CN1277574C - Beautifying and climacteric syndrome treating composition, its preparing process and usage - Google Patents
Beautifying and climacteric syndrome treating composition, its preparing process and usage Download PDFInfo
- Publication number
- CN1277574C CN1277574C CNB2004100568463A CN200410056846A CN1277574C CN 1277574 C CN1277574 C CN 1277574C CN B2004100568463 A CNB2004100568463 A CN B2004100568463A CN 200410056846 A CN200410056846 A CN 200410056846A CN 1277574 C CN1277574 C CN 1277574C
- Authority
- CN
- China
- Prior art keywords
- chinese medicine
- medicine composition
- solution
- amount
- methanol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Abstract
The present invention relates to a Chinese medicinal composition for treating climacteric syndrome, beautifying skin and improving skin moisture, and the preparation method, the purposes and the detection method of the Chinese medicinal composition. The present invention is characterized in that the Chinese medicinal composition comprises the following raw material medicines of the weight proportioning: 16 to 32% of white peony root, 12 to 25% of glossy privet fruit, 16 to 32% of dendrobium, 8 to 20% of fleeceflower root and 1 to 8% of pearl. The preparation method is characterized in that the glossy privet fruit, the dendrobium and the fleeceflower root are extracted by alcohol, the medicine residues and the white peony root are extracted by water after being mixed, the alcohol is deposited, the pressure is reduced, and then, the mixture is concentrated into extract; the extract is baked and pulverized, and then, fine pearl powder is added to the pulverized extract to be evenly mixed to be prepared into various preparations. The medicine effect experiment and the clinical test of human bodies prove that the Chinese medicinal composition has obvious efficiency and safety for improving climacteric symptoms and physical symptoms, overcoming the toxic and side effects of the existing western medicine hormonotherapy, promoting the endocrine function of women to restore to the corresponding level, beautifying skin and improving skin moisture. The Chinese medicinal composition of the present invention has the purposes of preparing cosmetics or functional food or medicines for treating climacteric syndrome.
Description
Technical field;
The present invention relates to Chinese medicine composition and preparation method thereof, be specifically related to a kind of treat climacteric syndrome and have improve skin moisture, have Chinese medicine composition of beautification function and preparation method thereof, purposes.
Background technology
At present, known climacteric syndrome is because ovarian function decline and even disappearance cause one group of syndrome that endocrine disturbance and autonomic nervous dysfunction are produced.Its pathological consequences relates to hormonal system, and (estrone, estradiol reduce, follicle stimulating hormone, lutropin increase, menoxenia etc.), autonomic nervous system (is warmed sweating, vasomotoricity imbalance-fluctuation of blood pressure etc.), a plurality of tissue target organs such as neural psychiatric system (irritated, anxiety and various climacteric psychoneurosis shape etc.).
Existing Western medicine is normally used gonadal hormone (mainly being estrogen) alternative medicine to this treatment of diseases, but a lot of people of its side effect (metrorrhagia, target organ malignant change etc.) influence can not accept the treatment of this method.
Chinese medicine composition does not have the similar toxic and side effects of Western medicine, but existing Chinese medicine composition action target spot mainly embodies the improvement to autonomic nervous dysfunction syndrome group, and the endocrine Accommodation seems not enough relatively.Retrieval State Food and Drug Administration basic database in the Chinese medicine by the treatment climacteric syndrome of national official approval, does not still have and possesses the Chinese medicine that improves autonomic nervous dysfunction syndrome (taking stopgap measures) and two effects of adjustment endocrine (effecting a permanent cure) simultaneously.Analyze reason, Chinese medicine is many to reach adjustment endocrine purpose by adjusting body function and prescription flavour of a drug estrogen-like effect.The quality of the selection of prescription flavour of a drug, composition proportion and extraction process is directly connected to the curative effect of medicine.Therefore, the innovation research of Chinese medicine composition and preparation method is particularly important.
As improve skin moisture, beautifying use mostly is cosmetics for external use, cosmetics or functional food for oral administration are less.This Chinese medicine composition is mainly by Chinese medicine the kidney invigorating and plant parhormone sample effect endocrine regulation, and the human body endotoxin is got rid of in relieving constipation simultaneously, specific in addition skin care skin moistening Chinese medicine, and the pharmacological action that is in many ways reaches skin moistening water conservation purpose at many levels.Retrieval national drug and health food storehouse still do not have identical with the present invention Chinese medicine composition and preparation method thereof.
Current Chinese Medicine Act regulation: after the crude drug of formation medicine component must be obtained national statutory standards, just can use in the preparation.Thereby the research of the brand-new Chinese medicine preparation of structure comprise crude drug innovation research, obtain national standard, carry out the innovation research plurality of processes of preparation.The Chinese crude drug that the Chinese medicine of existing treatment climacteric syndrome records with " pharmacopeia " morely is a basis application Chinese medicine composition patent.Its essence or inventive point show to obtaining effective pharmaceutical component, with the write out a prescription innovation research of component and content proportioning of the form of substance method feature.
The treatment climacteric syndrome also has the Chinese medicine composition preparation method research of beautification function, and its key is how the effective active composition in the medicine to be screened as far as possible to remain, or obtains new effective active composition by preparation process.The present more innovation research that is embodied in optimum extracting method and best process flow of Chinese medicine composition preparation method characteristic.Given this Chinese medicine composition new characteristic by preparation method, made its improvement that can be used for climacteric syndrome symptom, sign and endocrine regulation, and beauty treatment improves the specific purposes of skin moisture.
Summary of the invention
For the toxic and side effects and the existing Chinese medicine that overcome existing Western medicine Hormone Replacement Therapy are adjusted the insufficient problem of endocrine dynamics, the invention provides a kind of treatment climacteric syndrome, improve the autonomic nervous dysfunction syndrome, adjust the endocrine level, there is not the Western medicine toxic and side effects again, and have beauty treatment, improve the effect of skin moisture, Chinese medicine composition of safety, excellent effect and preparation method thereof, with and demarcation, detection method.
Technical scheme:
The technical solution adopted for the present invention to solve the technical problems is as follows:
The present invention discloses a kind of treatment climacteric syndrome and beauty treatment, improves the Chinese medicine composition of skin moisture, it is characterized in that it contains the following raw materials by weight proportions thing: Radix Paeoniae Alba 16-32%, Herba Dendrobii 16-32%, Fructus Ligustri Lucidi 12-25%, Radix Polygoni Multiflori 8-20%, Margarita 1-8%.
The preferred weight proportioning of each raw material is: the Radix Paeoniae Alba 16, Herba Dendrobii 16, Fructus Ligustri Lucidi 13, Radix Polygoni Multiflori 9, Margarita 2.
This compositions can be made any pharmaceutics regular dosage form.
Can adopt the following steps preparation:
It is standby that Margarita water flies to be ground into impalpable powder; Fructus Ligustri Lucidi, Herba Dendrobii, the Radix Polygoni Multiflori alcohol reflux of 60-90% concentration, merge extractive liquid, reclaims solvent and gets extractum I, and is standby; Medicinal residues and the Radix Paeoniae Alba merge, extracting in water, merge extractive liquid, suitably concentrates, add ethanol and make and contain the alcohol amount and reach 60-80%, precipitation, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, concentrating under reduced pressure, extractum II; Merge extractum I and II, drying is ground into fine powder, adds the Margarita fine powder, and mixing is made various preparations.
The preferred for preparation method is:
(1) to fly to be ground into impalpable powder standby for Margarita water.
