CN111450171B - Wuzi Yanzong soft capsule and preparation method thereof - Google Patents
Wuzi Yanzong soft capsule and preparation method thereof Download PDFInfo
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- CN111450171B CN111450171B CN202010122477.2A CN202010122477A CN111450171B CN 111450171 B CN111450171 B CN 111450171B CN 202010122477 A CN202010122477 A CN 202010122477A CN 111450171 B CN111450171 B CN 111450171B
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- filtrate
- ethanol
- soft capsule
- extract powder
- wuzi yanzong
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a preparation method of a Wuzi Yanzong soft capsule, which comprises the following steps: extracting fructus Lycii with ethanol, concentrating, and drying to obtain fructus Lycii extract powder; mixing semen Cuscutae, Rubi fructus, semen plantaginis, and fructus Schisandrae, and extracting with ethanol to obtain first filtrate and residue; extracting the filter residue with water, precipitating with ethanol to obtain a third filtrate, mixing the first filtrate and the third filtrate, concentrating, and drying to obtain mixed extract powder; adding fructus Lycii extract powder and mixed extract powder into the suspension, stirring, and degassing to obtain medicinal liquid; and forming the liquid medicine and the glue solution auxiliary material together to obtain a finished product of the Wuzi Yanzong soft capsule. The preparation method has high utilization efficiency of raw materials, can effectively improve the extraction rate of effective components, and can also avoid excessive impurities in the extract; the soft capsule has good drug effect and small dosage.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a Wuzi Yanzong soft capsule and a preparation method thereof.
Background
The Wuzi Yanzong pill is a Wuzi Jiangxian pill which is prepared from five traditional Chinese medicines including semen cuscutae, schisandra chinensis, wolfberry fruit, raspberry and semen plantaginis, is a famous prescription for nourishing yin and yang in traditional Chinese medicine, has the functions of tonifying liver and kidney, replenishing essence and benefiting marrow, and has obvious curative effects on lumbago due to kidney deficiency, dribbling after urination, spermatorrhea, premature ejaculation, impotence, sterility and the like. 2015 edition "Chinese pharmacopoeia" lists two dosage forms, namely Wuzi Yanzong pill and Wuzi Yanzong tablet; wherein, the Wuzi Yanzong tablet is prepared by 275g of medlar, 275g of dodder, 135g of raspberry, 35g of schisandra chinensis and 68g of plantain seed; the preparation process comprises the following steps: pulverizing part of semen Cuscutae into fine powder, and decocting part of semen Cuscutae and Rubi fructus with water; percolating three medicinal materials such as fructus Schisandrae with 70% ethanol, concentrating the two extractive solutions to obtain paste, mixing with semen Cuscutae fine powder and adjuvants, granulating, and making into 1000 tablets. The Wuzi Yanzong pill is prepared by 400g of medlar, 400g of dodder, 200g of raspberry, 50g of schisandra chinensis and 100g of plantain seed; the preparation process comprises the following steps: pulverizing the above materials, adding Mel, and making into honeyed pill. The dose of the Wuzi Yanzong pill is 12-18 g per day. Therefore, the dosage of the polarity of the existing wuzi Yanzong is higher; and the active ingredients in the prescription are difficult to completely reserve by the current process.
Thus, chinese patent CN1569049A discloses a novel preparation method of wuzi yanzong, which is to extract plantain seeds, medlar and dodder seeds by means of alcohol extraction and water extraction, extract schisandra chinensis by means of extraction of volatile components and water extraction and/or alcohol extraction, and then prepare the extracted components into preparations such as tablets, pills, dripping pills, capsules and the like. However, the extraction method is complicated in process and difficult to realize in mass production. And the dosage is still high.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a preparation method of Wuzi Yanzong soft capsules, which can realize full-automatic production, and has the advantages of high utilization efficiency of raw materials, high product stability, good curative effect and small dosage.
The invention also aims to solve the technical problem of providing a Wuzi Yanzong soft capsule.
