome, creat and Chinese mahonia. The preparation employs a sectionalized extraction method, which takes the mutual actions between the main pharmaceutical ingredients into consideration. The preparation has the advantages of high scutellaria root glycosides content, quick dissolving rate, and high biological availability, it can be used for treating herpes zoster.
Description
Technical field:
The present invention relates to the field of Chinese medicines, be specifically related to a kind of preparation of baikal skullcap root and preparation method that is used for laryngopharynx swelling and pain.
Background of invention:
The compound Radix Scutellariae sheet is by being made up of Radix Scutellariae, Rhizoma Polygoni Cuspidati, Herba Andrographis, Mahonia fortunei (Lindl.) Fedde etc., and compound Radix Scutellariae coated tablet dosage form is recorded in 18 in Chinese traditional patent formulation preparation, has heat-clearing and toxic substances removing, removing heat from blood repercussive function.Be used for laryngopharynx swelling and pain, aphtha of the mouth and tongue, cold, fever, damp-heat in the large intestine is had loose bowels, the puckery pain of pyretic stranguria, the carbuncle skin infection.Not clear and definite its prescription and method for making in the existing compound Radix Scutellariae sheet standard do not have content control project, are unfavorable for controlling the compound Radix Scutellariae tablet quality.
Monarch drug in the Radix Scutellariae side of being, baicalin are the main components of baikal skullcap root, have pharmacological actions such as anti-inflammation, antihypertensive diuretic, analgesic, antiviral, function of gallbladder promoting spasmolytic.The water solublity of Radix Scutellariae and stability are not good, are easy to destroy in alkaline environment, as not adopting suitable extracting method and pharmaceutical adjunct, will be difficult to guarantee effective ingredient content of baicalin in the preparation.
Mahonia fortunei (Lindl.) Fedde is dry stem or leaf or the root of Berberidaceae plant Mahonia bealei (Fort.) Carr. Mahonia bealei (Fort.) Carr. or mahonia fortuneiFedde Mahonia fortunei (Lindl.) Fedde.Be used for damp-heat dysentery, jaundice, conjunctival congestion and swelling pain, toothache due to stomach-fire, furuncle, carbuncle, dysentery more; Icterohepatitis.Existing oneself extraction separation from the Mahonia fortunei (Lindl.) Fedde platymiscium goes out tens kinds of alkaloids, as oxyacanthine, berberine, isosinomenine, berbamine, jateorhizine, palmatine, columbamine etc.More these alkaloids have and have anticancer, antiinflammatory, physiologically active widely such as anti-staphylococcus aureus, bacillus pyocyaneus and analgesia, blood pressure lowering.
Herpes zoster (herpes zoster) is the acute inflammation dermatoses that is caused by varicella zoster virus.Its main feature is for bunch catchmenting bubble, along the zonal distribution of trooping of side peripheral nerve do, with obvious neuralgia.Primary infection shows as chickenpox, and virus can be hidden for a long time at the spinal cord posterior root ganglion later on, and immunologic function weakens can bring out varicella zoster virus activity once again, and growth and breeding involves skin along peripheral nerve, and herpes zoster takes place.Existing various chemotherapys are not satisfactory.
Summary of the invention:
The invention discloses a kind of prescription proportioning of compound Radix Scutellariae tablet raw material; and in conjunction with the interactional characteristics of effective medicinal part of each medical material; simple and reliable extract respectively is provided; add the formulation method of suitable adjuvant protection baicalin; purpose is to provide a kind of compound preparation of baikal skullcap root and preparation method that improves drug effect; it has the advantages that effective ingredient content height, baicalin are stable, human bioavailability is high; can improve curative effect in the absorption by human body utilization by improving medicine, and herpes zoster is had therapeutical effect.
The present invention specifically passes through the selection to the physical behavior of medicinal substances extract, as determining of thick paste relative density, medicine dried cream powder smashing fineness, and drop pill adjuvant, drop pill ratio of adjuvant, drop pill dripped the selection of system condition, drop pill coating conditions, determine the production method of compound Radix Scutellariae drop pill; By the kind of soft capsule disperse medium, suspending agent, emulsifying agent, antiseptic etc., the selection of consumption have been realized the production of compound Radix Scutellariae soft capsule; By to the determining of dispersible tablet supplementary product kind, consumption, dispersible tablet preparation technology, realized the production of compound Radix Scutellariae dispersible tablet.The preparation method of other peroral dosage forms is disclosed in addition.