(2) Fructus Ligustri Lucidi, Herba Dendrobii, Radix Polygoni Multiflori add the alcohol reflux of the 60-90% that 4-10 doubly measures, and each 0.5-2.5 hour, 2-3 time altogether, the extracting solution filtration.Merge extractive liquid, is evaporated to proportion 1.25-1.40, gets extractum I, and is standby.
(3) medicinal residues and the Radix Paeoniae Alba merge, and add 4-10 times of water gaging and extract, each 0.5-2 hour, extract 2-3 time, extracting solution filters.Merge extractive liquid, is evaporated to proportion 1.05-1.20, add ethanol and make and contain alcohol amount and reach 60-80%, standing over night, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, is evaporated to proportion 1.25-1.40, extractum II.
(4) merge extractum I and II, put oven dry in the 60-80 ℃ of vacuum drying oven, be ground into fine powder, add the Margarita fine powder, mixing.
(5) fine powder of step (4) gained is made various preparations, it is characterized in that making preparation is capsule, tablet, granule, pill, drop pill, powder, oral liquid, mixture, injection, unguentum, medicated wine or syrup.
The function of this Chinese medicine composition cures mainly and is nourishing the kidney for subduing the hyperactivity of liver-YANG, clearing away heart-fire for tranquillization, is used for the climacteric syndrome hepatic and renal YIN deficiency, hyperactivity of hesrt-fire and liver-fire card and beauty treatment, improves the purposes of medicine or the cosmetics or the functional food of skin moisture.Card is seen: warm sweating, Blushing, soreness of the waist and knees, anxious state of mind, susceptible to lose temper due to restlessness, easily excitation, palpitation and insomnia, dreaming often and waking easily, feel dizzy, related symptoms such as vertigo and tinnitus, dry mouth and throat, feverish sensation in the palms and soles, xerosis cutis, menoxenia, vaginal dryness; The while integumentary musculature can not get QI and blood and moistens foster then change of color because of fear, the influence beauty treatment.This Chinese medicine composition helps the climacteric women physical function to be adjusted to normally, and the endocrine function of impelling the women to lack of proper care returns to respective horizontal, and by nourishing kidney, moisten foster skin and reach beauty treatment, improve the skin moisture purpose.
Blood stored in the liver, kidney storing essence, The liver and the kidney have a common source.Blood deficiency is liver-yang hyperactivity then, and the deficiency of YIN is hyperactivity of fire then, and the assertive evidence hepatic and renal YIN deficiency is this, so the first nourishing the kidney and liver of working as.
The Radix Paeoniae Alba tonifying YIN that nourishes blood, suppressing liver-YANG, yin fluid astringing is received antiperspirant, easing the affected liver emergency.At the characteristics of the assertive evidence hepatic and renal YIN deficiency, it is that ministerial drug is kept fit liver blood, holds back liver-yin, delayed liver suddenly that this product is reused the Radix Paeoniae Alba, moistens foster skin, and so that it is a monarch drug admittedly.
The kind yin nourishing benefit of Fructus Ligustri Lucidi merit is smart, nourishing the liver and kidney.The nourishing the kidney and liver that we use, the yin nourishing benefit is smart to be ministerial drug to help its source.
The Herba Dendrobii merit is apt to tonifying YIN, is promoted the production of body fluid, heat clearing away.This product is with it sweet light promoting the production of body fluid, the kidney tonifying heat clearing away, the principal drug assistance nourishing YIN and clearing away heat, the double climacteric heating spontaneous perspiration and the will of feeling relieved increases liquid benefit skin moistening of controlling, with Fructus Ligustri Lucidi be ministerial drug altogether.
The Margarita merit is apt to tranquilizing mind, and yin nourishing relieves dizziness, high fever, infantile convulsions, epilepsy, etc., clearing away heat to improve acuity of vision.This product helps monarch-minister drug mind calming sedate, tranquilizing mind, the skin moistening wrinkle removal and be the assistant help.
Radix Polygoni Multiflori go into Liver and kidney through tonifying liver, kidney tonifying, nourish blood, specially go into Liver and kidney, take a tonic or nourishing food to build up one's health Kidney-Yinly, have the flat secret effect of negative and positive, the kind all diseases for the treatment of the liver deficiency of the kidney yin, holding concurrently stagnates with the relieving constipation row, gets rid of internal metabolism refuse and toxin.This product helps the nourishing the liver of monarch-minister drug kidney tonifying with it, thinks that assistant helps.
The assertive evidence disease is positioned at the heart, liver, kidney, and all medicines are included into the heart, liver, kidney channel respectively, so establish the tying-in messenger drug no longer in addition.
Full side's nourishing the kidney for subduing the hyperactivity of liver-YANG, clearing away heart-fire for tranquillization are used for the card of climacteric syndrome hepatic and renal YIN deficiency, hyperactivity of hesrt-fire and liver-fire, make Liver and kidney cloudy multiple, and the conscience fire is clear, and disease is to more, and skin is made moist simultaneously, and appearance is normal again, to obtain its merit.
The pharmacological action of this Chinese medicine composition:
The main pharmacodynamics experiment
1. this Chinese medicine composition is to the influence of rat sweat gland secretion due to the pilocarpine nitrate
Rat by body weight, sex random packet, is established totally 5 groups of the high, medium and low dosage groups of this Chinese medicine composition, GENGNIANAN PIAN matched group, negative control group.Each organizes equal one week of continuous oral administration.Subcutaneous injection Pilocarpine Nitrate solution after the last administration is observed the antiperspirant of rat paw portion appearance and is counted result's statistical procedures with magnifier.
Experimental result shows, this Chinese medicine composition has inhibitory action to rat sweat gland secretion due to the pilocarpine, and with GENGNIANAN PIAN matched group ratio apparent property difference arranged.Thereby illustrate that this Chinese medicine composition has inhibitory action to neuro irritability, improve climacteric patient hyperhidrosis symptom.
2. this Chinese medicine composition is to the influence of pentobarbital sodium mouse sleep time
With 50 of mices, be divided at random: totally 5 groups of the high, medium and low dosage groups of this Chinese medicine composition, GENGNIANAN PIAN matched group, negative control group by body weight, sex.Each organizes equal one week of continuous oral administration.Last administration pneumoretroperitoneum injection pentobarbital sodium solution, the record mouse sleep time.Result's statistical procedures.
Experimental result shows, this Chinese medicine composition is to the prolongation effect of pentobarbital sodium mouse sleep time, and with GENGNIANAN PIAN matched group ratio apparent property difference arranged.Point out it to have calm stabile effect.Can improve climacteric patient sleep benefit and dysphoria symptom.
3. this Chinese medicine composition is to the influence of levothyrocine deficiency of YIN mice body weight, body temperature, heart rate
Mice is divided at random by body weight, sex: totally 6 groups of the high, medium and low dosage groups of this Chinese medicine composition, GENGNIANAN PIAN matched group, blank group, model group.Except that the blank group, respectively organize equal one week of continuous oral administration.The 3rd day beginning subcutaneous injection levothyrocine weighs, surveys body temperature, heart rate after the administration after the last administration.Result's statistical procedures.
Experimental result shows that each dosage group of this Chinese medicine composition is to levothyrocine deficiency of YIN mice body weight and not obviously influence of heart rate.This Chinese medicine composition has cooling effect to levothyrocine induced mice deficiency of YIN models show, points out this Chinese medicine composition to help climacteric hyperactivity of fire caused by deficiency of YIN and the improvement of warming symptom.
