CN106138675A - A kind of concentrated pill treating chronic pharyngitis and preparation method thereof - Google Patents
A kind of concentrated pill treating chronic pharyngitis and preparation method thereof Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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Abstract
The present invention provides a kind of concentrated pill treating chronic pharyngitis and preparation method thereof, the method is by weight, select Radix Scutellariae 15 parts, Radix Adenophorae 16 parts, Radix Scrophulariae 16 parts, Bulbus Lilii 16 parts, winter folium mori 12 parts, Folium Eriobotryae (processed) 12 parts, Radix Salviae Miltiorrhizae 12 parts, Calyx Seu Fructus Physalis 15 parts, FRUCTUS TERMINALIAE IMMATURUS 7 parts, Fructus Schisandrae Chinensis 7 parts, FLOS MUME 7 parts, Vascular aurantii 7 parts, Retinervus Luffae Fructus 7 parts, Radix Glycyrrhizae 7 parts is as crude drug, extracted by control, concentrate and art for coating, obtain good effect, effective ingredient is fully utilized, taking convenience, energy disintegrate rapidly after taking, the concentrated pill leached and absorb.The preparation technology of the present invention is simple, it is easy to implementing, cost is relatively low, really can adhere to that Long-term taking medicine brings the material benefit in price for chronic.
Description
Technical field
The invention belongs to pharmaceutical engineering field, be specifically related to a kind of concentrated pill treating chronic pharyngitis and preparation method thereof.
Background technology
Traditional Chinese medicine is generally decoction, the most not readily portable but also mouthfeel is poor.It is fabricated to be easy to by Chinese medicine formula
The dosage form carried and take, such as pill and capsule, is conventional way.But, due to the complicated component of Chinese medicine, carry out preparation
Time, how to select be suitable for the preparation process of property of raw material and how to ensure that curative effect is unaffected, be by corresponding preparations work
As time the subject matter that faces.For the Chinese medicine formula that raw material components is more, the problems referred to above are particularly important.
Through retrieval, the relevant report of pill for treatment chronic pharyngitis is less at present, and formula used and preparation side
Method is different, such as " preparation of the sore-throat relieving ball that wets one's whistle and clinical practice ", " preparation of the peaceful ball of summer ginseng pharynx and clinical practice " and " medicine for treating pharyngitis ball
Preparation and clinical practice ".
Therefore, find a kind of can be prepared as being easy to carry about with one by the Chinese medicine formula to chronic pharyngitis with good therapeutic effect and
The method of the pill taken, is this area technical problem urgently to be resolved hurrily.
Summary of the invention
For the shortcoming of prior art, it is an object of the invention to provide the preparation of a kind of concentrated pill treating chronic pharyngitis
Method, this preparation method comprises the steps:
(1) by weight, following medical material is prepared:
Radix Scutellariae 15 parts, Radix Adenophorae 16 parts, Radix Scrophulariae 16 parts, Bulbus Lilii 16 parts, winter folium mori 12 parts, Folium Eriobotryae (processed) 12 parts, Radix Salviae Miltiorrhizae 12
Part, Calyx Seu Fructus Physalis 15 parts, FRUCTUS TERMINALIAE IMMATURUS 7 parts, Fructus Schisandrae Chinensis 7 parts, FLOS MUME 7 parts, Vascular aurantii 7 parts, Retinervus Luffae Fructus 7 parts, Radix Glycyrrhizae 7 parts；
(2) Bulbus Lilii and FLOS MUME are ground into fine powder；
(3) add water to 12 taste medicines in addition to Bulbus Lilii and FLOS MUME and soak, carry out heating extraction afterwards；
(4) step (3) gains being concentrated into relative density at 60 DEG C is 1.2-1.25；
(5) step (2) gains, step (4) gains, starch and carboxymethyl starch are received mixing, then carries out pill；
Wherein, step (2) gains are 62: 71 with the weight ratio of step (4) gains, and the addition of starch is step (4) gains
The 15% of weight, the addition that carboxymethyl starch is received is the 10% of step (4) gains weight；
(6) step (5) gains are dried；
(7) utilize gastric solubility film coating pre-mix dose that step (6) gains are coated process；Wherein, at preparation bag
Clothing liquid and when being coated process, coating powder is 10: 100 with the weight ratio of purified water, and coating powder is 3 with the weight ratio of pill:
100。
Preferably, in step (2), Bulbus Lilii and FLOS MUME fine powder are not more than 100 mesh.
