CN100420471C - Traditional Chinese medicine oral preparation for nourishing kidney and lung and preparation method thereof - Google Patents

Abstract

The present invention relates to an oral preparation of traditional Chinese medicine for nourishing kidney and lung and its preparation method. It is mainly prepared into capsules, dripping pills, tablets, Granules, pills or oral liquids, etc.; compared with the prior art, the preparation method adopted in the present invention can make the obtained medicine more refined, and the drug effect is more significant, and it is suitable for lung and kidney yin deficiency, hot flashes and night sweats, dry throat and hemoptysis, and dizziness Tinnitus, soreness of the waist and knees, etc. have a good therapeutic effect.

Description

Traditional Chinese medicine oral preparation for nourishing kidney and lung and preparation method thereof

Technical field:

The invention relates to a traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung and a preparation method thereof, belonging to the field of pharmaceutical technology.

Technical background: Yin deficiency of the lung and kidney, dizziness, tinnitus, soreness of the waist and knees and other diseases are common diseases that threaten the health of the people today, and bring great misery to the majority of patients. The commercially available Maiwei Dihuang Tablets, Maiwei Dihuang Pills and Maiwei Dihuang Oral Liquid have the effect of nourishing the kidneys and nourishing the lungs. The prescription is based on the Liuwei Dihuang preparation, which is composed of eight herbs including Ophiopogon japonicus and Schisandra chinensis. In the prescription, Shudihuang nourishes the kidneys Yin, filling essence and marrow, dogwood nourishing liver and kidney, nourishing spleen yin; The power of promoting body fluid. It is one of the better medicines for treating lung and kidney yin deficiency, hot flashes and night sweats, dry throat and coughing up blood, dizziness and tinnitus, soreness of waist and knees and thirst. In the method for producing Maiwei Dihuang preparations, the method recorded in the existing ministerial standards is more representative, wherein Maiwei Dihuang tablets are made by pulverizing Ophiopogon japonicus, Chinese yam, Poria cocos and Cortex Moutan into fine powder; Schisandra chinensis, Rehmannia glutinosa, Cornus officinalis and Alisma alisma are decocted with water, concentrated into a thick paste, then mixed with fine powder, granulated and pressed into tablets to obtain medicines. Maiwei Dihuang Oral Liquid is prepared by decocting all the medicinal materials with water, concentrating them, leaving them overnight, concentrating the filtrate, refrigerating, and mixing them with sucrose; Qingpao; Rehmannia glutinosa is decocted separately and concentrated into Qingpao; Schisandra chinensis, 56% of Moutan bark and 59% of Cornus officinalis are extracted by percolation with 70% ethanol, and the ethanol is recovered and concentrated into Qingpao; the remaining yam, Moutan bark and Cornus officinalis is crushed into fine powder, then mixed with the above-mentioned clear pastes, and made into pills to obtain medicines. And the preparation method of Maiwei Dihuang Pills recorded in Chinese Pharmacopoeia 2005 edition is to pulverize all the medicinal materials into fine powder, sieve, mix and make medicines with Lianmi Panwan Pills. After research, we found that due to the imperfection of the above process, the Maiwei Dihuang preparation prepared by the above method contains a large number of invalid ingredients and impurities, and the dosage is large when used, which brings psychological anxiety to the patient. Not high; through a large number of experiments, we found that among the eight herbs that constitute the preparation of Maiwei Dihuang, Moutan Cortex contains paeonol, Cornus officinalis contains ursolic acid, Schisandra chinensis contains Schizandrin B, and Ophiopogon japonicus contains wheat Total winter saponins, because paeonol, ursolic acid, schisandrin, and total saponins of Ophiopogon japonicus are all ingredients with important effects in this medicine. In addition, because paeonol is a volatile component, if it is directly used after crushing, the impurity content will be reduced. It is easy to volatilize paeonol by boiling in water or percolating with ethanol; while ursolic acid, schisandrin, and total saponins of Ophiopogon japonicus are insoluble in water and easily soluble in alcohol, so the simple boiling method makes the above The extraction rate of active ingredients is low, and if it is directly used as medicine after crushing, the medicine will contain a large amount of ineffective ingredients, and the extraction rate of active ingredients from Schisandra chinensis and Cornus officinalis by ethanol percolation is not high enough, so the clinical application of Maiwei Dihuang preparation prepared by the above method Curative effect is not ideal enough.

Invention content:

The object of the present invention is to provide a kind of traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung and its preparation method. This preparation refers to all clinical oral preparations, including: capsules, dripping pills, tablets, granules, pills, oral Liquid, etc.; Another object of the present invention is to disclose the preparation method of these traditional Chinese medicine preparations for nourishing the kidney and nourishing the lung. In the present invention, aiming at the volatile characteristics of paeonol in Moutan cortex, the present invention extracts paeonol by steam distillation, and aims at ursolic acid in Cornus officinalis, Schizandrin B in Schisandra chinensis and Radix Ophiopogon japonicus. The total saponins of Ophiopogon japonicus are difficult to dissolve in water and easily soluble in alcohol. The present invention adopts the method of ethanol extraction to extract ursolic acid, schisandra B and total saponins of Ophiopogon japonicus. Because the Maiwei Dihuang preparation prepared by the method of the invention has the characteristics of high content of active ingredients, it can achieve the effect of improving bioavailability. The present invention is constituted as follows: calculated according to weight components: it is mainly composed of 30-120 Ophiopogon japonicus, 20-80 schisandra chinensis, 80-320 rehmannia glutinosa, 40-160 dogwood 40-160, 30-120 moutan cortex, 40-160 yam , Poria 30-120, Alisma 30-120 and auxiliary materials. Specifically: Calculated according to weight components: it is mainly prepared from 60 Ophiopogon japonicus, 40 schisandra chinensis, 160 rehmannia glutinosa, 80 dogwood, 60 Moutan cortex, 80 yam, 60 Poria cocos, 60 Alisma 60 and auxiliary materials. preparation. Including: capsules, dripping pills, tablets, granules, pills or oral liquid.

The preparation process of the preparation of the present invention is as follows: part or all of Poria cocos is crushed into fine powder of more than 100 meshes, paeonol is extracted from Moutan cortex with steam distillation; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted with ethanol, filtered, and the filtrate is concentrated to thick Paste; decoct the distilled aqueous solution of Moutan cortex and dregs, ethanol-extracted dregs of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma, filter the extract, and combine the filtrates. Concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste, Poria powder and paeonol, mix evenly, and then add different auxiliary materials to make different preparations according to conventional methods.

The specific preparation method is as follows: part or all of Poria cocos is crushed into a fine powder of more than 100 meshes, paeonol is extracted from Moutan cortex by steam distillation; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours , filter, combine the filtrates and concentrate into extracts, add the distilled aqueous solution of Moutan cortex and medicinal residues, the medicinal residues after ethanol extraction of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma, add 3- Decoct with 10 times the amount of water for 1-5 times, each time for 1-5 hours, filter the extract, combine the filtrate, concentrate it into an extract, then add the above-mentioned Radix Ophiopogon japonicus, Schisandra, Cornus officinalis extract, Poria powder and paeonol Mix evenly, and then add different auxiliary materials to make different preparations according to conventional methods.

