CN101904883A - Antiphlogistic capsule used for treating acute and chronic infectious diseases and preparation method thereof - Google Patents
Antiphlogistic capsule used for treating acute and chronic infectious diseases and preparation method thereof Download PDFInfo
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- CN101904883A CN101904883A CN2010101801579A CN201010180157A CN101904883A CN 101904883 A CN101904883 A CN 101904883A CN 2010101801579 A CN2010101801579 A CN 2010101801579A CN 201010180157 A CN201010180157 A CN 201010180157A CN 101904883 A CN101904883 A CN 101904883A
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Abstract
The invention discloses an antiphlogistic capsule used for treating acute and chronic infectious diseases and a preparation method thereof. The preparation method comprises the following steps: taking herba andrographitis and picrasma quassioides as raw materials, respectively preparing the herba andrographitis and the picrasma quassioides into pure pastes, and mixing the pure pastes; and adding auxiliary materials of microcrystalline cellulose, silicon dioxide, starch and magnesium stearate, and evenly mixing to prepare the antiphlogistic capsule used for treating the acute and chronic infectious diseases. The invention organically combines the efficacies of the herba andrographitis and the picrasma quassioides, has the functions of clearing heat, detoxicating, eliminating dampness and relieving dysentery, and can be used for treating bacillary dysentery, acute and chronic enteritis, infection of the upper respiratory tract, urinary tract infection and other various acute and chronic infectious diseases; and compared with the single preparation of the herba andrographitis or the picrasma quassioides, the antiphlogistic capsule is a medicine with better curative effect, better quality and more convenient use.
Description
Affiliated technical field
The present invention relates to a kind of Chinese Traditional Medicines and preparation method thereof, specifically a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases and preparation method thereof.
Background technology
By the acute chronic enteritis due to the enterobacterial infection, dysentery, respiratory tract infection and the flu that causes, tonsillitis, bronchitis, pneumonia etc. are the most common clinically acute and chronic infectious diseases at present.Modern pharmacodynamic study proves that Herba Andrographis has killing action to Zhi Jiashi dysentery bacterium, Bao Shi dysentery bacterium, shigella flexneri, escherichia coli, Bacillus typhi etc.Wherein creat lactone proves clinically has specially good effect to the treatment bacillary dysentery, and its curative effect is excellent than furazolidone, and has no side effect and toxicity.Ramulus Et Folium Picrasmae has anti-inflammation, damp eliminating antidotal function, is used for the treatment of the infective fever disease for a long time, and is respond well.Clinically except that being used for the treatment of illness such as flu, tonsillitis, enteritis, bacillary dysentery, Ramulus Et Folium Picrasmae also is used for various acute inflammation such as pneumonia, acute bronchitis, trauma infection contamination, skin infection, ophthalmology acute inflammation and urinary system infection simultaneously, and good result is arranged.The clinical acute and chronic infectious diseases such as intestinal, respiratory tract that are used for the treatment of such as the single preparation of Herba Andrographis, Ramulus Et Folium Picrasmae such as andrographolide injection, andrographis tablet, KUMU ZHUSHEYE, Ramulus Et Folium Picrasmae sheet, curative effect are better, untoward reaction and toxic and side effects be also less.
Summary of the invention
Technical problem to be solved by this invention be to propose a kind of better efficacy, quality more excellent, use and be used for the treatment of antiphlogistic capsule of acute and chronic infectious diseases and preparation method thereof more easily.
For solving the problems of the technologies described above, a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases of the present invention is a raw material with Herba Andrographis and Ramulus Et Folium Picrasmae, mixes after described Herba Andrographis and Ramulus Et Folium Picrasmae are made clear paste respectively, adds mixing behind the adjuvant again and makes.
Above-mentioned a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases, described adjuvant are one or more the mixture in microcrystalline Cellulose, silicon dioxide, starch or the magnesium stearate.
Above-mentioned a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases, making the Herba Andrographis consumption that 1000 capsules are adopted is 200g, and the Ramulus Et Folium Picrasmae consumption is 200g, and described adjuvant is an amount of and magnesium stearate 1g of microcrystalline Cellulose 60g, silicon dioxide 5g, starch.
