CN111467423B - Honeysuckle flower and lotus root heat-clearing spray and preparation method thereof - Google Patents

Honeysuckle flower and lotus root heat-clearing spray and preparation method thereof Download PDF

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CN111467423B
CN111467423B CN202010411402.6A CN202010411402A CN111467423B CN 111467423 B CN111467423 B CN 111467423B CN 202010411402 A CN202010411402 A CN 202010411402A CN 111467423 B CN111467423 B CN 111467423B
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heat
clearing
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tropaeolum
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窦啟玲
徐蓉
尹萍
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Guizhou Yibai Pharmaceutical Co Ltd
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Abstract

The invention belongs to the technical field of pharmacy, and particularly relates to a honeysuckle flower heat-clearing spray and a preparation method thereof. The globeflower heat-clearing spray is prepared from the following raw materials in parts by weight: 18-25g of tropaeolum heat-clearing compound extract, 3-6g of absorption enhancer, 0.02-0.04g of preservative and 0.05-0.1g of stabilizer. Compared with the prior art, the tropaeolum heat-clearing agent provided by the invention overcomes the defects of poor direct absorption, low bioavailability, large dosage of the tropaeolum heat-clearing oral preparation, good stability, high bioavailability, good patient compliance, convenience and safety in administration, and is more suitable for patient groups.

Description

Honeysuckle flower and lotus root heat-clearing spray and preparation method thereof
Technical Field
The invention belongs to the technical field of pharmacy, and particularly relates to a honeysuckle flower heat-clearing spray and a preparation method thereof.
Background
The syndrome of exogenous heat refers to the type of exogenous heat with the main clinical manifestations of disharmony cold, flushed face, restlessness, rapid pulse, etc., which are caused by wei-defensive-ying disharmony, disharmony between zang-fu organs and yin-yang disharmony, and pathological rise of body temperature. The syndrome of exogenous heat has the characteristics of acute onset and rapid change of the disease condition, and needs to be diagnosed in time and treated in a targeted manner in a short time according to the cause of disease. At present, antiviral drugs such as axivir, ribavirin and amantadine are mainly selected clinically to treat patients with exogenous heat syndrome, but the overall curative effect is poor, and chemical drugs easily generate side effects on human bodies. The traditional Chinese medicine accumulates abundant experience in the aspects of syndrome differentiation, prevention and treatment of exogenous fever, and has remarkable advantages in the aspect of prevention and treatment of exogenous fever.
The flos Trollii heat clearing preparation is in the form of granule, effervescent tablet, capsule, etc. and is prepared from flos Trollii, folium Isatidis, Gypsum Fibrosum, rhizoma anemarrhenae, rehmanniae radix, radix scrophulariae, and parched semen Armeniacae amarum; has the effects of clearing away heat and toxic materials, relieving sore throat, promoting salivation, relieving cough and eliminating phlegm; mainly treats the syndrome of exogenous heat; the symptoms include high fever, thirst, dry throat, pharyngalgia, cough and thick phlegm, and is also suitable for influenza and upper respiratory tract infection with the symptoms. The Jinlian Qingre effervescent tablet, the Jinlian Qingre capsule and the Jinlian Qingre granule are the Chinese patent medicines commonly used for treating exogenous heat syndrome at present. The trollius chinensis bunge heat-clearing effervescent tablets, the trollius chinensis bunge heat-clearing capsules and the trollius chinensis bunge heat-clearing granules belong to oral preparations, and the influence of low compliance on patients can be caused due to large dosage of the tablets taken each time; the effect is slow; moreover, the dosage of the medicine is large, and some side effects are caused after long-term use. Due to the defects of the oral preparation, a plurality of researchers adopt atomization treatment of the tropaeolum heat-clearing effervescent tablets to solve the problem that the tropaeolum heat-clearing effervescent tablets have slow effect, directly reach focuses and have better effect.
