CN113876885A - Preparation method of Xintong preparation - Google Patents

Preparation method of Xintong preparation Download PDF

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CN113876885A
CN113876885A CN202111328814.4A CN202111328814A CN113876885A CN 113876885 A CN113876885 A CN 113876885A CN 202111328814 A CN202111328814 A CN 202111328814A CN 113876885 A CN113876885 A CN 113876885A
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preparation
volatile oil
water
ethanol
solution
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关永霞
王立友
张兰
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Shandong New Time Pharmaceutical Co Ltd
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Shandong New Time Pharmaceutical Co Ltd
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Abstract

The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a preparation method of a Xintong preparation. The Xintong preparation is prepared from 13 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, longspur epimedium, kudzuvine root, angelica, salvia miltiorrhiza, spina gleditsiae, seaweed, kelp, oyster and immature bitter orange. The preparation method comprises extracting radix Puerariae and Saviae Miltiorrhizae radix by ultrasonic method, respectively extracting volatile oil of radix Angelicae sinensis and fructus Aurantii Immaturus, and performing cyclodextrin-based clathration on the volatile oil. The Xintong preparation prepared by the method has high content of active ingredients and good taste, improves the medication compliance of patients, and improves the stability and clinical curative effect of the Xintong preparation product.

Description

Preparation method of Xintong preparation
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, relates to a preparation method of a traditional Chinese medicine composition for treating coronary heart disease and angina pectoris, and particularly relates to a preparation method of a Xintong preparation.
Background
Coronary heart disease and angina pectoris refer to angina pectoris caused by myocardial ischemia and anoxia due to coronary sclerosis or spasm, and account for about 90% of angina pectoris patients. The disease is a common cardiovascular disease, middle-aged and elderly people are high-incidence people, is the most common death reason in the population of developed countries in the world, is also the main death reason of the population in the last twenty years in China, and becomes one of the main diseases threatening human health. Coronary heart disease and angina pectoris are frequently seen in middle-aged and elderly patients before, and with the development of society and the improvement of living standard, the onset age of the patients tends to be younger, and the prevention and treatment tasks are very heavy. With the development of modern science and technology, people have made some progress on the diagnosis and prevention of coronary heart disease, for example, in the aspect of examination, from the original conventional electrocardiogram and load electrocardiogram examination, the application of dynamic electrocardiogram, echocardiography, coronary angiography and electron beam CT machine is updated, the biochemical examination and the cardiac function measuring method are continuously improved, a good means is provided for early diagnosis, in the aspect of prevention and treatment, coronary collateral circulation, coronary artery bypass surgery and the like are established, in the aspect of drug therapy, on the basis of coronary artery dilation (nitrate and nitrite esters), the application of calcium ion antagonist, beta-receptor blocker and thrombolytic drug appears, and a plurality of means are provided for treating coronary heart disease and angina pectoris. However, clinical practice shows that pure western medicine treatment only treats the symptoms and the root causes, and particularly the side effects of the medicine cause the patients to be difficult to accept and take the medicine for a long time.
The traditional Chinese medicine considers that the coronary heart disease and the angina belong to the categories of chest stuffiness and heartache in the traditional Chinese medicine. The occurrence of this disease is closely related to age, addiction to thick flavor of sorrel, overwork or lack of physical activity, addiction to tobacco and wine, and seven-emotion internal injury. The main pathogenesis is that the principal deficiency indicates excess, the heart vessels are malnutrition or the heart vessels are obstructed, the principal deficiency indicates deficiency of qi, blood, yin and yang, the principal deficiency indicates phlegm turbidity, congealing cold and blood stasis, and the secondary excess indicates that coronary arteriosclerosis or spasm causes the narrowing of the lumen, and causes the insufficiency of blood supply of the coronary artery, thereby causing the clinical symptoms of acute or temporary ischemia, anoxia and the like of the cardiac muscle.
The Xintong granules and the Xintong oral liquid are Chinese medicinal preparations prepared by refining thirteen raw material medicaments of kudzuvine root, salvia miltiorrhiza, immature bitter orange, Chinese angelica, astragalus root, pilose asiabell root, dwarf lilyturf tuber, tuber fleeceflower root, epimedium herb, Chinese honeylocust spine, seaweed, kelp and oyster, and have the effects of tonifying qi, activating blood, reducing phlegm and dredging collaterals. Can be used for treating thoracic obstruction due to deficiency of both qi and yin and stagnation of phlegm and blood stasis, with symptoms of cardialgia, chest distress, short breath, nausea, and anorexia; coronary heart disease and angina pectoris.
