CN104147077A - Preparation method of traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving - Google Patents
Preparation method of traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving Download PDFInfo
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Abstract
The invention discloses a preparation method of a traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving. The traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving contains glabrous sarcandra herb, honeysuckle flower and menthol, and the dosage form of the traditional Chinese medicinal preparation can be a tablet, a capsule, a granule or a pill. A clarifier is used in the preparation method, the clarifier can complex and precipitate proteins, tannins, phlegmatic temperaments and gums, the clearance rate can reach above 90%, and active components in medicines, such as polysaccharides, glycosides, alkaloids and amino acids are not complexed and are retained in an extract liquid, so the extract liquid contains a high content of the effective components and has high purity. A test result shows that the content of the effective components in the tablet can be increased by above 25%.
Description
Technical field
The invention belongs to field of traditional Chinese, particularly a kind of preparation method of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation.
Background technology
In Chinese patent ZL200410012694.7, disclose a kind of preparation of relieving sore throat and pain, said preparation has wind and heat dispersing, removing toxic substances and promoting subsidence of swelling, and the effect of relieving sore throat and pain, has good curative effect to treatment acute pharyngitis due to wind-heat and the anxious larynx of anemopyretic.But because the preparation technology of described relieving sore throat and pain preparation is perfect not, its effective ingredient cohort content is low, and the quality of the pharmaceutical preparations is stable not, and finished product storage process is easily affected by environment, very large on product large-scale production impact.Wherein, in preparation, contain Mentholum composition, in existing preparation technology, Mentholum alcoholic solution is sprayed in granule to mix homogeneously.The vexed appropriate time tabletting again of putting, in products storage process, temperature drift is just easy to crystallization, user is thought by mistake and be mildew, affect product quality and sale.
In sum, at present, on market, be badly in need of a kind of active constituent content high, evident in efficacy, and the relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of preparation stabilization.
Summary of the invention
The preparation method that the object of this invention is to provide a kind of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae and Mentholum, and in described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2.Function cures mainly: dispelling wind is antipyretic, relieving sore throat and pain, can improve that throat dry burns, pain, and the symptoms such as hoarseness are a kind of safe and reliable, pure Chinese medicinal preparations of effectively treating acute/chronic pharyngitis.
The object of the invention is to be achieved through the following technical solutions:
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is tablet, and preparation process is as follows:
I. raw material pre-treatment:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10～1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.02; Described clear paste mixture is carried out to pelletization treatment, dried, the clear paste compound particles obtaining;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing, tabletting processing, Cotton seeds successively, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation tablet finished product;
The weight ratio of described granule, Pulvis Talci, magnesium stearate is 100:1～3:0.15～0.3.
Another object of the present invention is achieved through the following technical solutions:
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is capsule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10～1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.05; Described clear paste mixture is carried out to pelletization treatment, dried, the clear paste compound particles obtaining;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing successively, obtain capsule 's content; Described granule, the weight ratio of magnesium stearate are 100:0.15～0.5;
Described capsule 's content is incapsulated in housing, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation capsule finished product.
Another object of the present invention is achieved through the following technical solutions:
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is granule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 55 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain medicinal liquid, the relative density that described medicinal liquid is measured under 55 ℃ of conditions is 1.08～1.10;
G. described medicinal liquid is carried out to spray drying treatment, obtain dried cream powder;
II. finished product preparation:
Described dried cream powder and lactose, cane sugar powder are mixed to processing, pelletization treatment successively, obtain granule, be the agent of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation granules;
The weight ratio of described dried cream powder, lactose, cane sugar powder is 1:0.05～0.1:0.01～0.02.
Another object of the present invention is achieved through the following technical solutions:
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is drop pill, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10～1.20;
G. will in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%～70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment, concentration successively containing alcohol clear paste, obtain thick paste, the relative density that described thick paste is measured under 75 ℃ of conditions is 1.25～1.30; The described cold preservation processing time is 30～40 hours;
II. finished product preparation:
Described thick paste, polyethylene glycol 6000 fused mass are mixed to processing, then splash in cooling liquid paraffin, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation drop pill;
The weight ratio of described thick paste, Mentholum fine powder, polyethylene glycol 6000 is 1:0.01～0.03:0.02～0.025.