For example, the document "clinical observation of the atomization inhalation treatment of chronic pharyngitis by using the tropaeolum heat-clearing effervescent tablet (journal of clinical rational medication, 2017) discloses that: a Chinese medicinal effervescent tablet for clearing away heat is prepared from flos Trollii, folium Isatidis, Gypsum Fibrosum, rhizoma anemarrhenae, rehmanniae radix, radix scrophulariae, and semen Armeniacae amarum by pulverizing and inhaling 2 tablets per time (3 times per day) for 1 treatment course 5 days.
Also, for example, the literature "observation of the effect of jinlian effervescent tablets for clearing heat by aerosol inhalation on chronic pharyngitis (written by the college of noble yang traditional Chinese medicine, 2013) discloses: JINLIANQINGRE effervescent tablet (Tianjin Zhongsheng Haitian pharmaceutical Co., Ltd., batch number: national standard character Z20103076, specification: 4 g/tablet) is administered by 3 tablets at a time, dissolved in physiological saline 20ml, and inhaled by atomization for 3 times/day for 7 days/treatment course; the effective rate is 96.66%.
The two documents disclose that the tool for treating chronic pharyngitis by adopting the tropaeolum heat-clearing effervescent tablets through atomization and inhalation has good curative effect. However, the above-mentioned aerosol therapy still has the following disadvantages: 1. the dosage of the tropaeolum heat-clearing effervescent tablet is large; 2. patients, especially children patients, are easy to have restlessness and dysphoria in the atomization treatment process, so that the atomization treatment is not favorable to be smoothly carried out, and the absorption of medicaments is influenced. 3. The atomization treatment time is longer, the single inhalation time is 5min-40min, and the single treatment time is longer, thus being not beneficial to the compliance of patients. 4. Controlled by the atomizing device, the device needs to be maintained, cleaned, disinfected and the like, thus adding additional medical cost and being not portable.
Disclosure of Invention
In order to make up for the defects of the prior art, the invention provides the trollius chinensis bunge heat-clearing spray which is convenient to carry and high in bioavailability on the basis of the existing trollius chinensis bunge heat-clearing preparation.
The specific technical scheme is as follows:
a globeflower heat-clearing spray is prepared from the following raw materials in parts by weight: 18-25g of tropaeolum heat-clearing compound extract, 3-6g of absorption enhancer, 0.02-0.04g of preservative and 0.05-0.1g of stabilizer.
Preferably, the globeflower heat-clearing spray is prepared from 22g of globeflower heat-clearing compound extract, 5g of absorption enhancer, 0.02g of preservative and 0.08g of stabilizer in parts by weight.
Preferably, the absorption enhancer is one of borneol, chitosan and soybean lecithin; the preservative is sorbic acid; the stabilizer is trehalose.
Preferably, the preparation method of the tropaeolum heat-clearing compound extract comprises the following steps: weighing flos Trollii, folium Isatidis, Gypsum Fibrosum, rhizoma anemarrhenae, rehmanniae radix, radix scrophulariae, and parched semen Armeniacae amarum at a certain ratio, mixing, adding water 7-8 times the weight of the raw materials and plant refined compound enzyme 0.3-0.4% of the weight of the raw materials, heating in water bath to 40 deg.C, keeping the temperature for 8-10min, inactivating enzyme, and decocting for 90 min; then adding water 5-6 times the weight of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.2(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preferably, the plant refined complex enzyme is plant refined complex enzyme SPE-007.
Preferably, the compound Jinlian extract for clearing heat is prepared from the following raw materials in parts by weight: 1400-1600 parts of globeflower, 1400-1600 parts of dyers woad leaf, 1100-1200 parts of gypsum, 700-800 parts of rhizoma anemarrhenae, 700-800 parts of rehmannia, 700-800 parts of radix scrophulariae and 1100-1200 parts of fried bitter almond.
Preferably, the compound Jinlian extract for clearing heat is prepared from the following raw materials in parts by weight: 1500 parts of globeflower, 1500 parts of dyers woad leaf, 1125 parts of gypsum, 750 parts of rhizoma anemarrhenae, 750 parts of rehmannia root, 750 parts of figwort root and 1125 parts of fried bitter almond.