The 2020 th edition of Chinese pharmacopoeia discloses a preparation method of Xintong oral liquid, wherein the thirteen medicinal materials are prepared by taking kudzuvine root and red sage root, adding 70% ethanol, heating and refluxing for two times, 1 hour each time, and combining ethanol extract for later use; decocting the residue and eleven materials such as astragalus root and the like with water twice, the first time lasts for 2 hours, the second time lasts for 1.5 hours, merging the decoction, filtering, concentrating the filtrate to 1000ml, merging the filtrate with the ethanol extract, adding a proper amount of ethanol until the content of the ethanol reaches 65%, refrigerating for 24-48 hours, filtering, recovering the ethanol from the filtrate, concentrating to 870ml, refrigerating for 24-48 hours, filtering, adding 210g of simple syrup, adjusting the pH value to 7.0 by using 20% sodium hydroxide solution, adding water to 1000ml, stirring uniformly, filtering, encapsulating and sterilizing to obtain the traditional Chinese medicine.
CN101780212A discloses a method for preparing sugar-free Chinese medicinal oral liquid for treating coronary heart disease and angina pectoris, which adopts beta-cyclodextrin inclusion technique to correct taste, so as to prepare sugar-free Chinese medicinal oral liquid, improve the taste of the preparation, improve the medication compliance of patients, ensure the clinical curative effect of the product, and increase the water solubility of low-polarity active ingredients and improve the quality stability of the preparation.
In the above processes, radix Puerariae and Saviae Miltiorrhizae radix are extracted with 70% ethanol under reflux at 80 deg.C, so that thermosensitive medicinal components in radix Puerariae and Saviae Miltiorrhizae radix are easily decomposed, and the extraction time is long, the extraction efficiency is low, and the energy consumption is high; in addition, volatile components in the angelica and the immature bitter orange are seriously lost in the processes of extraction and subsequent reduced pressure concentration, and the effects of the preparation on relieving asthma, relieving cough, relieving spasm, calming, resisting bacteria and the like are reduced.
Disclosure of Invention
Aiming at the defects and shortcomings of the existing preparation method of Xintong preparation, the invention provides a novel preparation method of Xintong preparation through process improvement. The inventor optimizes and promotes the extraction process route according to the medicinal component composition characteristics and the physicochemical properties of the medicinal components of the Xintong preparation prescription, effectively improves the extraction rate and the extraction efficiency of the medicinal components of the medicinal materials, improves the utilization degree of the raw medicinal materials, improves the taste of the preparation, increases the medicine taking compliance of patients, and fully ensures the exertion of the clinical curative effect of the product.
The technical purpose of the invention is mainly realized by the following technical scheme.
A preparation method of a Xintong preparation is characterized in that radix puerariae and radix salviae miltiorrhizae are extracted by an ultrasonic method, volatile oil of angelica and immature bitter orange is respectively extracted, and the obtained volatile oil is quantitatively included by cyclodextrin; wherein the Xintong preparation is prepared from 13 raw medicinal materials of astragalus, codonopsis pilosula, dwarf lilyturf tuber, tuber fleeceflower root, epimedium herb, kudzuvine root, Chinese angelica, salvia miltiorrhiza, spina gleditsiae, seaweed, kelp, oyster and immature bitter orange.
The following will further describe the technical solution of the present invention.
