CN102114054A - Production method of pine pollen tablets for treating premature ovarian failure of women - Google Patents
Production method of pine pollen tablets for treating premature ovarian failure of women Download PDFInfo
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- CN102114054A CN102114054A CN 201010607393 CN201010607393A CN102114054A CN 102114054 A CN102114054 A CN 102114054A CN 201010607393 CN201010607393 CN 201010607393 CN 201010607393 A CN201010607393 A CN 201010607393A CN 102114054 A CN102114054 A CN 102114054A
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Abstract
The invention relates to the technical field of production of tablets, particularly relates to a production method of pine pollen tablets for treating premature ovarian failure of women. The production method comprises the following steps: removing impurities from pine pollen, performing wall-breaking treatment by airflow grinding, soaking in water of normal pressure and temperature, performing ultrasonic treatment, centrifuging with a refrigerated centrifuge at a rotation speed of 8,000-12,000 rpm, collecting supernatant, and separating pine pollen water-soluble extract of molecular weight less than 5,000 D at 1-5 DEG C, and lyophilizing the pine pollen water-soluble extract to obtain pine pollen lyophilized powder with water content less than 5%; and mixing pine pollen lyophilized powder with lecithin, water-soluble starch and microcrystalline cellulose PH102, and tabletting. The pine pollen tablets provided by the invention have the advantages of no adverse effects, no liability of oxidative deterioration, good rehydration, and easy absorption.
Description
Technical field
The present invention relates to the tablet manufacturing technical field, particularly treat the tablet manufacturing method of women's premature ovarian failure.
Background technology
Tablet grows up on the pill basis, is created 19th-century forties, updates along with the development of compression machinery to 19 end of the centurys, and the application of tablet has obtained development rapidly.In recent ten years, tablet manufacturing technology and plant equipment aspect have bigger development, as boiling granulating, direct compression of full-powder, half film coating etc.The research of Chinese medicinal tablet and production start from the fifties in last century, and along with the comprehensive study of Chemistry for Chinese Traditional Medicine, pharmacology, preparation and aspect such as clinical, the kind of Chinese medicinal tablet, quantity constantly increase, and Technology is improved day by day, and the quality of tablet improves gradually.Chinese medicinal tablet on type except that general compressed tablet, coated tablet, also have microencapsule tablet, buccal tablet, external sheet and effervescent tablet etc.Find out a cover gradually at the tablet manufacturing process aspect and be applicable to the process conditions that Chinese medicinal tablet is produced, as preparation to fatty oil and volatile oil tablet, how to improve Chinese medicinal tablet hardness, improve disintegration, tablet coating etc. and accumulate experience gradually, quality is improved constantly.In addition, to the research of aspects such as the dissolution rate of Chinese medicinal tablet Chinese medicine and bioavailability, progressively carrying out.In a word, at present tablet become wide in variety, output is big, purposes is wide, use and store and transport conveniently, one of steady quality dosage form, tablet all accounts for more than 1/3 in the preparation that the pharmacopeia of China and other many countries is recorded, visible use wide.
The women that premature ovarian failure (POF) is meant normal development caused ovarian function failure with preceding because of certain reason at 40 years old.It shows as secondary amenorrhea, low estrogen and high promoting sexual gland hormone state, and custom is referred to as menopause early.The sickness rate of premature ovarian failure is about 1% one 3% before 40 years old, and the sickness rate in 30 years old is 0.1%.Research at present thinks that the number of primordial germ cell deposit is the key factor of decision female fertility phase length, and the formation of primordial germ cell is subjected to the control of a plurality of genes.Except that being subjected to congenital heredity factor regulation and control, keeping of mature women's ovarian function also is subjected to posteriori influence of various factors, and the true cause of its morbidity fully aware of not still up to now is so become the focus and the difficult point of domestic and international reproductive development circle to the research of this disease.
At present, premature ovarian failure still lacks ideal Therapeutic Method.To having fertility to require or preventing too early dotard, generally can take the method for Comprehensive Treatment to nurse one's health.Western medicine has certain effect, and mainly is complementing estrogen, but has bigger risk, need use progestogen under doctor's guidance simultaneously.When using estrogen and progestogen therapy according to the study, have certain effect, can improve symptom, but unsatisfactory to the recovery of ovarian function, mainly show discontinue medication after, symptom reappears, lutropin and follicule-stimulating hormone (FSH) raise once again, that is to say, Western medicine has only played the effect that takes stopgap measures, particularly, act on not ideal enough to the conceived women who requires is arranged.