Preferably, in step (3), the addition of water is 6-8 times of medical material gross weight.It is furthermore preferred that the addition of water is
8 times of medical material gross weight.
Preferably, in step (3), soak time is 30 minutes.
Preferably, in step (3), during heating extraction, extraction conditions is to extract 90 minutes under boiling water.
Preferably, in step (4), step (3) gains are concentrated into relative density at 60 DEG C is 1.22.
Preferably, in step (6), when being dried, temperature is 60 DEG C, and drying time is 24 hours.
Further object is that and the concentrated pill prepared by said method is provided.
Beneficial effects of the present invention:
1, the present invention has good therapeutic effect to chronic pharyngitis；
2, gained concentrated pill of the present invention improves the shortcoming that Chinese medicine decoction dose is big, mouthfeel is poor and patient swallow is difficult；
3, after gained concentrated pill of the present invention is taken, energy disintegrate rapidly, leaches and absorbs, can fully ensure that holding of preparation curative effect
Supervention is waved, convenient use；
4, the preparation technology of the present invention is simple, it is easy to implementing, cost is relatively low, can really adhere to taking for a long time for chronic
Medicine brings the material benefit in price.
Detailed description of the invention
Below by embodiment, the present invention is specifically described, it is necessary to it is pointed out here that be that following example are simply used
In the present invention is further detailed, it is impossible to be interpreted as limiting the scope of the invention, being skilled in technique of this field
Some nonessential improvement and adjustment that personnel are made according to foregoing invention content, still fall within protection scope of the present invention.
Embodiment 1
Prescription
Radix Scutellariae 15g, Radix Adenophorae 16g, Radix Scrophulariae 16g, Bulbus Lilii 16g, winter folium mori 12g, Folium Eriobotryae (processed) 12g, Radix Salviae Miltiorrhizae 12g, brocade lamp
Cage 15g, FRUCTUS TERMINALIAE IMMATURUS 7g, Fructus Schisandrae Chinensis 7g, FLOS MUME 7g Vascular aurantii 7g, Retinervus Luffae Fructus 7g, Radix Glycyrrhizae 7g
Note: above-mentioned prescription expansion 30 times (4680g) is produced:
Radix Scutellariae 450g, Radix Adenophorae 480g, Radix Scrophulariae 480g, Bulbus Lilii 480g, winter folium mori 360g, Folium Eriobotryae (processed) 360g, Radix Salviae Miltiorrhizae
360g, Calyx Seu Fructus Physalis 450g, FRUCTUS TERMINALIAE IMMATURUS 210g, Fructus Schisandrae Chinensis 210g, FLOS MUME 210g, Vascular aurantii 210g, Retinervus Luffae Fructus 210g, Radix Glycyrrhizae
210g
Make 1000g
Bulbus Lilii 0.48kg, FLOS MUME 0.21kg were ground into the fine powder of 100 mesh sieves, rewinding 0.62kg (rewinding rate
90%), standby；
The 12 taste medical material 3.99kg such as Radix Scutellariae are put in hot reflux extracting-concentration machine, adds the drinking water of medical material amount 8 times
31kg → immersion 30 minutes.
The 12 taste medicines such as remaining Radix Scutellariae, add in hot reflux extracting-concentration machine, carry out extracting dense after soaking 30 minutes
Contracting.Extract 90 minutes (after boiling), filtrate suction concentration tank is concentrated into the clear paste that relative density is 1.2～1.25 (60 DEG C)；
By above-mentioned clear paste, medicated powder and appropriate amount of starch, mixing, pill, drying, coating, to obtain final product.
Pan-fried extract suction concentration tank → be concentrated to a relative density of 1.2--1.25 (60 DEG C) → Clean paste collecting vehicle is received cream
Standby.Receive cream rate ± 18%.
