CN111920858B - Composition and application thereof in preparation of medicine for adjuvant treatment of prostatitis - Google Patents
Composition and application thereof in preparation of medicine for adjuvant treatment of prostatitis Download PDFInfo
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- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
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Abstract
The invention belongs to the technical field of peony processing, and particularly relates to a composition prepared by taking peony sterol and alpha linolenic acid as main raw materials, and application of the composition in preparation of a medicament for adjuvant treatment of prostatitis. The composition contains the paeonol, the peeled and cored ginkgo seed powder, the tuckahoe powder, the raspberry powder and the alpha linolenic acid microcapsule powder. The invention has the beneficial effects that: (1) the composition provided by the invention is derived from natural plants, and has the characteristics of no side effect and high safety; (2) the composition has remarkable effect after being applied to the preparation of the medicament for assisting in treating prostatitis; (3) the composition has the advantages of rich raw materials, low cost, easy popularization and application and large-scale production.
Description
Technical Field
The invention belongs to the technical field of peony processing, and particularly relates to a composition prepared from raw materials of paeonol and alpha-linolenic acid, and application of the composition in preparation of a medicament for adjuvant treatment of prostatitis.
Background
Chronic prostatitis is a common disease and frequently encountered disease of adult males, the morbidity of the male in China is 8% by epidemiological statistics, and the disease in the male in the age of 30-40 and 60-70 is two peak disease stages. Clinically, female prostatosis is also a disease similar to prostatic hyperplasia at home and abroad, and is often seen in middle-aged women, especially in old women. The patient suffers from the disease. Symptoms such as frequent micturition, odynuria, and urinary stuttering can occur due to long-term hyperemia of glands and hypofunction of gland tubules and glands. The etiology and pathogenesis of the disease are not fully elucidated. Abacterial prostatitis is the most common prostatitis syndrome, the cause of which is not clear and is often described as immunological abnormality.
In the treatment of this disease, the use of antibiotics is not justified, and currently there are mainly 3 protocols: 1. alpha-receptor blocker can relax smooth muscle of prostate, bladder and other parts to improve lower urinary tract symptoms and pain, and is a basic medicine for prostatitis. 2. The plant preparation mainly refers to pollen preparations and plant extracts, and the clinically used plant preparations comprise: pudulai, Shabaozu and their extracts. 3. Non-steroidal anti-inflammatory drugs, which belong to empirical drugs. Its primary purpose is to relieve pain and discomfort.
Many scholars believe that prostatectomy affects the endocrine coordination of the body. Therefore, it is not suitable for treating prostatitis. The syndrome is an annoying chronic disease and no very good treatment has been available to date.
If the drug therapy is adopted, no specific drug exists at present, and clinical applications such as non-steroidal anti-inflammatory drugs, slow-acting antirheumatic immunosuppressive chemical preparations, botanical drugs and the like are mainly available. Has the function of relieving pain for treating rheumatoid arthritis, but the action mechanism and the curative effect are all to be improved.
CN103190504A discloses a processing method of peony pistil tea, which is characterized in that the method comprises the following steps: (1) selecting raw materials: picking fresh peony pistils which bloom for 1-2 days, and placing the peony pistils in a container with good cleanness and air permeability; (2) airing: spreading the picked fresh peony pistil in a ventilating and air-permeable dry environment, and airing to a semi-dry state, wherein the water content of the semi-dry state is 30-35%; (3) and (3) drying: microwave drying the peony pistil which is dried in shade at the frequency of 2400 plus 2500 MHz and the temperature of 60-90 ℃ until the moisture content of the peony pistil is 3.8-7.5 percent; (4) separating big impurities and pollen: screening the dried peony pistil tea by using a vibrating screen to separate out large impurities and pollen, wherein the screening is double-layer screen screening, the upper-layer screen is 10 meshes, and the lower-layer screen is 40-120 meshes; (5) and (3) scented tea screening: and (4) selecting the discolored scented tea by using a photoelectric color selector, and reserving the unchangeable scented tea to obtain the finished product of the peony pistil tea.
The tea bag has certain effect on the prevention and treatment effect of prostatitis, but the tea bag has longer action period and larger using amount and can not take effect in a short time.
Disclosure of Invention
In order to solve the technical problems, the invention provides a composition which takes the paeonol, the peeled and cored semen ginkgo powder, the tuckahoe powder, the raspberry powder and the alpha linolenic acid microcapsule powder as main raw materials, has no side effect, takes effect in a short time, has high safety, good application effect and low cost;
the invention also provides a preparation method of the composition;
and the application of the composition in preparing the medicament for assisting in treating the prostatitis.