In order to solve the technical problems, the invention provides a preparation method of Wuzi Yanzong soft capsules, which comprises the following steps:
(1) extracting the wolfberry fruit by adopting 60-80% ethanol for at least one time to obtain filtrate; concentrating the filtrate, and drying to obtain fructus Lycii extract powder;
(2) mixing semen Cuscutae, Rubi fructus, semen plantaginis, and fructus Schisandrae to obtain mixture; extracting the mixture for at least one time by adopting 60-80% ethanol to obtain a first filtrate and filter residue;
(3) extracting the filter residue with water at least once to obtain a second filtrate;
(4) adding ethanol into the second filtrate to enable the ethanol content in the second filtrate to reach 50% -70%, standing and filtering to obtain a third filtrate;
(5) mixing the first filtrate and the third filtrate, concentrating, and drying to obtain mixed extract powder;
(6) adding the medlar extract powder and the mixed extract powder into the suspension, stirring and degassing to obtain a liquid medicine; and forming the liquid medicine and the glue solution auxiliary material together to obtain a finished product of the Wuzi Yanzong soft capsule.
As an improvement of the above technical scheme, in the step (1), the ratio of the weight of the medlar to the volume of the ethanol is 1: (1.5-5); extracting by a heating reflux method;
wherein the volume fraction of the ethanol is 60-70%.
As an improvement of the above technical scheme, in the step (2), the ratio of the weight of the mixture to the volume of the ethanol is 1: (2-5), extracting by using a percolation method or a heating reflux method;
wherein the volume fraction of the ethanol is 70-80%.
As an improvement of the technical scheme, the step (3) comprises the following steps:
(3.1) mixing the filter residue with water according to the weight ratio of 1: (4-10), boiling and extracting for 0.5-2 h, and filtering to obtain a fourth filtrate;
(3.2) concentrating the fourth filtrate under reduced pressure until the relative density is 1-1.2, and cooling to obtain a second filtrate.
As an improvement of the technical scheme, the step (5) comprises the following steps:
(5.1) combining the first filtrate and the third filtrate, and concentrating under reduced pressure to obtain a mixed thick paste with the relative density of 1.2-1.5;
(5.2) drying the mixed thick paste under reduced pressure and vacuum at the temperature of below 70 ℃, and crushing to obtain mixed extract powder.
As an improvement of the technical scheme, the step (1) comprises the following steps:
(1.1) refluxing and extracting the wolfberry fruit twice by adopting 60-80% ethanol to obtain a filtrate;
(1.2) recovering ethanol from the filtrate under reduced pressure, and concentrating to obtain a thick paste of the Chinese wolfberry fruit, wherein the relative density of the thick paste is 1.2-1.4;
(1.3) drying fructus Lycii soft extract at below 70 deg.C under reduced pressure under vacuum, and pulverizing to obtain fructus Lycii extract powder.
As an improvement of the technical scheme, the step (2) comprises the following steps:
(2.1) crushing the semen cuscutae, sieving with a 60-100-mesh sieve, and taking the undersize product of the semen cuscutae;
(2.2) respectively crushing raspberry, plantain seed and schisandra chinensis, sieving with a 40-mesh sieve, and mixing undersize materials with undersize materials of semen cuscutae to obtain a mixture;
and (2.3) carrying out reflux extraction twice on the mixture by adopting 70-80% ethanol to obtain a first filtrate and filter residue.
As an improvement of the above technical scheme, the suspension is a mixture of soybean oil, coconut oil and beeswax, and the ratio of soybean oil: coconut oil: beeswax (1-3): (3-20): (1-3).
As an improvement of the technical scheme, the auxiliary materials are selected from gelatin and/or glycerol.
Correspondingly, the invention also provides a Wuzi Yanzong soft capsule which is prepared by adopting the preparation method.
The implementation of the invention has the following beneficial effects:
1. the invention extracts the medlar by adopting 60-80% ethanol, which can effectively retain polysaccharide, flavonoid and alkaloid substances in the medlar and improve the extraction rate of effective components in the medlar.
2. The invention extracts the four traditional Chinese medicines of the dodder, the raspberry, the plantain seed and the kadsura longepedunculata by adopting the processes of alcohol extraction and water extraction and alcohol precipitation, and the process can effectively improve the extraction rate of effective components such as flavonoid, alkaloid, lignan and the like and can also avoid the increase of dosage caused by excessive impurities contained in the extract. The Wuzi Yanzong soft capsule of the invention is 0.55-0.65 g in weight per capsule, 3 capsules are taken each time, and 9 capsules are taken each day.
3. The invention adopts the soft capsule dosage form, and has short disintegration time, convenient taking and better curative effect.
4. The Wuzi Yanzong soft capsule can be produced by a full-automatic process, and has high quality controllability and high production efficiency.
Drawings
FIG. 1 is a flow chart of the process for preparing Wuzi Yanzong soft capsules of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings and detailed description.
The Wuzi Yanzong soft capsule consists of medicine, suspending agent and supplementary material.