Another object of the present invention is achieved through the following technical solutions:
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is oral liquid, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10～1.20;
G. in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%%～70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively containing alcohol clear paste, obtain dealcoholysis clear paste; The described cold preservation processing time is 30～40 hours;
II. finished product preparation:
To in described dealcoholysis clear paste, add cane sugar powder, active carbon, carry out successively heat treated, filtration treatment, dilution process, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product; Described dealcoholysis clear paste and the weight ratio of cane sugar powder are 1:0.1～0.3; Described dealcoholysis clear paste and the weight ratio of active carbon are 1:0.001～0.002;
Described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product are carried out to filtration treatment, minute tank processing, sterilization treatment successively, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation oral liquid finished product.
Described clarifier is a kind of native compound 1+1, there is the effect of " complexation " protein, the matter of trampling on, lymphatic temperament, natural gum Precipitation, clearance rate can reach more than 90%, and active component is not retained in extracting solution by " complexation " as polysaccharide, glycoside, alkaloid, aminoacid etc., extracting solution impurity reduces, extract effective ingredient improves, and can improve effective group content.
Described clarifier adds at twice, and the addition of twice is respectively and is 2%, and the concentrated solution of every 100L adds clarifier 2kg.
The present invention's beneficial effect is compared to existing technology:
1, in the preparation method of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of the present invention, used clarifier, described clarifier has conjugated protein matter, tannin, phlegmatic temperament, natural gum and by the effect of its Precipitation, clearance rate can reach more than 90%, and active component in medicine is as polysaccharide, glycoside, alkaloid, aminoacid etc., but can be retained in extracting solution by complexation, make like this that active constituent content in extracting solution is high, purity is high, experiment results proved, in tablet, the content of effective ingredient can improve more than 25%;
2, clarifier of the present invention belongs to nontoxic food additive, in clarifying process, remove the magazine in extracts of Chinese herbal medicine, both can instead of ethanol, although and overcome ethanol can Precipitation protein, natural gum, phlegmatic temperament (clearance approximately 50%～70%), but simultaneously also can Precipitation polysaccharide, the shortcoming of the effective ingredient such as saponin, alkaloid, simultaneously than the cost with ethanol Precipitation magazine more than 60%;
3, in the preparation method of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of the present invention, described Mentholum adopts method with slurry to add in thick paste and granulates, Mentholum is embedded in thick paste granule completely, be not vulnerable to temperature impact, effectively solved the phenomenon that Mentholum temperature drift in original product is just easy to crystallization, the product obtaining by preparation method of the present invention, deposit 2 years under rated condition, there is no crystallization, constant product quality;
4, the Chinese medicine preparation that utilizes the preparation method of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of the present invention to prepare, extract active component significantly improves, main active isofraxidin, chlorogenic acid, content all more traditional preparation technology improves more than 25%;
5, the preparation method of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of the present invention, product quality controllability is strong, quality stability improves greatly, has reduced production cost simultaneously, is applicable to market demand.
Accompanying drawing explanation
Fig. 1,4 is the liquid chromatogram of isofraxidin reference substance, and A, B are two groups of parallel tests;
Fig. 2, Fig. 3 are the liquid chromatogram of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation tablet samples of the present invention, and A, B are two groups of parallel tests;
Fig. 5, Fig. 6 are the liquid chromatogram of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation capsule sample of the present invention, and A, B are two groups of parallel tests.
The specific embodiment
Embodiment 1
A preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000～1600:300～1200:0～2;
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is tablet, and preparation process is as follows:
I. raw material pre-treatment:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10～1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.02; Described clear paste mixture is carried out to pelletization treatment, dried, the clear paste compound particles obtaining;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing, tabletting processing, Cotton seeds successively, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation tablet finished product;
The weight ratio of described granule, Pulvis Talci, magnesium stearate is 100:1～3:0.15～0.3.