A kind of preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases, it comprises following processing step: 1, Herba Andrographis is ground into coarse powder, decoct with water secondary, add for the first time the water of 12 times of amounts, decocted 2 hours, add the water of 10 times of amounts for the second time, decocted 2 hours, collecting decoction filters, and filtrate is concentrated into the clear paste of relative density 1.30 under 80 ℃ of temperature conditions; 2, Ramulus Et Folium Picrasmae is ground into coarse powder,, makes solvent, flood after 48 hours slowly percolation, collection percolate, recovery ethanol and to be concentrated into relative density under 80 ℃ of temperature conditions be 1.30 clear paste with ethanol according to fluid extract and extractum item percolation down; 3, merge above-mentioned two kinds of clear paste, mixing adds adjuvant, and is encapsulated after mixing, drying, the pulverizing, makes.
Above-mentioned a kind of preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases, described adjuvant are one or more the mixture in microcrystalline Cellulose, silicon dioxide, starch or the magnesium stearate.
Above-mentioned a kind of preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases, the consumption of described Herba Andrographis is 200g, the consumption of described Ramulus Et Folium Picrasmae is 200g; Collect percolate 2400ml during percolation; After with described Herba Andrographis clear paste and the merging of Ramulus Et Folium Picrasmae clear paste, adding microcrystalline Cellulose 60g, silicon dioxide 5g and starch are an amount of, and mixing is dry below 80 ℃, be ground into fine powder, add magnesium stearate 1g, mixing, encapsulated, make 1000 of capsules, every about 0.2 gram of loading amount.
The present invention is owing to adopted technique scheme, it organically combines the stronger sterilization that Herba Andrographis had, anti-inflammation, the damp eliminating antidotal effect that bacteriostasis efficacy and Ramulus Et Folium Picrasmae had, has heat-clearing and toxic substances removing, the effect of dampness-eliminating and dysentery-stopping can be used for treating various acute and chronic infectious illness such as bacillary dysentery, acute chronic enteritis, upper respiratory tract infection, urinary tract infection.It adopts capsule formulation, patient's taking convenience not only, and medicine disintegrate and drug release rate are fast, bioavailability height in vivo, toxic and side effects is low, and medicine stability is good, low production cost.Compare with the single preparation of Herba Andrographis or Ramulus Et Folium Picrasmae, it be a kind of better efficacy, quality more excellent, use medicine more easily.The adjuvant that adopts in the scheme, consumption and data value can guarantee fully that the present invention can use up composite demands such as satisfying product quality, energy-saving and cost-reducing and suitability for industrialized production practical situation greatly possibly.
Description of drawings
Fig. 1 is the processing process figure of Herba Andrographis clear paste;
Fig. 2 is the processing process figure of Ramulus Et Folium Picrasmae clear paste;
Fig. 3 is the capsular processing process figure of the present invention;
Fig. 4 is the test graph of a relation of moisture absorption percentage rate and relative humidity.
The specific embodiment
1, a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases, it adopts following process to make:
I, as shown in Figure 1 is ground into coarse powder with 200g Herba Andrographis, decocts with water secondary, adds the water of 12 times of amounts for the first time, decocts 2 hours, leaches filtrate; In primary filtering residue, add for the second time the water of 10 times of amounts, decocted 2 hours, leach filtrate; The filtrate that twice is decocted gained merges, and filters, and filtrate is concentrated into the clear paste of relative density 1.30 (80 ℃);
II, as shown in Figure 2, the 200g Ramulus Et Folium Picrasmae is ground into coarse powder, according to the percolation under fluid extract and the extractum item (an appendix I of Chinese Pharmacopoeia version in 2005 O), make solvent with ethanol, flood after 48 hours slowly percolation, collect percolate 2400ml, reclaim ethanol and be concentrated into the clear paste that relative density is 1.30 (80 ℃);
III, as shown in Figure 3 merges above-mentioned two kinds of clear paste, and mixing adds microcrystalline Cellulose 60g, silicon dioxide 5g, starch 65g, and mixing is dry below 80 ℃, is ground into fine powder, crosses 100 mesh sieves; Add magnesium stearate 1g, mixing, encapsulated (every about 0.2 gram of loading amount) makes 1000, promptly gets capsule of the present invention.
2, capsule of the present invention adopt oral, one time 2～3,3～4 times on the one.