Wherein, the dosage of the raw materials adopted by each 1000 Wuzi Yanzong soft capsules is as follows:
320-380 g of wolfberry fruit, 320-380 g of semen cuscutae (fried), 160-190 g of raspberry, 80-95 g of semen plantaginis (fried with salt) and 40-48 g of kadsura longepedunculata (steamed).
Preferably, the dosage of the raw materials adopted by each 1000 Wuzi Yanzong capsules is as follows:
340-376 g of wolfberry fruit, 340-376 g of semen cuscutae (fried), 175-188 g of raspberry, 85-94 g of semen plantaginis (fried with salt) and 42.5-47 g of kadsura longepedunculata (steamed).
Wherein, the suspension is used for stably suspending the raw material medicine in the liquid medicine of the soft capsule. Specifically, the suspension can be selected from superfine silica gel powder, Tween series, glycerol, methylcellulose water solution, starch water solution, oleum Cocois, soybean oil, Cera flava, etc.; preferably, soybean oil, coconut oil and beeswax are selected, and the ratio of soybean oil: coconut oil: beeswax (1-3): (3-20): (1-3).
The glue solution auxiliary material is used for forming a glue shell. Specifically, the adjuvant may be one or more of gelatin, glycerol, mannitol, and maltose, but is not limited thereto.
Referring to fig. 1, the invention provides a preparation method of wuzi yanzong soft capsules, which comprises the following steps:
s1: extracting the wolfberry fruit by adopting 60-80% ethanol for at least one time to obtain filtrate; concentrating the filtrate, and drying to obtain fructus Lycii extract powder;
specifically, S1 includes:
s11: extracting the wolfberry fruit twice by adopting 60-80% ethanol under reflux to obtain filtrate;
particularly, the medlar is one of the monarch drugs in the prescription, and the improvement of the extraction efficiency has positive significance for improving the curative effect of the prescription. Researches show that the effective components of the medlar are mainly medlar polysaccharide, flavonoid and alkaloid substances; wherein, the polysaccharide substance has strong polarity, the solubility of the polysaccharide substance in ethanol with the concentration of more than 80 percent is obviously reduced, and the flavone and alkaloid have weak polarity and are difficult to dissolve in the ethanol with low concentration. Therefore, the invention uses 60-80% ethanol to extract the effective components in the medlar as much as possible. Preferably, ethanol with the volume concentration of 60-70% is adopted for reflux extraction; further preferably, 65-75% ethanol is used.
Furthermore, in order to improve the extraction efficiency, the traditional percolation method extraction is changed into a reflux extraction mode. Specifically, the wolfberry is subjected to reflux extraction twice, and the effective components in the wolfberry can be basically extracted out through the reflux extraction twice. During the reflux extraction process, the weight ratio of the medlar to the volume of the ethanol is controlled to be 1: (1.5-5), the operation temperature is controlled to be 60-80 ℃, and when the operation temperature is higher than 80 ℃, some effective components in the medlar extract are damaged, so that the curative effect of the medicine is reduced.
S12: recovering ethanol from the filtrate under reduced pressure, and concentrating to relative density of 1.2-1.4 to obtain fructus Lycii soft extract;
specifically, the concentration in the present invention may be performed by, but not limited to, concentration under reduced pressure, membrane concentration, vacuum membrane concentration, and the like. Preferably, concentration under reduced pressure is adopted; the processing temperature of the reduced pressure concentration is lower (less than or equal to 70 ℃), and the effective components can be retained to the maximum extent.
The relative density of the thick paste of the medlar obtained after concentration is 1.2 to 1.4 (relative to water), so that the energy consumed in the later drying process can be saved.
S13: vacuum drying fructus Lycii soft extract at below 70 deg.C under reduced pressure, and pulverizing to obtain fructus Lycii extract powder.
Specifically, the drying in the present invention may be carried out by a method such as spray drying, freeze drying, vacuum drying under reduced pressure, or the like, but is not limited thereto. Preferably, reduced pressure vacuum drying is adopted; the processing temperature of the vacuum drying under reduced pressure is lower (less than or equal to 70 ℃), and the effective components can be retained to the maximum extent.
S2: mixing semen Cuscutae, Rubi fructus, semen plantaginis, and fructus Schisandrae to obtain mixture; extracting the mixture for at least one time by adopting 60-80% ethanol to obtain a first filtrate and filter residue;
specifically, fructus Schisandrae chinensis is pulverized, sieved with 40 mesh sieve, and undersize product is mixed with semen Cuscutae, Rubi fructus, and semen plantaginis to obtain mixture, which is then extracted with ethanol.