In the present embodiment, the consumption of each raw material of described relieving sore-throat by clearing away heat Chinese medicine preparation can be in the ratio range providing flexible combination, at this, do not enumerate one by one;
In the present embodiment, each raw material in described relieving sore-throat by clearing away heat Chinese medicine preparation is conventional products, and the office that all can and be correlated with in market buys and obtains;
In the present embodiment, equipment used is conventional equipment, all can on market, buy and obtain;
In the present embodiment, the overall process of described preparation method is carried out in drug's GMP workshop;
In the present embodiment, discriminating and the assay of isofraxidin (C11H1005), meet the requirement of the standard WS-5402 of National Drug Administration (B-0402)-2002.Utilize high performance liquid chromatograph (U.S. scientific system SSI Alliance, 310SFT05EV) to measure the content of described effective ingredient.
As shown in Figure 1, isofraxidin reference substance concentration is 5.1 μ g/ml, and the first pin peak area is that 160885.000, the second pin peak areas are 160148.000, and average peak area is 160516.500; As shown in Figure 2, sample 1 sampling 2.0010g, the first pin peak area is that 126681.000, the second pin peak areas are 125957.000; As shown in Figure 3, sample 2 sampling 2.0035g, the first pin peak area is that 126083.000, the second pin peak areas are 127531.000.
Computing formula:
In every tablet of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation tablet, contain the amount of isofraxidin
Wherein, A
xsample peak area, A
rreference substance peak area, C
rreference substance concentration, W sample volume.
According to computing formula, obtain sample 1 first pin Determination of isofraxidin 0.0202mg/ sheet, the second pin 0.0200mg/ sheet; Sample 2 first pin Determination of isofraxidin 0.0200mg/ sheets, the second pin 0.0203mg/ sheet; Therefore average content 0.020mg/ sheet, RSD is 0.54%.
Described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the effect of tool wind and heat dispersing, removing toxic substances and promoting subsidence of swelling, relieving sore throat and pain.For verifying its curative effect, Yi Fu institute of Colleges Of Traditional Chinese Medicine Of Guangxi, the People's Hospital's outpatient service of Er Fuyuanhe Guangxi District have been carried out clinical verification in October, 2013-December to 60 routine patients, and result is summarized as follows:
Clinical data
Treatment group and matched group be totally 180 examples, and 20 examples are respectively observed by Yi Fu institute of Colleges Of Traditional Chinese Medicine Of Guangxi, the People's Hospital, Er Fuyuanhe Guangxi District.
One, physical data
The object of observation of being included in is 18～65 years old, and Chinese medical discrimination belongs to the acute pharyngitis patient of acute pharyngitis due to wind-heat, or Chinese medical discrimination belongs to the acute laryngitis patient of anemopyretic acute hoarseness.Treatment group 60 examples, are used described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation.Matched group 30 examples, are used FUFANG CAOSHANHU HANPIAN.Two groups of sexes, age distribution there are no significant difference (P > 0.05 is in Table 1).
(1) tcm diagnosis standard:
1, acute pharyngitis due to wind-heat: pharyngalgia, dryness and heat, mouthful micro-thirsty, heating, slight chill, pharyngeal mild hyperaemia edema.Tongue tip side of red, white and thin fur, floating and rapid pulse.
2, acute hoarseness (anemopyretic): uncomfortable in larynx, dry itching and coughing, sound is low and thick, and it is unfavorable that sound goes out, or in larynx, have scorching hot pain, can and see heating, the diseases such as aversion to cold, headache, limbs are indolent and listless, arthralgia.Tongue limit is micro-red, Tai Bai or the Huang of holding concurrently, floating and rapid pulse.
(2) Western medicine diagnose standard:
1, acute pharyngitis:
(1) often have suffer from cold, tired, tobacco and wine are excessive, the inducements such as stimulation of various physics and chemistries.
(2) more anxious, pharyngeal dry, scorching hot, the pain of onset or odynophagia, heating, fear of cold, inappetence, extremities aching pain.