1. this technique concentrates and takes extraction limit, limit condensing mode, to shorten concentration time, lowers production cost.
2. be we have concluded that by test: after concentration, the relative density of extractum is appropriate for ± 1.22, less than 1.20, extractum
Too clear, more than 1.30, extractum is the oldest, is all unfavorable for pill.The more flowability of extractum when receiving cream temperature 60 C, it is simple to rewinding bucket
Collect.
By above-mentioned extractum 0.71kg, add crude drug fine powder (Bulbus Lilii and FLOS MUME) 0.62kg and 0.10kg starch, 0.07kg
Carboxymethyl starch sodium → mixing → pill → baking ball → capping → select ball → inspection (ball size, weight, moisture).In order to make ball
Grain is rounder and more smooth, puts into coating pan and rotate after going out ball, and rotation time is no less than 60 minutes.
Hot-air oven is put in wet ball sabot, 60 DEG C of hot-air seasonings.Baking time is 24 hours.Period constantly turns over
Dish, makes pill be heated evenly.
Capping:
A ball dried row ball re-detection, according to ball re-computation capping amount, ball after capping is important ask reach every weight ±
0.1g。
1. calculate: random 3 times respectively 10 balls of extraction weigh and take average: for the first time: 0.88g/10 grain；For the second time:
0.86g/10 grain；For the third time: 0.86g/10 grain.(0.88+0.86+0.86) every ball counterpoise of ÷ 3=0.87g/10 grain=
The known total ball weight of 0.087g: 1.08kg
If adding a cover flour x, then computing formula is: a: b=(a+x): c
Wherein: a=ball weight；Every ball weight before b=capping；Ball weight required after c=capping.
Above-mentioned numeral is substituted into formula obtain: 1080: 0.087=(1080+x): 0.1
Calculate: x=161.4g=0.16kg
It is computed drawing: a 1.08kg ball need to add 0.16kg capping powder can reach every ball 0.1g weight.
2. rotate coating pan during capping, add appropriate pure water abundant moistening pill, be slowly added into quantitative capping powder, do not stop
Rotating coating pan makes pill fully bond with fine powder, until the capping powder of amount of calculation adds；After pill light is mellow and full；Lid
Hot-air blower is opened to dry amount of water during capping, ball weight after capping: 2.2kg during face.
3. having added appropriate pure water time because of capping, so still needing to after capping carry out drying ball, the time is no less than 8 hours, a ball
By sufficiently drying, its moisture gets to the requirement of pharmacopeia.Dry ball weight: 1.24kg after ball.
Select ball:
A ball after capping is screened.Respectively select No. 4 sieve and No. 5 sieves, cross No. 4 sieve and only No. 5 sieve be not
Qualified ball, selects defective abnormity ball simultaneously.A diameter of ± the 4.5mm of qualified ball, pill rounding, 10 ball weight ± 1g.Do not conform to
Lattice ball weight 0.3kg；Qualified ball weight 0.94kg.The defective ball selected crosses 100 mesh sieves after pulverizing, standby as capping powder next time.
Qualified ball need to carry out semi-finished product detection, detection content: (1) ball re-detection；(2) moisture detection.Testing result
Reach the requirement of pharmacopeia, next process can be entered.
Coating:
Heavily weigh coating powder → by coating powder to be proportionally added into purified water fully dissolve → open air compressor machine → open according to ball
Open hot-air blower → coating.
Ball weight: 1.0kg coating powder: 0.94 × 3%=0.028kg pure water=0.03 × 10=0.028kg
Ball weight=1.0kg after coating
Inner packing:
Take medicine for convenience of patient, use medicinal polyethylene bottle to pack, every bottle of 30g, each serving 5g, 3 times on the one.
Sichuan Provincial Academy of Traditional Chinese Medicine has carried out acute toxicity test to concentrated pill of the present invention, and conclusion is: record mice mouth
The maximum tolerated dose taking concentrated pill is 132.3 crude drug in whole g/kg.Therefore, concentrated pill one consumption per day of the present invention is equivalent to primary crude drug
156g is safety non-toxic.On this basis, determine its usage and dosage: an oral 5g, three times on the one.