3, in this process, be evaluation criteria, the water consumption of Herba Andrographis when decocting boils carried out process optimization with andrographolide and dehydrorographolide.Experimental technique: get Herba Andrographis medicinal material coarse powder 1000g, decoct with water secondary, each 2 hours, each amount of water saw the following form, and merged decoction liquor twice, filtered, and was concentrated into finite concentration, was settled to 500ml, shook up.Measure the content of its andrographolide and dehydrorographolide with HPLC, the results are shown in following table.
| The scheme numbering | Inventory (g) | Add for the first time water (doubly) | Add for the second time water (doubly) | Andrographolide and dehydrorographolide (%) |
| Scheme one | ?1000? | 8? | 6? | 0.105? |
| Scheme two | ?1000? | 10? | 8? | 0.138? |
| Scheme three | ?1000? | 12? | 10? | 0.154? |
| Scheme four | ?1000? | 15? | 12? | 0.159? |
| Scheme five | ?1000? | 17? | 15? | 0.161? |
As can be known from the table data: when the extraction water consumption reaches the level of scheme three, increase water consumption again, the content of andrographolide and dehydrorographolide no longer increases significantly.In line with guaranteeing product quality and energy-saving and cost-reducing aim, determine that selection scheme three adds the water conservancy project skill as extraction and meets industrialized great production.
4, in this process, be evaluation criteria, the amount and the dip time of Ramulus Et Folium Picrasmae percolate carried out process optimization with must measuring of thick paste.Experimental technique: get Ramulus Et Folium Picrasmae medicinal material coarse powder 1000g, add alcohol dipping percolation slowly after 48 hours, collect the percolation liquid measure and see the following form, percolate reclaims ethanol, is concentrated into relative density 1.30 (80 ℃), claims to decide weight, the results are shown in following table.
| The scheme numbering | Inventory (g) | Percolation liquid measure (ml) | Thick paste amount (g) | Thick paste rate (%) |
| Scheme one | 1000? | 8000? | 226.76? | 22.68? |
| Scheme two | 1000? | 10000? | 255.38? | 25.54? |
| Scheme three | 1000? | 12000? | 278.07? | 27.81? |
| Scheme four | 1000? | 14000? | 279.16? | 27.92? |
| Scheme five | 1000? | 16000? | 280.22? | 28.02? |
As can be known from the table data: when extraction reaches the level of scheme three with amount of alcohol, increase the percolation liquid measure again, the thick paste rate no longer increases significantly.In line with guaranteeing product quality and energy-saving and cost-reducing aim, determine that selection scheme three meets industrialized great production as the percolation extraction process.
5, in this process, be evaluation criteria, the dip time of Ramulus Et Folium Picrasmae percolation is carried out process optimization with must measuring of thick paste.Experimental technique: get Ramulus Et Folium Picrasmae medicinal material coarse powder 1000g, add slowly percolation of alcohol dipping, collect percolate 12000ml, dip time sees the following form, and percolate reclaims ethanol, is concentrated into relative density 1.30 (80 ℃), claims to decide weight, the results are shown in following table.
| The scheme numbering | Inventory (g) | Dip time (h) | Thick paste amount (g) | Thick paste rate (%) |
| Scheme one | 1000? | 24? | 245.23? | 24.52? |
| Scheme two | 1000? | 36? | 266.39? | 26.64? |
| Scheme three | 1000? | 48? | 278.07? | 27.81? |
| Scheme four | 1000? | 60? | 278.90? | 27.89? |
| Scheme five | 1000? | 72? | 279.58? | 27.96? |
As can be known from the table data: when extraction reaches the level of scheme three with amount of alcohol, increase dip time again, the thick paste rate no longer increases significantly.In conjunction with the practical situation of industrialized great production, determine the extraction process of selection scheme three as the percolation dip time.
6, in this process, the selection of adjuvant has been carried out screening test according to following table.
| Form (g) | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 |
| Clear paste | 1 recipe quantity | 1 recipe quantity | 1 recipe quantity | 1 recipe quantity | 1 recipe quantity |
| Starch | ?-? | ?130? | ?70? | ?65? | ?65? |
| Microcrystalline Cellulose | ?-? | ?-? | ?60? | ?60? | ?60? |
| Silicon dioxide | ?-? | ?-? | ?-? | ?5? | ?5? |
| Magnesium stearate | ?-? | ?-? | ?-? | ?-? | ?1? |
Prescription (1): get mixing in the clear paste of recipe quantity, dry below 80 ℃, be ground into fine powder, incapsulate.The result: fine powder viscosity is big, and the capsule disintegration time is long, therefore adds starch as filler and disintegrating agent in next one prescription.