4. this Chinese medicine composition is to the influence of young female rat uterus, ovary and oestrous cycle
Rat is divided at random by body weight, sex: 5 groups of the high, medium and low dosage groups of this Chinese medicine composition, diethylstilbestrol group, blank group.Remove diethylstilbestrol group continuous subcutaneous injection 5 beyond the highest heavens, each organizes equal one week of continuous oral administration.Carry out vaginal smear examination, observe the oestrous cycle variation.Each is organized administration and finishes back execution, dissection, observes uterine hydrops and situation occurs, calculates uterus, ovary weight ratio, result's statistical procedures.
Experimental result shows, this Chinese medicine composition to young female rat uterus/weight ratio tangible effect of gain is arranged, to the effect of being significantly improved of young female rat incidence rate in rutting period, estradiol content in the young female rat blood serum is had tangible rising effect, and apparent property difference is arranged with blank group ratio.Show that this Chinese medicine composition has certain estrogen-like or short gonad effect, points out this Chinese medicine composition to have the function of sex hormone level regulation.
5. this Chinese medicine composition is to the influence of castrated rats hormone serum level
Remove gesture 50 of rats completely, be divided into totally 5 groups of model control group, GENGNIANAN group, this Chinese medicine composition administration group (dividing high, medium and low dosage), blank group at random by body weight.Successive administration 15 days.Measure the level of short folliculus generation hormone (FSH), luteotropic hormone (LH), estradiol (E2) and progestogen (PROG) in the serum after the last administration with typical double antibody radioimmune method, uterus and adrenal gland weigh.
Experimental result shows that this Chinese medicine composition is compared uterus and adrenal gland's coefficient that can obviously increase castrated rats with matched group, help the improvement of climacteric syndrome.
Above experimental result shows that this Chinese medicine composition has the climacteric syndrome of improvement related symptoms, the pharmacological action of endocrine regulation hormonal readiness.
The acute toxicity test of this Chinese medicine composition
The application mice carries out this Chinese medicine composition acute toxicity testing and shows: this Chinese medicine composition of mice oral administration gavage is under 150.8g crude drug/kg dosage, observed 7 days continuously, none animal dead, mice overall health of patients, diet, take the photograph water and body weight gain is all normal, the sacrifice of animal no pathology that become celestial change.LD
50＞150.8g crude drug/kg.The prompting clinical drug safety.
24 weeks of this Chinese medicine composition rat oral gavage are toxicity test for a long time
If high, medium and low 3 the dosage groups of this Chinese medical concrete and 1 solvent control group.Use 30 of rats, male and female half and half for every group.Every day gastric infusion once, totally 24 weeks.Result of study shows, give the medicine of above-mentioned dosage after, the rat general signs, body weight gain and matched group do not have apparent difference.Each organizes hematological indices, blood parameters, the uroscopy of rat, and all in normal range, internal organs are not found the toxic reaction relevant with medicine with histological examination.
This Chinese medicine composition human trial conclusion and effect
For effectiveness and the safety of estimating this traditional Chinese medicine composition for treating climacteric syndrome.In December, 2003～2004 carried out in four tame national drug clinical research bases year April district's group at random, double blinding, positive drug parallel control, multiple center clinical study.In order to accomplish to maintain secrecy and avoid public use at home, signing before the test and in each clinical trial unit's contract has confidentiality agreement, and strictly observes security regulation in clinical trial.
Research number: plan number 240 people; Actual selected 234 people.Matched group 116 examples wherein, test group 118 examples.
Trial drug: this Chinese medicine composition;
Control drug: the accurate word treatment of the traditional Chinese medicines of national up-to-date approval listing climacteric syndrome medicine.
Dosage regimen: oral.One time 4,3 times on the one, took for 4 weeks continuously.
Include the case standard in:
1, between 45～55 years old age.
2, meet female climacteric syndrome Western medicine diagnose standard, in the menopause 5 years, and FSH 〉=40miu/ml, the experimenter of E2＜168pg/l.
3, the experimenter uses the Hormone Replacement Therapy for the treatment of climacteric syndrome more than 3 months, and Chinese medicine is more than 2 months.
4, the Chinese medical discrimination hepatic and renal YIN deficiency, hyperactivity of hesrt-fire and liver-fire card person.
5, signature Informed Consent Form.
Analysis of comparable between group before the treatment: two groups of ages, the course of disease, gynecological's B ultrasonic situation, use climacteric drug condition, blood pressures relatively, difference does not have apparent property meaning (P＞0.05).The disease baseline case: treatment is preceding except that the cardiopalmus test group state of an illness lays particular stress on, all the other traditional Chinese medical science are warmed sweating, fidgety irritability, soreness of the waist and knees, uncomfortable in chest, dreaming often and waking easily, insomnia, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles, hypochondriac pain, symptoms such as dry mouth with bitter taste, picture of the tongue, pulse condition, tcm syndrome integration, estradiol (E2), follicle stimulating hormone (FSH) relatively, difference does not have apparent property meaning (P＞0.05).
The prompting of comparability testing result, the principal element that influences two groups of prognosis has harmony.
Climacteric syndrome curative effect determinate standard: formulate with reference to " new Chinese medicine clinical research guideline "
1. face control: clinical symptoms, sign disappear, and the physico-chemical examination result recovers respective horizontal, and treatment back integrated value reduces more than 95% than before treating.
2. produce effects: clinical symptoms, sign are clearly better, and the physico-chemical examination result recovers respective horizontal substantially, and treatment back integrated value reduces more than 70% before than treatment.
3. effective: clinical symptoms, sign take a turn for the better to some extent, and physico-chemical examination is the result make moderate progress, and treatment back integrated value reduces more than 30% than treatment is preceding.
4. invalid: clinical symptoms, sign, physico-chemical examination result all do not have improvement or worsen, and reduce less than 30% before the integrated value ratio treatment of treatment back.
Tcm syndrome curative effect determinate standard: judge the tcm syndrome curative effect according to integration method.
Integration * 100% before therapeutic index (n)=(integration before the test-test back integration)/test
1. clinic control: the tcm syndrome integration improves and surpasses 95%
2. produce effects: the tcm syndrome integration improves and surpasses 70% and be less than 95%
3. effective: the improvement of tcm syndrome integration surpasses 30% and is less than 70%
4. invalid: the improvement of tcm syndrome integration is lower than 30%
Tcm symptom integration standard: (formulating) according to perimenopausal syndrome " improvement Kupperman " point system
Warm sweating: 0 minute (-): do not have.
4 minutes (+): every day, outbreak was＜3 times.
8 minutes (++): show effect 3-9 every day.
12 minutes (+++): every day, outbreak was 〉=10 times.
Irritated irritability: 0 minute (-): do not have.
2 minutes (+): idol has outbreak.
4 minutes (++): often outbreak, but can adhere to daily life, work.
6 minutes (+++): continue outbreak, influence daily life, work.
Insomnia: 0 minute (-): do not have.
2 minutes (+): sleep is awakened often or is slept and unstable, and morning is early awake, but does not influence work.
4 minutes (++): do not have enough sleep 4 hours, and still can adhere to work.
6 minutes (+++): do not have enough sleep 3 hours or lay awake all night, be difficult to adhere to work.
Dizziness and tinnitus: 0 minute (-): do not have.
1 minute (+): idol has.
2 minutes (++): dizziness and tinnitus is often arranged.
3 minutes (+++): often occur, continue not understand.
Dysphoria with feverish sensation in the chest palms and soles: 0 minute (-): do not have.
1 minute (+): idol has.
2 minutes (++): often have.
3 minutes (+++): often occur, continue not understand.
Soreness of the waist and knees: 0 minute (-): do not have.
1 minute (+): idol has.
2 minutes (++): often have.
3 minutes (+++): often occur, continue not understand.
