CN104225035B - Application of traditional Chinese medicine composition in preparation of medicine for treating male infertility - Google Patents
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Abstract
The invention discloses application of a traditional Chinese medicine composition in preparing a medicine for treating male infertility. The traditional Chinese medicine composition disclosed by the invention is prepared from 8 traditional Chinese medicines such as astragalus, talcum, selfheal and the like, and can be used for regulating qi, promoting diuresis, softening hardness and dissipating stagnation.
Description
Technical Field
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of a traditional Chinese medicine composition in preparing a medicine for treating male infertility.
Background
In recent decades, the fertility of human beings is gradually reduced along with the influence of factors such as environmental pollution, poor living habits, disease spreading and the like, infertility becomes a common disease, is considered by World Health Organization (WHO) to be one of three diseases which endanger the health and life of human beings in twenty-first century, male infertility is not an independent disease but a relatively complex clinical syndrome, generally means that the male sex is more than 1 year after marriage, contraception measures are not taken, female infertility is caused by male infertility reasons, 10% of married couples are sterile in China, 60% of female infertility is caused by gulf and 40% of male infertility, 10% of both parties are caused by common reasons, 10% of the disease causes are complicated, many diseases or factors can cause male infertility, the male infertility can be classified into azonia, severe oligospermia, sperm count normal sperm count, sterility, multiple sterility and sperm sterility, the sperm motility of male infertility can not be treated according to sperm reproduction examination results, the sperm reproduction disorder of male infertility can be treated by adopting specific sperm reproduction and sperm reproduction disorder treatment methods (the sperm) of sperm reproduction disorder, sperm reproduction disorder, sperm.
The following are generally used in the treatment: 1. the infertility caused by genital tract infection is mainly treated by antibiotic anti-inflammatory therapy, and is supplemented by medicine for improving sperm motility. 2. For azoospermia, oligospermia and idiopathic infertility, sex hormones should be used as endocrine therapy. 3. For patients with low sperm motility, the drug therapy for improving sperm motility is mainly used. 4. Patients with infertility caused by varicocele, obstruction of the spermatic duct, cryptorchidism and up-and-down fissure of urethra should be treated by surgery and supplemented with endocrine drugs and other adjuvant drugs. 5. For those with absolute sterility (such as azoospermia), artificial insemination should be performed.
Although the development of modern medicine has made great progress in the diagnosis and treatment of the etiology of male infertility, especially the emergence and wide application of intracytoplasmic sperm microinjection (ICSI) technology have greatly improved the treatment of male infertility. However, in addition to the debates in all aspects such as ethics and laws, according to the research results of the literature of Retzlof et al, the distortion rate and the chromosome abnormality rate of the infants born by the ICSI technology are higher than those of the infants born naturally. The traditional Chinese medicine plays an important role in treating male infertility, can obtain satisfactory curative effect usually, and has no obvious adverse reaction generally.
The invention is an improved invention based on Chinese patent ZL 200410091455.5, and the content of the patent document is cited in the whole content. The Chinese patent ZL 200410091455.5 does not describe the application of the traditional Chinese medicine composition in the preparation of the medicine for treating male infertility.
Disclosure of Invention
The invention aims to provide application of a traditional Chinese medicine composition in preparing a medicine for treating male infertility.
Preferably, the male infertility is infertility caused by blockage of sperm export channels or congenital blockage of sperm export channels or varicocele or spermatitis or immune abnormality.
Preferably, the male infertility is infertility caused by chronic prostatitis or male genital tuberculosis.
The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
30-150 parts of astragalus mongholicus, 7-28 parts of talcum, 10-40 parts of selfheal, 7-28 parts of glossy privet fruit
10-40 parts of lychee seed, 1-4 parts of amber, 1.5-6 parts of cinnamon, and 3-15 parts of phellodendron bark.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
70 parts of astragalus mongholicus, 14 parts of talcum, 21 parts of selfheal and 14 parts of glossy privet fruit
Litchi seeds 21 parts, amber 2.1 parts, cinnamon 2.8 parts, phellodendron bark 7 parts.