Pollen Pini is the pollen of pinasters such as gymnosperm Pinaceae Pinus Pinus massoniana Lamb and Pinus tabuliformis, and China utilizes and edible Pollen Pini country the earliest in the world.The resource major part of global Pollen Pini is distributed in China, but as the exclusive living resources of China, the pollen of Pinus massoniana Lamb and Pinus tabuliformis is not also developed fully.Whole nation Pollen Pini output is very abundant, the pollen of Pinus massoniana Lamb only, annual renewable output is just at nearly ten million ton, China also has more than 2,000 ten thousand hectares Chinese pine pollen can supply to gather in addition, because Pollen Pini is a wind pollination system, will be wasted if the resource of so many Pollen Pini can not in time be gathered and process.
The research of China's Pollen Pini at present is in the leading level in the world; external research also is in the primary research stages such as analysis of nutritional labeling; and a series of difficult problems such as China has solved well that Pollen Pini is fresh-keeping, breaking cellular wall and production; realized large-scale production; and improved alimentation rate behind the edible Pollen Pini greatly, for Pollen Pini industry leading position in the world provides powerful guarantee.However external pollen product is but more extensive on using than China, and Sweden is applied to beauty treatment with pollen food, and Japan is used as nutriment with pollen food, and France is with the function food of pollen as the growth encourage childhood development.By comparison, though the developmental research of China's Pollen Pini has been carried out the more than ten years, a large amount of Pollen Pini products has appearred, but the comprehensive processing and utilization level is also not high, the product category of existing Pollen Pini is single on the market, and quality is uneven, and the degree of intensive processing is not high yet, exported product is rare especially, and the resource of valuable Pollen Pini is not well utilized.
But because the easy moisture absorption moisture regain of the long-time storage of the lyophilized powder of the pollen water extract that tradition is collected, it is sticking to cause product to be stained with, and has both influenced product quality, makes the reduction of tiring of product activity, influences product again and takes, and greatly influences the product use.
Summary of the invention
The object of the invention be to invent a kind of be beneficial to long preservation, and can effectively keep the production method of its active Pollen Pini treatment women premature ovarian failure tablet.
The present invention includes following steps:
1) Pollen Pini with remove impurity is immersed in the normal pressure and temperature water after the comminution by gas stream broken wall treatment, with ultrasonic Treatment, through rotating speed is 8000～12000 refrigerated centrifuger centrifugal treating of changeing, get supernatant, again with supernatant under 1～5 ℃ ambient temperature, cross the following molecular sieve of 5000D, isolate the Pollen Pini hydrotrope of molecular weight less than 5000D;
2) with molecular weight less than the Pollen Pini hydrotrope of 5000D after lyophilisation, obtain water content and be lower than 5% Flos pini lyophilized powder;
3) with described Flos pini lyophilized powder and lecithin, water soluble starch and microcrystalline Cellulose PH102 mixing film-making.
The present invention utilizes pollen water extract treatment women premature ovarian failure effect remarkable, and has no side effect, and expense is cheap, and is simple.Products characteristics after the present invention's processing is: packing dosage is accurate; Reservation function material activity; Medicine is difficult for oxidation deterioration; Easily absorb; Rehydration is good; Be fit to long-distance transport, long preservation and use.
In addition, the frequency of the classification motor of comminution by gas stream broken wall treatment is 55～60Hz in the step 1) of the present invention, and bleed pressure is 0.7～1.0MPa.
Ultrasonic treatment time described in the described step 1) is 20～40 minutes.
Described step 2) during lyophilisation, temperature of charge is-40 ℃～60 ℃ when sublimation drying and desorbing, and vacuum condition is 3～7Pa.
Mass ratio when lyophilized powder, lecithin, water soluble starch and microcrystalline Cellulose PH102 mix in the described step 3) is 1 ︰, 0.1～5 ︰, 0.1～5 ︰ 0.1～5.
The specific embodiment
One, the lyophilized powder of preparation treatment women premature ovarian failure pollen water extract:
1, go-on-go pollen: remove impurity in the Pollen Pini at normal temperatures.
2, breaking cellular wall: is 55～60Hz with the pollen of remove impurity in the frequency of classification motor, broken wall treatment under bleed pressure 0.7～1.0MPa.
3, soak supersound process: the pollen after the broken wall treatment is immersed in the normal pressure and temperature water, with ultrasonic Treatment 20～40 minutes.
