Liuwei Dihuang Pills, a Chinese patent medicine. It is composed of cooked rehmannia root, wine-soaked cornus fruit, Chinese yam, peony bark, Poria cocos, and oriental water plantain. It has the effect of nourishing yin and tonifying the kidney. It is used for kidney yin deficiency, dizziness, tinnitus, soreness of waist and knees, bone steaming, hot flashes, night sweats, and spermatorrhea.
Element
Rehmannia root, cornus fruit with wine, yam, peony bark, poria, and oriental water plantain.
Characteristics
This product is brown-black water pills, water-honey pills, brown to dark brown small honey pills or large honey pills; it tastes sweet and sour.
Main Benefits
Nourishes yin and tonifies kidney.
Indications
This product is used for kidney yin deficiency, dizziness, tinnitus, soreness of waist and knees, bone steaming, hot flashes, night sweats and spermatorrhea.
Clinical Application and Guidelines
1. Ma Huanqing conducted a study on the effect of Liuwei Dihuang Pills in the treatment of diabetes and concluded that Liuwei Dihuang Pills in the treatment of diabetes is effective, can quickly lower blood sugar levels, and is relatively safe. (Northern Pharmacy, 2019(03):131-132.)
2. Shi Jingyan conducted a clinical study on the treatment of diabetes with Liuwei Dihuang Pills and concluded that Liuwei Dihuang Pills have a definite clinical effect in the treatment of diabetes, can effectively control the patient’s condition, correct blood sugar and insulin indicators, and have no obvious adverse reactions. It is safe and reliable. (Guangming Chinese Medicine, 2019, 34(04):580-582.)
3. Gong Zhuyun conducted a clinical study on the treatment of irregular menstruation with Liuwei Dihuang Pills and concluded that Liuwei Dihuang Pills can help patients with irregular menstruation improve their condition quickly, with good therapeutic effects, and is worthy of promotion and application. (Journal of Clinical Traditional Chinese Medicine, 2018, 30(08):1517-1519.)
Specification
Each bag of water pills contains 5g; each bag of water-honey pills contains 6g; each bottle of small honey pills contains 120g; each large honey pill weighs 9g.
Dosage
Oral administration: 5g water pills at a time, 6g water honey pills at a time, 9g small honey pills at a time, 1 large honey pill at a time, twice a day.
Adverse Reactions
Monitoring data show that there are reports of adverse reactions to Liuwei Dihuang preparations, including diarrhea, abdominal pain, abdominal distension, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations, and allergies.
Taboo
It is contraindicated for those who are allergic to this product and its ingredients.
Precautions
1. Avoid spicy and indigestible foods.
2. People with severe chronic diseases such as hypertension, heart disease, liver disease, diabetes, kidney disease, etc. should take the medicine under the guidance of a physician.
3. Patients with cold and fever should not take it.
4. Children, pregnant women and breastfeeding women should take the medicine under the guidance of a physician.
5. If symptoms are not relieved after taking the medicine for 4 weeks, you should go to the hospital for treatment.
6. People who are allergic to this product are forbidden to use it, and those with allergic constitution should use it with caution.
7. It is forbidden to use this product when its properties change.
8. Children must use this product under adult supervision.
9. Please keep this product out of reach of children.
10. If you are using other medicines, please consult your physician or pharmacist before using this product.
Drug interactions
Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.
Storage method
seal.
Validity
60 months
Implementation Standards
Chinese Pharmacopoeia 2015 Edition.
Identification
1. Take this product and observe it under a microscope: the starch granules are triangular, oval or rectangular, with a diameter of 24-40μm, and the umbilicus is short, slit-shaped or herringbone-shaped (Chinese yam). The irregular branched masses are colorless and dissolve in chloral hydrate test solution; the hyphae are colorless, with a diameter of 4-6μm (Poria). The thin wall tissue is gray-brown to black-brown, and the cells are mostly wrinkled, containing brown nuclei (Rehmannia glutinosa). Calcium oxalate clusters exist in colorless thin-walled cells, sometimes several of them are arranged in rows (Paeonia suffruticosa). The epidermal cells of the fruit peel are orange-yellow, polygonal in surface view, and the anticlinal wall is beaded and thickened (Cornus glutinosus). The thin-walled cells are round, with elliptical pits and integrated pit groups; the anticlinal wall of the endodermal cells is wavy, thick, lignified, and has sparse fine pores (Alismatis orientalis).