But in the experiment, we found that the preparation of the present invention has not yet reached the best refining effect. If the macroporous adsorption resin method is used to extract the active ingredients in the medicinal material in this preparation, the medicine will be more refined and the drug effect will be more significant. So the preparation method of the preparation of the present invention can also be: Poria cocos part or all is ground into the fine powder of more than 100 orders; Cortex Moutan steam distillation extracts paeonol; After 0.5-5 hours, filter, combine the filtrates and concentrate into an extract, distill the aqueous solution of Moutan cortex and herbal residues, extract the medicinal residues of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, Add 3-10 times the amount of water to decoct Alisma 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, and elute with 50-80% ethanol, The ethanol is recovered, concentrated into an extract, and then the extracts of Ophiopogon japonicus, Schisandra, Cornus officinalis, Poria powder and paeonol are added and mixed evenly, and then different auxiliary materials are added to make different preparations according to conventional methods.

During the experiment, we also found that the paeonol contained in the Maiwei Dihuang preparation prepared by the above method still has the disadvantage of being volatile. If paeonol is included with cyclodextrin, it can prevent paeonol from being released. Volatilize to ensure the curative effect of this medicine. Therefore, the preparation method of the preparation of the present invention can also be as follows: Poria cocos is partially or completely crushed into fine powder of more than 100 mesh; Moutan cortex is steam distilled, and the distillate is clathrated with 0.5-5 times the amount of cyclodextrin, and the clathrate is low-temperature Dried and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filtered, combined filtrates and concentrated into extract, distilled aqueous solution of Moutan bark and Add 3-10 times the amount of water to decoct the dregs of Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis after ethanol extraction and the remaining Poria cocos, yam, rehmannia glutinosa, and Alisma 1-5 times, each time for 1-5 hours, extract Filtrate the liquid, combine the filtrates, pass through the macroporous adsorption resin column, elute with 50-80% ethanol, recover the ethanol, concentrate it into an extract, then add the extracts of Radix Ophiopogon japonicus, Schisandra, Cornus officinalis, Poria cocos powder and paeonol The inclusion compound of phenol cyclodextrin is mixed evenly, and then different auxiliary materials are added according to conventional methods to prepare different preparations.

More specifically: the preparation process of the capsules of the present invention is as follows: Poria cocos is partly or completely pulverized into fine powder above 100 mesh; Cortex Moutan is steam-distilled to extract paeonol; -5 times, each time for 0.5-5 hours, filter, combine the filtrate and concentrate to a thick paste, distill the water solution and dregs of Moutan cortex, extract dregs of Radix Ophiopogon japonicus, Schisandra, Cornus officinalis and the remaining Poria cocos , yam, Rehmannia glutinosa, and Alisma, add 3-10 times the amount of water and decoct 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, and use 50-80% The ethanol was eluted, the ethanol was recovered, concentrated to a thick paste, and then the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste, and Poria powder were mixed and granulated, microwave dried, pulverized, then mixed with paeonol evenly, granulated, and packed Serve in capsules.

The preparation process of the dripping pills of the present invention is as follows: Poria cocos is partially or completely pulverized into 80-100 mesh fine powder; then it is placed in an ultra-fine pulverizing device to continue pulverizing into 200-300 mesh fine powder; The solution is clathrated with 0.5-5 times the amount of cyclodextrin, the clathrate is dried at low temperature, and crushed into a fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, Filtrate, combine the filtrates and condense into a clear paste, add the distilled aqueous solution of Moutan cortex and medicinal residues, the medicinal residues extracted by ethanol from Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma, for 3-10 minutes. Doubling the amount of water and decocting 1-5 times, 1-5 hours each time, filtering the extract, combining the filtrate, passing through a macroporous adsorption resin column, eluting with 50-80% ethanol, recovering the ethanol, and concentrating into clear Then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis ointment and Poria cocos powder, mix and granulate, dry, and mix evenly with paeonol cyclodextrin inclusion compound: Add the obtained medicine powder or granules to polyethylene glycol that has been heated and melted Alcohol 4000, polyethylene glycol 6000, sodium stearate or glycerin gelatin matrix, keep a constant temperature of 78-102 ° C, drop into methyl silicone oil with a dropper, and collect drop pills.

The preparation process of the pills of the present invention is as follows: part or all of Poria cocos is crushed into a fine powder of more than 100 meshes; paeonol is extracted from Moutan cortex by water steam distillation; 0.5-5 hours, filter, combine the filtrate and concentrate to a thick paste, distill the aqueous solution of Moutan cortex and herbal residues, extract the medicinal residues of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, Add 3-10 times the amount of water to decoct Alisma 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, and elute with 50-80% ethanol, Recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria cocos powder to mix, spray dry, pulverize, pass through a sieve of 60 mesh or above, add paeonol and mix evenly, then Add 0.3-1 times the amount of powdered honey and medicine to make honeyed pills.

The preparation process of the tablet of the present invention is as follows: part or all of Poria cocos is crushed into a fine powder of more than 100 meshes; Moutan cortex is distilled with water steam, and the distillate is clathrated with 0.5-5 times the amount of cyclodextrin, and the clathrate is low-temperature Dried and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were extracted with ethanol reflux 1-5 times, each time for 0.5-5 hours, filtered, combined filtrates and concentrated to a thick paste, distilled Moutan cortex aqueous solution and medicinal dregs, the medicinal dregs after ethanol extraction of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma, add 3-10 times the amount of water to decoct 1-5 times, each time for 1-5 hours, Filtrate the extract, combine the filtrates, pass through a macroporous adsorption resin column, elute with 50-80% ethanol, recover the ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder to mix , carry out spray drying, add 5-20% of the prescription amount of starch and the above paeonol-cyclodextrin inclusion compound and mix, granulate with ethanol, then add 0.5-1% of dry granule amount of magnesium stearate, mix evenly, and press into tablets , Coat the plain tablet with 2-8% film coating agent to obtain the tablet.

The preparation process of the granules of the present invention is as follows: paeonol is extracted by water steam distillation from Moutan cortex; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filtered, combined filtrates and concentrated To a thick paste, add 3-10 times the amount of water to decoct the distilled aqueous solution of Moutan cortex and dregs, ethanol-extracted dregs of Ophiopogon japonicus, Schisandra, and Cornus officinalis, Poria cocos, yam, Rehmannia glutinosa, and Alisma. 5 times, each time for 1-5 hours, filter the extract, combine the filtrates, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste, paeonol and 2-5 times the amount of auxiliary materials and mix well, Granulation, that is, granules. The auxiliary materials used in the granules of the present invention include dextrin, sucrose, sweeteners, and lactose.

The preparation process of the oral liquid preparation of the present invention is as follows: steam distillation of Cortex Moutan, collect the distillate to get final product; add 3-10 times the amount of water to decoct the remaining medicine for 1-5 times, each time for 1-5 hours, Filter the extract, combine the filtrate, filter, concentrate the filtrate, let it stand for 10-50 hours, take the supernatant, filter, continue to concentrate the filtrate, refrigerate for 10-50 hours, add sucrose to the filtrate to make the final sugar content 5 -60%, boil to dissolve, filter, add 0.06%-0.8% sodium benzoate, add water to the full amount, stir well, and get ready.

The method for directly extracting paeonol from Cortex Moutan in the present invention is: adding 5-10 times the amount of water to the medicinal material, adding 1.0-2.5% ethyl acetate to the improved oil-water separator, distilling and extracting for 8-14h, and extracting the distillate After volatile oil, recover ethyl acetate under reduced pressure, dry at low temperature, and grind into fine powder. The method for the inclusion of volatile oil cyclodextrin is a saturated aqueous solution method; the inclusion temperature is 30-40° C., and the ultrasonic time is 25-35 minutes. Said cyclodextrin in the present invention includes α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, and the best is β-cyclodextrin.