4, remove impurity: it is centrifugal 10～15 minutes of 8000～12000 refrigerated centrifugers that change that the material after the supersound process is placed rotating speed, removes solid impurity, gets supernatant.
5, ultrafiltration: supernatant under 1～5 ℃ ambient temperature, is crossed the following molecular sieve of 5000D, isolate the hydrotrope of molecular weight, be the pollen hydrotrope that is used for the treatment of women's premature ovarian failure less than 5000D.
6, lyophilization: the pollen hydrotrope that will be used for the treatment of women's premature ovarian failure is-30 ℃～60 ℃ at temperature of charge, and vacuum condition is lyophilization 20～48 hours under the condition of 3～7Pa, obtains water content and is lower than 5% lyophilized powder.
Two, tabletting:
1, prescription:
Weight ratio with lyophilized powder, lecithin, water soluble starch and microcrystalline Cellulose PH102 is 1 ︰, 0.1～5 ︰, 0.1～5 ︰, 0.1～5 weighing respectively.
2, production technology:
Mix: lyophilized powder and lecithin, water soluble starch and the microcrystalline Cellulose PH102 of accurate weighing are put in the batch mixer, build cover, open the batch mixer counter-rotating and stirred 10～20 minutes, just changeing again and stirring 5 minutes, behind the mix homogeneously, the material that mixes crossed 18 mesh sieves after, standby.
Tabletting: environmental condition is a relative humidity 45%～65% between the control tabletting, 18 ℃～26 ℃ of temperature, and it is 6～10kg/mm that tabletting hardness requires
2, sheet heavily is 0.5 gram.
Coating: syrup is with film coating pre-mix dose and 55%(percent by volume) ethanol continue to stir and became syrup in about 1 hour, cross 100 mesh sieves after, carry out coating.
Three, application and curative effect:
Certain woman, 40 years old, the premature ovarian failure symptom shows as estradiol and follicle stimulating hormone is unusual.
Take 2～4 in the Pollen Pini tablet made every day, after 30-60 days, taking a turn for the better appears in gonadal hormone and gonadotrophin secretion continuously, and recovers normal gradually.
Claims (5)
1. be used for the treatment of the production method of the Pollen Pini tablet of women's premature ovarian failure, it is characterized in that may further comprise the steps:
1) Pollen Pini with remove impurity is immersed in the normal pressure and temperature water after the comminution by gas stream broken wall treatment, with ultrasonic Treatment, through rotating speed is 8000～12000 refrigerated centrifuger centrifugal treating of changeing, get supernatant, again with supernatant under 1～5 ℃ ambient temperature, cross the following molecular sieve of 5000D, isolate the Pollen Pini hydrotrope of molecular weight less than 5000D;
2) with molecular weight less than the Pollen Pini hydrotrope of 5000D after lyophilisation, obtain water content and be lower than 5% Flos pini lyophilized powder;
3) with described Flos pini lyophilized powder and lecithin, water soluble starch and microcrystalline Cellulose PH102 mixing film-making.
2. according to the described method of claim 1, the frequency that it is characterized in that the classification motor of comminution by gas stream broken wall treatment in the described step 1) is 55～60Hz, and bleed pressure is 0.7～1.0MPa.
3. according to the described method of claim 1, it is characterized in that ultrasonic treatment time described in the described step 1) is 20～40 minutes.
4. according to the described method of claim 1, it is characterized in that described step 2) during lyophilisation, temperature of charge is-40 ℃～60 ℃ when sublimation drying and desorbing, vacuum condition is 3～7Pa.
5. according to the described method of claim 1, it is characterized in that the mass ratio when lyophilized powder in the described step 3), lecithin, water soluble starch and microcrystalline Cellulose PH102 mix is 1 ︰, 0.1～5 ︰, 0.1～5 ︰ 0.1～5.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201010607393 CN102114054A (en) | 2010-12-28 | 2010-12-28 | Production method of pine pollen tablets for treating premature ovarian failure of women |
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| CN 201010607393 CN102114054A (en) | 2010-12-28 | 2010-12-28 | Production method of pine pollen tablets for treating premature ovarian failure of women |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108606326A (en) * | 2018-05-10 | 2018-10-02 | 烟台金蕊女性用品有限公司 | Healthy reproduction maintains equilibrium liquid |
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2010
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108606326A (en) * | 2018-05-10 | 2018-10-02 | 烟台金蕊女性用品有限公司 | Healthy reproduction maintains equilibrium liquid |
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Application publication date: 20110706 |