Hypochondriac pain: 0 minute (-): do not have.
1 minute (+): idol has generation.
2 minutes (++): often outbreak.
Uncomfortable in chest: 0 minute (-): as not have.
1 minute (+): idol has.
2 minutes (++): often occur.
Cardiopalmus: 0 minute (-): do not have.
1 minute (+): idol has
2 minutes (++): often occur.
3 minutes (+++): continue not understand.
Dreaming often and waking easily: 0 minute (-): do not have.
1 minute (+): occur once in a while.
2 minutes (++): often occur.
Dry mouth with bitter taste: 0 minute (-): do not have.
1 minute (+): idol has.
2 minutes (++): often occur.
Result of the test:
Total mark changes relatively before and after two groups of treatments:
| Group | N | Integration before treating | Treat the back integration | Reduce integrated value | Statistic (t) in the group | P |
| Statistic (t) P between Chinese medicine composition group matched group group | 118 116 | 24.15±5.40 23.35±5.05 1.172 ＞0.05 | 6.43±4.75 7.79±4.71 2.185 ＜0.05 | 17.67±5.59 15.50±6.13 2.999 ＜0.01 | 26.352 24.214 | ＜0.01 ＜0.01 |
The two groups of experimenter's tcm syndrome integrations in treatment back all have obvious reduction, P＜0.01, and difference has apparent property meaning.Wherein this Chinese medicine composition group and matched group on average reduce integration differential relatively, P＜0.01, and difference has apparent property meaning, and this Chinese medicine composition group is better than matched group.
The total effective rate of this traditional Chinese medicine composition for treating climacteric syndrome is 99.1%, and it is 65.5% that control shows rate; The matched group total effective rate is 94.8%, and it is 43.5% that control shows rate; Two groups of curative effects relatively, P＜0.05, difference has apparent property meaning, this Chinese medicine composition is better than matched group.
This Chinese medicine composition is to the therapeutic effect of syndrome of the hepatic and renal YIN deficiency, hyperactivity of hesrt-fire and liver-fire card, and this Chinese medicine composition total effective rate is 99.1%, and it is 69.9% that control shows rate; The matched group total effective rate is 94.8%, and it is 44.4% that control shows rate; Two groups of curative effects relatively, P＜0.05, difference has apparent property meaning, this Chinese medicine composition is better than matched group.
This Chinese medicine composition is warmed sweating, fidgety irritability, cardiopalmus, soreness of the waist and knees, uncomfortable in chest, dreaming often and waking easily, insomnia, dizziness and tinnitus to improving the climacteric experimenter, dysphoria with feverish sensation in the chest palms and soles, and hypochondriac pain, symptoms such as dry mouth with bitter taste all have clinical efficacy preferably.Difference all has apparent property meaning (P＜0.01) before and after two groups of tcm symptoms treatments.
Treatment back this Chinese medicine composition group experimenter serum FSH value reduces, and on average reduces by 19.64 ± 28.470, and matched group experimenter serum FSH on average reduces by 9.30 ± 28.955.Two groups of differences that descend compare, and test group is better than matched group, P＜0.05.
Treatment back this Chinese medicine composition group experimenter blood E2 rises, and on average rises 30.0759 ± 58.10382, and matched group on average rises 14.4130 ± 36.01510, shows that both all can alleviate climacteric experimenter estrogen downward trend.Two groups of differences that rise compare, and test group is better than matched group, P＜0.05.
Above gynecological change of hormone contents illustrates that test group treatment back serum FSH value reduces, and the E2 value rises, and helps regulating the climacteric women hormone and returns to corresponding horizontal.
Test group adverse events incidence rate is 1 example (0.85%), experimenter 03.12.21 catch cold back flu aversion to cold, watery nasal discharge etc., symptom belongs to slight, take GANKANG after, symptom 03.12.27 disappears, it is constant to take former medicine dosage therebetween.The analysis reason is affirmed and medicine has nothing to do.
Matched group adverse events incidence rate 1 example (0.85%) occurred moderate untoward reaction such as dizzy, weak, sleepy, drowsiness on the 2nd day in the back of taking medicine, drug withdrawal natural remission after 3 days, and therefore withdraw from clinical trial.It is relevant with medicine probably to analyze reason.
Blood, urine are detected in the treatment front and back, just conventional regulating liver-QI, renal function, electrocardiogram do not have discovery not relevant with the test group medication, and the ANOMALOUS VARIATIONS of clinical meaning is arranged, and this Chinese medicine composition drug safety is described.Beauty treatment improves the human trial of skin moisture
In order to estimate the beauty treatment of this Chinese medicine composition, improve the effectiveness of skin moisture effect.This Chinese medicine composition in June, 2003～December has carried out 32 routine clinical own control anthroposcopies.Evaluation methodology is carried out with reference to Ministry of Public Health " health food function assessment assessment process ".
1 includes standard in: the age is 30-50 year, skin moisture≤12.
2 schedule of administration: oral.One time 1 bag, 2 times on the one, took for 4 weeks continuously.
3. effect index: the moisture content of test forehead glabella skin changes skin moisture before and after the test-meal and to add up.
4. effect criterion
Effectively: moisture content improves, and returns to＞12, and learns check by statistics apparent property difference is arranged.
Invalid: moisture content does not obtain showing improving.
5. the result judges: effective 27 people, invalid 5 people.Own control is observed before and after the treatment, and statistical result difference has apparent property meaning (P＜001).
| Group | N | Scoring before treating | Treat the back scoring | The rising score value | Statistic (t) | P |
| The Chinese medicine composition group | 32 | 10.22±1.18 | 12.84±1.08 | 2.63±1.04 | 6.65 | ＜0.01 |
The human trial conclusion:
More than two human research results show that this Chinese medicine composition has the climacteric syndrome of improvement related symptoms, sign, endocrine regulation hormonal readiness and have beauty treatment improves the pharmacological action of skin moisture.This Chinese medicine composition is treatment climacteric syndrome and beauty treatment, improves safe, the Chinese medicine composition effectively of skin moisture.
Beneficial effect
The beneficial effect of the present composition is that the toxic and side effects and the existing Chinese medicine that have overcome existing Western medicine Hormone Replacement Therapy are adjusted the horizontal dynamics defect of insufficient of women's endocrine.A kind of treatment climacteric syndrome is provided, had both improved the autonomic nervous dysfunction syndrome, adjusted the women's endocrine level simultaneously, and have beauty treatment, and improve the skin moisture effect, there is not the Western medicine toxic and side effects again, more safe and effective, Chinese medicine composition that quality is higher and preparation method.
The effect experiment proof present composition all has obvious inhibitory action to rat sweat gland secretion due to the Pilocarpine Nitrate; Fervescence due to the levothyrocine there is obvious inhibitory action; Obviously prolong the pentobarbital sodium mouse sleep time; To young female rat uterus weight ratio, rutting period animal number average occurs and be significantly increased; Can obviously improve estradiol level in the rat blood serum; Obviously increase uterus and adrenal gland's coefficient of castrated rats.In the anxious poison of animal, long poison experiment, do not find toxic and side effects.
Strict at random, double blinding, contrast, polycentric human trial show, present composition treatment climacteric syndrome, can show improve warm sweating, Blushing, soreness of the waist and knees, anxious state of mind, susceptible to lose temper due to restlessness, easily excitation, palpitation and insomnia, dreaming often and waking easily, feel dizzy, related symptoms such as vertigo and tinnitus, dry mouth and throat, feverish sensation in the palms and soles, xerosis cutis, menoxenia, vaginal dryness, help the climacteric women physical function to be adjusted to normally, the endocrine function of impelling the women to lack of proper care returns to respective horizontal.
