CN106138675B - A kind of condensed pill and preparation method thereof for treating chronic pharyngitis - Google Patents
A kind of condensed pill and preparation method thereof for treating chronic pharyngitis Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract
Of the invention provides a kind of condensed pill and preparation method thereof for treating chronic pharyngitis, this method is by weight, select 15 parts of radix scutellariae, 16 parts of adenophora tetraphylla, 16 parts of radix scrophulariae, 16 parts of lily, 12 parts of winter folium mori, 12 parts of honey-fried FOLIUM ERIABOTRYAE, 12 parts of Radix Salviae Miltiorrhizae, 15 parts of wintercherry fruit or calyx, 7 parts of FRUCTUS TERMINALIAE IMMATURUS, 7 parts of Schisandra chinensis, 7 parts of armeniaca mume, 7 parts of tangerine pith, 7 parts of luffa, 7 parts of licorice are used as crude drug, it is extracted by control, concentration and art for coating, good effect is obtained, effective component is fully utilized, it is convenient to take, it can be disintegrated rapidly after taking, the condensed pill for leaching and absorbing.Preparation process of the invention is simple, easy to implement, and 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 field of pharmaceutical engineering, and in particular to a kind of condensed pill and preparation method thereof for treating chronic pharyngitis.
Background technique
Traditional Chinese medicine is generally decoction, and not only not readily portable but also mouthfeel is poor.Chinese medicine preparation is fabricated to and is convenient for
The dosage form for carrying and taking is common way such as pill and capsule.However, carrying out preparation due to the complicated component of Chinese medicine
When, how to select the preparation process for being suitable for property of raw material and how to guarantee that curative effect is unaffected, is to carry out corresponding preparations work
As when the main problem that faces.The Chinese medicine preparation more for raw material components, the above problem are particularly important.
It is less for treating the relevant report of the pill of chronic pharyngitis at present by retrieval, and formula used and preparation side
Method is different, such as " preparation and clinical application of throat soothing relieving sore-throat ball ", " preparation and clinical application that summer ginseng swallows peaceful ball " and " medicine for treating pharyngitis ball
Preparation and clinical application ".
Therefore, find it is a kind of can chronic pharyngitis Chinese medicine preparation with good therapeutic effect will be prepared into be easy to carry about with one and
The method for the pill taken is this field technical problem urgently to be resolved.
Summary of the invention
In view of the shortcomings of the prior art, the purpose of the present invention is to provide a kind of preparations of condensed pill for treating chronic pharyngitis
Method, the preparation method include the following steps:
(1) by weight, prepare following medicinal material:
15 parts of radix scutellariae, 16 parts of adenophora tetraphylla, 16 parts of radix scrophulariae, 16 parts of lily, 12 parts of winter folium mori, 12 parts of honey-fried FOLIUM ERIABOTRYAE, Radix Salviae Miltiorrhizae 12
Part, 15 parts of wintercherry fruit or calyx, 7 parts of FRUCTUS TERMINALIAE IMMATURUS, 7 parts of Schisandra chinensis, 7 parts of armeniaca mume, 7 parts of tangerine pith, 7 parts of luffa, 7 parts of licorice；
(2) lily and armeniaca mume are ground into fine powder；
(3) add water to be impregnated to the 12 taste medicines in addition to lily and armeniaca mume, carry out heating extraction later；
(4) step (3) gains are 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 into mixing, then carries out pill；
Wherein, the weight ratio of step (2) gains and step (4) gains is 62: 71, and the additional amount of starch is step (4) gains
The 15% of weight, the additional amount that carboxymethyl starch is received are the 10% of step (4) gains weight；
(6) step (5) gains are dried；
(7) processing is coated to step (6) gains using gastric solubility film coating pre-mix dose；Wherein, packet is being prepared
Clothing liquid and when being coated processing, the weight ratio of coating powder and purified water is 10: 100, and the weight ratio of coating powder and pellet is 3:
100。
Preferably, in step (2), lily and armeniaca mume fine powder are not more than 100 mesh.
Preferably, in step (3), the additional amount of water is 6-8 times of medicinal material gross weight.It is furthermore preferred that the additional amount of water is
8 times of medicinal material gross weight.
Preferably, in step (3), soaking time is 30 minutes.
Preferably, in step (3), when heating extraction, extraction conditions are to extract 90 minutes under boiling water.
Preferably, in step (4), it is 1.22 that step (3) gains, which are concentrated into relative density at 60 DEG C,.
Preferably, in step (6), when being dried, temperature is 60 DEG C, and drying time is 24 hours.