Preferably, S2 includes:
s21: crushing the semen cuscutae, sieving with a 60-100-mesh sieve, and taking the undersize product of the semen cuscutae;
the dodder is another monarch drug in the prescription, and the improvement of the extraction efficiency has positive significance for improving the curative effect of the prescription. Because the seed coats of the semen cuscutae are compact and relatively difficult to extract, the fried semen cuscutae is selected firstly, and is easy to crush. Further, the semen cuscutae is crushed, the crushed semen cuscutae is sieved by a 60-100-mesh sieve, undersize products are removed for extraction, and preferably, the 60-mesh sieve is selected for sieving. Furthermore, in order to control the extraction amount, the sieving rate of a 60-mesh sieve after crushing is controlled to be 40-50%; under the sieving rate, the extraction rate is higher. Based on the content of the hyperoside, the content of the hyperoside in the undersize product is 0.335-0.38 wt% under the sieving rate. When the sieving rate exceeds 50%, the content of hyperin is in a descending trend.
S22: pulverizing Rubi fructus, semen plantaginis, and fructus Schisandrae respectively, sieving with 40 mesh sieve, and mixing undersize product with undersize product of semen Cuscutae to obtain mixture;
s23: and (3) carrying out reflux extraction twice on the mixture by adopting 60-80% ethanol to obtain a first filtrate and filter residues.
Specifically, the mixture can be extracted by a percolation method or a reflux extraction method, and preferably, the mixture is extracted by a reflux extraction method, so that the extraction efficiency is high.
Specifically, in the formula of the invention, the effective components of the four traditional Chinese medicines of the dodder, the raspberry, the plantain seed and the schisandra chinensis are concentrated in the polar substances such as flavonoid, alkaloid, lignan and the like, and the reflux extraction is carried out by 60-80% ethanol, thus obtaining higher extraction rate. Preferably, 70-80% ethanol is adopted for reflux extraction.
Specifically, the mixture is subjected to twice reflux extraction; in the reflux extraction process, the weight ratio of the mixture to the ethanol is controlled to be 1: (2-5).
S3: extracting the filter residue with water at least once to obtain a second filtrate;
specifically, S3 includes:
s31: mixing filter residue with water according to the ratio of 1: (4-10), boiling and extracting for 0.5-2 h, and filtering to obtain a fourth filtrate;
by carrying out water extraction on the filter residue, the improvement efficiency of the dodder, the raspberry, the plantain seed and the schisandra chinensis can be further improved, and the drug effect is improved.
S32: and concentrating the fourth filtrate under reduced pressure until the relative density is 1-1.2, and cooling to obtain a second filtrate.
Specifically, the concentration in the present invention may be performed by, but not limited to, concentration under reduced pressure, membrane concentration, vacuum membrane concentration, and the like. Preferably, concentration under reduced pressure is adopted; the processing temperature of the reduced pressure concentration is lower (less than or equal to 70 ℃), and the effective components can be retained to the maximum extent.
The relative density of the second filtrate obtained after concentration is 1-1.2 (relative to water), so that energy consumed in the later drying process can be saved.
S4: adding ethanol into the second filtrate to enable the ethanol content in the second filtrate to reach 50% -70%, standing and filtering to obtain a third filtrate.
Specifically, ethanol is added into the second filtrate for alcohol precipitation; the operation can remove excessive impurities and reduce the dosage of the medicine. Specifically, in the alcohol precipitation process, the concentration of ethanol is controlled to be 50-60%.
It is noted that, in the existing process, distillation extraction is mostly carried out on schisandra chinensis to obtain volatile oil components of schisandra chinensis; the applicant finds that the main components in the distillation extract (volatile oil) of the schisandra chinensis are terpenoids, aromatic compounds and aliphatic compounds; on one hand, the distillation extract has small influence on the main drug effect of the invention, and on the other hand, the distillation process temperature is higher, and partial components (deoxyschizandrin, schisandrin B and the like) with large influence on the main drug effect can be lost in the distillation process; and the distillation process is complex and the equipment cost is high. Therefore, the invention adopts the processes of alcohol extraction, water extraction and alcohol precipitation to extract the schisandra and other four medicinal materials together. By the process, volatile oil components in the schisandra chinensis can be retained to a greater extent, and the production flow is simplified.