A preparation method of a Xintong preparation comprises the following steps:
(1) taking decoction pieces of radix puerariae and radix salviae miltiorrhizae as raw medicinal materials, adding 6-10 times of 60-80% ethanol solution, and carrying out ultrasonic extraction for 2-3 times, wherein each time is 0.5-1h to obtain radix puerariae and radix salviae miltiorrhizae ethanol extract I and dregs I for later use;
(2) respectively adding 4-8 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 3-6 hr to obtain radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II; or adding 7-9 times of cyclodextrin into radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II for clathration to obtain cyclodextrin clathrate I and cyclodextrin clathrate II; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) decocting the residue I in the step (1), the residue II in the step (2) and the residue III with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times and 1-2 hours each time by adding 6-12 times of water, and mixing decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.10-1.15 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 60-70%, precipitating with ethanol for 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.15-1.35 at 50-60 deg.C to obtain a dry extract I for later use; or concentrating to 50-60 deg.C relative density of 1.05-1.1 to obtain preparation solution I
(6) Uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound I and the cyclodextrin inclusion compound II obtained in the step (2), and adding a proper amount of excipient to prepare an oral solid preparation;
or taking the preparation liquid I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring for dissolving, adding beta-cyclodextrin for inclusion, adding the immature bitter orange volatile oil II, stirring for dissolving, adjusting the pH, adding water to the total preparation amount, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
Preferably, the decoction pieces of the raw medicinal materials of the root of kudzu vine and the root of red-rooted salvia in the step (1) are added with 8 times of 70% ethanol solution for ultrasonic extraction for 2 times, and each time is 1 hour, so that the ethanol extract I of the root of kudzu vine and the root of red-rooted salvia and the herb residue I are obtained for later use;
preferably, the decoction pieces of the Chinese angelica and the immature bitter orange in the step (2) are respectively added with 6 times of water, and the volatile oil is extracted by a steam distillation method for 4 to 5 hours; or adding 6 times of cyclodextrin into the angelica volatile oil I and the immature bitter orange volatile oil II obtained in the step (2) for inclusion to prepare a cyclodextrin inclusion compound I and a cyclodextrin inclusion compound II for later use;
preferably, in the step (3), the medicine residue I in the step (1), the medicine residue II in the step (2), the medicine residue III, 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, longspur epimedium, spina gleditsiae, seaweed, kelp and oyster are decocted for 2 times by adding water, the water adding amount for the first time is 10-12 times of the medicine amount, the water adding amount for the second time is 6-8 times of the medicine amount, the first time is decocted for 2 hours, the second time is decocted for 1.5 hours, and decoction liquids are combined to obtain a water extracting solution I for later use;
preferably, the preparation liquid I prepared in the step (5) is taken in the step (6), filtered after being subjected to cold precipitation, the angelica volatile oil I is added, stirred and dissolved, then the beta-cyclodextrin which is 12 to 16 times of the amount of the angelica volatile oil I is added for inclusion, then the mixture is added with the immature bitter orange volatile oil II, stirred for dissolution, the pH value is adjusted, water is added to the total preparation amount, and the oral liquid preparation is obtained after stirring, filtering, encapsulation and sterilization.
Preferably, the preparation liquid I prepared in the step (5) is taken in the step (6), filtered after being subjected to cold precipitation, the angelica volatile oil I is added, stirred and dissolved, then the beta-cyclodextrin in an amount which is 14 times that of the angelica volatile oil I is added for inclusion, then the immature bitter orange volatile oil II is added, stirred and dissolved, the pH is adjusted, water is added to the total preparation amount, and the oral liquid preparation is obtained after stirring, filtering, encapsulation and sterilization.
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure BDA0003348139210000041
preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure BDA0003348139210000042
the preparation method has the technical advantages that:
1. compared with the traditional ethanol hot reflux method for extracting the kudzuvine root and the red sage root, the low-temperature ethanol ultrasonic extraction method adopted by the invention can prevent thermally unstable components of the kudzuvine root and the salvianolic acid B from being decomposed by heat, improve the content of the total puerarin and the salvianolic acid B of the preparation and improve the clinical curative effect of the product. And the extraction efficiency is high, the extraction time is short, the energy consumption is saved, the production cost is greatly reduced, and the comprehensive economic benefit is remarkable.
2. The preparation process adopts the process route of firstly extracting volatile oil and then decocting the two raw material medicines of the angelica and the immature bitter orange, improves the content of volatile components such as ligustilide, n-butyl phthalide, limonene, linalool and the like, and further improves the clinical curative effects of the Xintong preparation in the aspects of relieving asthma, relieving cough, relieving spasm, calming, resisting bacteria and the like.
3. According to the invention, the angelica volatile oil is quantitatively included by the cyclodextrin, so that the volatilization of volatile components of the medicine can be prevented, the unpleasant smell of the angelica volatile oil can be covered, the bitter taste of hesperidin and naringin can be covered, and the medication compliance of patients is obviously improved; meanwhile, the cyclodextrin has a good protection effect on puerarin, and the thermal stability of the puerarin is enhanced. The oral liquid after clathration keeps the unique fragrance of the volatile oil of the immature bitter orange, improves the taste of the oral liquid and improves the stability and clinical curative effect of the product.