Compared with the prior art, the present invention adopts steam distillation to extract paeonol in Moutan Cortex, which avoids the loss of volatile oil caused by conventional water decoction extraction or ethanol percolation extraction, or the high impurity content caused by direct crushing into medicine ; Encapsulate volatile oil with cyclodextrin, which can prevent paeonol from volatilizing; in addition, for ursolic acid in dogwood, schisandrin in Schisandra chinensis and total saponins of Radix Ophiopogon japonicus in Ophiopogon japonicus, which are insoluble in water and easily soluble in alcohol Features, using ethanol extraction method to extract ursolic acid, schisandra B and total saponins of Ophiopogon japonicus, avoiding the low extraction rate of the above active ingredients or the high content of ineffective ingredients directly crushed into medicine during conventional water decoction extraction or ethanol percolation extraction Disadvantages: The active ingredients in the medicinal materials are extracted by the macroporous adsorption resin method, which makes the drug more refined and more effective. It is better for lung and kidney yin deficiency, hot flashes and night sweats, dry throat and coughing up blood, dizziness, tinnitus, soreness of the waist and knees, etc. therapeutic effect. Compared with the existing preparations, the preparation prepared by the method of the present invention has reduced dosage and high bioavailability; in addition, the dropping pills and capsules prepared by the method of the present invention have the characteristics of large specific surface area and fast dissolution rate, which also cover the oral cavity of the existing preparations. Bitter, astringent, sour and other bad tastes of liquid and concentrated pills are more convenient for patients to take. The granule prepared by the method of the invention has the characteristics of small fineness, uniform granule, easy dissolution and absorption, good taste, no burnt taste, overcomes the sour taste of the medicine brought by the original preparation, and at the same time, removes some insoluble components in the oral cavity lingering side effects. The tablets, pills and oral liquid preparations of the present invention overcome the disadvantages of large dosage and poor absorption of the original preparations. Moreover, the formability and disintegration of the tablet are good, which can greatly reduce the hygroscopicity of the granules and increase the stability of the drug. In addition, the dosage form is diversified, which is convenient for medical needs and achieves the purpose of the invention.

Experiment 1 of the present invention: experimental research on the extraction process of Schisandra chinensis and Cornus officinalis

Weigh 50g each of Schisandra chinensis and Cornus officinalis, and reflux extract twice with 10 times the amount of 80% ethanol for 2 hours each time, and recover the ethanol from the extract; take another 50g each of Schisandra chinensis and Cornus officinalis, soak in 70% ethanol for 24 Percolation and extraction after 1 hour, the ethanol was reclaimed from the extract, and it was obtained; the contents of ursolic acid and schisandrin B were detected respectively, and the extraction rate was calculated, and the results were:

project Ursolic acid Ordinin B Ethanol reflux extraction 2.3% 56.2% Ethanol percolation extraction 1.51% 49.7%

According to the above experimental results, the ethanol reflux extraction is better than the ethanol percolation extraction.

Experiment 2 of the present invention: the influence of the preparation of the present invention on Yin deficiency syndrome model animals

1. Materials

1. Medicine: the tablets prepared by the present invention, the pills prepared by the present invention, and the capsules prepared by the present invention are all prepared according to the method of the present invention; Maiwei Dihuang Tablets and Maiwei Dihuang Pills are all commercially available; triiodothyronine (T ₃ ).

2. Animals Kunming mice and SD rats.

2. Methods and results

1. Effects on plasma CAMP and liver glycogen in mice with yin deficiency: The T ₃ method was used to establish an animal model of yin deficiency. Fifty male mice, weighing 18-22g, were randomly divided into 5 groups, fed with distilled water or drugs once a day for 10 consecutive days, starting from the 6th day of administration, and fed with _T3 18ul/mouse for 5 consecutive days. At the end of the experiment, the animals were sacrificed, the plasma CAMP was measured by the protein binding method, and the liver glycogen was measured by the anthrone method. The results are shown in the table below.

Tablet of the present invention is to the influence (x ± SD) of blood plasma CAMP, liver glycogen of yin-deficiency mice

group Dose (g/kg) Number of animals (only) Plasma CAMP (pM/ml) Liver glycogen (g/100g liver) control group - 10 92.74±27.05 1.27±0.41 Styling group - 10 127.88±29.75^ 0.85±0.37^ Tablet of the present invention 1.5 10 91.45±21.15 1.30±0.40 Wheat Rehmannia Slices 3 10 91.21±12.78 1.31±0.47

It can be seen from the above table that there is no significant difference P>0.05 between the 1.5g/kg dose group of the tablet of the present invention and the 3g/kg dose group of the commercially available Maiwei Dihuang tablet.

2. Effects on body weight, lipid peroxide, adrenal cortex function and blood picture of rats with yin deficiency: male and female rats, body weight 226.4±3.4g, were randomly divided into 5 groups, fed medicine or distilled water of the same volume once a day , for 10 consecutive days. From the 7th day of administration, T ₃ 500ul/kg was administered once a day for 3 consecutive days. At the end of the experiment, the animals were sacrificed, and the liver, adrenal gland and blood samples were taken, and the MDA in the liver was detected by the thiobarbituric acid colorimetric method, and the vitamin C content in the adrenal gland was determined by the 2,4-dinitrophenylhydrazine colorimetric method, and observed. Changes in hemogram, the results are shown in the table below

Effect (x ± SD) of pill of the present invention on body weight, MDA and VitC of yin deficiency rats

group Dose (g/kg) Weight gain or loss (g) (before and after administration) MDA (10^-7mol/g liver) VitC (mg/100g adrenal gland) control group - 8.0±12.3 1.9±0.1 295.1±21.3 Styling group - -13.5±4.1^^ 2.5±0.4^^ 229.4±83.4^ Pills of the present invention 1 -7.9±7.5 2.0±0.3 295.8±47.9 Mai Wei Di Huang Wan 2 -8.0±3.2 2.1±0.6 296.0±41.3

It can be seen from the above table that there is no significant difference between the 1 g/kg dosage group of the pills of the present invention and the 2 g/kg dosage group of the commercially available Maiwei Dihuang Pills, P>0.05.

The influence (x ± SD) of capsule of the present invention on the hemogram of yin-deficiency rats

It can be seen from the above table that there is no significant difference between the 1 g/kg dosage group of the pills of the present invention and the 2 g/kg dosage group of the commercially available Maiwei Dihuang Pills, P>0.05.

The above results show that the curative effect of the 1g/kg dosage group of the pills of the present invention is equivalent to that of the 2g/kg dosage group of the commercially available Maiwei Dihuang Pills.

3. Effects on the immune function of mice with yin deficiency

3.1 Hemolytic plaque test: Take mice weighing 17-22 g, both male and female, administer the drugs in groups and use the _T3 method to establish an animal model of yin deficiency syndrome, all the same as in 2.1. On the 6th day of administration, immunize with fresh sheep red blood cell suspension (SR-BC), 4×10 ⁸ RBC/0.5ml ip per mouse. Animals were sacrificed on the 4th day after immunization, serum was separated and splenocyte suspension was prepared, the number of plaques on each slide was counted by agarose slide method, and the volume of the small chamber was calculated. Correct the number of plaque-forming cells per million (1×10 ⁶ ) splenocytes (i.e., the number of PFCs/10 ⁶ splenocytes) according to the volume of the small chamber and the concentration of splenocytes in the mixture, and the results are shown in the table below; Serum lectin was detected, and the results were expressed in log2 titers, and the results are also shown in the table below; in another experiment, 60 mice, weighing 17-22 g, were administered drugs in groups in the same way, modeled by _T3 method and immunized with fresh SRBC. After the animals were sacrificed, blood samples were taken, and the E rosette formation experiment was performed with reference to the literature method to observe the E rosette formation rate, that is, the formation rate of erythrocyte rosette-forming cells (ERFC). The results are shown in the table below.