S5: mixing the first filtrate and the third filtrate, concentrating, and drying to obtain mixed extract powder;
specifically, S5 includes:
s51: mixing the first filtrate and the third filtrate, and concentrating under reduced pressure to obtain mixed soft extract with relative density of 1.2-1.5;
s52: vacuum drying the mixed soft extract at below 70 deg.C under reduced pressure, and pulverizing to obtain mixed extract powder.
The invention adopts an alcohol extraction process for medlar, and adopts the processes of alcohol extraction, water extraction and alcohol precipitation for other four medicines; the extraction efficiency of the monarch drug medlar and dodder is effectively improved, and the active ingredients are not damaged; meanwhile, the extraction amount of effective components in other components is ensured. The extraction process can effectively improve the utilization rate of the raw materials and the drug effect of the Wuzi Yanzong soft capsule.
S6: adding fructus Lycii extract powder and mixed extract powder into the suspension, stirring, and degassing to obtain medicinal liquid; and forming the liquid medicine and the glue solution auxiliary material together to obtain a finished product of the Wuzi Yanzong soft capsule.
Specifically, firstly adding the medlar extract powder and the mixed extract powder into soybean oil, then adding beeswax and coconut oil, stirring and degassing to obtain a liquid medicine; boiling gelatin, glycerol, and water, degassing, and making into gelatin solution. Pressing the medicinal liquid and the gelatin solution by soft capsule forming equipment.
The invention is illustrated below in specific examples:
example 1
The embodiment provides a preparation method of wuziyanzong soft capsules, which comprises the following steps:
adding 60% ethanol 2 times the weight of fructus Lycii 376g, heating and continuously refluxing for 2 times, filtering, recovering ethanol from filtrate under reduced pressure, concentrating to obtain soft extract with relative density of 1.25(65 deg.C), vacuum drying the soft extract at 70 deg.C below under reduced pressure, and pulverizing into fine powder to obtain fructus Lycii extract powder.
Taking 376g of semen cuscutae (fried), 188g of raspberry, 94g of semen plantaginis (fried with salt) and 47g of kadsura longepedunculata (steamed), adding 60% ethanol with the weight of 2 times of the medicinal materials, heating, continuously refluxing and extracting for 2 times, filtering, and combining to obtain filtrate A for later use; adding 8 times of water into the residue, boiling and extracting for 1 hr, filtering, concentrating the filtrate to relative density of 1.05(65 deg.C), and cooling. Adding ethanol into the water extract concentrate to make alcohol content reach 50%, standing, filtering to obtain filtrate B, mixing the above A, B solutions, and concentrating under reduced pressure to obtain soft extract with relative density of 1.35(65 deg.C). Vacuum drying the soft extract at 70 deg.C below, and pulverizing into fine powder to obtain mixed extract powder.
Uniformly and slowly adding the wolfberry fruit extract powder and the mixed extract powder into the suspension, and fully stirring until the mixture is uniform. Grinding the liquid medicine by a colloid mill until all the liquid medicine passes through a 100-mesh sieve. The liquid medicine is degassed in vacuum, stirred, covered and sealed. Wherein the suspension is a mixture of soybean oil, coconut oil and beeswax. Soybean oil: coconut oil: beeswax 1:4: 1.
Mixing the above medicinal liquid with gelatin solution prepared from gelatin and glycerol, and making into 1000 soft capsules by soft capsule molding equipment. Wherein the weight of each soft capsule is 0.6 g.
Example 2
The embodiment provides a preparation method of wuziyanzong soft capsules, which comprises the following steps:
352g of medlar is taken, 70 percent ethanol with the weight of 2 times of the weight of the medicinal materials is added, the heating and continuous reflux extraction is carried out for 2 times, the filtration is carried out, the ethanol (65 ℃) is recovered from the filtrate under reduced pressure, and the filtrate is concentrated into thick paste with the relative density of 1.3(60 ℃). Vacuum drying the soft extract at 60 deg.C under reduced pressure, and pulverizing into fine powder to obtain fructus Lycii extract powder.
352g of semen cuscutae (fried) is taken, crushed and sieved by a 60-mesh sieve, and the sieving rate is controlled to be 40%; taking 176g of raspberry, 88g of plantain seed (fried with salt) and 44g of kadsura longepedunculata (steamed), crushing and sieving by a 40-mesh sieve; mixing the undersize materials, adding 80% ethanol 2 times the weight of the materials, heating, continuously reflux-extracting for 2 times, filtering, and mixing to obtain filtrate A; adding 6 times of water into the residue, boiling and extracting for 1 hr, filtering, concentrating the filtrate to relative density of 1.10(60 deg.C), and cooling. Adding ethanol into the water extract concentrate to make alcohol content reach 60%, standing, filtering to obtain filtrate B, mixing the above A, B solutions, and concentrating under reduced pressure to obtain soft extract with relative density of 1.25(60 deg.C). Vacuum drying the soft extract at 60 deg.C under reduced pressure, and pulverizing into fine powder to obtain mixed extract powder.