In order to verify the beneficial effects brought by the improvement and the upgrade of the preparation method of the Xintong preparation, the inventor carries out the content comparison test research of the active ingredients and the taste masking effect comparison test research. It should be noted that the drug selected by the test is a drug obtained by the representative formulation and the preparation method of the present invention. The other formulations and methods of preparation of the present invention are not intended to be exhaustive, and the tests and results thereof are not intended to be limiting.
Experimental example 1 content comparison test study of puerarin and salvianolic acid B
In order to verify the improvement effect of the technical scheme of the invention on the contents of the active ingredients of puerarin and salvianolic acid B in the Xintong preparation, the contents of puerarin and salvianolic acid B in the Xintong preparation prepared by different extraction methods of the kudzu root and the salvia miltiorrhiza medicinal materials under the condition of the same raw materials and medicinal materials are investigated. The contents of puerarin and salvianolic acid B are determined by the method of the Chinese pharmacopoeia 2020 edition, and the results are shown in Table 1.
TABLE 1 Puerarin and salvianolic acid B content contrast test
Figure BDA0003348139210000051
The comparative test results in table 1 show that the content of puerarin and salvianolic acid B in the Xintong oral liquid prepared by the ultrasonic extraction method is superior to that of the ethanol reflux extraction method.
Experimental example 2 evaluation test of bitter taste masking Effect
10 (5 men and 5 women) adult men and women of 20-35 years old were selected as volunteers, and a taste evaluation group was established. The oral solutions for cardiac arrest prepared in examples 1 to 6 and comparative examples 1 to 3 were evaluated, respectively, and each sample was evaluated 3 times by an evaluation group, and the oral solutions for cardiac arrest prepared by a different method were tasted after gargling and left in the oral cavity for 30 seconds and then discharged. The bitterness after 0s and 30s was evaluated based on the oral liquid taste and was graded according to the bitterness evaluation criteria of table 2, with the higher the score, the worse the taste. Each volunteer was tested independently and the time interval between tasting the two samples was 2 min.
TABLE 2 bitter taste evaluation criteria rating Table for taste evaluation group
Figure BDA0003348139210000052
Examples 1 to 6 and comparative examples 1 to 3 are oral solutions for cardiac administration prepared by different preparation techniques based on the same weight parts of the raw medicinal materials, examples 1 to 6 are oral solutions for cardiac administration prepared by the method of the present invention, comparative examples 1 and 2 are oral solutions for cardiac administration prepared by the prior art method, and comparative example 3 is an oral solution for cardiac administration prepared by the extraction method of the present invention and the prior art preparation technique. The taste evaluation results are shown in table 3.
TABLE 3 oral liquid taste evaluation experiment for Xintong
Figure BDA0003348139210000053
Figure BDA0003348139210000061
The mouth feel test results in table 3 show that the preparation method provided by the invention extracts the volatile oil of angelica and immature bitter orange, so that the mouth feel of the medicine is further improved, and the medication compliance of patients is improved.
Detailed Description
The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.