It is another object of the present invention to provide condensed pills prepared by the above method.
Beneficial effects of the present invention:
1, the present invention has good therapeutic effect to chronic pharyngitis；
2, present invention gained condensed pill improves big traditional Chinese herbal decoction dose, poor taste and patient and swallows difficult disadvantage；
3, present invention gained condensed pill can be disintegrated rapidly after taking, and leached and absorbed, can fully ensure that holding for preparation curative effect
Supervention is waved, and is easy to use；
4, preparation process of the invention is simple, easy to implement, and cost is relatively low, really can adhere to taking for a long time for chronic
Medicine brings the material benefit in price.
Specific embodiment
The present invention is specifically described below by embodiment, it is necessary to which indicated herein is that following embodiment is only used
It is further detailed in the present invention, should not be understood as limiting the scope of the invention, which is skilled in technique
Some nonessential modifications and adaptations that personnel are made according to foregoing invention content, still fall within protection scope of the present invention.
Embodiment 1
Prescription
Radix scutellariae 15g, adenophora tetraphylla 16g, radix scrophulariae 16g, lily 16g, winter folium mori 12g, honey-fried FOLIUM ERIABOTRYAE 12g, Radix Salviae Miltiorrhizae 12g, bright and beautiful lamp
Cage 15g, FRUCTUS TERMINALIAE IMMATURUS 7g, Schisandra chinensis 7g, armeniaca mume 7g tangerine pith 7g, luffa 7g, licorice 7g
Note: above-mentioned prescription is expanded into 30 times (4680g) and is produced:
Radix scutellariae 450g, adenophora tetraphylla 480g, radix scrophulariae 480g, lily 480g, winter folium mori 360g, honey-fried FOLIUM ERIABOTRYAE 360g, Radix Salviae Miltiorrhizae
360g, wintercherry fruit or calyx 450g, FRUCTUS TERMINALIAE IMMATURUS 210g, Schisandra chinensis 210g, armeniaca mume 210g, tangerine pith 210g, luffa 210g, licorice
210g
1000g is made
Lily 0.48kg, armeniaca mume 0.21kg are ground into the fine powder sieved with 100 mesh sieve, rewinding 0.62kg (rewinding rate
90%), spare；
The 12 taste medicinal material 3.99kg such as radix scutellariae is put into hot reflux extracting-concentration machine, 8 times of medicinal material amount of drinking water is added
31kg → immersion 30 minutes.
The 12 taste medicine such as remaining radix scutellariae is added in hot reflux extracting-concentration machine, extracts after soaking in water 30 minutes dense
Contracting.It extracts 90 minutes (after boiling), filtrate suction concentration tank is concentrated into the clear cream that relative density is 1.2~1.25 (60 DEG C)；
By above-mentioned clear cream, medicinal powder and appropriate amount of starch, mixing, pill, drying, coating to get.
Pan-fried extract is pumped into concentration tank → be concentrated to a relative density of 1.2--1.25 (60 DEG C) → clean paste car and receives cream
It is spare.Receive cream rate ± 18%.
1. the condensing mode when extracting is taken in the concentration of this technique, to shorten concentration time, lower production cost.
2. by test we have concluded that: the relative density of medicinal extract is ± 1.22 appropriate after concentration, less than 1.20, medicinal extract
It is too clear, it is greater than 1.30, medicinal extract is excessively old, is unfavorable for pill.The more flowability of medicinal extract when receiving cream temperature 60 C, is convenient for rewinding bucket
It collects.
By above-mentioned medicinal extract 0.71kg, crude drug fine powder (lily and armeniaca mume) 0.62kg and 0.10kg starch, 0.07kg is added
Sodium carboxymethyl starch → mixing → pill → baking ball → capping → selects ball → inspection (ball size, weight, moisture).In order to make ball
Grain is rounder and more smooth, is put into coating pan rotation after ball out, and rotation time is no less than 60 minutes.
Wet ball sabot is put into hot-air oven, 60 DEG C of hot-air seasonings.Baking time is 24 hours.Period is constantly turned over
Disk is heated evenly pellet.
Capping:
Row ball re-detection after a ball is dry, according to ball re-computation capping amount, ball after capping is important ask reach every weight ±
0.1g。
1. calculating: extracting the weighing of 10 balls respectively and take mean value for random 3 times: for the first time: 0.88g/10；Second:
0.86g/10；For the third time: 0.86g/10.3=0.87g/10 every ball counterpoises of (0.88+0.86+0.86) ÷=
Total ball weight known to 0.087g: 1.08kg
If covering flour x, then calculation formula are as follows: a: b=(a+x): c
Wherein: a=ball weight；Every ball weight before b=capping；Required ball weight after c=capping.