The invention also provides a preparation method of the trollius chinensis bunge heat-clearing spray, which comprises the following steps: mixing the heat-clearing compound extract of the golden lotus, the preservative and the stabilizer, adding 50mL of distilled water, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding the absorption enhancer, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
Compared with the prior art, the heat-clearing spray containing flos Trollii has the following advantages: (1) the medicine enters blood circulation through mucosa absorption to play a role in treating exogenous heat syndrome, is not influenced by gastrointestinal tract digestive juice and liver first-pass effect, and has high bioavailability; can directly reach the focus of infection for throat swelling and pain patients, and can take effect rapidly; (2) the medicine directly enters the systemic circulation after being absorbed, takes effect quickly and achieves the purpose of systemic treatment; (3) the defects of poor direct absorption and low bioavailability of the tropaeolum heat-clearing oral preparation are overcome, and the bioavailability is higher than that of granules, capsules and effervescent tablets; (4) can be used for self-administration, has good patient compliance, and is convenient to carry and simple in use.
The specific research process is as follows:
experimental example 1 research on preparation process of tropaeolum heat-clearing compound extract
1. Screening an extraction mode: in the process of technological research, in order to extract the active ingredients in the medicine to the maximum extent, the active ingredients are respectively extracted by water decoction (the extraction rate of the total flavone is 1.13-1.25%), 60% ethanol reflux extraction (the extraction rate of the total flavone is 1.28-1.33%), 80% ethanol percolation extraction (the extraction rate of the total flavone is 1.18-1.31%), enzyme-assisted water extraction (the extraction rate of the total flavone is 1.32-1.45%), ultrasonic-assisted water extraction (the extraction rate of the total flavone is 1.18-1.26%) and the like, and the results show that the active ingredients of the medicinal materials in the formula are high in extraction efficiency and have a large amount of dissolved substances by adopting the enzyme-assisted water extraction method.
2. And (3) screening in a purification mode: in the process of technological research, in order to extract the extract prepared by the purified enzyme-assisted water extraction method to the maximum extent, the invention adopts the purification methods such as a macroporous resin method (the flavone content in the purified extract is 26.3-28.8%), an ethanol precipitation method (the flavone content in the purified extract is 21.2-24.5%), an ultrafiltration method (the total flavone content in the purified extract is 10.8-11.6%) and the like for investigation, and the result shows that the macroporous resin purification method is adopted, so that the enrichment of effective components can be ensured, impurities can be effectively removed, and the purification effect is best.
Experimental example 2 absorption enhancer screening study
(1) Test materials
Preparing a tropaeolum heat-clearing compound extract: mixing 1500g flos Trollii, 1500g folium Isatidis, 1125g Gypsum Fibrosum, 750g rhizoma anemarrhenae, 750g rehmanniae radix, 750g radix scrophulariae, 1125g parched semen Armeniacae amarum, adding water 7 times the mass of the raw materials and plant refined complex enzyme SPE-007 0.32% of the mass of the raw materials, heating in water bath to 40 deg.C, keeping the temperature for 10min, inactivating enzyme, and decocting for 90 min; then adding water with the mass 5 times of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.20(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preparing a spray: taking 18g of the tropaeolum heat-clearing compound extract, 3g of different absorption enhancers, 0.02g of sorbic acid and 0.05g of trehalose. Adding 50mL of distilled water into the compound heat-clearing extract of tropaeolum, sorbic acid and trehalose, heating to 60-70 ℃ on a water bath heater to completely dissolve the compound heat-clearing extract of tropaeolum, cooling to 40-50 ℃, adding an absorption enhancer, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
(2) Experimental methods
The research on the anti-inflammatory effect of the tropaeolum heat-clearing spray prepared from different absorption enhancers on the toe swelling of rats comprises the following steps: male SD rat rats, randomly grouped, 10 rats in each group; the heat-clearing spray prepared from different absorption enhancers is applied to each group of rats by throat spraying, and throat spraying administration is adopted, 3 sprays are applied each time; 4 times daily for 3 days, and the daily dosage (calculated by crude drugs) is 8 g/kg; the control group was given a corresponding volume of physiological saline; 30min after the last administration, 0.05ml of 1% carrageenan solution was injected subcutaneously into the right hind toes to prepare a model of acute inflammatory swelling in rats caused by 1% carrageenan. After injecting carrageenan, the volume of the right hind limb toe is measured after 1h, 2h, 4h and 6h respectively, and the swelling rate is calculated. The results are shown in Table 1.