Example 1 preparation of Xintong oral liquid
Figure BDA0003348139210000062
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 4 hours to obtain 3.0mL of Chinese angelica volatile oil and 2.8mL of immature bitter orange volatile oil for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times in water, decocting for 2 hours by adding 10 times of water for the first time, decocting for 1.5 hours by adding 8 times of water for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.12 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in step (4) with the ethanol extract I obtained in step 1, adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain ethanol precipitation solution I, recovering ethanol to relative density of 1.08 at 50-60 deg.C to obtain solution I for preparation
(6) Taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 42g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
Example 2 preparation of Xintong oral liquid
Figure BDA0003348139210000071
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 10 times of 60% ethanol solution, and ultrasonically extracting for 3 times, each time for 0.5 hr, to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 4 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 6 hours to obtain angelica volatile oil I2.9 mL and immature bitter orange volatile oil II 2.6mL for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times, adding 12 times of water for decocting for 2 hours for the first time, adding 6 times of water for decocting for 1 hour for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.05 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in step (4) with the ethanol extract I obtained in step 1, adding ethanol until the ethanol content reaches 70%, precipitating with ethanol for more than 24h, filtering to obtain ethanol precipitation solution I, recovering ethanol to relative density of 1.10 at 50-60 deg.C to obtain preparation solution I, and keeping
(6) Taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 34.8g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to be 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
EXAMPLE 3 preparation of Xintong oral liquid
Figure BDA0003348139210000072
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 6 times of 80% ethanol solution, and ultrasonically extracting for 2 times (2 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 8 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 1h to obtain 2.5mL of Chinese angelica volatile oil and 2.3mL of immature bitter orange volatile oil for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times in water, decocting for 2 hours with 8 times of water for the first time, decocting for 2 hours with 8 times of water for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.1 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) and the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 60%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol until the relative density is 1.05 at 50-60 ℃ to obtain a preparation solution I for later use;
(6) taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 40g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
Example 4 preparation of Xintong oral liquid
Figure BDA0003348139210000081
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 4 hours to obtain 3.1mL of Chinese angelica volatile oil and 2.8mL of immature bitter orange volatile oil for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times in water, decocting for 2 hours by adding 10 times of water for the first time, decocting for 1.5 hours by adding 8 times of water for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.07 at the temperature of 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) and the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol until the relative density is 1.08 at 50-60 ℃ to obtain a preparation solution I for later use;
(6) taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 31g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
Example 5 preparation of Xintong oral liquid
Figure BDA0003348139210000091
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 4 hours to obtain 3.1mL of Chinese angelica volatile oil and 2.9mL of immature bitter orange volatile oil for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times in water, decocting for 2 hours by adding 10 times of water for the first time, decocting for 1.5 hours by adding 8 times of water for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.06 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) and the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol until the relative density is 1.08 at 50-60 ℃ to obtain a preparation solution I for later use;
(6) taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 62g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
EXAMPLE 6 preparation of Xintong oral liquid
Figure BDA0003348139210000092
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of Chinese angelica and immature bitter orange raw materials, and extracting volatile oil by a steam distillation method for 4 hours to obtain 3.0mL of Chinese angelica volatile oil and 2.9mL of immature bitter orange volatile oil for later use;
(3) decocting the residue I in the step (1), the residue II and the residue III in the step (2) with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times in water, decocting for 2 hours by adding 10 times of water for the first time, decocting for 1.5 hours by adding 8 times of water for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.05 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) and the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol until the relative density is 1.08 at 50-60 ℃ to obtain a preparation solution I for later use;
(6) taking the prepared solution I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring to dissolve, adding 21g of beta-cyclodextrin to perform inclusion, adding the angelica volatile oil I and the immature bitter orange volatile oil II, stirring to dissolve, adjusting the pH value to 7.0, adding water to 10L, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
Example 7 preparation of Xintong granules
Figure BDA0003348139210000101
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus raw materials, extracting volatile oil by steam distillation for 4h, adding 7 times of cyclodextrin into the obtained radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II, and making into cyclodextrin inclusion; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) decocting the residue I in the step (1), the residue II in the step (2) and the residue III with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster by adding 6-12 times of water for 2 times, adding 10 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 1.5 hours for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.06 at 50-60 ℃ for later use;
(5) taking the extract I in the step (4) and the ethanol extract I in the step 1, mixing, adding ethanol until the ethanol content reaches 65%, carrying out ethanol precipitation for more than 24h, filtering to obtain ethanol precipitation liquid I, and recovering ethanol to obtain an extract with a relative density of 1.25 at 50-60 ℃ to obtain dry extract I for later use;
(6) and (3) uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound obtained in the step (2), adding a proper amount of sugar powder and starch, uniformly mixing, adding a proper amount of 90% ethanol to prepare a soft material, granulating, and drying to obtain granules.
Example 8 preparation of Xintong granules
Figure BDA0003348139210000111
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 10 times of 60% ethanol solution, and ultrasonically extracting for 3 times, 1 hr each time, to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 5 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 5 hr to obtain radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II, and adding 9 times of cyclodextrin to obtain cyclodextrin inclusion; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) decocting the residue I in the step (1), the residue II in the step (2) and the residue III with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster by adding 6-12 times of water for 2 times, adding 8 times of water for decocting for 2 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.08 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.15 at 50-60 ℃ to obtain a dry extract I for later use;
(6) and (3) uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound obtained in the step (2), adding a proper amount of sugar powder, hydroxypropyl starch and mannitol, uniformly mixing, granulating, drying and grading to obtain granules.