Or:
30 parts of astragalus mongholicus, 7 parts of talcum, 10 parts of selfheal and 7 parts of glossy privet fruit
Litchi seeds 10 parts of amber 1 part of cinnamon 1.5 parts of phellodendron bark 3 parts.
Or:
astragalus root 150 parts talc 28 parts prunella spike 40 parts ligustrum japonicum 28 parts
40 parts of lychee seeds, 4 parts of amber, 6 parts of cinnamon and 15 parts of golden cypress. Or:
30 parts of astragalus mongholicus, 28 parts of talc, 10 parts of selfheal and 28 parts of glossy privet fruit
Litchi seeds 10 parts, amber 4 parts, cinnamon 1.5 parts, phellodendron bark 15 parts.
The traditional Chinese medicine of the invention can be replaced by traditional Chinese medicines with the same or similar effects, and the traditional Chinese medicines can be processed according to national traditional Chinese medicine processing standard or traditional Chinese medicine dictionary.
The active ingredients of the Chinese medicinal composition can be prepared by a conventional extraction process [ such as Vanbitsin traditional Chinese medicine pharmacy (1 st 12 months 1997, Shanghai scientific Press), and more preferably, the active ingredients of the Chinese medicinal composition are prepared by the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight part ratio of the raw material medicines, respectively cleaning and crushing;
(2) extracting radix astragali and cortex Phellodendri with 50-70% ethanol under reflux for 0.5-3 hr for 1-3 times, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.20-1.25;
(3) extracting fructus Ligustri Lucidi with 6-10 times of 70-90% ethanol under reflux for 1-3 times (1-3 hr for each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.20-1.25;
(4) soaking the cinnamon in 4-8 times of water for 1-2 hours, extracting volatile oil for 2-6 hours, collecting the volatile oil in another container, filtering and collecting the water extract, and reserving residues for later use;
(5) taking selfheal, lychee seeds and the residues obtained in the step (4), adding 8-10 times of water, decocting twice, wherein the first time is 1-3 hours, the second time is 1-2 hours, filtering the extracting solution, combining, adding the aqueous solution obtained in the step (4), and concentrating into clear paste with the relative density of 1.20-1.25 for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh fine powder;
the clear paste obtained in the step (2), the clear paste obtained in the step (3), the volatile oil obtained in the step (4), the clear paste obtained in the step (5) and the fine powder obtained in the step (6) together form the active ingredient of the traditional Chinese medicine composition.
The preparation formulation of the traditional Chinese medicine composition provided by the invention is capsules, tablets, oral liquid or pills.
The invention also provides a preparation method of the Chinese medicinal composition capsule, which comprises the following steps:
(1) respectively cleaning and selecting the traditional Chinese medicinal materials, crushing, and weighing according to a proportion;
(2) extracting radix astragali and cortex Phellodendri with 50-70% ethanol under reflux for 0.5-3 hr for 1-3 times, preferably for 1-2 times, 8-12 times for the first time, 1-3 hr for the second time, 6-9 times for the second time, 0.5-2 hr for the second time, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20-1.25, and vacuum drying to obtain dry extract;
(3) extracting fructus Ligustri Lucidi with 6-10 times of 70-90% ethanol under reflux for 1-3 times (1-3 hr for each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20-1.25, and vacuum drying to obtain dry extract;
(4) soaking Cinnamomum cassia in 4-8 times of water for 1-2 hr, extracting volatile oil for 2-6 hr, collecting volatile oil with another container until the oil yield is not less than l.0%, filtering the water extractive solution, and collecting the residue;
(5) taking selfheal, lychee seeds and the residue obtained in the step (4), adding 8-10 times of water, decocting twice, wherein the first time is 1-3 hours, the second time is 1-2 hours, filtering the extracting solution, merging, adding the aqueous solution obtained in the step (4), concentrating into clear paste with the relative density of 1.20-1.25, drying in vacuum, mixing the obtained dry paste with the dry paste obtained in the step (2) and the dry paste obtained in the step (3), and crushing into 100-mesh powder for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh powder;
(7) uniformly mixing the dry paste powder obtained in the step (5), the fine powder obtained in the step (6) and a proper amount of auxiliary materials, using 80% ethanol as a binding agent, stirring at a high speed for granulation, drying at 60-70 ℃, and finishing granules;
(8) and (4) screening out fine powder, spraying the volatile oil obtained in the step (4), uniformly mixing with the granules, sealing, and encapsulating to obtain the capsule.