The influence (x ± SD) of capsule of the present invention on the antibody formation cell of yin-deficiency mouse

group Dose (g/kg) Hemolytic plaques (number of PFCs/10⁶ splenocytes) Serum agglutinin (log2 titer) ERFC(%) control group - 646.6±298.1 4.6±0.7 14.3±5.1 Styling group - 354.7±105.8 3.3±0.5 11.4±5.3 Capsules of the present invention 1 1043.9±164.8 3.8±0.6 18.3±7.4 Mai Wei Di Huang Wan 2 1044.9±448.9 3.7±0.9 17.0±4.7

The above results show that: each administration group can significantly increase the number of plaque-forming cells in the Yin-deficiency mice, and restore the serum lectin of the Yin-deficiency mice to the normal level. Increase the rosette formation rate of E in yin-deficiency mice. In addition, there is a significant difference between the capsule group of the present invention and the Maiwei Dihuang Wan group (P<0.05), so the curative effect of the 1 g/kg dosage group of the capsule of the present invention is equivalent to that of the commercially available Maiwei Dihuang Wan 2 g/kg dosage group.

Experiment 3 of the present invention: the intervention effect of the preparation of the present invention on the cytokine network of rats with pulmonary interstitial fibrosis

1. Materials and methods

1. Animals and grouping: 48 clean-grade SD male rats, weighing 180-210 g. Divide into 4 groups completely at random, every group of 12 is respectively: I group: blank control group, II group: model group, III group: the dripping pill group of the present invention, prepare according to the method of the present invention. Group IV: Maiwei Dihuang Wan (concentrated pill), commercially available.

2. Drugs: bleomycin hydrochloride.

3. Animal treatment: Bleomycin was injected into the trachea. Each group was anesthetized by intraperitoneal injection of 1% sodium pentobarbital (0.4ml/100g body weight), and the rats were fixed in the supine position, and the median neck incision was made under aseptic operation, the soft tissues were separated layer by layer, the trachea was exposed, and the trachea was punctured. Slowly inject bleomycin 5 mg/kg body weight into the trachea, rotate the animal immediately after injection, and suture the incision. The same amount of normal saline was injected into the bronchi of the control group in the same way. The drugs of each treatment group were made into 6% solution with sterile physiological saline. On the day after the modeling, the prepared pulmonary fibrosis animals were given intragastric administration at a dose of 1ml/100g, once a day. The same amount of normal saline was perfused into the stomach of the control group and the model group in the same way. On the 7th and 28th days after ink making, 6 rats in each group were anesthetized, fixed, and incised without taking arterial blood according to the above method.

4. Preparation of pathological tissue slices: Animals were sacrificed after bloodletting from the common carotid artery, the right lung was taken out and fixed in neutral formalin, sagittal section was made on the outside, embedded, and sliced (5um). Line HE staining.

5. Detection: Plasma TXB ₂ , ET-1, and ET-1 were determined by radioimmunoassay. Serum MCP-1 was measured by double antibody sandwich ELISA. The data of each group was analyzed by variance using SPSS11.0, and pairwise comparisons were made, and P<0.05 was considered to have a significant difference.

2. Results:

1. Plasma TXB ₂

Plasma TXB ₂ content of rats in each experimental group (pg/ml, x±s)

group Dose (g/kg) n 7d 28d Blank control group - 6 107.622±16.471 109.100±16.905 model group - 6 233.734±19.256 250.794±23.108 Dropping pills of the present invention 1g/kg 6 116.729±20.094 159.319±44.574 Maiwei Dihuang Wan Group 3g/kg 6 166.448±40.189 226.607±36.105

2. Plasma ET-1

Plasma ET-1 content of rats in each experimental group (pg/ml, x±s)

group Dose (g/kg) n 7d 28d Blank control group - 6 51.523±10.276 51.515±10.445 model group - 6 75.987±10.128 102.101±17.840 Dropping pills of the present invention 1g/kg 6 50.541±12.802 50.311±4.499 Maiwei Dihuang Wan Group 3g/kg 6 65.990±16.473 67.912±11.842

3. Serum MCP-1

Serum MCP-1 content of rats in each experimental group (pg/ml, x±s)

group Dose (g/kg) n 7d 28d Blank control group - 6 10.895±1.748 10.484±1.528 model group - 6 24.046±5.55 43.772±22.378 Dropping pills of the present invention 1g/kg 6 11.959±6.729 15.188±1.931 Maiwei Dihuang Wan Group 3g/kg 6 20.218±8.308 28.692±3.887

According to the above experimental results, since there is a significant difference (P＜0.05) between the treatment groups, the dripping pills group of the present invention is compared with the commercially available Maiwei Dihuang Pills (concentrated pills) group. Compared with the commercially available Maiwei Dihuang Wan, the pill group has better curative effect and higher bioavailability.

Detailed ways:

Example 1 of the present invention: Weighing: Ophiopogon japonicus 30g, Schisandra chinensis (made) 80g, Rehmannia glutinosa 80g, Cornus officinalis (made) 160g, Moutan bark 30g, Chinese yam 40g, Poria cocos 120g, Alisma 30g, soybean oil 75ml, Tween-8040ml , ethyl cellulose 50g; the preparation process is: Poria cocos is crushed into 150-mesh fine powder, Moutan cortex is added to 300ml of water, 2.5% ethyl acetate is added to the improved oil-water separator, distillation is extracted for 14 hours, and the volatile oil in the distillate is extracted , recover ethyl acetate under reduced pressure, dry at low temperature, and grind into fine powder to obtain Moutan Cortex extract; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were reflux extracted with 4050ml 80% ethanol for 5 times, respectively: 5h, 1h, 0.5h, 0.5h , 0.5h, filter, combine the filtrate and concentrate into extract, add the aqueous solution and dregs after the distillation of Moutan cortex, dregs after ethanol extraction of Ophiopogon japonicus, Schisandra, and Cornus officinalis, yam, rehmannia glutinosa, and Alisma, add 1500ml of water to decoct Boil 5 times, respectively: 5h, 3h, 1h, 1h, 1h, filter the extract, combine the filtrate, concentrate into an extract, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis extract, Poria powder, mix well, dry, and crush Make into 100 mesh fine powder, add paeonol and mix evenly, take soybean oil, Tween-80, ethyl cellulose and mix evenly, add the above powder into the mixed solution of soybean oil, Tween-80 and ethyl cellulose and mix Evenly, pelletized to obtain soft capsules.