Example 9 preparation of Xintong capsules
Figure BDA0003348139210000112
Figure BDA0003348139210000121
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 6 times of 80% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 5 hr to obtain radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II, and adding 8 times of cyclodextrin to obtain cyclodextrin inclusion; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) decocting the residue I in the step (1), the residue II in the step (2) and the residue III with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster by adding 6-12 times of water for 2 times, adding 9 times of water for decocting for 2 hours for the first time, adding 6 times of water for decocting for 1.5 hours for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.12 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.35 at 50-60 ℃ to obtain a dry extract I for later use;
(6) and (3) uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound obtained in the step (2), adding a proper amount of starch and microcrystalline cellulose, uniformly mixing, granulating, drying, grading, and filling into a capsule shell to obtain the capsule.
EXAMPLE 10 preparation of Xintong tablets
Figure BDA0003348139210000122
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 4 hr to obtain radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II, and adding 8 times of cyclodextrin to obtain cyclodextrin inclusion; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) taking the medicine residue I in the step (1), the medicine residue II and the medicine residue III in the step (2), 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster, adding 9 times of water for decocting for 2 times, adding 10 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 1.5 hours for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.11 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.30 at 50-60 ℃ to obtain a dry extract I for later use;
(6) and (3) uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound obtained in the step (2), adding a proper amount of mannitol, microcrystalline cellulose and magnesium stearate, uniformly mixing, and tabletting to obtain the tablet.
EXAMPLE 11 preparation of Xintong pills
Figure BDA0003348139210000131
(1) Taking decoction pieces of radix Puerariae and Saviae Miltiorrhizae radix, adding 8 times of 70% ethanol solution, and ultrasonically extracting for 2 times (1 hr each time) to obtain radix Puerariae and Saviae Miltiorrhizae radix ethanol extractive solution I and residue I;
(2) respectively adding 6 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 4 hr to obtain 1.3mL of radix Angelicae sinensis and fructus Aurantii Immaturus volatile oil, and adding 9.1g times of cyclodextrin for inclusion to obtain cyclodextrin inclusion; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) taking the medicine residue I in the step (1), the medicine residue II and the medicine residue III in the step (2), 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster, adding 9 times of water for decocting for 2 times, adding 10 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 1.5 hours for the second time, and combining the decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.10-1.15 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 65%, precipitating with ethanol for more than 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.20 at 50-60 ℃ to obtain a dry extract I for later use;
(6) and (3) uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound obtained in the step (2), adding a proper amount of dextrin, preparing pills, and drying to obtain the pills.
Comparative example 1 preparation of Xintong oral liquid
Figure BDA0003348139210000141
(1) Taking the kudzu root and the red sage root according to the prescription amount, adding 70% ethanol which is 8 times the amount of the kudzu root and the red sage root, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining ethanol extracting solutions, and storing the medicine residues in another container for later use;
(2) decocting 11 kinds of materials including radix Puerariae, Saviae Miltiorrhizae radix residue and radix astragali with water for 2 times, decocting with 10 times of water for 2 hr for the first time, decocting with 8 times of water for 1.5 hr for the second time, filtering, mixing decoctions, and concentrating;
(3) adding a proper amount of 95% ethanol into the ethanol extract obtained in the step (1) and the water extract obtained in the step (2) to ensure that the alcohol content is 65%, carrying out alcohol precipitation for more than 24 hours, and filtering to obtain an alcohol precipitation solution for later use;
(4) recovering ethanol from the ethanol precipitation solution obtained in the step (3), concentrating until the relative density is 1.08 at 50-60 ℃ to obtain a preparation solution, and performing cold precipitation for later use;
(5) and (4) cooling and precipitating the feed and preparation liquid obtained in the step (4), filtering, adding 2100g of simple syrup, adjusting the pH value to 7.0 by using 20% sodium hydroxide solution, adding water to 10L, stirring uniformly, filtering, filling and sealing, and sterilizing to obtain the feed and preparation liquid.