(3) check: pharyngeal mucosa is congested, and color is scarlet, pharynx rear wall lymph follicle and lateral pharyngeal band are red and swollen, local or have Huang, white secretions to adhere to; Uvula, soft palate edema; Throat swab is cultivated can pathogenic bacterium or feminine gender.
2, acute laryngitis:
(1) be common in after flu, concurrent with acute rhinitis, pharyngitis etc.Can because of by the excessive throat of sound wound, suck high heat steam and chemical gas etc. and cause, tobacco and wine excessively can bring out.
(2) cardinal symptom is hoarseness, laryngeal stridor, and throat is dry itches, pain and dry cough.Severe one heating, fear of cold, tired, inappetence.
(3) laryngoscopy: mucosa diffusivity is congested, swelling, sometimes has vocal cord dysraphism, and surface is with thick secretions.
More than possess part or all of symptom, and have 1 or 2 above finding positive signs that check, diagnosable.
Observational technique
Observe altogether 90 examples, be divided at random 2 groups.Wherein treatment group 60 examples, are used described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation.Matched group 30 examples, the FUFANG CAOSHANHU HANPIAN of using Jiangzhong Pharmaceutical Factory, Jiangxi Prov to produce.Usage and consumption are: per half an hour, buccal was 1 time, each 1, every day 10 times, was used in conjunction 7 days.Test front routine patient is made to detailed physical examination, survey peripheral blood leucocyte, test is inquired medicining condition respectively with examining 1 time in latter the 3rd, 5,7 days, records the state of an illness and side effect.Finish rear check peripheral blood leucocyte the course for the treatment of.Therapeutic effect is evaluated with scoring method.Efficacy determination is directly made by observer.Viewing duration is without other drug.
Result
One, efficacy assessment standard:
1, clinical recovery: medication alleviates with interior symptom for 3 days, disappears with interior clinical symptoms and sign for 5 days.
2, effective: medication alleviates with interior symptom for 5 days.Most of sign disappears.
3, effective: medication alleviates with interior symptom for 5 days, part sign disappears.
4, invalid: medication disappears with interior clinical symptoms and the sign of can not making for 1 week.
Two, therapeutic outcome:
1, before and after the treatment of witness integration, compare: in Table 2.
2, before and after peripheral blood WBC treatment, compare: in Table 2.
3, treatment group and the comparison of matched group curative effect: in Table 3.
Side effect
Treatment group 60 examples, matched group 30 examples, all do not find obvious adverse reaction and toxic and side effects at viewing duration.
Model case
Example 1, Lee, women, 23 years old.Because pharyngalgia is gone to a doctor on November 11st, 2013 for 3 days.Card is shown in that pharyngalgia while swallowing, dry pharynx are scorching hot.Check: T37.5 ℃, pharynx rear wall and the obvious congested flushing of lateral pharyngeal band, both sides tonsil is little, red tongue, white and thin fur, floating and rapid pulse.Tcm diagnosis: sore throat (wind-heat syndrome).Western medicine diagnose: acute pharyngitis.Give described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation for treating, per half an hour, buccal was 1 time, and each 1, every day 10 times.Be used in conjunction 7 days.After heat in 3 days is moved back, and temperature recovery is normal, and the scorching hot and pharyngeal hyperemia of pharyngalgia dry pharynx alleviates.After 5 days, pharyngalgia dry pharynx disappears, pharyngeal without congested, efficacy evaluation: recovery from illness.
Example 2, Zhang, women, 32 years old.Because of uncomfortable in larynx, hoarseness is gone to a doctor on October 20th, 2013 for 2 days.Card is shown in: uncomfortable in larynx, and hoarseness.Check: T37.5 ℃ of vocal cords are obviously congested over false vocal cord, reach under glottis.Red tongue, yellow and thin fur, floating pulse is number slightly.Tcm diagnosis is acute hoarseness (wind-heat syndrome).Give described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation for treating.After 3 days, symptom alleviates, and after 5 days, temperature recovery is normal, and vocal congestion alleviates, the transference cure such as discomfort, hoarseness in larynx after 7 days, and vocal cords are without hyperemia.Efficacy evaluation: effective.