Example 2 of the present invention: Weighing: Ophiopogon japonicus 60g, Schisandra chinensis (made) 40g, Rehmannia glutinosa 160g, Cornus officinalis (made) 80g, Moutan cortex 60g, Chinese yam 80g, Poria cocos 60g, Alisma 60g, micronized cellulose 45g, diatom 20g of soil; the preparation process is: 30g of poria cocos is crushed into 100-mesh fine powder; Moutan cortex is added to 300ml of water, and 1.0% ethyl acetate is added to the improved oil-water separator, and distillation is extracted for 8 hours. Recover ethyl acetate, dry it at low temperature, and grind it into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were respectively extracted twice with 1440ml 60% ethanol under reflux, each time for 2 hours, filtered, combined and concentrated into an extract, and peony The aqueous solution and dregs after distillation of the bark, the dregs after ethanol extraction of Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma were added to 990ml of water and decocted for 3 times, respectively for 3h, 2h, and 1h, and extracted Filtrate the liquid, combine the filtrates, pass through a macroporous adsorption resin column, elute with 50% ethanol, reclaim the ethanol, concentrate it into an extract, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis extract, and Poria powder, mix evenly, and dry. Grind into 100-mesh fine powder, add paeonol and mix evenly; take 200g of drug powder, mix with 45g of micropowder cellulose, and 20g of diatomaceous earth, put it in a coating granulator, and use 5% ethyl methylcellulose ethanol solution as The binder is first made into 40-mesh masterbatch, and then put into the turntable of the coating granulator after drying, then use 8% sodium carboxymethylcellulose aqueous solution as the binder, add the mixed medicine powder and roll to make it Micropills with a particle size of 2 mm are dried and packed into capsules to obtain sustained-release capsules. The process parameters are: spraying speed: 15r/min, host speed: 80r/min, powder supply speed: 15r/min.

Example 3 of the present invention: Weighing: Ophiopogon japonicus 120g, Schisandra chinensis (made) 20g, Rehmannia glutinosa 320g, Cornus officinalis (made) 40g, Moutan cortex 120g, Chinese yam 160g, Poria cocos 30g, Alisma 120g, β-cyclodextrin 40g, PVPP 57g, CMC-Ca 108g, micropowder silica gel 3g, MCC 200g, magnesium stearate 5g; the preparation process is as follows: Poria cocos 6g is crushed into 120 mesh fine powder; Moutan cortex is added to 960ml water, extracted by steam distillation, and the distillate is β -Cyclodextrin for inclusion, the inclusion method is a saturated aqueous solution method, the inclusion temperature is 35-40 ° C, and the ultrasonic time is 30 minutes; the inclusion compound is dried at low temperature and crushed into fine powder; used for Ophiopogon japonicus, Schisandra, and Cornus officinalis 1800ml 70% ethanol reflux extraction 3 times, each time for 1 hour, filter, combine the filtrate and concentrate into an extract, distill the aqueous solution and dregs of Moutan cortex, extract dregs and residues of Ophiopogon japonicus, Schisandra, and Cornus officinalis with alcohol Poria cocos, Chinese yam, Rehmannia glutinosa, and Alisma were added to 5000ml water and decocted for 3 times, respectively: 3h, 2h, 1h, the extract was filtered, the combined filtrate was passed through a macroporous adsorption resin column, and eluted with 80% ethanol , recover ethanol, concentrate into extract, then add above-mentioned Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis extract, Poria cocos powder, paeonol cyclodextrin inclusion complex, PVPP 30g, CMC-Ca 60g, mix well, dry, pulverize, pass 100 Mesh sieve, set aside; take the remaining PVPP27g, CMC-Ca48g and micropowder silica gel, MCC, magnesium stearate respectively, dry at 40°C for 6 hours, pulverize, pass through a 100 mesh sieve, set aside; take the remaining PVPP, CMC-Ca, Mix MCC, micropowder silica gel and the above drug powder evenly, use HPMC as a binder to make a soft material, pass through a 30-mesh sieve, dry at 60°C for 2 hours, add magnesium stearate, mix evenly, and press into tablets to obtain dispersible tablets.

Example 4 of the present invention: Weighing: Ophiopogon japonicus 60g, Schisandra chinensis (made) 40g, Rehmannia glutinosa 160g, Cornus officinalis (made) 80g, Moutan cortex 60g, Chinese yam 80g, Poria cocos 60g, Alisma 60g, β-cyclodextrin 20g, Polyethylene glycol 4000 or polyethylene glycol 6000-300ml; the preparation process is as follows: take poria cocos and pulverize it into 80-mesh fine powder; then place it in an ultra-fine pulverization equipment and continue pulverizing it into 200-mesh micropowder; Moutan cortex is distilled and extracted with water. Method: add 480ml of water, add 2.0% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, extract the volatile oil in the distillate, recover ethyl acetate under reduced pressure, and use β-cyclodextrin for inclusion in the distillate , the inclusion temperature is 35°C, and the ultrasonic time is 30min. The clathrate is dried at low temperature and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted by adding 1080ml 95% ethanol to reflux for 2 times, each time for 1 hour, filtering, combining the filtrates and concentrating them into a clear paste, distilling Moutan bark The aqueous solution and dregs of Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis ethanol extracted dregs, Chinese yam, rehmannia glutinosa, and Alisma are added to 2400ml of water and decocted for 3 times. The decoction time is 3h, 2h, 1h respectively, and the extract is filtered. Combine the filtrates, pass through a macroporous adsorption resin column, elute with 70% ethanol, recover the ethanol, concentrate into a clear paste, add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis clear paste and Poria micropowder, mix and granulate, dry, and then mix with dandelion Mix the skinphenol-cyclodextrin inclusion complex evenly, add the obtained powder or granules into the polyethylene glycol 4000 or polyethylene glycol 6000 that has been heated and melted, keep a constant temperature of 90-102°C, drop the methyl alcohol with a dropper In silicone oil, drop pill preparations are obtained.

Example 5 of the present invention: Weighing: Ophiopogon japonicus 60g, Schisandra chinensis (made) 40g, Rehmannia glutinosa 160g, Cornus officinalis (made) 80g, Moutan cortex 60g, Chinese yam 80g, Poria cocos 60g, Alisma 60g, α-cyclodextrin 20g, Sodium stearate or glycerin gelatin 300ml; the preparation process is: take poria cocos and pulverize it into a fine powder of 100 mesh; then place it in an ultra-fine pulverization equipment and continue pulverizing it into a fine powder of 300 mesh; distill and extract Moutan cortex with water steam, the method is: add 480ml of water, add 2.0% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, extract the volatile oil in the distillate, recover ethyl acetate under reduced pressure, and use α-cyclodextrin for inclusion in the distillate. The temperature is 35°C, and the ultrasonic time is 30min. The clathrate is dried at low temperature and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted by adding 1080ml 95% ethanol to reflux for 2 times, each time for 1 hour, filtering, combining the filtrates and concentrating them into a clear paste, distilling Moutan bark The aqueous solution and dregs of Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis ethanol extracted dregs, Chinese yam, rehmannia glutinosa, and Alisma are added to 2400ml of water and decocted for 3 times. The decoction time is 3h, 2h, 1h respectively, and the extract is filtered. Combine the filtrates, pass through a macroporous adsorption resin column, elute with 70% ethanol, recover the ethanol, concentrate into a clear paste, add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis clear paste and Poria micropowder, mix and granulate, dry, and then mix with dandelion Mix the skinphenol cyclodextrin inclusion compound evenly, add the obtained medicinal powder or granules into the heated and melted sodium stearate or glycerin gelatin base, keep a constant temperature of 78-90°C, drop into the methyl silicone oil with a dropper, That is the drop pill preparation.