The present invention takes following design:
1:1:1:1 such as Radix Scutellariae, Rhizoma Polygoni Cuspidati, Herba Andrographis, Mahonia fortunei (Lindl.) Fedde etc. by weight cooperate, and are preferably: Radix Scutellariae 400g～1500g, Rhizoma Polygoni Cuspidati 400g～1500g,
Herba Andrographis 400g～1500g, Mahonia fortunei (Lindl.) Fedde 400g～1500g
Make oral formulations, it makes total amount is 250 preparation units or its integral multiple.
More preferably: Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Make oral formulations such as dispersible tablet, effervescent tablet, drop pill, soft capsule, tablet, granule, capsule, it makes total amount is 250 preparation units or its integral multiple.
Above-mentioned medical material adopts the method for extract respectively, is respectively:
Radix Scutellariae decocts with water secondary, and 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction filtered, and filtrate is concentrated in right amount, and drying gets dry extract.
Get Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde merit and decoct with water secondary, each 1～3 hour, collecting decoction filtered, and filtrate is concentrated in right amount, and drying gets dry extract.
Above-mentioned two kinds of dry extracts merge, pulverize, and cooperate suitable adjuvant, make oral formulations such as dispersible tablet, effervescent tablet, drop pill, soft capsule, tablet, granule, capsule.
Or two groups of extracts cooperate adjuvant to make dry extract respectively, and then combination system becomes oral formulations such as dispersible tablet, effervescent tablet, drop pill, soft capsule, tablet, granule, capsule.
For example: described dispersible tablet can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1～3 hour, collecting decoction filtered, filtrate is concentrated in right amount, drying adds the Radix Scutellariae dry extract and is medicinal substances extract, with filler, disintegrating agent mixing granulation, dry, add disintegrating agent, lubricant, mixing, tabletting, promptly get dispersible tablet, or the coated compound preparation of baikal skullcap root of making---coated dispersing tablet.
The disintegrating agents of dispersible tablets can be preferably and be crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium one or more;
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone; Or the best is 90% a alcoholic solution of 4.5%～15% polyvinylpyrrolidone;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci or sodium lauryl sulphate etc.;
Filler is: starch, precoking starch, microcrystalline Cellulose, lactose etc. are excellent to select precoking starch proportioning lactose;
Used filler loading is 60～420g, and the disintegrating agent consumption is that 5～50g, lubricant quantity are 0.5～12g, or filler loading is preferably 165g, and disintegrating agent is with being 42g, and lubricant quantity is 5g.
Described effervescent tablet can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction, filter, filtrate is concentrated in right amount, and drying adds the Radix Scutellariae dry extract, be medicinal substances extract,, add disintegrating agent, lubricant with filler, effervescent acid-base pair mixing granulation, mixing, tabletting promptly gets effervescent tablet.
Described drop pill can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1～3 hour, collecting decoction filters, and filtrate is concentrated in right amount, drying adds the Radix Scutellariae dry extract, is medicinal substances extract, with drop pill substrate mix homogeneously, splash into molding in the coolant, promptly get compound preparation of baikal skullcap root---drop pill.
Substrate in its drop pill is that molecular weight is cured by 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, worm, carboxymethyl starch sodium one or more.Drop pill matrix optimization usage ratio is the polyethylene glycol 6000 of 30:1:0.5: poloxamer: the mixed-matrix of carboxymethyl starch sodium.
Described soft capsule can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction, filter, filtrate is concentrated in right amount, and drying adds the Radix Scutellariae dry extract, be medicinal substances extract, with disperse medium, suspending agent, antiseptic, one or more mix homogeneously of surfactant, suppress or drip and make soft capsule, promptly get compound preparation of baikal skullcap root---soft capsule.
Disperse medium is the oiliness disperse medium in the soft capsule: olive oil or other crude vegetals, as soybean oil or Oleum Arachidis hypogaeae semen, or triglyceride oils, or oleic acid sorbitol ester, or olein: propylene glycol, or Oleum Cocois C8/C10 monoglyceride, or dibasic acid esters or Oleum Cocois C8/C10 propylene glycol ester, or Oleum Cocois triglyceride or the acetylizad monoglyceride of purification, or olein or glyceryl linoleate, or one or more of Polyethylene Glycol glyceryl laurate ester or purification Oleum helianthi monoglyceride etc., or the best Oleum Cocois that uses: olein 9:1;
The suspending agent of its soft capsule is for increasing the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose etc.;
The emulsifying agent of its soft capsule is: medicinal surfactants such as soybean lecithin, Tween 80;
The antiseptic of its soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Described tablet can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction, filter, filtrate is concentrated in right amount, and drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverize mixing, system granule, compacting is in blocks, or coated again, promptly gets compound preparation of baikal skullcap root---tablet.
