Summary of the invention
At the deficiency of existing new snow prescription type, the present invention's research provides a kind of new snow side bad smell and moistureproof technology covered, and makes that patient is acceptant to take, and the new snow side capsule that is improved of medicine stability.
The present invention is achieved by the following technical solutions:
A kind of Xinxue capsule, include Magnetitum, Gypsum Fibrosum, Talcum, Mirabilitum crystallina, Sal Nitri, Natrii Sulfas, Fructus Gardeniae, Folium Bambosae, Radix Serratulae Chinensis, Herba Andrographis, Margarita layer powder, Lignum Aquilariae Resinatum, Borneolum Syntheticum, artificial Calculus Bovis or Calculus Bovis 14 flavor major ingredient and adjuvants, its wetting agent is 50%~95% ethanol liquid; Coating materials is two or more mixture or hydroxypropyl emthylcellulose or hydroxypropyl cellulose or Polyethylene Glycol or polyvinylpyrrolidone or a Lac of polyacrylic resin I number or II number or III number or IV number or its.
A kind of Xinxue capsule, its wetting agent are selected 50%~95% ethanol liquid for use; Coating materials is selected two or more mixture of polyacrylic resin I number or II number or III number or IV number or its for use.
A kind of preparation method of Xinxue capsule may further comprise the steps preparation:
(1) artificial Calculus Bovis or Calculus Bovis, the Borneolum Syntheticum pulverize, standby;
(2) Magnetitum, Gypsum Fibrosum, Talcum, Mirabilitum crystallina add the decocting that 8-12 doubly measures and boil 2 times, decoct 2-4 hour at every turn, filter, get filtrate, add Herba Andrographis, Folium Bambosae, Fructus Gardeniae, Lignum Aquilariae Resinatum and Radix Serratulae Chinensis in the filtrate, add 8-12 times of water gaging and decoct 2 times, each 2-4 hour, filter, get filtrate, concentrate, add Natrii Sulfas and Sal Nitri, heating is condensed into thick paste, and is standby;
(3) with the medicinal residues drying of Radix Serratulae Chinensis and Lignum Aquilariae Resinatum, be ground into powder, standby;
(4) the part Folium Andrographis is ground into powder, and is standby;
(5) get above-mentioned thick paste, add Margarita layer powder, powder of Radix Serratulae Chinensis and Lignum Aquilariae Resinatum and Folium Andrographis powder; mixing; spray 50%~95% ethanol liquid is as wetting agent, and drying is made granule; add artificial Calculus Bovis or Calculus Bovis, borneol powder; mixing sprays into coating materials and is two or more the ethanol liquid of mixture of polyacrylic resin I number or II number or III number or IV number or its, drying; incapsulate, promptly.
A kind of Xinxue capsule and preparation method thereof, described wetting agent are selected 85% ethanol liquid for use; Coating materials is selected for use polyacrylic resin IV number.
A kind of preparation method of Xinxue capsule, the decocting that Magnetitum, Gypsum Fibrosum, Talcum, Mirabilitum crystallina add 10 times of amounts in described step (3) boils 2 times, decocts 3 hours at every turn, filter, get filtrate, add Herba Andrographis, Folium Bambosae, Fructus Gardeniae, Lignum Aquilariae Resinatum and Radix Serratulae Chinensis in the filtrate, adding 10 times of water gagings decocts 2 times, each 3 hours, filter, get filtrate, concentrate, add Natrii Sulfas and Sal Nitri, heating is condensed into thick paste, and is standby.
The present invention has following advantage:
(1) can cover the bad smell of medicine
New snow side bitter in the mouth, salty can be covered bad smell after incapsulating, and helps patient and swallows.
(2) stability is improved
Contain the volatility flavour of a drug in the new snow side, the moisture absorption easily again, the coated formation afterwards of a capsule 's content skim has completely cut off and the contacting of air relatively, reinstalls in the opaque capsule, and stability improves.
(3) good looking appearance
The capsule appearance of making is clean and tidy, attractive in appearance, and the easier patient of making accepts.
(4) improve bioavailability of medicament
Do not need when capsule prepares to exert pressure,, better absorption is arranged, more be applicable to the alleviation of emergency case so disintegration time is short.