The invention is realized by the following technical scheme:
the weight parts of the paeonol, the peeled and cored ginkgo seed powder, the tuckahoe powder, the raspberry powder and the alpha linolenic acid microcapsule powder are as follows: 0.5-1: 30-45: 20-28: 15-25: 9-16;
wherein the paeonol satisfies the following requirements: the proportion of the iso-fucosterol is 50-60%, the proportion of the oat sterenol is 15-21%, the proportion of the beta-sitosterol is 5-9%, and the proportion of the squalene is 3-5%;
preferably, in the composition, the weight parts of the paeonol, the peeled and cored ginkgo seed powder, the tuckahoe powder, the raspberry powder and the alpha linolenic acid microcapsule powder are 0.75: 40: 25: 20: 13;
the application of the composition provided by the invention in preparing the medicine for assisting in treating prostatitis is the key point to be protected by the invention.
In the composition, the paeonol is prepared by taking peony pollen as a raw material;
the alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol is obtained by extracting peony pollen serving as a raw material, and the peony pollen is preferably danfeng peony pollen.
The alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The medicine related by the invention is in any form of capsule or tablet, granule, oral liquid, injection, powder and aerosol, and also comprises pharmaceutically acceptable auxiliary materials;
the adjuvant is at least one selected from disintegrant, diluent, lubricant, and glidant.
In the composition, 0.5-1 mg/kg of paeonol, 30-45 mg/kg of peeled and cored semen ginkgo powder, 20-28 mg/kg of tuckahoe powder, 15-25 mg/kg of raspberry powder and 9-16 mg/kg of alpha linolenic acid microcapsule powder are taken every day;
the dosage of the composition is as follows: 0.75mg/kg of paeonol taken every day, 40mg/kg of peeled and cored semen pruni radicis powder, 25mg/kg of tuckahoe powder, 20mg/kg of raspberry powder and 13mg/kg of alpha linolenic acid microcapsule powder.
Although there are reports on the application of phytosterol in the treatment of prostate diseases at present, most of the reports on the application of beta-sitosterol in the treatment of prostate diseases (Heandrostavia in the 'application progress of phytosterol in treating prostate diseases' article discloses that 200 benign prostatic hypertrophy patients are subjected to experimental study for 6 months, wherein the drug used in the drug administration group is beta-sitosterol, and the results show that the effect of beta-sitosterol treatment for 6 months on improving symptoms can be maintained for 18 months), and no relevant reports are found on the components of peosterol and whether the peosterol can be applied to prostate diseases. The content of beta-sitosterol in the adopted peosterol is not high and only accounts for 5-9%, but the content of isofucosterol is higher.
The efficacy of alpha linolenic acid microcapsule powder is proved at present: regulating blood lipid, preventing myocardial infarction and cerebral infarction, reducing blood viscosity, increasing blood oxygen carrying amount, lowering blood pressure, reducing weight, and inhibiting anaphylaxis.
The invention combines the peosterol with higher isofucosterol content and the alpha linolenic acid according to a certain proportion, has excellent effect on treating prostatitis diseases such as prostatauxe, and has good treatment effect (high cure rate) and short cure period.
Peeling and coring semen Ginkgo, which is roasted peeled and cored semen Ginkgo (hereinafter, all the peeled and cored semen Ginkgo); is a characteristic food material used as both medicine and food, and has the main effects of preventing hypertension, hyperlipidemia, hypertension and hyperglycemia, beautifying, improving memory, diminishing inflammation and sterilizing (pneumonia and respiratory tract inflammation diseases);
the tuckahoe has the functions of promoting diuresis, removing dampness, nourishing spleen, strengthening spleen, harmonizing stomach and eliminating edema;
rubi fructus has effects of nourishing yin, invigorating kidney, replenishing essence and blood, and warming kidney yang. Has good nourishing effect for patients with kidney deficiency; the ginkgo seed kernel powder without peel and core, the paeonol, the tuckahoe, the alpha linolenic acid microcapsule powder and the raspberry powder are combined, and the result shows that the combination of the raw materials has obvious effect on treating prostatitis.