Described capsule can be made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1～3 hour, collecting decoction filters, and filtrate is concentrated in right amount, drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverizes, mixing, filled capsules promptly gets compound preparation of baikal skullcap root---capsule; Or medicinal substances extract and auxiliary materials and mixing, granulation, drying, filled capsules promptly gets compound preparation of baikal skullcap root---capsule.
Described granule is made like this:
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1～3 hour, collecting decoction filters, and filtrate is concentrated in right amount, drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverizes, mixing, the system granule promptly gets compound preparation of baikal skullcap root---granule.
Owing to adopted extract respectively among the present invention, considered protective measure during preparation again to unsettled baicalin, the compound preparation of baikal skullcap root by the present invention makes can detect content of baicalin, and has worked out detection method, to control this product quality.
Effect of the present invention:
Compound Radix Scutellariae sheet treatment herpes zoster observation of curative effect
Purpose: checking compound Radix Scutellariae sheet shortens the herpes zoster course of disease, improves the effect of therapeutic effect.
1, data and method
1.1 physical data: treatment group and matched group patient have and random packet.
Treatment group: 60 examples, male 32 examples, women 28 examples, 18 ~ 30 years old age, 6 examples, 30 ~ 40 years old, 8 examples, 40 ~ 50 years old, 22 examples, 50 ~ 60 years old 18 example, 60 years old example more than 6.Dermexanthesis is to 2 ~ 7 days 35 examples of consultation time, 7 ~ 10 days 10 examples, 10 ~ 14 days 8 examples, 7 examples more than 14 days.Neural cranial nerve 13 examples of getting involved, cervical nerves 7 examples, 35 intercostal nerves examples, lumbar nerves 4 examples, sacral nerves 1 example.Wherein herpes zoster generalisatus 2 examples contain a routine lunger.4 examples due to illness journey length have infection and form fester.Matched group 56 examples, male 27 examples, women 29 examples, age, 21 ~ 30 years old 4 example.30 ~ 40 years old 7 examples.40 ~ 50 years old 19 examples, 50 ~ 60 years old 20 example, 6 examples more than 60 years old.Dermexanthesis is to consultation time, 1 ~ 7 day 26 example, 7 ~ 10 days 15 examples, 10 ~ 14 days 10 examples, 5 examples more than 14 days.Get involved nerve, cranial nerve 14 examples, cervical nerves 6 examples, intercostal nerves 25 examples, lumbar nerves 9 examples, sciatic nerve 1 example, sacral nerves 1 example.Herpes zoster generalisatus 1 example wherein.3 examples have infection and ulcer.All patients all have typical clinical manifestation, and neuralgia is in various degree arranged before the dermexanthesis, and weak point person's pain is dermexanthesis elder pain dermexanthesis after 7 days after 2 days.
1.2 Therapeutic Method:
The treatment group: give the oral administered compound scutellaria tablet, (Guangdong LuoFoshan Medicine Co., Ltd provides) a time 4,3/d, vitamin E 0.1g, 3/d, the 4 examples the infected of occurring together gives levofloxacin 0.3g, 1/d quiet time totally 7 days.Matched group: give virazole 500mg and add quiet of 5% glucose or 0.9% sodium chloride injection, 1 time/d.The identical use of vitamin E, the 3 examples the infected of occurring together gives levofloxacin too.
1.3 curative effect index
1. end the bleb time, from stopping the calculation of blistering.
2. form a scab the time, the water crust is all done chronic incrustation.
3. analgesic time, pain obviously alleviates or disappears.
4. the course of disease plays the incrustation of pain disappearance erythra from treatment and comes off, and fully recovers the used time.
2 results
Use compound Radix Scutellariae glycosides treatment herpes zoster than obviously shortening with virazole course of disease natural law.
Efficacy analysis sees Table 1.