Comparative example 2 preparation of Xintong oral liquid
Figure BDA0003348139210000142
(1) Extracting radix Puerariae and Saviae Miltiorrhizae radix with 8 times of 70% ethanol under reflux for 2 times, each for 2 hr, and filtering to obtain ethanol extractive solution;
(2) extracting radix Puerariae and Saviae Miltiorrhizae radix with ethanol to obtain residues, adding 8 times of water into 11 medicinal materials such as radix astragali, decocting for 2 times, each time for 2 hr, mixing decoctions, filtering, and concentrating under reduced pressure to obtain fluid extract with relative density of 1.20 at 50-60 deg.C;
(3) mixing the fluid extract obtained in step (2) with the ethanol extract obtained in step (1), adding 95% ethanol to make the ethanol content reach 65%, refrigerating for more than 24h, filtering, recovering ethanol from the filtrate, concentrating to relative density of 1.20 at 50-60 deg.C, adding 5 times of purified water, and cold precipitating to obtain water extract;
(4) and (3) filtering the water extract obtained in the step (3), adding 1% (g/ml) of activated carbon into the filtrate, heating to 70 ℃, keeping the temperature for 1h, filtering to remove carbon, adding purified water to the total preparation amount, adjusting the pH to 7.0, adding 0.5% (g/ml) of beta-cyclodextrin to the total preparation amount, stirring for inclusion for 60 min, filtering, adding purified water to 10L, filtering until the clarity is qualified, canning, and sterilizing to obtain the product.
Comparative example 3 preparation of Xintong oral liquid
Figure BDA0003348139210000151
(1) Taking the kudzu root and the red sage root according to the prescription amount, adding 70% ethanol with the amount of 8 times of the prescription amount, placing the mixture into an ultrasonic extractor, carrying out ultrasonic extraction for 2 times, 1 hour each time, filtering, combining ethanol extract, and storing the dregs in another container for later use;
(2) adding 6 times of water into angelica and immature bitter orange according to the prescription amount, decocting for 4h, collecting 5.0ml of volatile oil, storing the volatile oil in ethanol for later use, and storing the residual oil and the dregs in another container for later use;
(3) decocting radix Puerariae, Saviae Miltiorrhizae radix residue and radix Angelicae sinensis, fructus Aurantii Immaturus residue and radix astragali with 9 kinds of water for 2 times, decocting with 10 times of water for 2 hr for the first time, decocting with 8 times of water for 1.5 hr for the second time, filtering, and mixing decoctions;
(4) concentrating the oil extraction residual liquid of the angelica and the immature bitter orange and the decoction liquid obtained in the step (3) under reduced pressure to obtain a concentrated solution for later use;
(5) mixing the concentrated solution obtained in the step (4) with the ethanol extract of the medicinal materials of the root of kudzu vine and the root of red-rooted salvia, adding a proper amount of 95% ethanol to ensure that the ethanol content is 65%, carrying out ethanol precipitation for more than 24 hours, and filtering to obtain an ethanol precipitation solution for later use;
(6) recovering ethanol from the ethanol precipitation solution obtained in the step (5), concentrating until the relative density is 1.08 to obtain a preparation solution, and performing cold precipitation for later use;
(7) and (4) performing liquid precipitation on the mixture obtained in the step (6), filtering, adding the angelica and the immature bitter orange volatile oil, stirring to dissolve, adjusting the pH to 7.0, adding water to 10L, stirring, filtering, encapsulating and sterilizing to obtain the oral liquid preparation.

Claims (9)

1. A preparation method of a Xintong preparation is characterized in that radix puerariae and radix salviae miltiorrhizae are extracted by an ultrasonic method, volatile oil of angelica and immature bitter orange is respectively extracted, and the obtained volatile oil is quantitatively included by cyclodextrin; wherein the Xintong preparation is prepared from 13 raw medicinal materials of astragalus, codonopsis pilosula, dwarf lilyturf tuber, tuber fleeceflower root, epimedium herb, kudzuvine root, Chinese angelica, salvia miltiorrhiza, spina gleditsiae, seaweed, kelp, oyster and immature bitter orange.