Embodiment 2
Pilot scale (expands 175 times by original prescription to produce, count 27.3kg)
Prescription and preparation method
Radix Scutellariae 2.63kg, Radix Adenophorae 2.8kg, Radix Scrophulariae 2.8kg, Bulbus Lilii 2.8kg winter folium mori 2.1kg Folium Eriobotryae (processed) 2.1kg,
Radix Salviae Miltiorrhizae 2.1kg, Calyx Seu Fructus Physalis 2.63kg, FRUCTUS TERMINALIAE IMMATURUS 1.23kg, Fructus Schisandrae Chinensis 1.23kg, FLOS MUME 1.23kg, Vascular aurantii 1.23kg, Fructus Luffae
Network 1.23kg, Radix Glycyrrhizae 1.23kg
Make 5000g
Above ten four Chinese medicines, take Bulbus Lilii 2.8kg, FLOS MUME 1.2kg is ground into fine powder (cross 100 mesh sieves), standby；Remaining is yellow
A kind of reed mentioned in ancient books etc. 12 taste medicine, adds in hot reflux extracting-concentration machine, carries out extracting concentration after soaking 30 minutes.Extract 90 minutes
(after boiling), is concentrated into the clear paste that relative density is 1.2～1.25 (60 DEG C) by filtrate suction concentration tank；By above-mentioned clear paste, medicine
Powder and appropriate amount of starch, carboxymethyl starch sodium, mixing, pill, drying, coating, to obtain final product.
Pulverize and sieve: Bulbus Lilii 2.8kg, FLOS MUME 1.2kg were ground into the fine powder of 100 mesh sieves, rewinding 3.6kg (rewinding
Rate 90%), standby.
Soak:
The 12 taste medical material 23.27kg such as Radix Scutellariae are put in hot reflux extracting-concentration machine, adds the drinking water of medical material amount 8 times
185kg → immersion 30 minutes.
Extract, filter:
After immersion → open 90 minutes (after boiling) → filtrate suction basins of steam generator → heating extraction standby.
Concentrate
Pan-fried extract suction concentration tank → be concentrated to a relative density of 1.2--1.25 (60 DEG C) → Clean paste collecting vehicle is received cream
Standby.Extractum weighs: 4.1kg.Receive cream rate ± 18%.
Pill:
By above-mentioned extractum 4.1kg → addition crude drug fine powder (Bulbus Lilii and FLOS MUME) 3.6kg, starch 0.6kg (extractum amount
15%), carboxymethyl starch sodium 0.4kg (the 10% of extractum amount) → mixing → pill.In order to make pill rounder and more smooth, put into after going out ball
Coating pan rotates, and rotation time is no less than 60 minutes.
Wet ball weight: 8.5kg.
Dry ball
Dry ball after pill at once, hot-air oven is put in wet ball sabot, 60 DEG C of hot-air seasonings.Baking time is 24 hours.
Period variable interval turns over, and makes pill be heated evenly.Ball weight after baking: 5.8kg.
Capping
A ball dried row ball re-detection, according to ball re-computation capping amount, ball after capping is important ask reach every weight ±
0.1g。
Every equal re-detection of ball: ± 0.093g/ grain
Calculating capping amount: 5.8 ÷ 0.93-5.8=0.43kg
Hot-air blower is opened to dry amount of water during capping, ball weight after capping: 7.2kg during capping.
After capping, baking oven is put in ball sabot, added moisture during 60 DEG C of hot-air seasoning cappings.Baking time is 8 hours.Dry
Rear ball weight: 6.1kg.