Table 1 efficacy analysis
| Group | The example number | End the bleb time | The incrustation time | Analgesic time | The course of disease |
| The treatment group | 60 | 3.33±0.59 | 5.63±2.02 | 6.10±0.88 | 8.21±0.95 |
| Matched group | 56 | 4.84±0.71 | 8.43±0.87 | 11.54±0.77 | 13.42±1.27 |
| t | 12.58 | 9.66 | 36.27 | 24.81 | |
| P | <0.01 | <0.01 | <0.012 | <0.01 |
Last table show treatment group and matched group comparison end bleb incrustation, pain relieving and the whole course of disease on the time significantly between the shortening group every relatively t check and be respectively 12.58 9.66 36.27,24.81, P all＜0.01, illustrate that two groups of difference have highly significant meaning proof compound Radix Scutellariae sheet treatment herpes zoster curative effect obvious, all do not find untoward reaction simultaneously in therapeutic process.
Conclusion:
Herpes zoster is by the viral dermatosis due to the varicella zoster virus.The traditional Chinese medical science is referred to as herpes zoster, herpes zoster.And think because the depression of liver-QI fire-transformation.Spleen channel retention of damp-heat in the interior, excessive skin and give birth to or the malicious heresy of diseases caused by exogenous pathogenic factor, damp and hot fire-toxin are accumulate long-pending skin and caused.Its clinical primary symptom: erythra, pain.Doctor trained in Western medicine is a principle with antiviral, pain relieving, trophic nerve.The traditional Chinese medical science is based on heat clearing away, detoxifcation, pain relieving.
The known effective ingredient of compound Radix Scutellariae sheet is baicalin, berberine, isosinomenine, andrographolide etc., and heat clearing away, antiinflammatory, antiviral, analgesic effect are arranged.Find by two kinds of Drug therapy paired observations that the compound Radix Scutellariae sheets end in bleb, incrustation, pain relieving and the whole course of disease when the treatment herpes zoster and obviously be better than virazole, (P＜0.01), and have no adverse reaction and be adapted to different crowd.
Two of effect of the present invention:
Do not add the comparison of baicalin protectant compound Radix Scutellariae sheet content and dissolution
Baicalin is one of main pharmacodynamics composition in the compound Radix Scutellariae sheet, for guaranteeing that baicalin is not subjected to the influence of other alkaline components of prescription, add suitable HP-β-CD (hydroxypropyl doubly reaches cyclodextrin), this The effects different auxiliary material addition is to the influence of content of baicalin and release.
1, baicalin detects wavelength 274nm.
2, precision takes by weighing baicalin reference substance 10mg, add the water standardize solution in the measuring bottle of 50ml, precision takes by weighing 0.1,0.5 respectively, 1.02.0,2.5,5.0ml be in the 25ml measuring bottle, measure trap at the 274nm place, with trap baicalin concentration being made dependent linearity returns, get regression equation, C=16.644A-0.271 (R=0.9998).
3, sample preparation:
No. 1 tablet: the baicalin extract respectively does not add hydroxypropyl and doubly reaches cyclodextrin inclusion compound, not with disintegrating agent.
No. 2 tablets: the baicalin extract respectively adds radix scutellariae medicinal materials 1/20 hydroxypropyl and doubly reaches cyclodextrin inclusion compound, not with disintegrating agent.
No. 3 tablets: the baicalin extract respectively adds radix scutellariae medicinal materials 1/20 hydroxypropyl and doubly reaches cyclodextrin inclusion compound, with disintegrating agent.
Above sample all supplies after at least 6 months to detect with room temperature preservation.
4, trap is measured:
Get 10 in each sample, porphyrize, precision takes by weighing 0.5g, places the stripping rotor of 1000ml, and under 37 ℃ of conditions, rotating speed 150r/min stirred 6 hours down, and trap is measured in sampling, calculates content of baicalin, as 100% stripping quantity.
Other gets 10 in each sample, porphyrize, and precision takes by weighing 0.5g, places the stripping rotor of 1000ml, under 37 ℃ of conditions, adopts Chinese Pharmacopoeia to change the operation of basket method, in 60,120,180,240, the 360min sampling, measures concentration, calculates the stripping percentage rate.
Method is measured dissolution, and the result is as follows:
| Test piece | 60min | 120min | 180min | 240min | 300min | 360min | 100% stripping quantity |
| No. 1 | 8.5±2.0 | 24±14 | 44±12 | 58±14 | 67±16 | 72±20 | 31mg |
| No. 2 | 55±7.0 | 65±10 | 78±7.0 | 88±12 | 91±4.0 | 95±5.0 | 38mg |
| No. 3 | 75±10 | 88±7.0 | 92±12 | 96±4.0 | 99±1.0 | 99±1.0 | 42mg |
5, add that hydroxypropyl doubly reaches cyclodextrin and disintegrating agent (polyvinylpyrrolidone) can significantly improve the content of baicalin in storage, quicken the medicine stripping.