The Chinese medicinal composition has Latin name of active ingredient as raw material medicine and its preparation method from Chinese medicinal dictionary (7 months 1977, first edition, Shanghai science and technology Press) and Chinese pharmacopoeia (2005 edition, chemical industry Press).
The traditional Chinese medicine composition can be prepared into any pharmaceutically acceptable conventional dosage forms, such as capsules, tablets, granules, powder, oral liquid or pills and the like, according to a conventional preparation process, for example, a preparation process recorded in Vanbitsin traditional Chinese medicine pharmacy (published by Shanghai science, 1997, 12 months, 1 st edition).
In the application of the invention, the preparation formulation of the traditional Chinese medicine composition is capsules, tablets, granules, powder, oral liquid or pills, and in order to realize the above formulation, pharmaceutically acceptable auxiliary materials are added when the formulation is prepared, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the adhesive comprises starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; the sweetener comprises: saccharin sodium, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, and the like; the flavoring agent comprises: sweeteners and various essences; the preservative comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroacetidine acetate, eucalyptus oil, etc.; the matrix comprises: PEG6000, PEG4000, insect wax, etc. In order to realize the Chinese medicinal preparation in the dosage form, other pharmaceutically acceptable auxiliary materials (auxiliary materials recorded in each dosage form in the 12 th month and 1 st edition of Shanghai science Press 1997) are required to be added during preparation of the dosage forms.
To clarify the pharmaceutical use of the Chinese medicinal composition of the present invention for treating male infertility, the following experiments were conducted with the medicament prepared according to the method of example 1 (hereinafter referred to as the present invention medicament) to confirm the clinical effects of the pharmaceutical composition for treating male infertility, and to illustrate its new use in the pharmaceutical field.
Clinical data
1.1 general data: 122 patients were collected from male infertility patients who were collected in the department of Kyowa hospital in 2008 + 2012, and the inclusion criteria were: the male infertility patients who have two or more indexes abnormal in semen routine examination are 24-45 years old, the average age is 30 years old, and the course of the disease is 1-15 years. Among them, there were 3 cases of urethritis, 15 cases of genital tuberculosis, 15 cases of congenital sperm channel obstruction, 12 cases of seminiferous duct obstruction, 18 cases of orchitis, 20 cases of chronic prostatitis, 12 cases of varicocele, 6 cases of spermatitis, 8 cases of immune abnormality, and 13 cases of unknown cause.
Method of treatment
The medicine is orally taken, 2-4 granules are taken each time, 3 times a day, 30 days are taken as a treatment course, 3 treatment courses are continuously carried out, and antibiotics and other medicines are not used in the treatment course.
Observation of therapeutic effects
3.1 Observation indexes: before and after treatment, semen routine, urine routine and liver and kidney functions are checked. For routine semen detection, semen collection was prohibited for 3-5 days for all patients, according to WHO-specified criteria. Urine routine and liver and kidney function were examined before and after treatment. The curative effect is comprehensively evaluated after the treatment course is finished.
3.2 curative effect standard: (1) the recovery is realized, the clinical symptoms disappear, and various indexes of the semen routine examination are recovered to be normal or the female is pregnant; (2) the effect is obvious, the female is not pregnant, the clinical symptoms are obviously improved, and the routine examination of semen is close to normal; (3) the effect is achieved, the clinical symptoms are improved, and various indexes of the semen routine examination are improved compared with the indexes before treatment; (4) the semen examination index is not changed before and after treatment.
3.3 statistical method all data are processed by statistical software SPSS 11.5; the metering data adopts t inspection; technical data adoption of x2Checking; for parameters
And (4) showing.