Select ball
A ball after capping is screened.Respectively select No. 4 sieve and No. 5 sieves, cross No. 4 sieve and only No. 5 sieve be not
Qualified ball, selects defective abnormity ball simultaneously.A diameter of ± the 4.5mm of qualified ball, pill rounding, 10 ball weight ± 1g.Do not conform to
Lattice ball weight 1.2kg；Qualified ball weight 4.9kg.The defective ball selected crosses 100 mesh sieves after pulverizing, standby as capping powder next time.Close
Lattice ball carries out semi-finished product detection, detection content: (1) ball re-detection；(2) moisture detection.Testing result meets wanting of pharmacopeia
Ask: ball weight: ± 1.02g/10 grain；Moisture ± 9.8%.6.5.2.7, coating: a qualified ball is weighed according to the 3% of ball weight
Coating powder 0.15kg → by 10% concentration ratio, coating powder is added purified water 1.5kg, fully dissolves → opens air compressor machine, rotation
Coating pan, unlatching hot-air blower → coating.Weigh after coating: 5.02kg.
Inner packing
Medicinal polyethylene bottle is used to pack, every bottle of 30g, each serving 5g, 3 times on the one.
Experimental example 1
Extraction time and the determination of number of times:
12 taste medical material 3990g, the amount of water 31.L for the first time such as the Radix Scutellariae in addition to Bulbus Lilii and FLOS MUME, decoct 90 minutes；
Amount of water 24L (6 times of medical material amount) for the second time, decoct 60 minutes, determine that extraction time is with secondary according to pan-fried extract (extractum) weight
Number, by test, the results are shown in Table 1.
The medical materials such as table 1 Radix Scutellariae decoct number of times and comparative test result
Result shows:
According to above-mentioned experimental analysis, add water 31L, extracts for the first time 60 minutes and receives cream rate 13%, does not reaches ideal effect；Extract
Within 90 minutes, receiving cream rate 18%, get a desired effect, its effective ingredient extracts substantially completely. and the 24L that adds water makees second time and extracts, and carries
Take 60 minutes receipts cream rates with 90 minutes to be more or less the same, and it is the lowest to receive cream rate, less than 2%, if calculated at cost, can only increase
From production cost, preparation cost, therefore considers that second time is extracted without practical significance.Therefore this technique extraction time is set to
Good；Extraction time is set to latter 90 minutes of boiling, and to ensure enough extraction times, the effective ingredient making Chinese crude drug is the most complete
Put forward, the definite active constituent content ensureing preparation.
Extraction process:
After immersion → open 90 minutes (after boiling) → filtrate suction basins of steam generator → heating extraction standby.
Experimental example 2
The selection of adjuvant:
Starch: (1) is as excipient, it is ensured that go out the mellow and full and anti-bonding of ball when pill；
(2) as filler, to guarantee the accuracy of concentrated pill oral dose.
Carboxymethyl starch sodium: as the disintegrating agent of concentrated pill, with after assisting a ball oral can disintegrate as early as possible, dissolve and inhale
Receive.
Adjuvant is proportion in concentrated pill, see table:
Table 2 adjuvant prescription experiment table
Test result indicate that: physical behavior pelletization and disintegration (II) are preferable than (I), so selecting (II) is at technique
Side.I.e. add amount of starch=extractum amount × 15% during pill；Carboxymethyl starch sodium=extractum amount × 10% is optimal.By repeatedly
Test and monitoring, extractum adds starch and 10% carboxymethyl starch sodium of 15%, fully mixes, energy shaping, pill smoothly, and collapses
Solve the time limit the most lucky.
Experimental example 3
Coating material is selected:
Select gastric solubility film coating pre-mix dose as the coating material of this technique.The ratio of coating material and a ball and bag
The determination of clothing liquid concentration, divides two groups and studies, two groups of coatings carrying out various dose and concentration by every batch each 1000g ball,
Contrast coating effect, to determine optimal proportion.
Coating powder ratio and concentration studies, see table 3:
Table 3 coating powder ratio and concentration studies contrast table
Experimentation shows, prescription 3 is qualified, it is determined as this technology preparation amount, i.e. art for coating selection coating powder consumption is
3%, coating solution concentration is 10%.
Experimental example 4
Embodiment 1 gained pill is carried out clinical therapeutic efficacy monitoring.With reference to " hals,Nasen und Ohrenheilkunde disease that calls for specialized treatment tcm clinical practice is examined
Control " standard, 138 patients with chronic pharyngitis are tracked treatment, are randomly divided into experimental group 75 example, matched group 63 example.Experimental group
Take embodiment 1 gained concentrated pill, each serving 5g, 3 times on the one；Matched group takes Xuanmai Ganju grains, each 10g, every day 3
Secondary.Experimental group and matched group were all a course for the treatment of with 10 days.