Embodiment 6 of the present invention: Weigh: Ophiopogon japonicus 60g, Schisandra chinensis (made) 40g, Rehmannia glutinosa 160g, Cornus officinalis (made) 80g, Moutan cortex 60g, Chinese yam 80g, Poria cocos 60g, Alisma 60g; The preparation process is: Poria cocos 30g pulverized Become 120 mesh fine powder; Cortex Moutan extracts paeonol with steam distillation, method is to add 480ml water to Cortex Moutan, add 2.0% ethyl acetate in the improved oil-water separator, distill and extract 10h, after extracting the volatile oil in the distillate, Ethyl acetate was recovered under reduced pressure to obtain it; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were extracted 3 times with ethanol reflux, the extraction time was 1h, 0.5h, and 0.5h, respectively, filtered, and the filtrates were combined and concentrated to a thick paste. Add the distilled aqueous solution, the dregs of Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis ethanol, and the remaining Poria cocos, Chinese yam, Rehmannia glutinosa, and Alisma, into 3300ml of water and decoct for 5 hours, filter the extract, pass through a macroporous adsorption resin column, and use Elute with 50% ethanol, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste, Poria powder, mix and granulate, microwave dry, pulverize, pack into capsules, and obtain capsule preparations.

Example 7 of the present invention: Weighing: Ophiopogon japonicus 120g, Schisandra chinensis (made) 20g, Rehmannia glutinosa 320g, Cornus officinalis (made) 40g, Moutan cortex 120g, Chinese yam 160g, Poria cocos 30g, Alisma 120g, dextrin or sucrose 2000g; preparation The process is: Poria cocos is crushed into 100-mesh fine powder, and the cortex of Moutan is steam distilled. The method is: add 720ml of water to the cortex of Moutan, add 2.0% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, and extract the volatile oil in the distillate Finally, recover ethyl acetate under reduced pressure, dry it at low temperature, and grind it into fine powder to get it; extract Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis with ethanol, filter, and concentrate the filtrate to a thick paste; distill the aqueous solution and dregs of Moutan cortex, The dregs extracted by ethanol from Ophiopogon japonicus, Schisandra, and Cornus officinalis, and the remaining Poria cocos, Chinese yam, rehmannia glutinosa, and Alisma, add water to decoct, filter the extract, combine the filtrate, concentrate to a thick paste, and then add the above-mentioned Ophiopogon japonicus, Schisandra, The dogwood thick paste, paeonol and dextrin or sucrose are evenly mixed and granulated to obtain a granule preparation.

Example 8 of the present invention: Weighing: Ophiopogon japonicus 30g, Schisandra chinensis (made) 80g, Rehmannia glutinosa 80g, Cornus officinalis (made) 160g, Moutan cortex 30g, Chinese yam 40g, Poria cocos 120g, Alisma 30g, sweetener or lactose 320g; The preparation process is: water steam distillation of Moutan cortex, the method is: add 240ml of water to Moutan cortex, add 1.5% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, extract the volatile oil in the distillate, and recover ethyl acetate under reduced pressure Esters, dried at low temperature, and ground into fine powder to obtain; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis were extracted with ethanol reflux 4 times, each time for 0.5 hours, filtered, combined filtrates and concentrated to a thick paste, distilled aqueous solution of Moutan bark and Dregs, dregs extracted by ethanol from Ophiopogon japonicus, Schisandra, Cornus officinalis, Poria cocos, Chinese yam, Rehmannia glutinosa, and Alisma, add 1620ml of water to decoct 3 times, decoct for 3 hours, 1 hour, 1 hour respectively, filter the extract, combine the filtrate, Concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, schisandra, dogwood thick paste, paeonol and sweetener or lactose, mix evenly, and granulate to obtain granules.

Embodiment 9 of the present invention: Weighing: Ophiopogon japonicus 120g, Schisandra chinensis (made) 20g, Rehmannia glutinosa 320g, Cornus officinalis (made) 40g, Moutan cortex 120g, Chinese yam 160g, Poria cocos 30g, Alisma 120g, refined honey 250g; The preparation process is Poria cocos 9g is ground into the fine powder of more than 100 orders; Cortex Moutan is steam distilled, and method is: Cortex Moutan adds 1080ml water, adds 2.5% ethyl acetate in the improved oil-water separator, distills and extracts for 8h, extracts the After volatile oil, recover ethyl acetate under reduced pressure, dry at low temperature, and grind into fine powder. Radix Ophiopogon japonicus, schisandra, and dogwood were extracted with 2700ml of 90% ethanol for 5 hours, filtered, combined and concentrated to a thick paste, and the distilled aqueous solution and dregs of Moutan cortex, and the medicine after ethanol extraction of Ophiopogon japonicus, Schisandra, and dogwood Decoct the slag and the remaining Poria cocos, yam, rehmannia glutinosa, and Alisma in water, add 6210ml of water for 3 hours for the first time, and decoct for 1 hour with 4968ml of water for the second to fifth times, filter the extract, combine the filtrate, and pass Macroporous adsorption resin column, elute with 80% ethanol, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder, spray dry, pulverize, and pass through a 60-mesh sieve Net, add paeonol and mix evenly, then add refined honey and medicine to make honeyed pills to get pills.

Example 10 of the present invention: Weighing: Ophiopogon japonicus 120g, Schisandra chinensis (made) 20g, Rehmannia glutinosa 320g, Cornus officinalis (made) 40g, Moutan cortex 120g, Chinese yam 160g, Poria cocos 30g, Alisma 120g, refined honey 75g; The preparation process is Poria cocos 9g is pulverized into fine powder more than 100 orders; Cortex Moutan is steam distilled, and method is: Cortex Moutan adds 720ml water, adds 1.0% ethyl acetate in the improved oil-water separator, distills and extracts for 12h, extracts the After volatile oil, recover ethyl acetate under reduced pressure, dry at low temperature, and grind into fine powder. Radix Ophiopogon japonicus, schisandra, and dogwood were extracted with 2700ml of 90% ethanol for 5 hours, filtered, combined and concentrated to a thick paste, and the distilled aqueous solution and dregs of Moutan cortex, and the medicine after ethanol extraction of Ophiopogon japonicus, Schisandra, and dogwood Decoct the slag and the remaining Poria cocos, yam, rehmannia glutinosa, and Alisma in water, add 6210ml of water for 3 hours for the first time, and decoct for 1 hour with 4968ml of water for the second to fifth times, filter the extract, combine the filtrate, and pass Macroporous adsorption resin column, elute with 80% ethanol, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder, spray dry, pulverize, and pass through a 60-mesh sieve Net, add paeonol and mix evenly, then add refined honey and medicine to make honeyed pills to get pills.

Example 11 of the present invention: Weighing: Ophiopogon japonicus 30g, Schisandra chinensis (made) 80g, Rehmannia glutinosa 80g, Cornus officinalis (made) 160g, Moutan cortex 30g, Chinese yam 40g, Poria cocos 120g, Alisma 30g, γ-cyclodextrin 5g, 28.5g of starch and 0.73g of magnesium stearate; the preparation process is as follows: 96g of poria cocos is crushed into a fine powder of 150 mesh; Moutan cortex is steam distilled, and the distillation extraction method is as follows: add 300ml of water to the medicinal material, and add 2.5% acetic acid to the improved oil-water separator Ethyl, distilled and extracted for 8 hours, after extracting the volatile oil in the distillate, recover ethyl acetate under reduced pressure, that is. The distillate is clathrated with γ-cyclodextrin, the clathrate temperature is 35-40°C, and the ultrasonic time is 30-35min. The clathrate is dried at low temperature and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted with ethanol reflux 3 times, each time for 1 hour, filtered, combined filtrates and concentrated to a thick paste, and the aqueous solution distilled from Moutan bark and dregs of Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis after ethanol extraction and remaining Poria cocos, Chinese yam, Rehmannia glutinosa, and Alisma, add 522ml of water to decoct twice, each time for 2 hours, filter the extract, combine the filtrate, Pass through a macroporous adsorption resin column, elute with 60% ethanol, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder, spray dry, add starch and the above-mentioned dandelion The skinphenol-cyclodextrin inclusion compound is mixed evenly, granulated with ethanol, then added with magnesium stearate, mixed evenly, pressed into tablets, and coated with a 2% film coating agent to obtain tablets.