Discuss and sum up
1, relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, through 60 routine clinical observations, and FUFANG CAOSHANHU HANPIAN 30 examples of producing with Jiangzhong Pharmaceutical Factory, Jiangxi Prov are made positive control.Result proves, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation has good therapeutical effect to acute pharyngitis due to wind-heat and anemopyretic acute hoarseness, uncomfortable in patient's pharyngalgia, dry pharynx, heating, larynx after treatment, the diseases such as hoarseness are obviously improved (P < 0.01, in Table 2), the described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation of prompting has wind and heat dispersing, the effect of removing toxic substances and promoting subsidence of swelling, relieving sore throat and pain.
2, this organizes 60 examples, and the effective percentage for the treatment of acute pharyngitis due to wind-heat and anemopyretic acute hoarseness is respectively 96.7% and 96.7%.Matched group 30 examples, total effective rate is respectively 83.3% and 80%.Two groups of curative effects, relatively without significant difference (P > 0.05 is in Table 3), point out described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation for treating acute pharyngitis due to wind-heat and anemopyretic acute hoarseness curative effect consistent with FUFANG CAOSHANHU HANPIAN.
3, relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation safety is reliable, without obvious adverse reaction and toxic and side effects.
Table 1 treatment group and matched group sex, age
relatively
Note: two groups of equal > 0.05 of comparison P value.
Before and after table 2 witness integration and peripheral blood WBC (10P/L) treatment, compare
Note: compare * * P < 0.01 before and after treatment
Table 3 treatment group and the comparison of matched group curative effect (Ridit analysis)
Embodiment 2
The present embodiment is another preferred version on embodiment 1 basis, and the dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is capsule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10～1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.05; Described clear paste mixture is carried out to pelletization treatment, dried, the clear paste compound particles obtaining;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing successively, obtain capsule 's content; Described granule, the weight ratio of magnesium stearate are 100:0.15～0.5;
Described capsule 's content is incapsulated in housing, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation capsule finished product.
As shown in Figure 4, isofraxidin reference substance concentration is 3.68 μ g/ml, and the first pin peak area is that 123379.000, the second pin peak areas are 122869.000, and average peak area is 123124.000; As shown in Figure 5, sample 1 sampling 2.0089g, the first pin peak area is that 211365.000, the second pin peak areas are 210769.000; As shown in Figure 6, sample 2 sampling 2.0125g, the first pin peak area is that 215752.000, the second pin peak areas are 215174.000.
Computing formula:
In every described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation capsule, contain the amount of isofraxidin
Wherein, A
xsample peak area, A
rreference substance peak area, C
rreference substance concentration, W sample volume.According to computing formula, obtain sample 1 first pin Determination of isofraxidin 0.0318mg/g, the second pin 0.0317mg/g; Sample 2 first pin Determination of isofraxidin 0.0324mg/g, the second pin 0.0324mg/g; Therefore average content 0.032mg/g, RSD is 1.10%.
Embodiment 3
The present embodiment is another preferred version on embodiment 1 basis, and the dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is granule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 55 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain medicinal liquid, the relative density that described medicinal liquid is measured under 55 ℃ of conditions is 1.08～1.10;
G. described medicinal liquid is carried out to spray drying treatment, obtain dried cream powder;
II. finished product preparation:
Described dried cream powder and lactose, cane sugar powder are mixed to processing, pelletization treatment successively, obtain granule, be the agent of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation granules;
The weight ratio of described dried cream powder, lactose, cane sugar powder is 1:0.05～0.1:0.01～0.02.
Embodiment 4
The present embodiment is another preferred version on embodiment 1 basis, and the dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is drop pill, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10～1.20;
G. will in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%～70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment, concentration successively containing alcohol clear paste, obtain thick paste, the relative density that described thick paste is measured under 75 ℃ of conditions is 1.25～1.30; The described cold preservation processing time is 30～40 hours;
II. finished product preparation:
Described thick paste, polyethylene glycol 6000 fused mass are mixed to processing, then splash in cooling liquid paraffin, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation drop pill;
The weight ratio of described thick paste, Mentholum fine powder, polyethylene glycol 6000 is 1:0.01～0.03:0.02～0.025.