Criterion of therapeutical effect:
Recovery from illness: pharyngeal transference cure, pharynx rear wall mucosa recovers normal, and 3 months without recurrence；
Effective: pharyngeal symptom is obviously improved or accidentally occurs curing, and pharyngeal mucosa tends to normal；
Invalid: pharyngeal symptom is not improved, pharyngeal mucosa still congested hypertrophy or dry all without taking a turn for the better.
Therapeutic outcome is as shown in table 4.
Table 4
Claims (9)
1. the preparation method of the concentrated pill treating chronic pharyngitis, it is characterised in that described preparation method comprises the steps:
(1) by weight, following medical material is prepared:
Radix Scutellariae 15 parts, Radix Adenophorae 16 parts, Radix Scrophulariae 16 parts, Bulbus Lilii 16 parts, winter folium mori 12 parts, Folium Eriobotryae (processed) 12 parts, Radix Salviae Miltiorrhizae 12 parts, brocade
15 parts of lantern, FRUCTUS TERMINALIAE IMMATURUS 7 parts, Fructus Schisandrae Chinensis 7 parts, FLOS MUME 7 parts, Vascular aurantii 7 parts, Retinervus Luffae Fructus 7 parts, Radix Glycyrrhizae 7 parts；
(2) Bulbus Lilii and FLOS MUME are ground into fine powder；
(3) add water to 12 taste medicines in addition to Bulbus Lilii and FLOS MUME and soak, carry out heating extraction afterwards；
(4) step (3) gains being concentrated into relative density at 60 DEG C is 1.2-1.25；
(5) step (2) gains, step (4) gains, starch and carboxymethyl starch are received mixing, then carries out pill；Its
In, step (2) gains are 62: 71 with the weight ratio of step (4) gains, and the addition of starch is step (4) gains weight
The 15% of amount, the addition that carboxymethyl starch is received is the 10% of step (4) gains weight；
(6) step (5) gains are dried；
(7) utilize gastric solubility film coating pre-mix dose that step (6) gains are coated process；Wherein, at preparation coating solution
And when being coated process, coating powder is 10: 100 with the weight ratio of purified water, coating powder is 3: 100 with the weight ratio of pill.
Method the most according to claim 1, it is characterised in that in step (2), Bulbus Lilii and FLOS MUME fine powder are not more than
100 mesh.
Method the most according to claim 1, it is characterised in that in step (3), the addition of water is the 6-of medical material gross weight
8 times.
Method the most according to claim 3, it is characterised in that the addition of water is 8 times of medical material gross weight.
Method the most according to claim 1, it is characterised in that in step (3), soak time is 30 minutes.
Method the most according to claim 1, it is characterised in that in step (3), during heating extraction, extraction conditions is boiling
Extract 90 minutes under water.
Step (3) gains are concentrated into 60 by method the most according to claim 1, it is characterised in that in step (4)
At DEG C, relative density is 1.22.
Method the most according to claim 1, it is characterised in that in step (6), when being dried, temperature is 60 DEG C, dry
The dry time is 24 hours.
9. the concentrated pill prepared according to method described in any one of claim 1-9.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709326A (en) * | 2005-06-23 | 2005-12-21 | 修涞贵 | Method for preparing concentrated pill for treating mammary gland proliferation disease |
| CN105709107A (en) * | 2016-04-15 | 2016-06-29 | 罗翼 | Chinese herbal medicine formula for treating chronic pharyngitis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709326A (en) * | 2005-06-23 | 2005-12-21 | 修涞贵 | Method for preparing concentrated pill for treating mammary gland proliferation disease |
| CN105709107A (en) * | 2016-04-15 | 2016-06-29 | 罗翼 | Chinese herbal medicine formula for treating chronic pharyngitis |
Non-Patent Citations (1)
| Title |
|---|
| 黄世敬等: "《中药临床合理应用手册》", 30 April 2009, 金盾出版社 * |
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