The own control human trial shows, result difference has apparent property meaning before and after the present composition treatment, has beauty treatment, improves the effect of skin moisture.
In human trial, do not find obvious toxic and side effects, to blood, urine, just conventional regulating liver-QI, renal function, electrocardiogram do not have obvious influence.Show that this Chinese medicine composition has the climacteric syndrome of improvement related symptoms, sign, endocrine regulation hormonal readiness and beauty treatment, improving the pharmacological action of skin moisture, is treatment climacteric syndrome and beauty treatment, improves the safe and effective Chinese medicine composition of skin moisture.
Above-mentioned treatment climacteric syndrome and beauty treatment improve the Chinese medicine composition of skin moisture, can also add other crude drug to strengthen its curative effect, for example liver heat removing, soothing liver-QI class medicine Folium Mori, Ramulus Uncariae Cum Uncis, Radix Gentianae, Flos Rosae Rugosae; Invigorating the liver and kidney, benefiting essence-blood class medicine Semen Sesami Nigrum, Fructus Lycii; One to multiple kind in mind tranquilizing and the heart calming class medicine Semen Platycladi, the Flos Albiziae.
The preferred adding proportion of other raw material is 44% of full side's weight, for example: the Radix Paeoniae Alba 16%, Herba Dendrobii 16%, Fructus Ligustri Lucidi 13%, Radix Polygoni Multiflori 9%, Margarita 2%, other crude drug 44%.
The specific embodiment:
Embodiment 1
Prescription: the Radix Paeoniae Alba 16, Fructus Ligustri Lucidi 13, Herba Dendrobii 16, Radix Polygoni Multiflori 9, Margarita 2.
(1) to fly to be ground into impalpable powder standby for Margarita water.
(2) Fructus Ligustri Lucidi, Herba Dendrobii, Radix Polygoni Multiflori add 90% alcohol reflux of 6 times of amounts, and each 2 hours, totally 2 times, extracting solution filtered.Merge extractive liquid, is evaporated to proportion 1.25-1.30, gets extractum I, and is standby.
(3) medicinal residues such as Radix Polygoni Multiflori and the Radix Paeoniae Alba merge, and add 6 times of water gagings and extract, and each 2 hours, extract the extracting solution filtration 2 times.Merge extractive liquid, is evaporated to proportion 1.05-1.20, add ethanol and make and contain alcohol amount and reach 75%, standing over night, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, is evaporated to proportion 1.25-1.30, extractum II.
(4) merge extractum I and II, put oven dry in 65 ℃ of vacuum drying ovens, be ground into fine powder, add the Margarita fine powder, mixing.
(5) step (4) gained mixing fine powder is made granule with the ethanol of debita spissitudo, drying, granulate is pressed into 1000, promptly.
Every day, dosage was amounted to crude drug amount 30-40g, divided and took for 3 times.
Embodiment 2
Prescription: the Radix Paeoniae Alba 16%, Herba Dendrobii 16%, Fructus Ligustri Lucidi 13%, Radix Polygoni Multiflori 9%, Margarita 2%, Flos Rosae Rugosae 15%, Fructus Lycii 10%, Semen Platycladi 10%, Flos Albiziae 9%.
Method for making:
(1) to fly to be ground into impalpable powder standby for Margarita water.
(2) Fructus Ligustri Lucidi, Herba Dendrobii, Radix Polygoni Multiflori add 75% alcohol reflux of 8 times of amounts, and each 1.5 hours, totally 3 times, extracting solution filtered.Merge extractive liquid, is evaporated to proportion 1.30-1.35, gets extractum I, and is standby.
(3) medicinal residues and the Radix Paeoniae Alba, Fructus Lycii, Flos Albiziae, Flos Rosae Rugosae, Semen Platycladi merge, and add 8 times of water gagings and extract, each 1.5 hours, extract 3 times, extracting solution filters.Merge extractive liquid, is evaporated to proportion 1.05-1.20, add ethanol and make and contain alcohol amount and reach 70%, standing over night, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, is evaporated to proportion 1.30-1.35, extractum II.
(4) merge extractum I and II, put oven dry in 70 ℃ of vacuum drying ovens, be ground into fine powder, add the Margarita fine powder, mixing.
(5) step (4) gained mixing fine powder is made granule with the ethanol of debita spissitudo, drying, granulate is made granule 1000g, promptly.
Every day, dosage was amounted to crude drug amount 35-45g, divided and took for 3 times.
Embodiment 3
Prescription: the Radix Paeoniae Alba 17%, Herba Dendrobii 17%, Fructus Ligustri Lucidi 14%, Semen Sesami Nigrum 14%, Radix Polygoni Multiflori 10%, Ramulus Uncariae Cum Uncis 9%, Radix Gentianae 8%, Folium Mori 8%, Margarita 3%.
Method for making:
(1) to fly to be ground into impalpable powder standby for Margarita water.
(2) Fructus Ligustri Lucidi, Herba Dendrobii, Radix Polygoni Multiflori, Ramulus Uncariae Cum Uncis, Semen Sesami Nigrum add 65% alcohol reflux of 10 times of amounts, and each 1 hour, totally 3 times, extracting solution filtered.Merge extractive liquid, is evaporated to proportion 1.30-1.40, gets extractum I, and is standby.
(3) medicinal residues and the Radix Paeoniae Alba, Folium Mori, Radix Gentianae merge, and add 10 times of water gagings and extract, each 1 hour, extract 3 times, extracting solution filters.Merge extractive liquid, is evaporated to proportion 1.05-1.20, add ethanol and make and contain alcohol amount and reach 65%, standing over night, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, is evaporated to proportion 1.30-1.40, extractum II.
(4) merge extractum I and II, put oven dry in 75 ℃ of vacuum drying ovens, be ground into fine powder, add the Margarita fine powder, mixing.
(5) step (4) gained mixing fine powder is incapsulated, promptly.
Present composition dosage every day is amounted to crude drug amount 40-45g, divides and takes for 3 times.
The application's various compositionss can be used following detection method, and for detecting and differentiate each constituent in this Chinese medicine composition, discriminated union is distinguished each component chromatograph and the stratographic difference of Chinese medicine composition.