Example 12 of the present invention: Weighing: Ophiopogon japonicus 30g, Schisandra chinensis (made) 80g, Rehmannia glutinosa 80g, Cornus officinalis (made) 160g, Moutan cortex 30g, Chinese yam 40g, Poria cocos 120g, Alisma 30g, γ-cyclodextrin 30g, 114g of starch and 1.73g of magnesium stearate; the preparation process is as follows: 96g of poria cocos is crushed into a fine powder of 150 mesh; Moutan cortex is steam distilled, and the distillation extraction method is as follows: add 300ml of water to the medicinal material, and add 2.5% ethyl acetate to the improved oil-water separator Esters, distilled and extracted for 8h, after extracting the volatile oil in the distillate, recover ethyl acetate under reduced pressure, that is. The γ-cyclodextrin in the distillate is clathrated, the clathrate temperature is 35-40° C., and the ultrasonic time is 30-35 min. The clathrate is dried at low temperature and crushed into fine powder; Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis are extracted with ethanol reflux 3 times, each time for 1 hour, filtered, combined filtrates and concentrated to a thick paste, and the aqueous solution distilled from Moutan bark and dregs of Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis after ethanol extraction and remaining Poria cocos, Chinese yam, Rehmannia glutinosa, and Alisma, add 522ml of water to decoct twice, each time for 2 hours, filter the extract, combine the filtrate, Pass through a macroporous adsorption resin column, elute with 70% ethanol, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder, spray dry, add starch and the above-mentioned dandelion The skinphenol-cyclodextrin inclusion compound is mixed evenly, granulated with ethanol, then added with magnesium stearate, mixed evenly, pressed into tablets, and coated with 8% film coating agent to obtain tablets.

Example 13 of the present invention: weighing: Ophiopogon japonicus 45g, Schisandra chinensis 30g, Rehmannia glutinosa 120g, Cornus officinalis (made) 60g, Moutan bark 45g, Chinese yam 60g, Poria cocos 45g, Alisma 45g, sucrose 50g, sodium benzoate 0.6g; Moutan bark Distillation with water steam, the distillation extraction method is as follows: add 480ml of water to the medicinal material, add 2.0% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, extract the volatile oil in the distillate, and recover ethyl acetate under reduced pressure to obtain the product; Add 5400ml of water for the first time to decoct the remaining medicine for 4 hours, add 4320ml of water for the second time and decoct for 2 hours, add 3240ml of water for the third time and decoct for 1 hour, filter the extract, combine the filtrates, filter, and concentrate the filtrate , stand still for 12 hours, take the supernatant, filter, continue to concentrate the filtrate, refrigerate for 24 hours, add sucrose to the filtrate, boil to dissolve, filter, add sodium benzoate, add water to the full amount, stir well, and obtain the oral liquid.

Example 14 of the present invention: Weigh: Ophiopogon japonicus 45g, Schisandra 30g, Rehmannia glutinosa 120g, Cornus officinalis (made) 60g, Moutan bark 45g, Chinese yam 60g, Poria cocos 45g, Alisma 45g, sucrose 600g, sodium benzoate 8g; Moutan bark water Steam distillation, the distillation extraction method is as follows: add 600ml of water to the medicinal materials, add 2.0% ethyl acetate to the improved oil-water separator, distill and extract for 10 hours, extract the volatile oil in the distillate, and recover ethyl acetate under reduced pressure to obtain the product; Add 5400ml of water for the first time and decoct for 4 hours, add 4320ml of water for the second time and decoct for 2 hours, add 3240ml of water for the third time and decoct for 1 hour, filter the extract, combine the filtrates, filter, concentrate the filtrate, Stand still for 12 hours, take the supernatant, filter, continue to concentrate the filtrate, refrigerate for 24 hours, add sucrose to the filtrate, boil to dissolve, filter, add sodium benzoate, add water to the full amount, stir well to obtain the oral liquid.

Claims (13)