The specific embodiment:
Embodiment 1: the compound Radix Scutellariae dispersible tablet
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Filler: lactose 52.5g
Precoking starch 95g
Mannitol 17.5g
Disintegrating agent: crospolyvinylpyrrolidone 21g
Carboxymethyl starch sodium 21g
Lubricant: micropowder silica gel 5g;
Binding agent: 85% alcoholic solution of 8% polyvinylpyrrolidone
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1 hour, collecting decoction filtered, filtrate is concentrated in right amount, drying adds the Radix Scutellariae dry extract and is medicinal substances extract, with above-mentioned filler, disintegrating agent mixing granulation, dry, add disintegrating agent, lubricant, mixing, tabletting, promptly get dispersible tablet, or the coated compound preparation of baikal skullcap root of making---coated dispersing tablet.
Embodiment 2: the compound Radix Scutellariae dispersible tablet
Radix Scutellariae 1500g, Rhizoma Polygoni Cuspidati 1500g,
Herba Andrographis 1500g, Mahonia fortunei (Lindl.) Fedde 1500g
Filler: lactose 150g
Precoking starch 120g
Mannitol 150g
Disintegrating agent: crospolyvinylpyrrolidone 25g
Carboxymethyl starch sodium 25g
Lubricant: micropowder silica gel 12g;
Binding agent: 85% alcoholic solution of 8% polyvinylpyrrolidone
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 2 hours, collecting decoction filtered, filtrate is concentrated in right amount, drying adds the Radix Scutellariae dry extract and is medicinal substances extract, with above-mentioned filler, disintegrating agent mixing granulation, dry, add disintegrating agent, lubricant, mixing, tabletting, promptly get dispersible tablet, or the coated compound preparation of baikal skullcap root of making---coated dispersing tablet.
Embodiment 3: the compound Radix Scutellariae dispersible tablet
Radix Scutellariae 400g, Rhizoma Polygoni Cuspidati 400g,
Herba Andrographis 400g, Mahonia fortunei (Lindl.) Fedde 400g
Filler: lactose 20g
Precoking starch 30g
Mannitol 10g
HYDROXYPROPYL BETA-CYCLODEXTRIN 20g
Disintegrating agent: crospolyvinylpyrrolidone 4g
Carboxymethyl starch sodium 1g
Lubricant: micropowder silica gel 0.5g;
Binding agent: 85% alcoholic solution of 8% polyvinylpyrrolidone
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, add HYDROXYPROPYL BETA-CYCLODEXTRIN, spray drying gets the Radix Scutellariae extract dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 3 hours, collecting decoction, filter, filtrate is concentrated in right amount, drying, add the Radix Scutellariae extract dry extract, with above-mentioned filler, disintegrating agent mixing granulation, drying, add disintegrating agent, lubricant, mixing, tabletting promptly gets dispersible tablet, or the coated compound preparation of baikal skullcap root of making---coated dispersing tablet.
Illustrate: Radix Scutellariae extract adds the HYDROXYPROPYL BETA-CYCLODEXTRIN of medical material 1/20 consumption, and final preparation content of baicalin, stability are significantly improved, and adds the use of above-mentioned disintegrating agent, has accelerated the dissolution rate of baicalin.Embodiment 4: the compound Radix Scutellariae effervescent tablet
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Filler: lactose 30g
Mannitol 30g
Precoking starch 10g
Microcrystalline Cellulose 10g
Effervescent: sodium bicarbonate 45g
Tartaric acid 25g
Citric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 20g
Carboxymethyl starch sodium 10g
Lubricant: magnesium stearate 4g
Correctives: aspartame 0.5g
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 2 hours, collecting decoction, filter, filtrate is concentrated in right amount, and drying adds the Radix Scutellariae dry extract, be medicinal substances extract,, add disintegrating agent, lubricant with filler, effervescent acid-base pair mixing granulation, mixing, tabletting promptly gets effervescent tablet.