Above-mentioned number is substituted into formula to obtain: 1080: 0.087=(1080+x): 0.1
It calculates: x=161.4g=0.16kg
Be computed and obtain: a 1.08kg ball need to add 0.16kg capping powder that can reach every ball 0.1g weight.
2. rotating coating pan when capping, appropriate pure water is added and sufficiently soaks pellet, is slowly added into quantitative capping powder, does not stop
Rotation coating pan bonds pellet sufficiently with fine powder, until the capping powder of calculation amount adds；After pellet light is mellow and full；Lid
Unlatching air-heater is when face to dry amount of water when capping, ball weight after capping: 2.2kg.
3., so still needing to carry out baking ball after capping, the time is no less than 8 hours, a ball because having added suitable pure water when capping
By adequately drying, moisture content gets to the requirement of pharmacopeia.Ball weight after baking ball: 1.24kg.
Select ball:
A ball after capping is screened.No. 4 sieves and No. 5 sieves are selected respectively, cross No. 4 sieves and only No. 5 sieves are not
Qualified ball, while selecting unqualified special-shaped ball.The diameter of qualified ball is ± 4.5mm, pellet rounding, 10 ball weight ± 1g.Do not conform to
Lattice ball weight 0.3kg；Qualified ball weight 0.94kg.The unqualified ball selected smashes it through 100 meshes, spare as next capping powder.
Qualified ball need to carry out semi-finished product detection, detection content: (1) ball re-detection；(2) moisture content detects.Testing result
Reach the requirement of pharmacopeia, next process can be entered.
Coating:
It weighs coating powder → coating powder is proportionally added into purified water sufficiently to dissolve → again according to ball and opens air compressor machine → open
Open air-heater → coating.
Ball weight: 1.0kg coating powder: pure water=0.03 0.94 × 3%=0.028kg × 10=0.028kg
Ball weight=1.0kg after coating
Inner packing:
For convenience of patient's medication, packed using medicinal polyethylene bottle, every bottle of 30g, each taking 5g, 3 times a day.
Sichuan Provincial Academy of Traditional Chinese Medicine has carried out acute toxicity test, conclusion to condensed pill of the present invention are as follows: measures mouse mouthful
The maximal tolerance dose for taking condensed pill is 132.3 crude drug in whole g/kg.Therefore, one consumption per day of condensed pill of the present invention is equivalent to primary crude drug
156g is safe and non-toxic.On this basis, it determines its usage and dosage: taking orally a 5g, three times per day.
Embodiment 2
Pilot scale (expands 175 times by original prescription to be produced, count 27.3kg)
Prescription and preparation method
Radix scutellariae 2.63kg, adenophora tetraphylla 2.8kg, radix scrophulariae 2.8kg, lily 2.8kg winter folium mori 2.1kg honey-fried FOLIUM ERIABOTRYAE 2.1kg,
Radix Salviae Miltiorrhizae 2.1kg, wintercherry fruit or calyx 2.63kg, FRUCTUS TERMINALIAE IMMATURUS 1.23kg, Schisandra chinensis 1.23kg, armeniaca mume 1.23kg, tangerine pith 1.23kg, sponge gourd
Network 1.23kg, licorice 1.23kg
5000g is made
Above ten four traditional Chinese medicine takes lily 2.8kg, armeniaca mume 1.2kg to be ground into fine powder (sieving with 100 mesh sieve), spare；Remaining is yellow
The 12 taste medicine such as a kind of reed mentioned in ancient books is added in hot reflux extracting-concentration machine, extracts concentration after soaking in water 30 minutes.It extracts 90 minutes
Filtrate suction concentration tank is concentrated into the clear cream that relative density is 1.2~1.25 (60 DEG C) by (after boiling)；By above-mentioned clear cream, medicine
Powder and appropriate amount of starch, sodium carboxymethyl starch, mixing, pill, drying, coating to get.
It pulverizes and sieves: lily 2.8kg, armeniaca mume 1.2kg is ground into the fine powder sieved with 100 mesh sieve, rewinding 3.6kg (rewinding
Rate 90%), it is spare.
It soaks in water:
The 12 taste medicinal material 23.27kg such as radix scutellariae is put into hot reflux extracting-concentration machine, 8 times of medicinal material amount of drinking water is added
185kg → immersion 30 minutes.
It extracts, filtering:
After immersion → opening 90 minutes (after boiling) → filtrate of steam generator → heating extraction, to be pumped into basin spare.