Adding soybean oil, coconut oil and beeswax into the above fructus Lycii extract powder and mixed extract powder, and stirring. Grinding the liquid medicine by a colloid mill until all the liquid medicine passes through a 100-mesh sieve. The liquid medicine is degassed in vacuum, stirred, covered and sealed. Wherein, the ratio of soybean oil: coconut oil: beeswax 1:4: 1.
Mixing the above medicinal liquid with gelatin solution prepared from gelatin and glycerol, and making into 1000 soft capsules by soft capsule molding equipment. Wherein the weight of each soft capsule is 0.58 g.
Example 3
The embodiment provides a preparation method of wuziyanzong soft capsules, which comprises the following steps:
adding 70% ethanol 4 times the weight of fructus Lycii 344g, heating and continuously reflux-extracting for 2 times, filtering, recovering ethanol from the filtrate under reduced pressure (60 deg.C), and concentrating to obtain soft extract with relative density of 1.25(60 deg.C). Vacuum drying the soft extract at 60 deg.C under reduced pressure, and pulverizing into fine powder to obtain fructus Lycii extract powder.
344g of semen cuscutae (fried) is taken, crushed and sieved by a 60-mesh sieve, and the sieving rate is controlled to be 50%; taking 172g of raspberry, 86g of plantain seed (fried with salt) and 43g of kadsura longepedunculata (steamed), crushing, sieving with a 40-mesh sieve, and taking undersize materials to mix; adding 80% ethanol 4 times the weight of the medicinal materials, heating, continuously reflux-extracting for 2 times, filtering, and mixing to obtain filtrate A; adding 6 times of water into the residue, boiling and extracting for 1 hr, filtering, concentrating the filtrate to relative density of 1(60 deg.C), and cooling. Adding ethanol into the water extract concentrate to make alcohol content reach 60%, standing, filtering to obtain filtrate B, mixing the above A, B solutions, and concentrating under reduced pressure to obtain soft extract with relative density of 1.25(60 deg.C). Vacuum drying the soft extract at 60 deg.C under reduced pressure, and pulverizing into fine powder to obtain mixed extract powder.
Adding the fructus Lycii extract powder and the mixed extract powder into soybean oil, adding oleum Cocois and Cera flava, and stirring. Grinding the liquid medicine by a colloid mill until all the liquid medicine passes through a 100-mesh sieve. The liquid medicine is degassed in vacuum, stirred, covered and sealed. Wherein, the ratio of soybean oil: coconut oil: beeswax 1:4: 1.
Mixing the above medicinal liquid with gelatin solution prepared from gelatin and glycerol, and making into 1000 soft capsules by soft capsule molding equipment. Wherein the weight of each soft capsule is 0.55 g.
Comparative example 1
The comparative example provides a wuzi yanzong pill, which has the following formula:
400g of wolfberry fruit, 400g of semen cuscutae (fried), 200g of raspberry, 50g of schisandra fruit (steamed) and 100g of salted plantain seed;
the preparation method comprises the following steps:
pulverizing the five medicines into fine powder, sieving, mixing, adding 1000g, and making into big honeyed pill.
Comparative example 2
The present embodiment provides a wuzi yanzong tablet, which has a formula:
275g of wolfberry fruit, 275g of dodder seed (fried), 135g of raspberry, 35g of schisandra fruit (steamed) and 68g of salted plantain seed;
the preparation method comprises the following steps:
145g of semen cuscutae is taken and crushed into fine powder. Decocting the rest semen Cuscutae and Rubi fructus with water twice, each for 2 hr, mixing decoctions, filtering, and keeping filtrate; percolating fructus Schisandrae, salted semen plantaginis, and fructus Lycii with 70% ethanol, collecting percolate, recovering ethanol, adding the above filtrate, and concentrating under reduced pressure to obtain soft extract with relative density of 1.32. Adding semen Cuscutae fine powder and appropriate amount of starch, mixing, granulating, and drying. Pressing into 1000 tablets, and coating sugar.