Embodiment 5: the compound Radix Scutellariae effervescent tablet
Radix Scutellariae 1500g, Rhizoma Polygoni Cuspidati 1500g,
Herba Andrographis 1500g, Mahonia fortunei (Lindl.) Fedde 1500g
Filler: lactose 45g
Mannitol 45g
Precoking starch 10g
Microcrystalline Cellulose 10g
Effervescent: sodium bicarbonate 45g
Tartaric acid 25g
Citric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 20g
Carboxymethyl starch sodium 10g
Lubricant: magnesium stearate 4g
Correctives: aspartame 0.5g
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, adds HYDROXYPROPYL BETA-CYCLODEXTRIN, spray drying, get the Radix Scutellariae extract dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 2.5 hours, collecting decoction filters, and filtrate is concentrated in right amount, drying, add the Radix Scutellariae extract dry extract,, add disintegrating agent, lubricant with filler, effervescent acid-base pair mixing granulation, mixing, tabletting promptly gets effervescent tablet;
Embodiment 6: the compound Radix Scutellariae effervescent tablet
Radix Scutellariae 400g, Rhizoma Polygoni Cuspidati 400g,
Herba Andrographis 400g, Mahonia fortunei (Lindl.) Fedde 400g
Filler: lactose 45g
Mannitol 45g
Precoking starch 10g
Microcrystalline Cellulose 10g
Effervescent: sodium bicarbonate 45g
Tartaric acid 25g
Citric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 20g
Carboxymethyl starch sodium 10g
Lubricant: magnesium stearate 4g
Correctives: aspartame 0.5g
Make 1000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated in right amount, adds HYDROXYPROPYL BETA-CYCLODEXTRIN, and spray drying gets the Radix Scutellariae extract dry extract, and is standby;
Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 2.5 hours, collecting decoction filtered, and filtrate is concentrated in right amount, and drying is standby;
Lactose, mannitol, tartaric acid, citric acid etc., crospolyvinylpyrrolidone are one group and make acid particles; All the other extracts and adjuvant are made alkali grain, mix, and tabletting promptly gets effervescent tablet.
Illustrate: Radix Scutellariae extract adds the HYDROXYPROPYL BETA-CYCLODEXTRIN of medical material 1/20 consumption, can make final preparation content of baicalin, have more the Acidity of Aikalinity of effervescent, baicalin and acid effervescent are one group make granule, helping baicalin stability significantly improves, add the use of above-mentioned disintegrating agent, effervescent, accelerated the dissolution rate of baicalin.
Embodiment 7: the compound Radix Scutellariae drop pill
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Polyethylene glycol 6000 180g
Poloxamer 6g
Carboxymethyl starch sodium 3g
Make 3000
Get Radix Scutellariae and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 2 hours, collecting decoction, filter, filtrate is concentrated in right amount, drying, add the Radix Scutellariae dry extract, be medicinal substances extract;
Taking polyethylene glycol 85 ℃ of following heating and melting, adds medicinal substances extract, other adjuvants of base, and mix homogeneously is incubated under 60 ℃ of conditions, and mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets drop pill, or coated again technology is made coated drop pill; Promptly.
The mixture that keeps medicinal substances extract and substrate when dripping system is in 80～90 ℃, 75 centimetres of cooling column effective column lengths, and 8 ℃ of liquid coolants are dripped 55 on fast every part of clock, dropper mouth external diameter 2.5mm, internal diameter 2.0mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Embodiment 8: the compound Radix Scutellariae drop pill
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
HYDROXYPROPYL BETA-CYCLODEXTRIN 30g
Macrogol 4000 20g
Polyethylene glycol 6000 70g
Poloxamer 3g
Polyvinylpyrrolidone 1.5g
Make 3000
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated in right amount, adds HYDROXYPROPYL BETA-CYCLODEXTRIN, and spray drying gets the Radix Scutellariae extract dry extract, and is standby;
Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction filtered, and filtrate is concentrated in right amount, and drying is standby;
Taking polyethylene glycol 95 ℃ of following heating and melting, adds above-mentioned two kinds of medicinal substances extracts, and other adjuvants, mix homogeneously is incubated under 60 ℃ of conditions, and mix homogeneously splashes into molding in the coolant, remove coolant, promptly get drop pill, or coated again technology is made coated drop pill; Promptly.
Coolant is a dimethicone, or liquid paraffin, or Oleum Camelliae, or one or more of vegetable oil etc., or the best is a component weight proportion methyl-silicone oil: liquid paraffin (7:4).
Coating solution is made by following proportioning:
Polyvinylpyrrolidone 20g
Diethyl phthalate 6g
Hydroxypropyl methylcellulose 5g
90% alcoholic solution 200ml
Pulvis Talci 6g
Magnesium stearate 2g
Titanium dioxide 4g
Polyethylene glycol 6000 4g
Pigment 1g
Illustrate: Radix Scutellariae extract adds the HYDROXYPROPYL BETA-CYCLODEXTRIN of medical material 1/50 consumption, can make final preparation content of baicalin stable, and a small amount of polyvinylpyrrolidone is effectively in the release of baicalin.