The invention has the beneficial effects that:
(1) the composition provided by the invention is derived from natural plants, namely peony which is a peony sterol source, and alpha linolenic acid microcapsule powder is also derived from plants; the peeled and cored ginkgo kernel powder, the tuckahoe and the raspberry in the raw materials are homologous raw materials for medicine and food, and compared with western medicines with side effects on human bodies, the ginkgo kernel powder, the tuckahoe and the raspberry have the characteristics of no side effect and high safety;
(2) the composition has remarkable effect after being applied to the preparation of the medicine for assisting in treating prostatitis; the effective rate of the treatment is as high as about 96%.
(3) The composition has the advantages of rich raw materials, low cost, easy popularization and application and large-scale production.
Detailed Description
The present invention will be further described with reference to specific examples so that those skilled in the art may better understand the present invention, but the present invention is not limited thereto.
Example 1
The composition comprises the paeonol, peeled and cored ginkgo seed powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder in parts by weight as follows: 0.75: 40: 25: 20: 13;
the paeonol is prepared by taking peony pollen as a raw material;
peeling semen Ginkgo powder (stewed), Poria powder, and Rubi fructus powder, and micronizing into powder with particle size of 400 mesh; wherein the peeled and cored ginkgo seed powder is obtained by steaming and boiling at high temperature (100 ℃) for 20-30 min, drying and crushing, and then micronizing; semen Ginkgo has certain toxicity, and needs to be heated at high temperature to improve its safety. The following examples all do this.
The alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol meets the following requirements: wherein the proportion of iso-fucosterol is 52%, the proportion of oat sterol is 13%, the proportion of beta-sitosterol is 7%, squalene is 3%, and the balance is other sterols or other substances.
Because the content of each component in the peosterol is influenced by a plurality of factors, such as picking time and batches, planting conditions of different fields, condition control in the production batch process and the like, the content of the isofucosterol, the avenantrenol, the beta-sitosterol and the squalene in the peosterol has small fluctuation, but is generally within the following content range: the proportion of the iso-fucosterol is 50-60%, the proportion of the oat sterol is 15-21%, the proportion of the beta-sitosterol is 5-9%, and the proportion of the squalene is 3-5%.
Example 2
The composition comprises the paeonol, peeled and cored ginkgo seed powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder in parts by weight: 0.6: 32: 26: 18: 12;
the paeonol is prepared by taking peony pollen as a raw material;
the alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol meets the following requirements: the content of the iso-fucosterol is 55%, the content of the oat sterenol is 18%, the content of the beta-sitosterol is 8%, the content of the squalene is 4%, and the balance of other components.
Example 3
The composition comprises the paeonol, peeled and cored ginkgo seed powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder in parts by weight: 0.65: 45: 25: 16: 10;
the paeonol is prepared by taking peony pollen as a raw material;
the alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol meets the following requirements: wherein the proportion of iso-fucosterol is 52%, the proportion of oat sterol is 13%, the proportion of beta-sitosterol is 7%, squalene is 3%, and the balance is other sterols or other substances.
Example 4
The composition comprises the paeonol, peeled and cored ginkgo seed powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder in parts by weight: 0.7: 38: 24: 22: 14;
the paeonol is prepared by taking peony pollen as a raw material;
the alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol meets the following requirements: the content of the iso-fucosterol is 55%, the content of the oat sterenol is 18%, the content of the beta-sitosterol is 8%, the content of the squalene is 4%, and the balance of other components.
Example 5
The composition comprises the paeonol, peeled and cored ginkgo seed powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder in parts by weight: 0.9: 34: 27: 15: 16;
the paeonol is prepared by taking peony pollen as a raw material;
the alpha linolenic acid microcapsule powder is prepared from peony seed oil or linseed oil and perilla seed oil as raw materials.
The paeonol meets the following requirements: the content of the iso-fucosterol is 55%, the content of the oat sterenol is 18%, the content of the beta-sitosterol is 8%, the content of the squalene is 4%, and the balance of other components.
Example 6
The product of example 1 was made into tablets by the following specific steps:
(1) mixing the composition of example 1 with mannitol, then adding lactose, microcrystalline cellulose, magnesium stearate, citric acid, stevioside, mixing in a blender for 15 minutes to obtain a final mixture, adding the final mixture into a roller press for dry granulation to obtain granules;
(2) preparing the material obtained in (1) into a tablet-shaped medicament having a hardness of 1 to 2kp and a weight of about 75mg per 10 tablets by a tablet press using a MUST punch having a diameter of 2 mm.