Prescription (2): get mixing in the clear paste of recipe quantity, add starch 130g, mixing, dry below 80 ℃, be ground into fine powder, incapsulate.The result: fine powder viscosity reduces, and encapsulated back disintegration time shortens, but therefore moisture＞9.0% adds microcrystalline Cellulose as filler and disintegrating agent in next one prescription.
Prescription (3): get mixing in the clear paste of recipe quantity, add starch 70g, microcrystalline Cellulose 60g, mixing, dry below 80 ℃, be ground into fine powder, incapsulate.The result: fine powder viscosity reduces, and encapsulated back disintegration time shortens, and moisture＜9.0% intends adding silicon dioxide with oiliness composition in the absorption extractum in next one prescription.
Prescription (4): get mixing in the clear paste of recipe quantity, add starch 65g, microcrystalline Cellulose 60g, silicon dioxide 5g, mixing, dry below 80 ℃, be ground into fine powder, incapsulate.The result: the fine powder flowability is relatively poor, therefore adds magnesium stearate to improve the flowability of fine powder in next one prescription.
Prescription (5): get mixing in the clear paste of recipe quantity, add starch 65g, microcrystalline Cellulose 60g, silicon dioxide 5g, mixing, dry below 80 ℃, be ground into fine powder, add magnesium stearate 1g, incapsulate.The result: the fine powder good fluidity, moisture＜9.0%, suitable encapsulated, the capsule disintegration time meets the requirements.
So select prescription 5.Consider the difference of every batch of yield of extract when producing,, in method for making, filler starch is decided to be in right amount, to do necessary adjusting in order to keep the unanimity of every batch of crude drug representative amount.
7, the capsule that makes is carried out the research of preparations shaping.
The mensuration of I, critical relative humidity
Capsule medicated powder is put into the flat weighing botle that is dried to constant weight, and accurately weighing places the exsiccator that fills different constant humidity solution respectively, places 7 days in 25 ℃ of constant temperature, weighs, and asks the moisture absorption percentage rate, sees the following form.
| Constant humidity solution | Relative humidity (%) | Medicated powder weight (g) | (g) gains in weight | Moisture absorption percentage rate (%) |
| NaOH solution (37.00%) | 25? | ?1.0521? | ?0.0331? | 3.15? |
| NaOH solution (33.28%) | 35? | ?1.0212? | ?0.0355? | 3.48? |
| NaOH solution (29.86%) | 45? | ?1.0354? | ?0.0400? | 3.86? |
| NaOH solution (26.42%) | 55? | ?1.0552? | ?0.0457? | 4.33? |
| NaOH solution (22.80%) | 65? | ?1.0105? | ?0.0588? | 5.82? |
| NaOH solution (18.80%) | 75? | ?1.0045? | ?0.0909? | 9.05? |
| NaOH solution (13.32%) | 85? | ?1.0588? | ?0.1728? | 16.32? |
| |
100? | ?1.0425? | ?0.3115? | 29.88? |
With the moisture absorption percentage rate is vertical coordinate, and the relative humidity of different constant humidity solution is an abscissa, the moisture equilibrium at dry side curve, make straight line from the point of intersection of tangents at these curve two ends again perpendicular to abscissa, the intersection point of straight line and abscissa promptly gets critical relative humidity.See Fig. 4.
The result: when relative humidity during greater than 72%RH, the rate of moisture absorption of medicated powder begins to increase, and the critical relative humidity of trying to achieve is about 72%RH.So should will divide encapsulated prodrug powder to be sealed in dry place when the preparation capsule, the relative humidity of processing environment should be controlled at below the 70%RH.
II, respectively carry out in three batches trial production trial-production at twice.Inventory is 10 times of recipe quantities, to the relevant preparation technology parameter of each batch, and yield rate, physical and chemical index, the content of andrographolide and dehydrorographolide is investigated.The result shows that this technology is basicly stable, is applicable to big production.Three batches of pilot products are tested according to this product quality standard, and are all up to specification, and every data see the following form.