Concentration
Pan-fried extract is pumped into concentration tank → be concentrated to a relative density of 1.2--1.25 (60 DEG C) → clean paste car and receives cream
It is spare.Medicinal extract weighs: 4.1kg.Receive cream rate ± 18%.
Pill:
By above-mentioned medicinal extract 4.1kg → addition crude drug fine powder (lily and armeniaca mume) 3.6kg, starch 0.6kg (medicinal extract amount
15%), sodium carboxymethyl starch 0.4kg (the 10% of medicinal extract amount) → mixing → pill.In order to keep pellet rounder and more smooth, it is put into after ball out
Coating pan rotation, rotation time are no less than 60 minutes.
Wet ball weight: 8.5kg.
Dry ball
Ball is dried after pill at once, wet ball sabot is put into hot-air oven, 60 DEG C of hot-air seasonings.Baking time is 24 hours.
Period not timing turns over, and is heated evenly pellet.Ball weight after baking: 5.8kg.
Capping
Row ball re-detection after a ball is dry, according to ball re-computation capping amount, ball after capping is important ask reach every weight ±
0.1g。
The equal re-detection of every ball: ± 0.093g/
Calculate capping amount: 5.8 ÷ 0.93-5.8=0.43kg
Unlatching air-heater is when capping to dry amount of water when capping, ball weight after capping: 7.2kg.
Ball sabot is put into baking oven after capping, whens 60 DEG C of hot-air seasoning cappings added moisture.Baking time is 8 hours.It dries
Ball weight afterwards: 6.1kg.
Select ball
A ball after capping is screened.No. 4 sieves and No. 5 sieves are selected respectively, cross No. 4 sieves and only No. 5 sieves are not
Qualified ball, while selecting unqualified special-shaped ball.The diameter of qualified ball is ± 4.5mm, pellet rounding, 10 ball weight ± 1g.Do not conform to
Lattice ball weight 1.2kg；Qualified ball weight 4.9kg.The unqualified ball selected smashes it through 100 meshes, spare as next capping powder.It closes
Lattice ball carries out semi-finished product detection, detection content: (1) ball re-detection；(2) moisture content detects.Testing result meets wanting for pharmacopeia
It asks: ball weight: ± 1.02g/10；Moisture ± 9.8%.6.5.2.7, it is coated: a qualified ball is weighed according to the 3% of ball weight
Coating powder 0.15kg → by coating powder by 10% concentration ratio be added purified water 1.5kg, abundant dissolution → unlatching air compressor machine, rotation
Coating pan opens air-heater → coating.It weighs after coating: 5.02kg.
Inner packing
It is packed using medicinal polyethylene bottle, every bottle of 30g, each taking 5g, 3 times a day.
Experimental example 1
The determination of extraction time and number:
12 taste medicinal material 3990g, the first time amount of water 31.L such as radix scutellariae in addition to lily and armeniaca mume are decocted 90 minutes；
Second of amount of water 24L (6 times of medicinal material amount), decoct 60 minutes, according to pan-fried extract (medicinal extract) weight determine extraction time and time
Number the results are shown in Table 1 by test.
The medicinal materials such as 1 radix scutellariae of table decoct number and comparative test result
The result shows that:
According to above-mentioned experimental analysis, adds water 31L, extract 60 minutes receipts cream rates 13% for the first time, do not reach ideal effect；It extracts
90 minutes receipts cream rates 18%, get a desired effect, and effective component extracts complete substantially and water 24L is added to make second of extraction, mention
It takes 60 minutes and 90 minutes receipts cream rates is not much different, and receipts cream rate is very low, less than 2%, if calculated at cost, can only increase
Preparation cost, therefore consider to extract without practical significance for second from production cost.Therefore this technique extraction time is set to once most
It is good；Extraction time is set to after boiling 90 minutes, to guarantee enough extraction times, keeps the effective component of Chinese medicine as complete as possible
Put forward, the definite active constituent content for ensureing preparation.
Extraction process:
After immersion → opening 90 minutes (after boiling) → filtrate of steam generator → heating extraction, to be pumped into basin spare.
Experimental example 2
The selection of auxiliary material:
Starch: (1) it is used as excipient, guarantees the mellow and full and anti-bonding of ball out in pill；
(2) it is used as filler, to ensure the accuracy of condensed pill oral dose.
Sodium carboxymethyl starch: as the disintegrating agent of condensed pill, to assist to be disintegrated as early as possible, dissolve and inhaling after a ball is oral
It receives.