Embodiment 9: the compound Radix Scutellariae preparation of soft capsule:
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Disperse medium: olive oil 135g;
Suspending agent: second class cellulose 10g;
Emulsifying agent: liquid egg phosphatidase 11 0g;
Antiseptic: propyl p-hydroxybenzoate 0.2g;
Make 500
I) medicinal substances extract preparation: get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction, filter, filtrate is concentrated in right amount, drying, add the Radix Scutellariae dry extract, be medicinal substances extract;
Ii) modulate capsule liquid: get mixture, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Iii) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
Iv) make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.Embodiment 10 compound Radix Scutellariae preparation of soft capsule:
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Disperse medium: Oleum Cocois: 180g
Acid glyceride 20g;
Suspending agent: Cera Flava 18g
Carbomer 2g;
Emulsifying agent: liquid egg phosphatidase 11 0g;
Antiseptic: propyl p-hydroxybenzoate 0.2g;
Baicalin protective agent: HYDROXYPROPYL BETA-CYCLODEXTRIN 34g
Make 500
I) medicinal substances extract preparation: get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, add HYDROXYPROPYL BETA-CYCLODEXTRIN, spray drying gets the Radix Scutellariae extract dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 3 hours, collecting decoction filters, and filtrate is concentrated in right amount, drying adds the Radix Scutellariae extract dry extract, is medicinal substances extract;
Ii) modulate capsule liquid: get mixture, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Iii) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
Iv) make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.Softgel shell is by gelatin 39.5%, water 36%, and glycerol 24%, antiseptic 0.35%, pigment 0.15% forms
Illustrate: through multiple substrate contrast, it is stable that a small amount of olein helps baicalin.
Embodiment 11: the compound Radix Scutellariae preparation of soft capsule:
Radix Scutellariae 950g, Rhizoma Polygoni Cuspidati 950g,
Herba Andrographis 950g, Mahonia fortunei (Lindl.) Fedde 950g
Disperse medium: Oleum Cocois: olein (9:1) 145g;
Suspending agent: aluminum monostearate 20g;
Emulsifying agent: liquid egg phosphatidase 11 0g;
Antiseptic: propyl p-hydroxybenzoate 2g;
Make 500
I) medicinal substances extract preparation: get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 is little for the second time
The time, collecting decoction filters, filtrate is concentrated in right amount, drying must dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and
Mahonia fortunei (Lindl.) Fedde decocts with water secondary, and each 1～3 hour, collecting decoction filtered, and filtrate is concentrated in right amount, does
Dry, add the Radix Scutellariae dry extract, be medicinal substances extract;
Ii) modulate capsule liquid: get mixture, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Iii) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
Iv) make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Embodiment 12: the capsular preparation of compound Radix Scutellariae:
Radix Scutellariae 850g, Rhizoma Polygoni Cuspidati 850g,
Herba Andrographis 850g, Mahonia fortunei (Lindl.) Fedde 850g
Beta-schardinger dextrin-: 20g
Dextrin: 60g
Lactose 100g
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated in right amount, adds beta-schardinger dextrin-, spray drying, get dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 2 hours, collecting decoction filters, and filtrate is concentrated in right amount, drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverizes, mixing, filled capsules promptly gets compound preparation of baikal skullcap root---capsule; Or medicinal substances extract and auxiliary materials and mixing, granulation, drying, filled capsules promptly gets compound preparation of baikal skullcap root---capsule.Embodiment 13: the capsular preparation of compound Radix Scutellariae:
Radix Scutellariae 850g, Rhizoma Polygoni Cuspidati 850g,
Herba Andrographis 850g, Mahonia fortunei (Lindl.) Fedde 850g
Beta-schardinger dextrin-: 100g
Get Radix Scutellariae and decoct with water secondary, 2 hours for the first time, 0.5 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, adds beta-schardinger dextrin-30g, spray drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1 hour, collecting decoction, filter, be concentrated in right amount, add beta-schardinger dextrin-70g, spray drying with preceding described Radix Scutellariae extract fine powder mixing, filled capsules, promptly gets compound preparation of baikal skullcap root---capsule.