Embodiment 5
The present embodiment is another preferred version on embodiment 1 basis, and the dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is oral liquid, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1～2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1～2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10～1.20;
G. in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%%～70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively containing alcohol clear paste, obtain dealcoholysis clear paste; The described cold preservation processing time is 30～40 hours;
II. finished product preparation:
To in described dealcoholysis clear paste, add cane sugar powder, active carbon, carry out successively heat treated, filtration treatment, dilution process, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product; Described dealcoholysis clear paste and the weight ratio of cane sugar powder are 1:0.1～0.3; Described dealcoholysis clear paste and the weight ratio of active carbon are 1:0.001～0.002;
Described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product are carried out to filtration treatment, minute tank processing, sterilization treatment successively, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation oral liquid finished product.
Claims (7)
1. a preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000 ~ 1600:300 ~ 1200:0 ~ 2; It is characterized in that:
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is tablet, and preparation process is as follows:
I. raw material pre-treatment:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1 ~ 2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1 ~ 2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10 ~ 1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.02; Described clear paste mixture is carried out to pelletization treatment, dried, obtain clear paste compound particles;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing, tabletting processing, Cotton seeds successively, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation tablet finished product;
The weight ratio of described granule, Pulvis Talci, magnesium stearate is 100:1～3:0.15～0.3.
2. a preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000 ~ 1600:300 ~ 1200:0 ~ 2; It is characterized in that:
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is capsule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1 ~ 2 hour, merge and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1 ~ 2 hour, and filter, obtain clear filtrate;
F. under 70 ℃ of conditions, it is 1.10 ~ 1.20 that described clear filtrate is evaporated to relative density, obtains clear paste;
G. described clear paste and starch are mixed to processing, obtain clear paste mixture; Described clear paste and the weight ratio of starch are 1:0.01～0.05; Described clear paste mixture is carried out to pelletization treatment, dried, the clear paste compound particles obtaining;
II. finished product preparation:
A. described granule and Pulvis Talci, magnesium stearate are mixed to processing successively, obtain capsule 's content; Described granule, the weight ratio of magnesium stearate are 100:0.15～0.5;
Described capsule 's content is incapsulated in housing, obtain relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation capsule finished product.
3. a preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000 ~ 1600:300 ~ 1200:0 ~ 2; It is characterized in that:
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is granule, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1 ~ 2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1 ~ 2 hour, and filter, obtain clear filtrate;
F. under 55 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain medicinal liquid, the relative density that described medicinal liquid is measured under 55 ℃ of conditions is 1.08～1.10;
G. described medicinal liquid is carried out to spray drying treatment, obtain dried cream powder;
II. finished product preparation:
Described dried cream powder and lactose, cane sugar powder are mixed to processing, pelletization treatment successively, obtain granule, be the agent of relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation granules;
The weight ratio of described dried cream powder, lactose, cane sugar powder is 1:0.05～0.1:0.01～0.02.
4. a preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000 ~ 1600:300 ~ 1200:0 ~ 2; It is characterized in that:
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is drop pill, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1 ~ 2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1 ~ 2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10 ~ 1.20;
G. will in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%～70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment, concentration successively containing alcohol clear paste, obtain thick paste, the relative density that described thick paste is measured under 75 ℃ of conditions is 1.25～1.30; The described cold preservation processing time is 30～40 hours;
II. finished product preparation:
Described thick paste, polyethylene glycol 6000 fused mass are mixed to processing, then splash in cooling liquid paraffin, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation drop pill;
The weight ratio of described thick paste, Mentholum fine powder, polyethylene glycol 6000 is 1:0.01～0.03:0.02～0.025.