To checking that its disintegration is qualified the disintegration of this product, check result sees the following form the capsule of the present invention of getting III, disintegration three batches of the above-mentioned first time by Chinese Pharmacopoeia version appendix in 2005 XIIA.
| Lot number | 1? | 2? | 3? |
| Disintegration time | 22min? | 25min? | 23min? |
Claims (6)
1. an antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases is characterized in that, it is a raw material with Herba Andrographis and Ramulus Et Folium Picrasmae, mixes after described Herba Andrographis and Ramulus Et Folium Picrasmae are made clear paste respectively, adds mixing behind the adjuvant again and makes.
2. a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases as claimed in claim 1 is characterized in that, described adjuvant is one or more the mixture in microcrystalline Cellulose, silicon dioxide, starch or the magnesium stearate.
3. a kind of antiphlogistic capsule that is used for the treatment of acute and chronic infectious diseases as claimed in claim 2, it is characterized in that, making the Herba Andrographis consumption that 1000 capsules are adopted is 200g, the Ramulus Et Folium Picrasmae consumption is 200g, and described adjuvant is an amount of and magnesium stearate 1g of microcrystalline Cellulose 60g, silicon dioxide 5g, starch.
4. preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases, it is characterized in that, it comprises following processing step: I, Herba Andrographis is ground into coarse powder, decocts with water secondary, adds the water of 12 times of amounts for the first time, decocted 2 hours, add for the second time the water of 10 times of amounts, decocted collecting decoction 2 hours, filter, filtrate is concentrated into the clear paste of relative density 1.30 under 80 ℃ of temperature conditions; II, Ramulus Et Folium Picrasmae is ground into coarse powder,, makes solvent, flood after 48 hours slowly percolation, collection percolate, recovery ethanol and to be concentrated into relative density under 80 ℃ of temperature conditions be 1.30 clear paste with ethanol according to fluid extract and extractum item percolation down; III, the above-mentioned two kinds of clear paste of merging, mixing adds adjuvant, and is encapsulated after mixing, drying, the pulverizing, makes.
5. a kind of preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases as claimed in claim 4 is characterized in that, described adjuvant is one or more the mixture in microcrystalline Cellulose, silicon dioxide, starch or the magnesium stearate.
6. a kind of preparation method that is used for the treatment of the antiphlogistic capsule of acute and chronic infectious diseases as claimed in claim 5 is characterized in that the consumption of described Herba Andrographis is 200g, and the consumption of described Ramulus Et Folium Picrasmae is 200g; Collect percolate 2400ml during percolation; After with described Herba Andrographis clear paste and the merging of Ramulus Et Folium Picrasmae clear paste, adding microcrystalline Cellulose 60g, silicon dioxide 5g and starch are an amount of, and mixing is dry below 80 ℃, be ground into fine powder, add magnesium stearate 1g, mixing, encapsulated, make 1000 of capsules, every about 0.2 gram of loading amount.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104189266A (en) * | 2014-09-25 | 2014-12-10 | 广西中医药大学 | Pharmaceutical composition for treating upper respiratory infection, and preparation method thereof |
| CN107496500A (en) * | 2017-09-10 | 2017-12-22 | 广东罗浮山国药股份有限公司 | A kind of application of Chinese medicine composition in the medicine for the treatment of helicobacter pylori infections and acute urethritis is prepared |
| CN109157561A (en) * | 2018-10-22 | 2019-01-08 | 崔俊山 | A kind of quassia Herba Andrographitis concentrate for Neulized inhalation and rectally |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562245A (en) * | 2004-03-31 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | Compound quassia capsule for diminishing inflammation and preparation method |
-
2010
- 2010-05-20 CN CN2010101801579A patent/CN101904883A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562245A (en) * | 2004-03-31 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | Compound quassia capsule for diminishing inflammation and preparation method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104189266A (en) * | 2014-09-25 | 2014-12-10 | 广西中医药大学 | Pharmaceutical composition for treating upper respiratory infection, and preparation method thereof |
| CN107496500A (en) * | 2017-09-10 | 2017-12-22 | 广东罗浮山国药股份有限公司 | A kind of application of Chinese medicine composition in the medicine for the treatment of helicobacter pylori infections and acute urethritis is prepared |
| CN109157561A (en) * | 2018-10-22 | 2019-01-08 | 崔俊山 | A kind of quassia Herba Andrographitis concentrate for Neulized inhalation and rectally |
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Application publication date: 20101208 |