TABLE 1 anti-inflammatory effect of heat-clearing spray of globeflower prepared from different absorption enhancers
Figure BDA0002493391110000051
The experimental result shows that: comparing the relieving results of the tropaeolum heat-clearing spray prepared by various absorption promoters on the swelling of the rat foot, the finding shows that the tropaeolum heat-clearing spray prepared by taking borneol, soybean phospholipid and chitosan as the absorption promoters has better relieving effect on the swelling of the rat foot.
Experimental example 3 pharmaceutical experiment
1. Toxicity test
(1) Experimental materials:
the preparation of the compound tropaeolum heat-clearing extract is the same as that of experimental example 2.
Honeysuckle flower heat-clearing spray: 25g of flos Trollii heat clearing compound extract, 6g of chitosan, 0.04g of sorbic acid and 0.1g of trehalose. Adding 50mL of distilled water into the heat-clearing compound extract of the tropaeolum, sorbic acid and trehalose, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding chitosan, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
(2) Experimental methods
Selecting 30 SD rats with half male and female, randomly dividing into 3 groups, each group comprising 10 rats, 1 group being JINLIANQINGRE spray group, and administering by spraying throat 3 times; 4 times daily, and the daily dosage (calculated by crude drugs) is 11 g/kg; 2 groups are blank control groups, and equivalent distilled water is given; and 3 groups are adjuvant groups (equal amount of adjuvant, and flos Trollii heat clearing compound extract is not added in the spray). The medicine is taken 4 times/d at intervals of 6h every time, and 3 times of spraying is carried out at the throat. After administration, the rats were fixed with a holder to ensure that the rats were in contact with the drug for at least 4 h. After administration and within 6 days, the rats were observed and recorded for toxicosis and death, and the presence of red swelling and ulceration at the administration site was observed. At the end of the observation, all surviving rats were sacrificed for necropsy and viscus and throat, trachea, bronchial mucosa were visually observed.
(3) The experimental results are as follows: after the administration of the drug to the throat of the rat and within 7 days after the administration, no obvious poisoning symptom and death condition appear, and no irritation reaction such as red swelling, congestion, ulceration and the like appears at the drug spraying part. The rat is examined by necropsy, and the mucous membranes of the viscera, the throat, the trachea and the bronchus are observed by naked eyes without generating irritation reactions such as red swelling, hyperemia, ulceration and the like.
2. Experiment of therapeutic effect
2.1 Rabbit fever reduction experiment
(1) Experimental animals: 65 New Zealand rabbits, half female and half male, 2kg body weight.
(2) The experimental method comprises the following steps: the anal temperature of the rabbits is measured for 2 times at intervals of about 1h for 3 days continuously, so that the rabbits are suitable for operation, and all the rabbits are fasted and are not forbidden in water 1d afternoon before the official test. In the formal test, all rabbits are used for measuring the anal temperature twice by the same method on the same day, 60 rabbits with the body temperature of 38.0-39.2 ℃ and the temperature change of no more than 0.3 ℃ for twice are selected for the test, and the average value is taken as the basal body temperature before causing fever. Then, 200ng/kg of escherichia coli endotoxin is injected into the ear veins of 60 selected rabbits, the anal temperature is measured 1.0h after injection, 54 new zealand rabbits with the body temperature rising of about 0.8-1.7 ℃ are selected, and the animals are divided into 9 groups according to the rising condition of the body temperature, wherein each group comprises 6 rabbits. 1-4 groups of the tropaeolum heat-clearing spray prepared in the embodiment 1-4 are respectively administrated by a throat spraying method, 3 times of spraying are carried out on each time, and 4 times of a day are carried out; 5-7 groups of preparations of comparative examples 1-3 groups of intragastric administration, 4 times daily; the 8 groups adopt flos Trollii heat clearing effervescent tablet solution (3 flos Trollii heat clearing effervescent tablets, dissolved in normal saline 20ml), and adopts throat spraying method for administration, wherein throat spraying is performed 3 times per time, 4 times per day. The 9 groups were the model control group given the same volume of saline. The administration groups 1.5-2h after endotoxin injection are respectively administered with corresponding drugs according to corresponding methods and dosages, and the model control group is administered with physiological saline with the same volume. The administration was continued for 3 d. The anal temperature is measured once 1h, 2h, 4h and 6h after the last administration, and the method for measuring the anal temperature is the same as the method for measuring the anal temperature, and the actual temperature value and the temperature difference before and after administration are used as observation indexes. The results are shown in Table 2.