5. a preparation method for relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation contains Herba Sarcandrae, Flos Lonicerae, Mentholum; In described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation, the weight ratio of each raw material is: 1000 ~ 1600:300 ~ 1200:0 ~ 2; It is characterized in that:
The dosage form of described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation is oral liquid, and preparation process is as follows:
I. raw material is processed:
A. described Herba Sarcandrae, Flos Lonicerae are shredded respectively, obtain Herba Sarcandrae fragment, Flos Lonicerae fragment;
B. described Flos Lonicerae fragment, Herba Sarcandrae fragment are carried out respectively to twice decoction processing, obtain respectively Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid; During twice described decoction processed, the weight ratio of the weight ratio of Flos Lonicerae fragment and water and Herba Sarcandrae fragment and water is 1:5～15; The time that twice decoction processed is 1～3 hour; Mentholum dissolve with ethanol by described, obtains Mentholum solution;
Described Flos Lonicerae decocting liquid, Herba Sarcandrae decocting liquid and Mentholum solution are merged, obtain total decocting liquid;
C. described total decocting liquid is carried out to concentrating under reduced pressure 6-10 doubly, obtain concentrated solution;
D. in described concentrated solution, add clarifier, standing 1 ~ 2 hour, and filter, obtain primary filtrate;
E. heat described primary filtrate, again add clarifier, standing 1 ~ 2 hour, and filter, obtain clear filtrate;
F. under 85 ℃ of conditions, described clear filtrate is carried out to filtration treatment, concentration successively, obtain clear paste, the relative density that described clear paste is measured under 85 ℃ of conditions is 1.10 ~ 1.20;
G. in described clear paste, add ethanol, obtain containing alcohol clear paste, described is 65%% ~ 70% containing alcohol clear paste containing alcohol amount; Described carried out to cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively containing alcohol clear paste, obtain dealcoholysis clear paste; The described cold preservation processing time is 30 ~ 40 hours;
II. finished product preparation:
To in described dealcoholysis clear paste, add cane sugar powder, active carbon, carry out successively heat treated, filtration treatment, dilution process, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product; Described dealcoholysis clear paste and the weight ratio of cane sugar powder are 1:0.1 ~ 0.3; Described dealcoholysis clear paste and the weight ratio of active carbon are 1:0.001 ~ 0.002;
Described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation semi-finished product are carried out to filtration treatment, minute tank processing, sterilization treatment successively, obtain described relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation oral liquid finished product.
6. according to the preparation method of the relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation described in claim 1 ~ 5, it is characterized in that, described clarifier is native compound 1+1.
7. according to the preparation method of the relieving sore-throat by clearing away heat Traditional Chinese medicine used as analgesic preparation described in claim 1 ~ 5, it is characterized in that, described clarifier adds at twice, and the addition of twice is 2%, and the concentrated solution of every 100L adds clarifier 2kg.
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| CN104897789A (en) * | 2015-03-17 | 2015-09-09 | 广西昌弘制药有限公司 | Quality control method for sore-throat-relieving and pain-relieving preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101810766A (en) * | 2010-04-14 | 2010-08-25 | 深圳市永安堂医药有限公司 | Chinese medicinal composition and preparation method and application thereof |
| CN101879211A (en) * | 2010-07-23 | 2010-11-10 | 阙锋 | Chinese medicinal preparation for clearing heat, relieving sore-throat and stopping pain and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810766A (en) * | 2010-04-14 | 2010-08-25 | 深圳市永安堂医药有限公司 | Chinese medicinal composition and preparation method and application thereof |
| CN101879211A (en) * | 2010-07-23 | 2010-11-10 | 阙锋 | Chinese medicinal preparation for clearing heat, relieving sore-throat and stopping pain and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104897789A (en) * | 2015-03-17 | 2015-09-09 | 广西昌弘制药有限公司 | Quality control method for sore-throat-relieving and pain-relieving preparation |
| CN104897789B (en) * | 2015-03-17 | 2018-07-13 | 广西昌弘制药有限公司 | A kind of method of quality control of the preparation of relieving sore throat and acesodyne |
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Application publication date: 20141119 |