4. Results
4.1 examination of the routine index of semen: the semen quality analysis and comparison before and after treatment have obvious difference (P < 0.01), which shows that the medicine of the invention has the effects of obviously improving the semen quality, the sperm density and the sperm motility and obviously improving the rapid motility of the sperm, and the results are shown in table 1:
TABLE 1 analysis results of major indices of pre-and post-treatment semen
Note: p <0.05 compared to pre-treatment,
4.2 comprehensive curative effect: after 3 treatment courses, 45 patients in 122 patients (38 women are pregnant and account for 84.4% of the patients who are cured), 36 patients with obvious effect, 40 patients with effective effect and 1 patient with ineffective effect, the total effective rate is 99.1%, and the results are shown in table 2:
TABLE 2 evaluation results of comprehensive therapeutic effects
| Number of examples | Recovery method | Show effect | Is effective | Invalidation | Total effective rate |
| 122 | 45（36.9%） | 36（29.5） | 40（32.7%） | 1（0.8%） | 99.2% |
4.3 summary: the experimental results show that the medicine can obviously improve the semen volume, treat the infertility caused by oligospermia and azoospermia, and treat the male infertility caused by congenital sperm output channel blockage, sperm output channel blockage and the like; increasing sperm motility, and treating infertility caused by chronic prostatitis or male genital tuberculosis; meanwhile, the medicine can also treat male infertility caused by varicocele, spermatitis, immunologic abnormality and unknown reasons. In a word, clinical experiments prove that the medicine can treat male infertility caused by various reasons, and has remarkable clinical effect and no obvious side effect.
Detailed Description
Example 1: preparation of the inventive pharmaceutical capsules
Prescription:
astragalus root 70 g talcum 14 g selfheal 21 g ligustrum japonicum 14 g
Litchi seed 21 g amber 2.1 g cinnamon 2.8 g phellodendron bark 7 g
The preparation method comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the prescription amount, respectively cleaning and crushing;
(2) extracting radix astragali and cortex Phellodendri with 60% ethanol under reflux for 2 times, 10 times for the first time and 2 hours and 8 times for the second time for 1 hour, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20, and vacuum drying to obtain dry extract;
(3) extracting fructus Ligustri Lucidi with 8 times of 80% ethanol under reflux for 2 times (2 hr each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20, and vacuum drying to obtain dry extract;
(4) soaking the cinnamon in 6 times of water for 1 hour, extracting volatile oil for 4 hours, collecting the volatile oil in another container, filtering and collecting a water extracting solution, and reserving residues for later use;
(5) taking selfheal, lychee seeds and the residue obtained in the step (4), adding 9 times of water, decocting twice, decocting for 2 hours for the first time and 1.5 hours for the second time, filtering the extracting solution, combining, adding the aqueous solution obtained in the step (4), concentrating into clear paste with the relative density of 1.20, drying in vacuum, mixing the obtained dry paste with the dry paste obtained in the step (2) and the dry paste obtained in the step (3), and crushing into 100-mesh powder for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh powder;
(7) uniformly mixing the dry paste powder obtained in the step (5), the fine powder obtained in the step (6) and a proper amount of auxiliary materials, using 80% ethanol as a binding agent, stirring at a high speed for granulation, granulating at 60 ℃, drying and finishing;
(8) and (4) screening out fine powder, spraying the volatile oil obtained in the step (4), uniformly mixing with the granules, sealing, and encapsulating to obtain the capsule.