(1) it is an amount of to get this Chinese medicine composition, adds methanol and puts heating and refluxing extraction in the water-bath, filters, and filtrate evaporate to dryness, residue add methanol makes dissolving, as need testing solution; It is an amount of that other gets the Fructus Ligustri Lucidi control medicinal material, shines medical material solution in pairs with legal system; Even up pier fruit acid reference substance again, add methanol and make the suitable solution of concentration, product solution in contrast; Each is an amount of to draw above-mentioned three kinds of solution, put respectively on silica gel g thin-layer plate, and be developing solvent with petroleum ether-acetone-ammonia solution (7: 5: 0.1), launch, to dry, spray is dried with 5% vanillin sulphuric acid test solution; In this Chinese medicine composition test sample thin layer chromatography, respectively with Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance thin layer chromatography relevant position on, show the speckle of same color;
(2) it is an amount of to get this Chinese medicine composition, adds 60-80% ethanol and puts heating and refluxing extraction in the water-bath, filters the filtrate evaporate to dryness; Residue adds an amount of methanol makes dissolving, as need testing solution; It is an amount of that other gets the Radix Polygoni Multiflori control medicinal material, shines medical material solution in pairs with legal system; Each is an amount of to draw above-mentioned two kinds of solution, puts respectively on the silica GF254 lamellae, with benzene-ethanol (2-4: 1) be developing solvent, launch, dry, put under the ultra-violet lamp and inspect; In this Chinese medicine composition test sample thin layer chromatography, respectively with the corresponding position of control medicinal material on, show the fluorescence speckle of same color;
(3) it is an amount of to get this Chinese medicine composition, adds ammonia and stirs after moistening, places 1-1.5 hour, and it is an amount of to add chloroform, puts reflux, extract, in the water-bath, filters the filtrate evaporate to dryness.Residue adds an amount of chloroform makes dissolving, as need testing solution; It is an amount of that other gets the Herba Dendrobii control medicinal material, shines medical material solution in pairs with legal system; Each is an amount of to draw above-mentioned two kinds of solution, put respectively on silica gel g thin-layer plate, and be developing solvent with chloroform-methanol (10: 1.5), launch, to dry, spray is put oven for drying with 10% ethanol solution of sulfuric acid; In this Chinese medicine composition test sample thin layer chromatography, with the corresponding position of control medicinal material on, show the speckle of same color;
(4) Margarita detects: it is an amount of to get this Chinese medicine composition, adds dilute hydrochloric acid, promptly produces a large amount of bubbles, filters, and filtrate shows the calcium salt reaction;
(5) Radix Paeoniae Alba high performance liquid chromatography is carried out assay:
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Acetonitrile-0.1% phosphoric acid (16: 84) is mobile phase, and flow velocity 1.0ml/min detects wavelength 230nm; Number of theoretical plate should be not less than 3000 by paeoniflorin.
It is an amount of to take by weighing the paeoniflorin reference substance, makes the methanol solution of debita spissitudo, in contrast product solution; It is an amount of to get this Chinese medicine composition, quantitatively adds methanol, and supersound extraction is crossed 0.4-0.5 μ m microporous filter membrane, as need testing solution; Draw each 5 μ l of reference substance solution and this Chinese medicine composition need testing solution respectively, inject chromatograph of liquid, measure.
Detect embodiment 1
Use the tlc determination Fructus Ligustri Lucidi.
Get this Chinese medicine composition 1g, add methanol and put heating and refluxing extraction in the water-bath, filter, filtrate evaporate to dryness, residue add methanol and make the need testing solution that every 1ml methanol contains this Chinese medicine composition 1g; It is an amount of that other gets the Fructus Ligustri Lucidi control medicinal material, shines medical material solution in pairs with legal system; Even up pier fruit acid reference substance again, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; Drawing each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with petroleum ether-acetone-ammonia solution (7: 5: 0.1), launches, and dries, and spray is put in the baking oven and dried with 5% vanillin sulphuric acid test solution; In this Chinese medicine composition test sample thin layer chromatography, respectively with Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance thin layer chromatography relevant position on, show the speckle of same color; And other speckle that this Chinese medicine composition manifested, on Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance chromatograph relevant position, lack as;
Detect embodiment 2
Use the tlc determination Radix Polygoni Multiflori.
Get this Chinese medicine composition 1g, add 60-80% ethanol and put heating and refluxing extraction in the water-bath, filter the filtrate evaporate to dryness; Residue adds methanol and makes the need testing solution that every 2ml methanol contains this Chinese medicine composition 1g; It is an amount of that other gets the Radix Polygoni Multiflori control medicinal material, shines medical material solution in pairs with legal system; Draw each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica GF254 lamellae, with benzene-ethanol (2-4: 1) be developing solvent, launch, dry, put under the ultra-violet lamp and inspect; In this Chinese medicine composition test sample thin layer chromatography, respectively with the corresponding position of control medicinal material on, show the fluorescence speckle of same color; Spray with the phosphomolybdic acid test solution, hot a little, speckle shows blue under the daylight again; And other speckle that this Chinese medicine composition manifested, on control medicinal material and reference substance thin layer chromatography relevant position, lack as;
Detect embodiment 3
Use the tlc determination Herba Dendrobii:
Get this Chinese medicine composition 2g, add ammonia and stir after moistening, placed 1-1.5 hour, add 8-10 and doubly measure chloroform, put reflux, extract, in the water-bath, filter the filtrate evaporate to dryness.The residue chlorination is copied into the need testing solution that every 1ml chloroform contains this Chinese medicine composition 2g; It is an amount of that other gets the Herba Dendrobii control medicinal material, shines medical material solution in pairs with legal system; Drawing each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol (10: 1.5), launches, and dries, and spray is put oven for drying with 10% ethanol solution of sulfuric acid; In this Chinese medicine composition test sample thin layer chromatography, with the corresponding position of control medicinal material on, show the speckle of same color; And other speckle that this Chinese medicine composition manifested, on control medicinal material and reference substance thin layer chromatography relevant position, lack as;
More than 3 mensuration show that this Chinese medicine composition thin layer chromatography is different with the thin layer chromatography of single control medicinal material or reference substance, after illustrating that the single Chinese crude drug extracts through this preparation technology, its compositions has possessed the thin layer chromatography feature different with former single medical material, and it can and differentiate with the thin layer chromatography demarcation.Simultaneously in the compositions thin layer chromatography, respectively with control medicinal material and reference substance chromatograph relevant position on, the speckle that shows same color, the feature speckle that contains single control medicinal material or reference substance thin layer chromatography in the Chinese medicine composition thin layer chromatography is described, it can and differentiate with the thin layer chromatography demarcation.
Detect embodiment 4
Margarita detects: get this Chinese medicine composition 1g, add the 20ml dilute hydrochloric acid, promptly produce a large amount of bubbles, filter, filtrate shows the calcium salt reaction.
Detect embodiment 5
Radix Paeoniae Alba assay: according to high effective liquid chromatography for measuring.
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Acetonitrile-0.1% phosphoric acid (16: 84) is mobile phase, and flow velocity 1.0ml/min detects wavelength 230nm; Number of theoretical plate should be not less than 3000 by paeoniflorin.
The preparation of reference substance solution takes by weighing paeoniflorin reference substance 1mg, adds methanol and makes the solution that 1ml contains 0.1mg, in contrast product solution.
This Chinese medicine composition 1g is got in the preparation of need testing solution, puts in the 50ml measuring bottle, adds methanol 30ml, supersound extraction 15-30 minute, add methanol and be diluted to scale, shake up, filter, discard filtrate just, draw subsequent filtrate and cross 0.4-0.5 μ m microporous filter membrane, as need testing solution.
Algoscopy is drawn reference substance solution and each 5 μ l of need testing solution respectively, injects chromatograph of liquid, measures, and the every 1g of this Chinese medicine composition contains paeoniflorin (C
23H
28O
11) meter, must not be lower than 4.8mg.
Claims (13)
1. the Chinese medicine composition for the treatment of climacteric syndrome and having beautification function is wherein made raw materials of effective components weight and is mainly consisted of: Radix Paeoniae Alba 16-32%, Herba Dendrobii 16-32%, Fructus Ligustri Lucidi 12-25%, Radix Polygoni Multiflori 8-20%, Margarita 1-8%.
2. Chinese medicine composition according to claim 1, wherein making raw materials of effective components weight consists of: the Radix Paeoniae Alba 16%, Herba Dendrobii 16%, Fructus Ligustri Lucidi 13%, Radix Polygoni Multiflori 9%, Margarita 2%, other crude drug 44%, described other crude drug are the one to multiple kind in Folium Mori, Ramulus Uncariae Cum Uncis, Radix Gentianae, Flos Rosae Rugosae, Semen Sesami Nigrum, Fructus Lycii, Semen Platycladi, the Flos Albiziae.