Example 7
The product in example 1 is prepared into a granule medicament, and the specific steps are as follows:
the composition in the embodiment 1, mannitol, dextrin, starch and sugar are taken, the raw materials are uniformly mixed, distilled water is added to prepare a soft material, the soft material is sieved by a 20-mesh sieve, dried and sieved by a 18-mesh sieve, and subpackaging is carried out to obtain the granular medicine.
Example 8
The product of example 1 was prepared as a capsule drug, with the following specific steps:
(1) uniformly mixing the composition in the example 1 with microcrystalline cellulose, spraying mannitol with the concentration of 95% into the mixed powder in a high-speed mixing state, extruding and crushing the obtained mixture into particles by using an extruder, drying, and crushing the particles and sieving the particles by using a 80-mesh sieve;
(2) mixing starch and dextrin with the materials in the step (1) to obtain mixed powder;
(3) mixing the sulfur aid, the lubricant and the mixed powder in the step (2) in a mixer for 5-10 minutes to obtain a final mixture which is used as a filling material in the capsule;
(4) and (4) filling the filler in the step (3) into a capsule shell, and sealing to obtain the capsule medicament.
Example 9
With respect to the drug of the present invention, the present inventors conducted the following experiments:
the clinical symptom parameters of 50 patients taking the combination product are shown in Table 1.
The change of the residual urine (Ru) is that the difference of X1 compared with X2 and X3 and X2 compared with X3 are statistically significant (P is less than 0.05), which indicates that the residual urine is continuously reduced after the medicine is taken. Maximum urine flow rate (Qmax) change: the difference between X1 and X2 and X3 and between X2 and X3 was statistically significant (P < o.05), indicating that the maximum uroflow rate continued to increase after administration of the drug. IPSS changes: the comparison of X1 with X2 and X3 and the comparison of X2 with X3 show that the differences have statistical significance (P <0.O5), which indicates that the IPSS scores are all reduced after the administration. Quality of life score (QOL) change: the difference between X1 and X2 and X3 and between X2 and X3 has statistical significance (P is less than 0.05), which indicates that the quality score of life is reduced after the medicine is taken. Prostate volume (V) change: the difference between X1 and X2 and X3 is not statistically significant (P >0.05), which indicates no change in prostate volume after administration. Blood total prostate specific antigen PSA content changes: compared with X2 and X3, X2 and X3, the difference has no statistical significance (P is more than 0.05), which indicates that the content of the blood total prostate specific antigen PSA is not changed after the medicine is taken.
TABLE 1 variation of clinical symptom parameters (X + -s) before and after taking the product
The observation and statistics result shows that after the patient takes the product, the urination symptoms (residual urine volume and urine flow rate) of the patient are obviously improved within 1 month, the IPSS score of the patient is obviously reduced, the disease condition is obviously relieved, and the life quality score is changed from a less satisfied stage and a distressing stage to a substantially satisfied stage and a more acceptable stage. With respect to changes in prostate volume, there are cases where prostate volume shrinkage is evident.
Example 10
With respect to the compositions of examples 1 to 5, the present inventors carried out the following animal experiments:
70 Kunming rats with the body weight of 300-400 g and the age of 3-4 months are selected. Injecting sodium pentobarbital into abdominal cavity at 100mg/kg, anesthetizing, removing abdominal incision under aseptic condition, directly reaching abdominal cavity, taking out bladder and two side seminal vesicles, exposing prostate dorsal lobe attached to seminal vesicle, injecting 25% hemorrhoid eliminating injection 0.2mL, and suturing muscle and skin.