Execute the preparation of example 13 compound Radix Scutellariae sheets:
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Filler: lactose 55g
Precoking starch 75g
Mannitol 15g
Lubricant: micropowder silica gel 5g;
Binding agent: 85% alcoholic solution
Make 1000
Get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, and each 1～3 hour, collecting decoction, filter, filtrate is concentrated in right amount, and drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverize mixing, system granule, compacting is in blocks, or coated again, promptly gets compound preparation of baikal skullcap root---tablet.
Coating is made by following proportioning:
Polyvinylpyrrolidone 24g
Diethyl phthalate 5g
Hydroxypropyl methylcellulose 7g
90% alcoholic solution 200ml
Pulvis Talci 6g
Magnesium stearate 2g
Titanium dioxide 3g
Polyethylene glycol 6000 6g
Pigment 1g
Embodiment 14: the particulate preparation of compound Radix Scutellariae:
Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g,
Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g
Filler: lactose 75g
Precoking starch 75g
Disintegrating agent: crospolyvinylpyrrolidone 21g
Binding agent: 75% alcoholic solution of 11% polyvinylpyrrolidone
Make 500 bags
Get Radix Scutellariae and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction, filter, filtrate is concentrated in right amount, and drying gets dry extract, standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 3 hours, collecting decoction filters, and filtrate is concentrated in right amount, drying adds Radix Scutellariae dry extract and appropriate amount of auxiliary materials, pulverizes, mixing, the system granule promptly gets compound preparation of baikal skullcap root---granule.
Claims (4)
1. compound preparation of baikal skullcap root is characterized in that used medical material weight proportion is:
Radix Scutellariae: Rhizoma Polygoni Cuspidati: Herba Andrographis: Mahonia fortunei (Lindl.) Fedde is 1:1:1:1, and every flavor medical material consumption is 800g, and described medical material is through extracting, and makes 1000 in tablet with suitable pharmaceutically alleged adjuvant.
2. a kind of compound preparation of baikal skullcap root according to claim 1 is characterized in that:
(1) used medical material proportioning is: Radix Scutellariae 800g, Rhizoma Polygoni Cuspidati 800g, Herba Andrographis 800g, Mahonia fortunei (Lindl.) Fedde 800g;
(2) get Radix Scutellariae and decoct with water secondary, 1～3 hour for the first time, 0.5～2 hour for the second time, collecting decoction filters, and filtrate is concentrated in right amount, drying gets dry extract, and is standby, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde decoct with water secondary, each 1～3 hour, collecting decoction filtered, filtrate is concentrated in right amount, drying adds the Radix Scutellariae dry extract and is medicinal substances extract, with filler, disintegrating agent mixing granulation, dry, add disintegrating agent, lubricant, mixing, tabletting, promptly get dispersible tablet, or the coated compound preparation of baikal skullcap root coated dispersing tablet of making.
3. a kind of compound preparation of baikal skullcap root according to claim 2 is characterized in that: disintegrating agent is one or more of crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium.
4. compound preparation of baikal skullcap root as claimed in claim 2 is characterized in that: after Radix Scutellariae filtrate was concentrated in right amount, the twentieth hydroxypropyl of adding radix scutellariae medicinal materials doubly reached cyclodextrin and carries out enclose, and drying gets dry extract.
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| CN106234478A (en) * | 2016-07-22 | 2016-12-21 | 广西素安生态农业有限公司 | A kind of Fructus Musae yellowtop herbal control agent and preparation method thereof |
| CN107184651B (en) * | 2017-06-12 | 2021-02-23 | 南京市中西医结合医院 | Traditional Chinese medicine composition for clearing away heat and toxic materials and preparation method and application thereof |
| CN112569281B (en) * | 2020-12-26 | 2022-02-08 | 迪沙药业集团有限公司 | Yiqing composition and preparation method thereof |
| CN116098936A (en) * | 2023-03-14 | 2023-05-12 | 肇庆星湖制药有限公司 | Compound baical skullcap root sustained-release tablet and preparation method thereof |
| CN116350683A (en) * | 2023-03-14 | 2023-06-30 | 肇庆星湖制药有限公司 | Compound Baical skullcap root film coated tablet and preparation method thereof |
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Non-Patent Citations (4)
| Title |
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| 复方黄芩片真伪鉴别. 黄文峰，林瑞群.时珍国医国药，第11卷第3期. 2000 |
| 复方黄芩片真伪鉴别. 黄文峰，林瑞群.时珍国医国药，第11卷第3期. 2000 * |
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