Preparation technology's research
One, the extraction of four flavor mineral drugs such as Magnetitum
For each amount of water and decocting times that decocts of four flavor mineral drugs such as clear and definite Magnetitums, existing with solid content and Fe
2+Stripping quantity be index, it is carried out preferably.Test method is: get four flavor mineral drugs such as Magnetitum, totally nine parts, be divided into three groups, every group three parts, each group adds the water of 8,10,12 times of amounts respectively, decocts twice, each group of decocting time is respectively 2,3,4 hours, filter, merging filtrate concentrates, drying under reduced pressure becomes dried cream, weigh, calculate solid content, and measure Fe
2+Stripping quantity.Measurement result sees the following form 1, table 2.
Different amount of water of table 1 and the solid content of extraction time
Different amount of water of table 2 and the Fe of extraction time
2+Stripping quantity
According to above result of the test, in conjunction with factors such as big production costs, boil 2 times before selecting 10 times of water gagings for use, be advisable in each 3 hours.
Two, the investigation of amount of water
In former " new snowflake " standard to the extraction process of plant amedica describe comparatively rough, for clear and definite each water consumption and decocting time that decocts, be index with the ferulaic acid content earlier, amount of water is carried out preferably.Test method is: get five kinds of Chinese medicine 508g such as Fructus Gardeniae, totally 9 parts, be divided into three groups, each group adds 8,10,12 times of amounts of decocting liquid (not enough water is supplied) such as Magnetitum respectively, decocts secondary, and each group of decocting time is respectively 2,3,4 hours, filter, merging filtrate, heating is concentrated into relative density and is about 1.30 thick paste, measures ferulaic acid content.The results are shown in following table.
The ferulic acid amount of different amount of water of table 3 and extraction time
As can be seen from the above table, the ferulic acid amount that 10 times and 12 times of water gagings are carried is all many than 8 times of amounts, extracts 3 hours ferulic acid amounts with 4 hours gained all than more than 2 hours at every turn.Consider factors such as industrial cost, select for use 10 times of water gagings to decoct twice, be advisable in each 3 hours.
According to above result of study, determine that the Xinxue capsule optimum extraction process is: Magnetitum, Gypsum Fibrosum, Mirabilitum crystallina, Talcum add 10 times of water gagings and decoct each 3 hours 2 times, filter, merging filtrate adds the Lignum Aquilariae Resinatum and the Radix Serratulae Chinensis of Herba Andrographis, Folium Bambosae, Fructus Gardeniae and the cloth bag of packing in the filtrate, add water to 10 times of amounts, decoct 2 times, each 3 hours, merging filtrate was concentrated into an amount of, add Natrii Sulfas and Sal Nitri, heating is concentrated into relative density and is about 1.30 thick paste (50 degrees centigrade).
Study on Forming
One, the rate demonstration test of the dried cream of former prescription
Take by weighing the prescription flavour of a drug in the prescription ratio, according to preferred technology dried cream yield is investigated, and investigated 5 batches, the result shows that the dried cream yield of this extraction process is about 23%.
Two, the selection of wetting agent
For the needs of granulating, we are index with grain forming and flowability, investigate the pelletizing forming situation of different wetting agent, to select best wetting agent.
1, Liu Dongxing investigation method
Flowability with reference to 248 pages of described powders of Xi Nianzhu chief editor's higher medical universities and colleges' teaching materials " pharmaceutics ", adopt the fixed funnel method to measure angle of repose, be about to the suitable height on the graph paper that funnel is fixed in horizontal positioned, making the funnel end opening is H apart from the distance of graph paper, carefully medicated powder is poured in the funnel, till the outlet of the tip of the cone that funnel forms down contact funnel, the radius of cylinder can be measured by graph paper, by formula
Obtain α angle of repose.
With angle of repose reckling be good.
2, molding situation
Main moistening uniformity, the difficulty or ease of sieving and the particulate elasticity of investigating wetting agent.
(1) experimental technique
Press the dried cream powder that optimised process extracts, spray an amount of wetting agent, cross 30 mesh sieves, granulate, 50 ℃ of oven dry, granulate is observed the molding situation and is measured its flowability.
(2) investigation the results are shown in following table.