3. the Chinese medicine composition for the treatment of climacteric syndrome and having beautification function is wherein made raw materials of effective components weight and is consisted of: the Radix Paeoniae Alba 16, Herba Dendrobii 16, Fructus Ligustri Lucidi 13, Radix Polygoni Multiflori 9, Margarita 2.
4. the Chinese medicine composition for the treatment of climacteric syndrome and having beautification function is wherein made raw materials of effective components weight and is mainly consisted of: the Radix Paeoniae Alba 16, Herba Dendrobii 16, Fructus Ligustri Lucidi 13, Radix Polygoni Multiflori 9, Margarita 2.
5. according to the preparation method of the described Chinese medicine composition of arbitrary claim among the claim 1-4, it is characterized in that carrying out according to the following steps: it is standby that Margarita water flies to be ground into impalpable powder; Fructus Ligustri Lucidi, Herba Dendrobii, the Radix Polygoni Multiflori alcohol reflux of 60-90% concentration, merge extractive liquid, reclaims solvent and gets extractum I, and is standby; Medicinal residues and the Radix Paeoniae Alba merge, extracting in water, merge extractive liquid, suitably concentrates, add ethanol and make and contain the alcohol amount and reach 60-80%, precipitation, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, concentrating under reduced pressure, extractum II; Merge extractum I and II, drying is ground into fine powder, adds the Margarita fine powder, and mixing is made various preparations.
6. the preparation method of Chinese medicine composition according to claim 5, it is characterized in that carrying out according to the following steps: it is standby that Margarita water flies to be ground into impalpable powder; Fructus Ligustri Lucidi, Herba Dendrobii, Radix Polygoni Multiflori add the alcohol reflux of the 60-90% that 4-10 doubly measures, and each 0.5-2.5 hour, 2-3 time altogether, extracting solution filtered, and merge extractive liquid, is evaporated to proportion 1.25-1.40, must extractum I, and standby; The medicinal residues and the Radix Paeoniae Alba merge, and add 4-10 times of water gaging and extract, each 0.5-2 hour, extract 2-3 time, extracting solution filters; Merge extractive liquid, is evaporated to proportion 1.05-1.20, add ethanol and make and contain alcohol amount and reach 60-80%, standing over night, inclining supernatant, precipitation centrifugal filtration merges supernatant and filtrate, is evaporated to proportion 1.25-1.40, extractum II; Merge extractum I and II, put oven dry in the 60-80 ℃ of vacuum drying oven, be ground into fine powder, add the Margarita fine powder, mixing is made various preparations.
7. the Chinese medicine composition of treatment climacteric syndrome according to claim 1 is characterized in that also adding the one to multiple kind in the following raw material: Folium Mori, Ramulus Uncariae Cum Uncis, Radix Gentianae, Flos Rosae Rugosae, Semen Sesami Nigrum, Fructus Lycii, Semen Platycladi, Flos Albiziae.
8. the Chinese medicine composition for the treatment of climacteric syndrome and having beautification function is wherein made raw materials of effective components weight and is consisted of: the Radix Paeoniae Alba 16%, Herba Dendrobii 16%, Fructus Ligustri Lucidi 13%, Radix Polygoni Multiflori 9%, Margarita 2%, Flos Rosae Rugosae 15%, Fructus Lycii 10%, Semen Platycladi 10%, Flos Albiziae 9%.
9. the Chinese medicine composition for the treatment of climacteric syndrome and having beautification function is wherein made raw materials of effective components weight and is consisted of: the Radix Paeoniae Alba 17%, Herba Dendrobii 17%, Fructus Ligustri Lucidi 14%, Semen Sesami Nigrum 14%, Radix Polygoni Multiflori 10%, Ramulus Uncariae Cum Uncis 9%, Radix Gentianae 8%, Folium Mori 8%, Margarita 3%.
10. according to the described treatment climacteric syndrome of arbitrary claim among claim 1-4, the 7-9 and have the Chinese medicine composition of beautification function, it is characterized in that the preparation of making is capsule, tablet, granule, pill, drop pill, powder, oral liquid, mixture, injection, unguentum, medicated wine or syrup.
11. according to claim 1-4, the described treatment climacteric syndrome of arbitrary claim and have the detection method of the Chinese medicine composition of beautification function among the 7-9 is characterized in that adopting the one to multiple kind in the following method:
(1) it is an amount of to get this Chinese medicine composition, makes methanol extract liquid, as need testing solution; It is an amount of that other gets the Fructus Ligustri Lucidi control medicinal material, shines medical material solution in pairs with legal system; Even up pier fruit acid reference substance again, add methanol and make the suitable solution of concentration, product solution in contrast; Each is an amount of to draw above-mentioned three kinds of solution, puts respectively on silica gel g thin-layer plate, is mixed into developing solvent with petroleum ether-acetone-ammonia solution by 7: 5: 0.1, launches, and dries, and spray is dried with 5% vanillin sulphuric acid test solution; In this Chinese medicine composition test sample thin layer chromatography, respectively with Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance thin layer chromatography relevant position on, show the speckle of same color;
(2) it is an amount of to get this Chinese medicine composition, uses the 60-80% ethanol extraction, the extracting solution evaporate to dryness; Residue adds an amount of methanol makes dissolving, as need testing solution; It is an amount of that other gets the Radix Polygoni Multiflori control medicinal material, shines medical material solution in pairs with legal system; Each is an amount of to draw above-mentioned two kinds of solution, puts in silica gel G F respectively
254On the lamellae, press 2-4 with benzene-ethanol: 1 is developing solvent, launches, and dries, and puts under the ultra-violet lamp and inspects; In this Chinese medicine composition test sample thin layer chromatography, respectively with the corresponding position of control medicinal material on, show the fluorescence speckle of same color;
(3) it is an amount of to get this Chinese medicine composition, adds ammonia and stirs after moistening, places 1-1.5 hour, extracts in right amount with chloroform, filters, and filtrate evaporate to dryness, residue add an amount of chloroform makes dissolving, as need testing solution; It is an amount of that other gets the Herba Dendrobii control medicinal material, shines medical material solution in pairs with legal system; Each is an amount of to draw above-mentioned two kinds of solution, puts respectively on silica gel g thin-layer plate, is mixed into developing solvent with chloroform-methanol by 10: 1.5, launches, and dries, and spray is put oven for drying with 10% ethanol solution of sulfuric acid; In this Chinese medicine composition test sample thin layer chromatography, with the corresponding position of control medicinal material on, show the speckle of same color;
(4) Margarita detects: it is an amount of to get this Chinese medicine composition, adds dilute hydrochloric acid, promptly produces a large amount of bubbles, filters, and filtrate shows the calcium salt reaction;
(5) Radix Paeoniae Alba carries out assay with high performance liquid chromatography:
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Acetonitrile-0.1% phosphoric acid was mixed into mobile phase by 16: 84, and flow velocity 1.0ml/min detects wavelength 230mm; Number of theoretical plate is not less than 3000 by paeoniflorin;
It is an amount of to take by weighing the paeoniflorin reference substance, makes the methanol solution of debita spissitudo, in contrast product solution; It is an amount of to get this Chinese medicine composition, quantitatively adds methanol, and supersound extraction is crossed 0.4-0.5 μ m microporous filter membrane, as need testing solution; Draw each 5 μ l of reference substance solution and this Chinese medicine composition need testing solution respectively, inject chromatograph of liquid, measure.