2. The preparation method of the Xintong preparation according to claim 1, which is characterized by comprising the following steps:
(1) taking decoction pieces of radix puerariae and radix salviae miltiorrhizae as raw medicinal materials, adding 6-10 times of 60-80% ethanol solution, and carrying out ultrasonic extraction for 2-3 times, wherein each time is 0.5-1h to obtain radix puerariae and radix salviae miltiorrhizae ethanol extract I and dregs I for later use;
(2) respectively adding 4-8 times of water into decoction pieces of radix Angelicae sinensis and fructus Aurantii Immaturus, extracting volatile oil by steam distillation for 3-6 hr to obtain radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II; or adding 7-9 times of cyclodextrin into radix Angelicae sinensis volatile oil I and fructus Aurantii Immaturus volatile oil II for clathration to obtain cyclodextrin clathrate I and cyclodextrin clathrate II; after distillation, the angelica dregs II and the immature bitter orange dregs III are obtained, and the distilled angelica aqueous solution I and the immature bitter orange aqueous solution II are obtained for later use;
(3) decocting the residue I in the step (1), the residue II in the step (2) and the residue III with 9 raw material medicines of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, epimedium, spina gleditsiae, seaweed, kelp and oyster for 2 times and 1-2 hours each time by adding 6-12 times of water, and mixing decoction to obtain a water extract I for later use;
(4) mixing the angelica water solution I distilled in the step (2), the immature bitter orange water solution II and the water extract I distilled in the step (3), and concentrating under reduced pressure to obtain an extract I with the density of 1.10-1.15 at 50-60 ℃ for later use;
(5) mixing the extract I obtained in the step (4) with the ethanol extract I obtained in the step (1), adding ethanol until the ethanol content reaches 60-70%, precipitating with ethanol for 24h, filtering to obtain an ethanol precipitation solution I, and recovering ethanol to obtain an extract with a relative density of 1.15-1.35 at 50-60 deg.C to obtain a dry extract I for later use; or concentrating to 50-60 deg.C relative density of 1.05-1.1 to obtain preparation solution I
(6) Uniformly mixing the dry paste I obtained in the step (5) with the cyclodextrin inclusion compound I and the cyclodextrin inclusion compound II obtained in the step (2), and adding a proper amount of excipient to prepare an oral solid preparation;
or taking the preparation liquid I in the step (5), performing cold precipitation, filtering, adding the angelica volatile oil I, stirring for dissolving, adding beta-cyclodextrin for inclusion, adding the immature bitter orange volatile oil II, stirring for dissolving, adjusting the pH, adding water to the total preparation amount, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid preparation.
3. The preparation method according to claim 2, wherein the decoction pieces of the raw materials of radix puerariae and radix salviae miltiorrhizae in the step (1) are added with 8 times of 70% ethanol solution for ultrasonic extraction for 2 times, and each time is 1 hour, so that the ethanol extract I of radix puerariae and radix salviae miltiorrhizae and the medicine residue I are obtained for later use.
4. The preparation method according to claim 2, wherein the decoction pieces of the raw materials of angelica and immature bitter orange in step (2) are respectively added with 6 times of water, and the volatile oil is extracted by steam distillation for 4-5 h; or (3) adding 6 times of cyclodextrin into the angelica volatile oil I and the immature bitter orange volatile oil II obtained in the step (2) for inclusion to prepare a cyclodextrin inclusion compound I and a cyclodextrin inclusion compound II for later use.
5. The preparation method according to claim 2, wherein the step (3) is to take the residue I in the step (1), the residue II in the step (2), the residue III, 9 raw medicinal materials of astragalus, codonopsis pilosula, ophiopogon root, polygonum multiflorum, longspur epimedium, spina gleditsiae, seaweed, kelp and oyster shell, add water and decoct for 2 times, the first time the water addition is 10-12 times of the amount of the medicinal materials, the second time the water addition is 6-8 times of the amount of the medicinal materials, the first time the decoction is for 2 hours, the second time the decoction is for 1.5 hours, and the decoction is combined to obtain a water extract I for later use.
6. The preparation method of claim 2, wherein the step (6) is to take the solution I prepared in the step (5), cool-precipitate and filter the solution, add the angelica volatile oil I, stir and dissolve the solution, add the beta-cyclodextrin 12 to 16 times of the solution to perform inclusion, add the fructus aurantii immaturus volatile oil II, stir and dissolve the solution, adjust the pH, add water to the total preparation amount, stir, filter, encapsulate and sterilize the solution to obtain the oral liquid preparation.
7. The preparation method according to claim 6, wherein the angelica volatile oil I is added in the step (6), stirred and dissolved, and then added with 14 times of beta-cyclodextrin for inclusion.
8. The preparation method according to any one of claims 1 to 7, wherein the Xintong preparation is prepared from the following traditional Chinese medicine components:
Figure FDA0003348139200000021
9. the preparation method of claim 8, wherein the Xintong preparation is prepared from the following traditional Chinese medicine components:
Figure FDA0003348139200000022
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