TABLE 2 influence of flos Trollii spray for clearing away heat and toxic materials on rabbit fever
Figure BDA0002493391110000071
The realized result is found that: comparing the anal temperature change difference (DEG C) of rats at different time points after administration of each group, the results show that the examples 1-4 have better heat-relieving effect, and the effect is better than that of other comparative groups.
2.2 rat carrageenan-induced toe swelling anti-inflammatory assay
(1) Male SD rat rats, randomly grouped, 10 rats in each group; 1-4 groups of the tropaeolum heat-clearing spray prepared in the embodiment 1-4 are respectively administrated by a throat spraying method, 3 times of spraying are carried out on each time, and 4 times of a day are carried out; 5-7 groups of preparations of comparative examples 1-3 groups of intragastric administration, 4 times daily; the 8 groups adopt flos Trollii heat clearing effervescent tablet solution (3 flos Trollii heat clearing effervescent tablets, dissolved in normal saline 20ml), and adopts throat spraying method for administration, wherein throat spraying is performed 3 times per time, 4 times per day. The model group was given the same volume of saline. Each group was administered for 3 consecutive days. 30min after the last administration, 0.05ml of 1% carrageenan solution was injected subcutaneously into the right hind toes to prepare a model of acute inflammatory swelling in rats caused by 1% carrageenan. After injecting carrageenan, the volume of the right hind limb toe is measured after 1h, 2h, 4h and 6h respectively, and the swelling rate is calculated. The results are shown in Table 3.
TABLE 3 influence of the Jinlian Heat-clearing spray on the swelling of the rat foot sole caused by carrageenan
Figure BDA0002493391110000081
The experimental result shows that: the plantar swelling relieving effect of the rats in each group is compared, and the results show that the rats in examples 1 to 4 and the comparative group have better plantar swelling relieving effect.
Experimental example 4 study of stability of finished product
The results of preliminary stability examination show that the spray prepared in the embodiments 1-4 of the invention is placed for 10 days under various influence factors, the accelerated test is carried out for 6 months, the spray is placed at room temperature for 6 months, all the examination indexes have no obvious change compared with 0 day, and the pH value is stable. The total flavone content and the vitexin content are stable, and no precipitate appears basically, which indicates that the preparation of the invention has good stability.
Detailed Description
The technical solution of the present invention is further defined below with reference to the specific embodiments, but the scope of the claims is not limited to the description.