12. according to claim 1-4, the detection method of the Chinese medicine composition of the described treatment climacteric syndrome of arbitrary claim among the 7-9 is characterized in that adopting the one to multiple kind in the following method:
(1) get this Chinese medicine composition 1g, add methanol and put heating and refluxing extraction in the water-bath, filter, filtrate evaporate to dryness, residue add methanol and make the need testing solution that every 1ml methanol contains this Chinese medicine composition 1g; It is an amount of that other gets the Fructus Ligustri Lucidi control medicinal material, shines medical material solution in pairs with legal system; Even up pier fruit acid reference substance again, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; Draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be mixed into developing solvent with petroleum ether-acetone-ammonia solution by 7: 5: 0.1, launch, dry, spray is dried with 5% vanillin sulphuric acid test solution; In this Chinese medicine composition test sample thin layer chromatography, respectively with Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance thin layer chromatography relevant position on, show the speckle of same color; And other speckle that this Chinese medicine composition manifested, on Fructus Ligustri Lucidi control medicinal material and oleanolic acid reference substance chromatograph relevant position, lack as;
(2) get this Chinese medicine composition 1g, add 60-80% ethanol and put heating and refluxing extraction in the water-bath, filter the filtrate evaporate to dryness; Residue adds methanol and makes the need testing solution that every 2ml methanol contains this Chinese medicine composition 1g; It is an amount of that other gets the Radix Polygoni Multiflori control medicinal material, shines medical material solution in pairs with legal system; Draw each 4 μ l of above-mentioned two kinds of solution, put in same silica gel G F respectively
254On the lamellae, with benzene-ethanol by 2-4: 1 is mixed into developing solvent, launches, and dries, and puts under the ultra-violet lamp and inspects; In this Chinese medicine composition test sample thin layer chromatography, respectively with the corresponding position of control medicinal material on, show the fluorescence speckle of same color; And other speckle that this Chinese medicine composition manifested, on control medicinal material and reference substance thin layer chromatography relevant position, lack as;
(3) it is an amount of to get this Chinese medicine composition, adds ammonia and stirs after moistening, places 1-1.5 hour, adds 8-10 and doubly measures chloroform, puts reflux, extract, in the water-bath, filters, and filtrate evaporate to dryness, residue chlorination are copied into the need testing solution that every 1ml chloroform contains this Chinese medicine composition 2g; It is an amount of that other gets the Herba Dendrobii control medicinal material, shines medical material solution in pairs with legal system; Draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be mixed into developing solvent with chloroform-methanol by 10: 1.5, launch, dry, spray is dried with 10% ethanol solution of sulfuric acid; In this Chinese medicine composition test sample thin layer chromatography, with the corresponding position of control medicinal material on, show the speckle of same color; And other speckle that this Chinese medicine composition manifested, on control medicinal material and reference substance thin layer chromatography relevant position, lack as;
(4) Margarita detects: get this Chinese medicine composition 1g, add the 20ml dilute hydrochloric acid, promptly produce a large amount of bubbles, filter, filtrate shows the calcium salt reaction;
(5) Radix Paeoniae Alba assay: according to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Acetonitrile-0.1% phosphoric acid was mixed into mobile phase by 16: 84, and flow velocity 1.0ml/min detects wavelength 230nm; Number of theoretical plate is not less than 3000 by paeoniflorin;
The preparation of reference substance solution takes by weighing paeoniflorin reference substance 1mg, adds methanol and makes the solution that 1ml contains 0.1mg, in contrast product solution;
This Chinese medicine composition 1g is got in the preparation of need testing solution, puts in the 50ml measuring bottle, adds methanol 30ml, supersound extraction 15-30 minute, add methanol and be diluted to scale, shake up, filter, discard filtrate just, draw subsequent filtrate and cross 0.4-0.5 μ m microporous filter membrane, as need testing solution;
Accurate respectively reference substance solution and each the 5 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.
13. according to claim 1-4, the described Chinese medicine composition of arbitrary claim prepares the purposes of the medicine of cosmetics or treatment climacteric syndrome among the 7-9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100568463A CN1277574C (en) | 2004-08-25 | 2004-08-25 | Beautifying and climacteric syndrome treating composition, its preparing process and usage |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100568463A CN1277574C (en) | 2004-08-25 | 2004-08-25 | Beautifying and climacteric syndrome treating composition, its preparing process and usage |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1602937A CN1602937A (en) | 2005-04-06 |
| CN1277574C true CN1277574C (en) | 2006-10-04 |
Family
ID=34666210
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100568463A Expired - Fee Related CN1277574C (en) | 2004-08-25 | 2004-08-25 | Beautifying and climacteric syndrome treating composition, its preparing process and usage |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1277574C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038972B (en) * | 2010-11-27 | 2013-08-07 | 大连大学 | Method for preparing gel-type natural indoor aromatic |
| CN104922388A (en) * | 2015-07-17 | 2015-09-23 | 孙根火 | Medicinal preparation for treating female climacteric syndromes |
-
2004
- 2004-08-25 CN CNB2004100568463A patent/CN1277574C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1602937A (en) | 2005-04-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1209128C (en) | Traditional Chinese medicine composition with function of treating dysmenorrhea and beautifying | |
| CN1857642A (en) | Quality control method for depression relieving and tranquilizing preparation | |
| CN1840166A (en) | Modern Chinese medicinal oral liquid of 'Wen Dan Tang' and preparation method thereof | |
| CN1947739A (en) | Traditional Chinese medicine composition for treating dermal titillation and chronic eczema and its prepn. method | |
| CN1233387C (en) | Chinese compound medicine for treating anhypnosis and its preparation metod | |
| CN1872235A (en) | Muskiness acesodyne ointment of chasing wind, and preparation method | |
| CN1446577A (en) | Medicine combination for treating child fastidium | |
| CN1883638A (en) | Compound medicine for treating depression and method for preparing same | |
| CN1239183C (en) | A pharmaceutical composition made from Chinese traditional medicine and preparation method thereof | |
| CN1277574C (en) | Beautifying and climacteric syndrome treating composition, its preparing process and usage | |
| CN1248718C (en) | Medicinal composition for treating mycoplasma pneumonia and preparation method and quality-control method | |
| CN1559495A (en) | Deer's fetus granular Chinese madicinal preparation and its production technology | |
| CN100337655C (en) | Medicine preparation for preventing and treating allergic rhinitis and compliance rhinitis | |
| CN101036722A (en) | Health-caring food for easing and improving climacteric Syndrome of men and the preparation thereof | |
| CN1899560A (en) | Compound preparation for treating summer wet type cold and its preparing method | |
| CN101073655A (en) | Chinese medicine for treating pityriasis roasea, psoriasis and drug eruption | |
| CN1562113A (en) | Medicine for treating chronic pelvic inflammation and its preparing method | |
| CN1857495A (en) | Compound chinese preparation for treating pain symptom and its preparing process | |
| CN1270762C (en) | Cough stopping and asthma relieving medicine and its preparation | |
| CN1990022A (en) | Traditional Chinese medicine composition, its preparation and quality controlling means | |
| CN1650903A (en) | Method of extracting roice clearing medicament from effective component in natural plant Chinese medicine | |
| CN1222305C (en) | Chinese medicine for treating liver-kidney insufficiency, qi and yin vacuity and its preparation method | |
| CN1650895A (en) | Method of extracting medicamout having memory strengthening function from natural plant compound preparation | |
| CN1742845A (en) | Medicine for treating rheumatism and rheumatoid diseases and preparing method | |
| CN1235841C (en) | Method for preparing extract of peanut leaf |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C57 | Notification of unclear or unknown address | ||
| DD01 | Delivery of document by public notice |
Addressee: Ji Wen Document name: Notification to Pay the Fees |
|
| DD01 | Delivery of document by public notice |
Addressee: Ji Wen Document name: Notification of Termination of Patent Right |
|
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20061004 Termination date: 20090925 |