1. A preparation method of traditional Chinese medicine oral preparation for nourishing kidney and lung, calculated according to weight components: it consists of Radix Ophiopogon 30-120, Schisandra 20-80, Rehmannia glutinosa 80-320, Cornus officinalis 40-160, Cortex Moutan 30-120, Chinese yam 40-160, Poria cocos 30-120, Alisma 30-120 and auxiliary materials; it is characterized in that part or all of Poria cocos is crushed into a fine powder of more than 100 mesh, Moutan bark is steam distilled to extract paeonol phenol; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted with ethanol, filtered, and the filtrate is concentrated to a thick paste; the aqueous solution and dregs of Moutan cortex after distillation, the dregs of dregs after ethanol extraction of Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis and the remaining Poria cocos, Chinese yam, Rehmannia glutinosa and Alisma chinensis are decocted with water, the extracts are filtered, the filtrates are combined, and concentrated to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis thick paste, Poria powder and paeonol and mix well, and finally add different excipients according to Different methods make different formulations. 2. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1, it is characterized in that: Poria cocos is partially or completely pulverized into a fine powder above 100 mesh, paeonol is extracted from Cortex Moutan with steam distillation; Ophiopogon japonicus , Schisandra chinensis and Cornus officinalis are extracted with ethanol reflux 1-5 times, each time for 0.5-5 hours, filtered, combined filtrates and concentrated into an extract, the distilled aqueous solution of Moutan cortex and medicinal residues, Ophiopogon japonicus, Schisandra and Cornus officinalis ethanol extraction Add 3-10 times the amount of water to decoct the remaining medicinal residues, Poria cocos, Chinese yam, Rehmannia glutinosa and Alisma 1-5 times, each time for 1-5 hours, filter the extract, combine the filtrates, concentrate into an extract, and then Add the above-mentioned Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis extract, Poria cocos powder and paeonol and mix evenly, and finally add different auxiliary materials and make different preparations according to different methods. 3. According to the preparation method of the Chinese medicine oral preparation for nourishing the kidney and nourishing the lung described in claim 1 or 2, it is characterized in that: Poria cocos is partly or completely pulverized into a fine powder of more than 100 mesh; Moutan cortex is steam distilled to extract paeonol; Radix Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted with ethanol reflux for 1-5 times, each time for 0.5-5 hours, filtered, combined filtrates and concentrated into an extract, distilled aqueous solution of Moutan cortex and medicinal residues, Ophiopogon japonicus, Schisandra and Cornus officinalis Add 3-10 times the amount of water to decoct the medicinal residue after ethanol extraction and the remaining Poria cocos, yam, Rehmannia glutinosa and Alisma 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, and absorb through macropores Resin column, eluted with 50-80% ethanol, recovered ethanol, concentrated into extract, then added the above-mentioned Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis extract, Poria powder and paeonol and mixed evenly, then added different auxiliary materials according to different different preparation methods. 4. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: Poria cocos is partly or completely pulverized into a fine powder of more than 100 mesh; -5 times the amount of cyclodextrin for inclusion, the inclusion compound is dried at low temperature, and crushed into a fine powder; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filtered, Combine the filtrates and concentrate them into an extract, add 3-10 times the amount of water to decoct the distilled aqueous solution of Moutan cortex and dregs, ethanol-extracted dregs of Ophiopogon japonicus, Schisandra chinensis, and Cornus officinalis, and the remaining Poria cocos, yam, Rehmannia glutinosa, and Alisma Boil 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, elute with 50-80% ethanol, recover the ethanol, concentrate it into an extract, and then add the above Ophiopogon japonicus, Schisandra chinensis, Cornus officinalis extract, Poria cocos powder and paeonol cyclodextrin inclusion compound are mixed evenly, and then different auxiliary materials are added to make different preparations according to different methods. 5. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 4, it is characterized in that: the cyclodextrin in the present invention includes α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin Refined. 6. according to the preparation method of the traditional Chinese medicine oral preparation of nourishing the kidney and nourishing the lung described in claim 5, it is characterized in that: described cyclodextrin is β-cyclodextrin. 7. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 4, it is characterized in that: the distillation extraction method is that the medicinal material is added with 5-10 times the amount of water, and 1.0-2.5% of the water is added to the improved oil-water separator. Ethyl acetate, distilled and extracted for 8-14h, after extracting the volatile oil in the distillate, recover ethyl acetate under reduced pressure to obtain that; the method of inclusion of the volatile oil cyclodextrin is a saturated aqueous solution method; the inclusion temperature is 30 -40°C, ultrasonic time is 25-35min. 8. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: the preparation process of the capsule is: Poria cocos is partially or completely crushed into fine powder above 100 mesh; Extract paeonol from the cortex by steam distillation; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filter, combine the filtrate and concentrate to a thick paste, distill the aqueous solution of Moutan cortex and medicinal dregs, the medicinal dregs extracted by ethanol from Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis, and the remaining Poria cocos, Chinese yam, rehmannia glutinosa and Alisma alisma, add 3-10 times the amount of water and decoct 1-5 times, each time for 1-5 hours, the extract Filtrate, combine the filtrates, pass through a macroporous adsorption resin column, elute with 50-80% ethanol, recover the ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder to mix and granulate , microwave-dried, pulverized, mixed with paeonol evenly, granulated, and packed into capsules. 9. according to the preparation method of the Chinese medicine oral preparation of nourishing the kidney and nourishing the lung described in claim 1 or 2, it is characterized in that: the preparation process of described dropping pill is: poria cocos part or all is pulverized into 80-100 purpose fine powder; Place it in the ultrafine pulverization equipment and continue pulverizing to 200-300 mesh micropowder; Moutan cortex is steam distilled, the distillate is clathrated with 0.5-5 times the amount of cyclodextrin, the clathrate is dried at low temperature, and pulverized into fine powder That is: Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filtered, combined filtrate and concentrated into a clear paste, distilled aqueous solution of Moutan cortex and medicinal residues, Ophiopogon japonicus, Ophiopogon japonicus, Add 3-10 times the amount of water to decoct the dregs after ethanol extraction of Schisandra chinensis and Cornus officinalis and the remaining Poria cocos, Chinese yam, Rehmannia glutinosa and Alisma 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, and pass The macroporous adsorption resin column is eluted with 50-80% ethanol, the ethanol is recovered, concentrated into a clear paste, and then the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis clear paste and Poria micropowder are mixed and granulated, dried, and then mixed with paeonol Mix the cyclodextrin inclusion compound evenly; add the obtained drug powder or granules into the dissolved or emulsified polyethylene glycol 4000, polyethylene glycol 6000, sodium stearate or glycerin gelatin matrix that has been heated and melted, and keep a constant temperature of 78 -102°C, use a dropper to drop into methyl silicone oil, and collect drop pills. 10. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: the preparation process of the pill is: Poria cocos is partially or completely pulverized into a fine powder above 100 mesh; Cortex Moutan Extract paeonol by steam distillation, and add 1mol/L hydrochloric acid to the collected distillate to crystallize, filter, wash the crystals with water, dry at low temperature, and grind into fine powder; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted with ethanol 1 -5 times, 0.5-5 hours each time, filter, combine the filtrates and concentrate to a thick paste, distill the aqueous solution of Moutan cortex and herb residues, the ethanol extracts of Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis and the remaining Poria cocos , Chinese yam, Rehmannia glutinosa and Alisma, add 3-10 times the amount of water and decoct 1-5 times, each time for 1-5 hours, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, and use 50-80% ethanol Perform elution, recover ethanol, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria powder, spray dry, crush, pass through a sieve of 60 mesh or above, add paeonol Mix evenly, then add 0.3-1 times the amount of powdered honey and medicine to make honeyed pills. 11. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: the preparation process of the tablet is: the poria cocos is partially or completely crushed into a fine powder of more than 100 mesh; The skin is distilled with steam, and the distillate is clathrated with 0.5-5 times the amount of cyclodextrin. The clathrate is dried at low temperature and crushed into a fine powder; Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux. After 0.5-5 hours, filter, combine the filtrates and concentrate to a thick paste, distill the aqueous solution of Moutan cortex and medicinal residues, the medicinal residues after ethanol extraction of Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis, and the remaining Poria cocos, Chinese yam, Rehmannia glutinosa and Ze Add 3-10 times the amount of water to decoct 1-5 times, each time for 1-5 hours, filter the extract, combine the filtrate, pass through a macroporous adsorption resin column, elute with 50-80% ethanol, and recover Ethanol, concentrated to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste and Poria cocos powder to mix, spray dry, add 5-20% of the prescription amount of starch and the above-mentioned paeonol-cyclodextrin inclusion compound and mix well, Granulate with ethanol, add 0.5-1% magnesium stearate to the dry granules, mix evenly, press into tablets, and coat the plain tablets with 2-8% film coating agent to obtain tablets. 12. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: the preparation process of the granule is: paeonol is extracted from Moutan cortex with steam distillation, and the collected Add 1mol/L hydrochloric acid to the distillate to crystallize, filter, wash the crystals with water, dry at low temperature, and grind into fine powder; Radix Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis are extracted 1-5 times with ethanol reflux, each time for 0.5-5 hours, filter After filtering and merging the filtrates and concentrating to a thick paste, add 3-10 times the amount of water to the distilled aqueous solution of Moutan cortex and medicinal residues, the medicinal residues after ethanol extraction of Ophiopogon japonicus, Schisandra chinensis and Cornus officinalis, Poria cocos, Chinese yam, rehmannia glutinosa and Alisma Decoct 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, concentrate to a thick paste, then add the above-mentioned Ophiopogon japonicus, Schisandra, Cornus officinalis thick paste, paeonol and 2-5 times the amount of The auxiliary materials are mixed and granulated to obtain granules; the auxiliary materials used in the granules of the present invention include dextrin, sucrose or lactose. 13. According to the preparation method of the traditional Chinese medicine oral preparation for nourishing the kidney and nourishing the lung according to claim 1 or 2, it is characterized in that: the preparation process of the oral liquid preparation is: the Cortex Moutan is steam distilled, and the distillate is collected; Add 3-10 times the amount of water to the drug and decoct 1-5 times, 1-5 hours each time, filter the extract, combine the filtrate, filter, concentrate the filtrate, let it stand for 10-50 hours, and take the supernatant , filter, continue to concentrate the filtrate, refrigerate for 10-50 hours, add sucrose to the filtrate to make the final sugar content 5-60%, boil to dissolve, filter, add 0.06%-0.8% sodium benzoate, add water to the full amount, stir well , that is.