Example 1
Preparing a tropaeolum heat-clearing compound extract:
1400g of trollius chinensis, 1600g of folium isatidis, 1100g of gypsum, 700g of rhizoma anemarrhenae, 800g of rehmannia, 800g of radix scrophulariae and 1150g of fried bitter apricot kernels are mixed, water with the amount of 8 times of the mass of the medicinal materials and plant refined compound enzyme SPE-007 with the mass of 0.3% of the mass of the medicinal materials are added, the mixture is heated in a water bath to 40 ℃, the temperature is kept for 8min, and the mixture is decocted for 90min after enzyme deactivation; then adding water with the mass 5 times of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.20(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preparing a spray:
taking 25g of the tropaeolum heat-clearing compound extract, 3g of chitosan, 0.02g of sorbic acid and 0.05g of trehalose; adding 50mL of distilled water into the heat-clearing compound extract of the tropaeolum, sorbic acid and trehalose, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding chitosan, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
Example 2
Preparing a tropaeolum heat-clearing compound extract:
mixing 1500g flos Trollii, 1500g folium Isatidis, 1125g Gypsum Fibrosum, 750g rhizoma anemarrhenae, 750g rehmanniae radix, 750g radix scrophulariae, 1125g parched semen Armeniacae amarum, adding water 7 times the mass of the raw materials and plant refined complex enzyme SPE-007 0.32% of the mass of the raw materials, heating in water bath to 40 deg.C, keeping the temperature for 10min, inactivating enzyme, and decocting for 90 min; then adding water with the mass 5 times of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.22(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preparing a spray:
taking 20g of the tropaeolum heat-clearing compound extract, 5g of borneol, 0.03g of sorbic acid and 0.06g of trehalose; adding 50mL of distilled water into the heat-clearing compound extract of tropaeolum, sorbic acid and trehalose, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding borneol, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
Example 3
Preparing a tropaeolum heat-clearing compound extract: 1600g of trollius chinensis bunge, 1600g of folium isatidis, 1200g of gypsum, 800g of rhizoma anemarrhenae, 800g of rehmannia, 800g of radix scrophulariae and 1200g of fried bitter almond are mixed, water with the amount which is 8 times of the mass of the medicinal materials and plant refined extraction compound enzyme SPE-007 with the mass of 0.4 percent of the mass of the medicinal materials are added, the mixture is heated in a water bath to 40 ℃, the temperature is kept for 10min, and the mixture is decocted for 90min after enzyme deactivation; then adding water with the mass 5 times of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.18(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preparing a spray:
taking 22g of the heat-clearing compound extract of the goldthread root, 5g of soybean lecithin, 0.04g of sorbic acid and 0.1g of trehalose; adding 50mL of distilled water into the compound heat-clearing extract of tropaeolum, sorbic acid and trehalose, heating to 60-70 ℃ on a water bath heater to completely dissolve the compound heat-clearing extract of tropaeolum, cooling to 40-50 ℃, adding soybean phospholipid, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
Example 4
Preparing a tropaeolum heat-clearing compound extract: mixing 1500g flos Trollii, 1400g folium Isatidis, 1100g Gypsum Fibrosum, 700g rhizoma anemarrhenae, 700g rehmanniae radix, 700g radix scrophulariae, and 1100g parched semen Armeniacae amarum, adding 8 times of water and 0.3% of plant refined compound enzyme SPE-007, heating in water bath to 40 deg.C, keeping the temperature for 8min, inactivating enzyme, and decocting for 90 min; then adding water with the mass 5 times of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.20(50 deg.C), and drying under reduced pressure to obtain JINLIANQINGRE compound extract.
Preparing a spray:
taking 18g of the tropaeolum heat-clearing compound extract, 3g of borneol, 0.04g of sorbic acid and 0.05g of trehalose; adding 50mL of distilled water into the heat-clearing compound extract of tropaeolum, sorbic acid and trehalose, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding borneol, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
Comparative example 1 Jinlian Heat clearing granule
The Jinlian Qingre granule is produced by Ningxia Qiyuan national medicine Co., Ltd, and has an approved document number: the national standard of medicine Z10940068; specification: each bag is 5 g. The usage and dosage are as follows: orally administered to adult in 1 bag 4 times a day; half bag for children under 1 year old each time, 3 times a day; half to 1 bag each time for 1-15 years old, 4 times a day.
Comparative example 2 Jinlian Qingre Capsule
Jinlian qingre jiao nang, produced by Ningxia Qiyuan national medicine limited company, approved by Wen dynasty: national drug standard Z20080081; specification: each granule weighs 0.4 g. The usage and dosage are as follows: it is administered orally 4 granules at a time, 3 times daily.