Example 2: preparation of the pharmaceutical tablet of the invention
Prescription:
astragalus root 30 g talcum 7 g selfheal 10 g ligustrum japonicum 7 g
Litchi seed 10 g amber 1 g cinnamon 1.5 g phellodendron bark 3 g
The preparation method comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the prescription amount, respectively cleaning and crushing;
(2) extracting radix astragali and cortex Phellodendri with 50% ethanol under reflux for 2 times, 9 times for the first time and 3 hr for the second time and 8 times for 1.5 hr, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.25;
(3) extracting fructus Ligustri Lucidi with 6 times of 70% ethanol under reflux for 1 hr for 1 time, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.25;
(4) soaking the cinnamon in 4 times of water for 1 hour, extracting volatile oil for 2 hours, collecting the volatile oil in another container, filtering and collecting a water extracting solution, and reserving residues for later use;
(5) taking selfheal, lychee seeds and the residues obtained in the step (4), adding 8 times of water, decocting twice, decocting for 1 hour for the first time and 2 hours for the second time, filtering the extracting solution, mixing, adding the aqueous solution obtained in the step (4), and concentrating into clear paste with the relative density of 1.20 for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh fine powder;
(7) and making into tablet by conventional method.
Example 3: preparation of the inventive pharmaceutical capsules
Prescription:
astragalus root 150 parts talc 28 parts prunella spike 40 parts ligustrum japonicum 28 parts
40 parts of lychee seeds, 4 parts of amber, 6 parts of cinnamon and 15 parts of golden cypress.
(1) Weighing the traditional Chinese medicinal materials according to the prescription amount, respectively cleaning and crushing;
(2) extracting radix astragali and cortex Phellodendri with 70% ethanol under reflux for 2 times, the first time with 10 times of ethanol for 0.5 hr and the second time with 8 times of ethanol for 2 hr, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20, and vacuum drying to obtain dry extract;
(3) extracting fructus Ligustri Lucidi with 10 times of 90% ethanol under reflux for 3 times (3 hr each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20, and vacuum drying to obtain dry extract;
(4) soaking the cinnamon in 8 times of water for 2 hours, extracting volatile oil for 6 hours, collecting the volatile oil in another container, filtering and collecting a water extracting solution, and reserving residues for later use;
(5) taking selfheal, lychee seeds and the residue obtained in the step (4), adding 10 times of water, decocting twice, decocting for 3 hours for the first time and 1 hour for the second time, filtering the extracting solution, combining, adding the aqueous solution obtained in the step (4), concentrating into clear paste with the relative density of 1.25, drying in vacuum, mixing the obtained dry paste with the dry paste obtained in the step (2) and the dry paste obtained in the step (3), and crushing into 100-mesh powder for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh powder;
(7) uniformly mixing the dry paste powder obtained in the step (5), the fine powder obtained in the step (6) and a proper amount of auxiliary materials, using 80% ethanol as a binding agent, stirring at a high speed for granulation, granulating at 70 ℃, drying and finishing;
(8) and (4) screening out fine powder, spraying the volatile oil obtained in the step (4), uniformly mixing with the granules, sealing, and encapsulating to obtain the capsule.
Example 4: preparation of the inventive medicinal pill
Prescription:
astragalus root 30 g talcum 28 g selfheal 10 g ligustrum japonicum 28 g
Litchi seed 10 g amber 4 g cinnamon 1.5 g phellodendron bark 15 g
The preparation method comprises the following steps: making into pill by conventional method.
Example 5: preparation of the medicinal oral liquid
Prescription:
astragalus root 34 g talcum 12 g selfheal 19 g ligustrum japonicum 18 g
Litchi seed 25 g amber 2.5 g cinnamon 4.5 g phellodendron bark 13 g
The preparation method comprises the following steps: making into oral liquid by conventional method.
Claims (8)
1. The application of a traditional Chinese medicine composition in preparing a medicine for treating male infertility caused by sperm output channel obstruction or varicocele or spermatitis or immune abnormality is characterized in that the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
30-150 parts of astragalus mongholicus, 7-28 parts of talcum, 10-40 parts of selfheal, 7-28 parts of glossy privet fruit
10-40 parts of lychee seed, 1-4 parts of amber, 1.5-6 parts of cinnamon, and 3-15 parts of phellodendron bark.
2. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
70 parts of astragalus mongholicus, 14 parts of talcum, 21 parts of selfheal and 14 parts of glossy privet fruit
Litchi seeds 21 parts, amber 2.1 parts, cinnamon 2.8 parts, phellodendron bark 7 parts.
3. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
30 parts of astragalus mongholicus, 7 parts of talcum, 10 parts of selfheal and 7 parts of glossy privet fruit
Litchi seeds 10 parts of amber 1 part of cinnamon 1.5 parts of phellodendron bark 3 parts.
4. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
astragalus root 150 parts talc 28 parts prunella spike 40 parts ligustrum japonicum 28 parts
40 parts of lychee seeds, 4 parts of amber, 6 parts of cinnamon and 15 parts of golden cypress.
5. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
30 parts of astragalus mongholicus, 28 parts of talc, 10 parts of selfheal and 28 parts of glossy privet fruit
Litchi seeds 10 parts, amber 4 parts, cinnamon 1.5 parts, phellodendron bark 15 parts.
6. The use according to any one of claims 1 to 5, characterized in that the active ingredients of the Chinese medicinal composition are prepared by the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, respectively cleaning and crushing;
(2) extracting radix astragali and cortex Phellodendri with 50-70% ethanol under reflux for 1-3 times (0.5-3 hr each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.20-1.25;
(3) extracting fructus Ligustri Lucidi with 6-10 times of 70-90% ethanol under reflux for 1-3 times (1-3 hr each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, and concentrating to obtain fluid extract with relative density of 1.20-1.25;
(4) soaking cortex Cinnamomi in 4-8 times of water for 1-2 hr, extracting volatile oil for 2-6 hr,
collecting volatile oil in another container, filtering water extractive solution, and collecting residue;
(5) taking selfheal, lychee seeds and the residues obtained in the step (4), adding 8-10 times of water, decocting twice, wherein the first time is 1-3 hours, the second time is 1-2 hours, filtering the extracting solution, combining, adding the aqueous solution obtained in the step (4), and concentrating into clear paste with the relative density of 1.20-1.25 for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh fine powder;
the clear paste obtained in the step (2), the clear paste obtained in the step (3), the volatile oil obtained in the step (4), the clear paste obtained in the step (5) and the fine powder obtained in the step (6) jointly form the active ingredients of the traditional Chinese medicine composition.
7. The use of any one of claims 1-5, wherein the formulation of the Chinese medicinal composition is in the form of a capsule, tablet, oral liquid or pill.
8. Use according to claim 7, characterized in that the capsules are made by the following steps:
(1) respectively cleaning and selecting the traditional Chinese medicinal materials, crushing, and weighing according to a proportion;
(2) extracting radix astragali and cortex Phellodendri with 50-70% ethanol under reflux for 0.5-3 hr for 1-3 times, filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20-1.25, and vacuum drying to obtain dry extract;
(3) extracting fructus Ligustri Lucidi with 6-10 times of 70-90% ethanol under reflux for 1-3 times (1-3 hr for each time), filtering the extractive solutions, mixing, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.20-1.25, and vacuum drying to obtain dry extract;
(4) soaking cortex Cinnamomi in 4-8 times of water for 1-2 hr, extracting volatile oil for 2-6 hr,
collecting volatile oil with other container, wherein the oil yield is not less than l.0%, filtering the water extractive solution, and collecting the residue;
(5) taking selfheal, lychee seeds and the residue obtained in the step (4), adding 8-10 times of water, decocting twice, wherein the first time is 1-3 hours, the second time is 1-2 hours, filtering the extracting solution, combining, adding the aqueous solution obtained in the step (4), concentrating into clear paste with the relative density of 1.20-1.25, drying in vacuum, mixing the obtained dry paste with the dry paste obtained in the step (2), and crushing into 100-mesh powder for later use;
(6) pulverizing pulvis Talci and Succinum into 100 mesh powder;
(7) uniformly mixing the dry paste powder obtained in the step (5), the fine powder obtained in the step (6) and a proper amount of auxiliary materials, using 80% ethanol as a binding agent, stirring at a high speed for granulation, drying at 60-70 ℃, and finishing granules;
(8) and (4) screening out fine powder, spraying the volatile oil obtained in the step (4), uniformly mixing with the granules, sealing, and encapsulating to obtain the capsule.
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| CN104225035A (en) | 2014-12-24 |
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