2. Take 3g of water pills and 4g of honey pills of this product, grind them into fine powder; or take 6g of small honey pills or large honey pills, cut them into pieces. Add 25ml of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 20ml of water to the residue to dissolve it, shake and extract with a mixed solution of n-butanol-ethyl acetate (1:1) twice, 20ml each time, combine the extracts, wash with 20ml of ammonia solution (1→10), discard the ammonia solution, evaporate the n-butanol solution to dryness, and add 1ml of methanol to the residue to dissolve it as the test solution. Take the morroniside reference substance and loganin reference substance separately, add methanol to make a mixed solution containing 2mg of each per 1ml, as the reference substance solution. According to the thin layer chromatography method (General Rule 0502), 5μl of the test solution and 2μl of the reference solution are respectively spotted on the same silica gel G thin layer plate, and chloroform-methanol (3:1) is used as the developing solvent. After development, the plate is taken out, dried, sprayed with 10% sulfuric acid ethanol solution, heated at 105°C until the spots are clearly colored, and examined under ultraviolet light (365nm). In the chromatogram of the test sample, a fluorescent spot of the same color appears at the corresponding position of the chromatogram of the reference.
3. Take 4.5g of water pills and 6g of honey pills of this product, grind them finely; or take 9g of small honey pills or large honey pills, cut them into pieces, add 4g of diatomaceous earth, and grind them evenly. Add 40ml of ether, reflux for 1 hour, filter, evaporate the ether from the filtrate, add 1ml of acetone to the residue to dissolve it, and use it as the test solution. Take another paeonol reference substance, add acetone to make a solution containing 1mg per 1ml, and use it as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions, spot them on the same silica gel G thin layer plate, use cyclohexane-ethyl acetate (3:1) as the developing agent, develop, take out, dry, spray with hydrochloric acid acid 5% ferric chloride ethanol solution, and heat until the spots are clearly colored. In the chromatogram of the test product, spots of the same color appear at the corresponding position of the chromatogram of the reference substance.
4. Take 4.5g of this product’s water pills and 6g of water honey pills, grind them finely; or take 9g of small honey pills or large honey pills, cut them into pieces, add 4g of diatomaceous earth, and grind them evenly. Add 40ml of ethyl acetate, heat and reflux for 20 minutes, cool, filter, and concentrate the filtrate to about 0.5ml as the test solution. Take 0.5g of the control medicinal material of Alisma orientalis, add 40ml of ethyl acetate, and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 5-10μl of each of the above two solutions, spot them on the same silica gel G thin layer plate, use chloroform-ethyl acetate-formic acid (12:7:1) as the developing agent, develop, take out, dry, spray with 10% sulfuric acid ethanol solution, and heat at 105℃ until the spots are clearly colored. In the chromatogram of the test product, spots of the same color appear at the corresponding positions of the chromatogram of the control medicinal material.
examine
It should comply with the relevant provisions under pills (General Rule 0108).
Content determination
Determined according to high performance liquid chromatography (General Rule 0512).
1. Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; acetonitrile is used as mobile phase A, 0.3% phosphoric acid solution is used as mobile phase B, and gradient elution is performed according to the provisions in the following table; the detection wavelength for morroniside and loganin is 240nm, and the detection wavelength for paeonol is 274nm; the column temperature is 40℃. The number of theoretical plates calculated based on the peaks of morroniside and loganin should not be less than 4000.
Time (min) Mobile phase A (%) Mobile phase B (%)
0-55→895→92
5-20892
20-358→2092→80
35-4520→6080→40
45-5560→840
2. Preparation of reference solution: Take appropriate amount of morroniside reference, loganin reference and paeonol reference, weigh accurately, add 50% methanol to make a mixed solution containing 20 μg of morroniside and loganin each and 45 μg of paeonol per 1 ml.
3. Preparation of test solution: Take water pills, grind them into powder, take about 0.5g, or take water honey pills, grind them into powder, take about 0.7g, weigh accurately; or take small honey pills or large honey pills under the weight difference item, cut them into pieces, take about 1g, weigh accurately. Place in a stoppered conical bottle, accurately add 25ml of 50% methanol, stopper, weigh the weight, heat and reflux for 1 hour, cool, weigh again, make up the lost weight with 50% methanol, shake well, filter, and take the filtrate to obtain.
4. Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.
5. The content of cornus officinalis in this product, calculated as the total amount of morroniside (C 17 H 26 O 11 ) and loganin (C 17 H 26 O 10 ), shall not be less than 0.9 mg per 1g of water pills; shall not be less than 0.75 mg per 1g of water-honey pills; shall not be less than 0.50 mg per 1g of small honey pills; and shall not be less than 4.5 mg per large honey pills. The content of peony bark, calculated as paeonol (C 9 H 10 O 3 ), shall not be less than 1.3 mg per 1g of water pills; shall not be less than 1.05 mg per 1g of water-honey pills; shall not be less than 0.70 mg per 1g of small honey pills; and shall not be less than 6.3 mg per large honey pills.