Auxiliary material proportion in condensed pill, see the table below:
2 auxiliary material prescription of table tests table
The results showed that physical behavior pelletization and disintegration time limited (II) are preferably than (I), so selecting (II) is at technique
Side.I.e. pill when be added amount of starch=medicinal extract amount × 15%；Sodium carboxymethyl starch=medicinal extract amount × 10% is best.By repeatedly
Test and monitoring, medicinal extract are added 15% starch and 10% sodium carboxymethyl starch, mix well, energy smooth shaping, pill, and collapse
It is also lucky to solve the time limit.
Experimental example 3
Coating material is selected:
Select coating material of the gastric solubility film coating pre-mix dose as this technique.The ratio and packet of coating material and a ball
The determination of clothing liquid concentration is divided to two groups to be studied, two groups of coatings by the every batch of each progress of 1000g ball various dose and concentration,
Coating effect is compared, to determine optimal proportion.
Coating powder ratio and concentration studies, see the table below 3:
3 coating powder ratio of table and concentration studies contrast table
Experimental study shows that prescription 3 is qualified, it is determined as this technology preparation amount, i.e. art for coating select the coating powder dosage to be
3%, coating solution concentration is 10%.
Experimental example 4
Clinical therapeutic efficacy monitoring is carried out to 1 gained pill of embodiment.Referring to " hals,Nasen und Ohrenheilkunde disease that calls for specialized treatment tcm clinical practice is examined
Control " standard, tracking treatment is carried out to 138 patients with chronic pharyngitis, is randomly divided into experimental group 75, control group 63.Experimental group
1 gained condensed pill of embodiment is taken, each taking 5g, 3 times a day；Control group takes Xuanmai Ganju grains, each 10g, and daily 3
It is secondary.Experimental group and control group are with 10 days as one therapeutic course.
Criterion of therapeutical effect:
Recovery from illness: pharyngeal symptom disappears, and pharynx rear wall mucous membrane restores normal, and 3 months without recurrence；
Effective: pharyngeal symptom is obviously improved or accidentally cures, and pharyngeal mucous membrane tends to be normal；
Invalid: pharyngeal symptom is not improved, pharyngeal mucous membrane still congested hyperplasia or dry without improvement.
Treatment results are as shown in table 4.
Table 4
Claims (9)
1. a kind of preparation method for the condensed pill for treating chronic pharyngitis, which is characterized in that the preparation method includes the following steps:
(1) by weight, prepare following medicinal material:
15 parts of radix scutellariae, 16 parts of adenophora tetraphylla, 16 parts of radix scrophulariae, 16 parts of lily, 12 parts of winter folium mori, 12 parts of honey-fried FOLIUM ERIABOTRYAE, 12 parts of Radix Salviae Miltiorrhizae, brocade
15 parts of lantern, 7 parts of FRUCTUS TERMINALIAE IMMATURUS, 7 parts of Schisandra chinensis, 7 parts of armeniaca mume, 7 parts of tangerine pith, 7 parts of luffa, 7 parts of licorice；
(2) lily and armeniaca mume are ground into fine powder；
(3) add water to be impregnated to the 12 taste medicines in addition to lily and armeniaca mume, carry out heating extraction later；
(4) step (3) gains are 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 into mixing, then carries out pill；Its
In, the weight ratio of step (2) gains and step (4) gains is 62: 71, and the additional amount of starch is step (4) gains weight
The 15% of amount, the additional amount that carboxymethyl starch is received are the 10% of step (4) gains weight；
(6) step (5) gains are dried；
(7) processing is coated to step (6) gains using gastric solubility film coating pre-mix dose；Wherein, coating solution is being prepared
And when being coated processing, the weight ratio of coating powder and purified water is 10: 100, and the weight ratio of coating powder and pellet is 3: 100.
2. the method according to claim 1, wherein lily and armeniaca mume fine powder are not more than in step (2)
100 mesh.
3. the method according to claim 1, wherein the additional amount of water is the 6- of medicinal material gross weight in step (3)
8 times.
4. according to the method described in claim 3, it is characterized in that, the additional amount of water is 8 times of medicinal material gross weight.
5. the method according to claim 1, wherein soaking time is 30 minutes in step (3).
6. the method according to claim 1, wherein in step (3), when heating extraction, extraction conditions are boiling
It is underwater to extract 90 minutes.
7. the method according to claim 1, wherein step (3) gains are concentrated into 60 in step (4)
Relative density is 1.22 at DEG C.
8. being done the method according to claim 1, wherein when being dried, temperature is 60 DEG C in step (6)
The dry time is 24 hours.
9. the condensed pill that any one of -8 the methods are prepared according to claim 1.
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| 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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| 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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