Rats 7 days after surgery were randomly divided into 7 groups of 10 rats each, namely, example 1 group, example 2 group, example 3 group, example 4 group and example 5 group; comparative example 1 group, comparative example 2 group;
the normal group is rats which are not treated by the operation, 10 rats are taken and filled with clear water;
in the examples 1-5, the rats were gavaged once every day at 8 am and 4 pm; the powder obtained by crushing the tablets prepared according to the compositions of examples 1 to 5 (see example 6 for the preparation method) was diluted with 10 ml of water;
amount of example 1 group:
0.75mg/kg of paeonol, 40mg/kg of peeled and cored ginkgo seed powder, 25mg/kg of tuckahoe powder, 20mg/kg of raspberry powder and 13mg/kg of alpha linolenic acid microcapsule powder;
amount used in example 2 group:
0.6mg/kg of paeonol, 32mg/kg of peeled and cored ginkgo seed powder, 26mg/kg of tuckahoe powder, 18mg/kg of raspberry powder and 12mg/kg of alpha linolenic acid microcapsule powder;
amount of example 3 group:
0.65mg/kg of paeonol, 45mg/kg of peeled and cored ginkgo seed powder, 25mg/kg of tuckahoe powder, 16mg/kg of raspberry powder and 10mg/kg of alpha linolenic acid microcapsule powder;
amount of example 4 group:
0.7mg/kg of paeonol, 38mg/kg of peeled and cored ginkgo seed powder, 24mg/kg of tuckahoe powder, 22mg/kg of raspberry powder and 14mg/kg of alpha linolenic acid microcapsule powder;
amount of example 5 group:
0.9mg/kg of paeonol, 34mg/kg of peeled and cored ginkgo seed powder, 27mg/kg of tuckahoe powder, 15mg/kg of raspberry powder and 16mg/kg of alpha linolenic acid microcapsule powder;
comparative example 1 group of pots compared with example 1, the peonies and alpha linolenic acid microcapsule powder were not perfused;
comparative example 2 group of Paeoniflorin was 0.75mg/kg, peeled and cored semen Ginkgo powder 40mg/kg, Poria powder 25mg/kg, and Rubi fructus powder 20 mg/kg;
the body indices of the rats 7 days after gavage are shown in table 2:
TABLE 2 comparison of prostate fluid leukocyte counts and lecithin bodies in various groups of rats
| WCB count (× 10)9One hundred million) | PACP(U/L) | Interstitial congestion and edema | Infiltration of inflammatory cells | |
| Normal group | 1.254±0.347 | 40782±10146** | - | - |
| Example 1 | 1.316±0.327 | 39215±12037** | + | + |
| Example 2 | 1.332±0.208 | 41024±11248** | + | + |
| Example 3 | 1.314±0.525 | 40789±12470** | + | + |
| Example 4 | 1.348±0.227 | 41574±13884** | + | + |
| Example 5 | 1.354±0.393 | 41495±13436** | + | + |
| Comparative example 1 | 1.816±0.636 | 56028±12668** | ++ | ++ |
| Comparative example 2 | 1.974±0.589 | 61358±12737** | ++ | ++ |
Note: interstitial congestion, edema were graded as follows: "-", "+ + + + + +"; the more "+" the more obvious the representation;
inflammatory cell infiltration was graded as follows: "-", "+ + + + + +"; the more "+" the greater the number.
As can be seen from the data in Table 2, the difference between the white blood cell count in the invention and the control group is not large, which indicates that inflammatory cells are controlled, and the white blood cell count in the comparative examples 1 and 2 is higher than that in the examples of the invention, which indicates that the single peosterol or alpha linolenic acid microcapsule powder has a certain control effect on prostatitis, but has a limited effect, and the synergistic effect of the combination of the two is not as remarkable; compared with the PACP, the invention is close to the normal group, which shows that the prostatitis of the rats in each embodiment group is better controlled, because the increase of the PACP is commonly seen in diseases such as prostatic hyperplasia, prostatitis and the like. From the viewpoint of interstitial congestion and inflammatory cells, the present example group had a slightly mild hyperemic edema condition as compared to the normal group, and inflammatory cells were less infiltrated. It was further verified that the composition of the present invention has a significant effect on treating prostate.
Claims (6)
1. The composition for adjuvant therapy of prostatitis is characterized in that the effective components in the composition comprise paeonol, peeled and cored semen ginkgo kernel powder, tuckahoe powder, raspberry powder and alpha linolenic acid microcapsule powder, wherein the paeonol, the peeled and cored semen ginkgo kernel powder, the tuckahoe powder, the raspberry powder and the alpha linolenic acid microcapsule powder are in parts by weight as follows: 0.75: 40: 25: 20: 13.
2. the use of the composition for the adjuvant treatment of prostatitis of claim 1 in the preparation of a medicament for the adjuvant treatment of prostatitis.
3. The use according to claim 2, wherein the composition is present in an amount of: 0.75mg/kg of paeonol, 40mg/kg of peeled and cored ginkgo seed powder, 25mg/kg of tuckahoe powder, 20mg/kg of raspberry powder and 13mg/kg of alpha linolenic acid microcapsule powder are taken every day.
4. The use according to claim 2, wherein the medicament is in the form of any one of capsules, tablets, granules, oral liquid or powder.
5. The use of claim 2, wherein the medicament further comprises a pharmaceutically acceptable excipient.
6. The use according to claim 5, wherein the excipient is at least one selected from the group consisting of disintegrants, diluents, lubricants, glidants.
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