Determining the contents of hyperoside and deoxyschizandrin in the medicines of examples 1-3 and comparative examples 1-2 by adopting a method in pharmacopoeia (2015 edition); the method for determining the Wuzi Yanzong soft capsule can refer to the processing method of the Wuzi Yanzong tablet. The specific test results are as follows:
| example 1 | Example 2 | Example 3 | Comparative example 1 | Comparative example 2 | |
| Hyperoside (mg/g) | 0.14 | 0.17 | 0.16 | 0.09 | 0.12 |
| Schisandra chinensis A (mu g/g) | 103 | 89 | 115 | 62 | 81 |
As can be seen from the table, the extraction process of the present invention has a high extraction efficiency.
Example 4 test of drug efficacy
(1) Grouping of laboratory animals
50 SD male young mice with the age of 3 weeks are taken and placed in a clean animal room at 25 ℃ for free drinking water, and after being adapted for one week, the SD male young mice are randomly divided into 5 groups: normal group (normal feeding), model group (oligoasthenospermia model prepared with tripterygium wilfordii, no treatment), experimental group (fed with the drug treatment in example 3), control group (fed with the drug treatment in comparative example 1), control group (fed with the drug treatment in comparative example 2).
(2) Dosage and method of administration
A. Normal group: feeding the rats with pellet feed in a conventional way, and taking materials after feeding the rats with normal diet and drinking water for 11 weeks;
B. model group: the tripterygium glycosides tablets are 30 mg/(kg. d), are irrigated to the stomach for 6 weeks, and are obtained after being generally raised for 5 weeks;
C. experimental groups: after 6 weeks of tripterygium glycosides administration, 3 wuzi yanzong soft capsules in example 3 are administered every day, and the administration is divided into 3 times for feeding, and the materials are taken after 5 weeks;
D. control group: after 6 weeks of tripterygium glycosides administration, 1 granule of the wuzi yanzong pill in comparative example 1 is administered every day, and the administration is divided into 3 times for feeding, and the materials are taken after 5 weeks;
E. control two groups: after 6 weeks of tripterygium glycosides administration, 6 tablets of wuzi yanzong tablets in comparative example 2 are given every day, and fed for 3 times, and the materials are taken after 5 weeks;
the treatment method comprises the following steps: the animal stomachs were tested.
(3) Observation index
Preparing paraffin tissue sections, selecting 5 seminiferous tubule sections from each section under an optical microscope, and counting the number of seminiferous protocells and primary spermatocyte in the seminiferous tubules.
(4) Statistical method
Data analysis was performed using SPSS13.0 statistical software. Selection of technical data2The test shows that P is less than 0.05, which has statistical significance.
(5) Results of the experiment
The sperm cell count in seminiferous tubules of testis tissue of each group of mice is shown in the following table:
| number of spermatogenic cells | |
| Normal group | 120.4±7.39 |
| Model set | 47.5±5.57 |
| Experimental group | 105.2±5.65 |
| Control group | 90.8±7.41 |
| Control two groups | 86.1±5.91 |
As can be seen from the table, the difference between the model group and each other group is statistically significant (P < 0.01), which indicates that the testis tissue of the rat is damaged and the number of spermatogenic follicles is reduced after feeding tripterygium glycosides. After the preparation of wuzi-derived zon in the examples and comparative examples of the present invention was used, the number of relevant cells was significantly increased. And the difference between the test group, the control group and the model group and the normal group is obvious, and the statistical significance is achieved. Therefore, the Wuzi Yanzong soft capsule has lower dosage and better drug effect.
While the foregoing is directed to the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.
Claims (10)
1. A preparation method of Wuzi Yanzong soft capsules is characterized by comprising the following steps:
(1) reflux-extracting 320-380 parts of wolfberry fruit by using 60-80% ethanol for at least one time to obtain a filtrate; concentrating the filtrate, and drying to obtain fructus Lycii extract powder;
(2) mixing 320-380 parts of semen cuscutae, 160-190 parts of raspberry, 80-95 parts of semen plantaginis and 40-48 parts of fructus schizandrae to obtain a mixture; carrying out reflux extraction on the mixture for at least one time by adopting 60-80% ethanol to obtain a first filtrate and filter residue;
(3) extracting the filter residue with water at least once to obtain a second filtrate;
(4) adding ethanol into the second filtrate to enable the ethanol content in the second filtrate to reach 50% -70%, standing and filtering to obtain a third filtrate;
(5) mixing the first filtrate and the third filtrate, concentrating, and drying to obtain mixed extract powder;
(6) adding the medlar extract powder and the mixed extract powder into the suspension, stirring and degassing to obtain a liquid medicine; forming the liquid medicine and glue solution auxiliary materials together to obtain a finished product of the Wuzi Yanzong soft capsule;
wherein the glue solution auxiliary material is an auxiliary material for forming a glue shell.
2. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein in step (1), the ratio of the weight of Goji fruit to the volume of ethanol is 1: (1.5-5);
wherein the volume fraction of the ethanol is 60-70%.
3. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein in step (2), the ratio of the weight of the mixture to the volume of ethanol is 1: (2-5);
wherein the volume fraction of the ethanol is 70-80%.
4. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein the step (3) comprises:
(3.1) mixing the filter residue with water according to the weight ratio of 1: (4-10), boiling and extracting for 0.5-2 h, and filtering to obtain a fourth filtrate;
(3.2) concentrating the fourth filtrate under reduced pressure until the relative density is 1-1.2, and cooling to obtain a second filtrate.
5. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein the step (5) comprises:
(5.1) combining the first filtrate and the third filtrate, and concentrating under reduced pressure to obtain a mixed thick paste with the relative density of 1.2-1.5;
(5.2) drying the mixed thick paste under reduced pressure and vacuum at the temperature of below 70 ℃, and crushing to obtain mixed extract powder.
6. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein the step (1) comprises:
(1.1) refluxing and extracting the wolfberry fruit twice by adopting 60-80% ethanol to obtain a filtrate;
(1.2) recovering ethanol from the filtrate under reduced pressure, and concentrating to obtain a thick paste of the Chinese wolfberry fruit, wherein the relative density of the thick paste is 1.2-1.4;
(1.3) drying fructus Lycii soft extract at below 70 deg.C under reduced pressure under vacuum, and pulverizing to obtain fructus Lycii extract powder.
7. The method for preparing Wuzi Yanzong soft capsule as claimed in claim 1, wherein the step (2) comprises:
(2.1) crushing the semen cuscutae, sieving with a 60-100-mesh sieve, and taking the undersize product of the semen cuscutae;
(2.2) respectively crushing raspberry, plantain seed and schisandra chinensis, sieving with a 40-mesh sieve, and mixing undersize materials with undersize materials of semen cuscutae to obtain a mixture;
and (2.3) carrying out reflux extraction twice on the mixture by adopting 70-80% ethanol to obtain a first filtrate and filter residue.
8. The method of preparing the wuziyanzon soft capsule of claim 1, wherein the suspension is a mixture of soybean oil, coconut oil and beeswax, and the ratio of soybean oil: coconut oil: beeswax (1-3): (3-20): (1-3).
9. The method of claim 1, wherein the gelatin solution adjuvant comprises gelatin and/or glycerin.
10. A Wuzi Yanzong soft capsule, which is prepared by the preparation method of any one of claims 1 to 9.
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| CN116059225A (en) * | 2021-10-29 | 2023-05-05 | 山西中医药大学 | Medicine for preventing and treating nerve tube deformity |
| CN115137783A (en) * | 2022-08-12 | 2022-10-04 | 佛山手心制药有限公司 | Application of Wuzi Yanzong soft capsule in preparing medicine for treating androgenetic alopecia |
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| CN101632750A (en) * | 2008-07-22 | 2010-01-27 | 天津达仁堂京万红药业有限公司 | Chinese medicinal composition for replenishing essence, filling marrow, boosting kidney and strengthening yang and preparation method thereof |
| CN105147863A (en) * | 2015-08-17 | 2015-12-16 | 三峡大学 | Extraction method and application of total polysaccharide of Wuzi Yanzong prescription |
| CN105998371A (en) * | 2016-07-19 | 2016-10-12 | 太极集团四川绵阳制药有限公司 | Wuzi yanzong pills and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101632750A (en) * | 2008-07-22 | 2010-01-27 | 天津达仁堂京万红药业有限公司 | Chinese medicinal composition for replenishing essence, filling marrow, boosting kidney and strengthening yang and preparation method thereof |
| CN105147863A (en) * | 2015-08-17 | 2015-12-16 | 三峡大学 | Extraction method and application of total polysaccharide of Wuzi Yanzong prescription |
| CN105998371A (en) * | 2016-07-19 | 2016-10-12 | 太极集团四川绵阳制药有限公司 | Wuzi yanzong pills and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 五子衍宗软胶囊治疗少弱精子症大鼠的实验观察;许克义等;《生物技术世界》;20161231(第5期);全文 * |
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