Comparative example 3 honeysuckle flower effervescent tablet for clearing heat
The jinlian heat-clearing effervescent tablet is produced by Tianjin Zhongsheng Haitian pharmacy Co., Ltd, and the approved document number is as follows: the national standard characters Z20103076; specification: each tablet weighs 4 g. The dosage is that a proper amount of water is added, and the effervescent tablet is orally taken after being dissolved; the tablet is taken for 4 times a day by an adult once, and is taken for 1 time every four hours during high fever; 1 tablet for 1 tablet at a time below 1 year old, 3 times a day, and 4 times a day during high fever; 1-2 tablets for 1-15 years old, 4 times a day, 1 time every four hours in high fever, or following the advice of doctor.
It should be noted that the above examples and test examples are only for further illustration and understanding of the technical solutions of the present invention, and are not to be construed as further limitations of the technical solutions of the present invention, and the invention which does not highlight essential features and significant advances made by those skilled in the art still belongs to the protection scope of the present invention.

Claims (6)

1. The flos Trollii heat clearing spray is characterized by being prepared from the following raw materials in parts by weight: 18-25g of tropaeolum heat-clearing compound extract, 3-6g of absorption enhancer, 0.02-0.04g of preservative and 0.05-0.1g of stabilizer;
the preparation method of the tropaeolum heat-clearing compound extract comprises the following steps: weighing flos Trollii, folium Isatidis, Gypsum Fibrosum, rhizoma anemarrhenae, rehmanniae radix, radix scrophulariae, and parched semen Armeniacae amarum at a certain ratio, mixing, adding water 7-8 times the weight of the raw materials and plant refined compound enzyme 0.3-0.4% of the weight of the raw materials, heating in water bath to 40 deg.C, keeping the temperature for 8-10min, inactivating enzyme, and decocting for 90 min; then adding water 5-6 times the weight of the medicinal materials, decocting for 40min, combining the two decoctions, and filtering; separating the filtrate with macroporous resin, eluting with 60% ethanol, recovering ethanol from the eluate, concentrating under reduced pressure to obtain extract with relative density of 1.2 at 50 deg.C, and drying under reduced pressure to obtain JINLIANQINGRE compound extract;
the absorption enhancer is one of borneol, chitosan and soybean lecithin; the preservative is sorbic acid; the stabilizer is trehalose.
2. The tropaeolum heat-clearing spray as claimed in claim 1, which is prepared from the following raw materials in parts by weight: 22g of a tropaeolum heat-clearing compound extract, 5g of an absorption enhancer, 0.02g of a preservative and 0.08g of a stabilizer.
3. The tropaeolum heat-clearing spray according to claim 1, wherein the plant refined compound enzyme is plant refined compound enzyme SPE-007.
4. The tropaeolum heat-clearing spray as claimed in claim 1, which is characterized in that the tropaeolum heat-clearing compound extract is prepared from the following raw materials in parts by weight: 1400-1600 parts of globeflower, 1400-1600 parts of dyers woad leaf, 1100-1200 parts of gypsum, 700-800 parts of rhizoma anemarrhenae, 700-800 parts of rehmannia, 700-800 parts of radix scrophulariae and 1100-1200 parts of fried bitter almond.
5. The tropaeolum heat-clearing spray as claimed in claim 4, which is characterized in that the tropaeolum heat-clearing compound extract is prepared from the following raw materials in parts by weight: 1500 parts of globeflower, 1500 parts of dyers woad leaf, 1125 parts of gypsum, 750 parts of rhizoma anemarrhenae, 750 parts of rehmannia root, 750 parts of figwort root and 1125 parts of fried bitter almond.
6. A preparation method of the tropaeolum heat-clearing spray as claimed in claim 1, which is characterized in that the preparation process comprises the following steps: mixing the heat-clearing compound extract of the golden lotus, the preservative and the stabilizer, adding 50mL of distilled water, putting on a water bath heater, heating to 60-70 ℃ to completely dissolve the compound extract, cooling to 40-50 ℃, adding the absorption enhancer, supplementing the distilled water to 100mL, and adjusting the pH to 6-7 by using sodium citrate.
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CN1733246A (en) * 2005-09-07 2006-02-15 北京因科瑞斯生物制品研究所 Effervescence tablet for reducing fever comprising tropaeolum and process for preparing the same
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