Agent of table 4 different wetting or binding agent pelletizing forming situation
Binding agent | The molding situation | Angle of repose (°) |
Ethanol 85% ethanol liquid 60% ethanol | It is loose to granulate, and easily sieves, and the more moistening of fine powder is even, granulation is easier to, and the moderate moistening of granule degree of tightness is even, but soft material is more sticking, more sad sieve, yield rate is low | 54.1 32.4 38.1 |
As seen from the above table, 85% ethanol liquid can make all granules preferably of mouldability and flowability as wetting agent.
3, the protection against the tide of capsule 's content is handled
This product is the moisture absorption easily, sprays into the moisture resistance that an amount of coating materials can increase content, improves the stability of this product greatly, is convenient to depositing and storing of this product.
Polyacrylic resin IV is good filmogen, is usually used in pill, tablet, the coating of granule.Owing to can form clear films, secluding air relatively, with an amount of acrylic resin coating, drying can improve the humidity-proof ability of capsule 's content, has increased the flowability of content simultaneously before encapsulated, and it is encapsulated to be convenient to mechanization.We adopt 5% polyacrylic resin IV ethanol liquid that granule is carried out protection against the tide and handle, and the coating materials consumption is about 1%, and have compared the moisture effect of coating front and back contents.
Assay method is as follows:
Get the 10g sample, the fixed (W of accurate title
1), put room temperature and open wide placement after 24 hours, the fixed (W of accurate title
2), calculating moisture increases percentage rate, and formula is as follows:
Table 5
Tested number | Coating not | Behind the coating |
Raw sample amount (g) | Sample size behind the 24h (g) | P (%) | X (%) | Raw sample amount (g) | Sample size behind the 24h (g) | P (%) | X (%) |
1 2 3 | 10.1320 10.2115 10.7811 | 10.6204 10.7327 11.3150 | 4.82 5.10 4.95 | 4.96 | 10.2558 10.4675 10.3889 | 10.4732 10.6819 10.6032 | 2.12 2.05 2.06 | 2.08 |
Through last table as can be known, add 5% polyacrylic resin IV ethanol liquid coating after, the humidity-proof ability of capsule 's content obviously improves.
The specific embodiment
Embodiment 1
Xinxue capsule includes Magnetitum, Gypsum Fibrosum, Talcum, Mirabilitum crystallina, Sal Nitri, Natrii Sulfas, Fructus Gardeniae, Folium Bambosae, Radix Serratulae Chinensis, Herba Andrographis, Margarita layer powder, Lignum Aquilariae Resinatum, Borneolum Syntheticum, artificial Calculus Bovis or Calculus Bovis 14 flavor major ingredients and the adjuvant its preparation method may further comprise the steps:
(1) artificial Calculus Bovis or Calculus Bovis, the Borneolum Syntheticum pulverize, standby;
(2) Magnetitum, Gypsum Fibrosum, Talcum, the Mirabilitum crystallina decocting that adds 10 times of amounts boils 2 times, decocts 3 hours at every turn, filters, get filtrate, add Herba Andrographis, Folium Bambosae, Fructus Gardeniae, Lignum Aquilariae Resinatum and Radix Serratulae Chinensis again, add 10 times of water gagings and decoct 2 times, each 3 hours, filter, get filtrate, above-mentioned filtrate is merged, concentrate, add Natrii Sulfas and Sal Nitri, heating is condensed into thick paste, and is standby;
(3) with the medicinal residues drying of Radix Serratulae Chinensis and Lignum Aquilariae Resinatum, be ground into powder, standby;
(4) get above-mentioned thick paste, add Margarita layer powder, powder of Radix Serratulae Chinensis and Lignum Aquilariae Resinatum and Common Andrographis Herd, mixing sprays 85% ethanol; granulate, drying adds artificial Calculus Bovis or Calculus Bovis, borneol powder, mixing; spray into polyacrylic resin IV ethanol liquid, drying incapsulates, promptly.
Embodiment 2
In the Xinxue capsule preparation method (5), spray into 50% ethanol liquid, granulate.All the other are with embodiment 1.
Embodiment 3
In the Xinxue capsule preparation method (5), spray into 95% ethanol liquid, granulate.All the other are with embodiment 1.