CN1323687C - Blood supplementing iron supplementing medicineal preparation and its preparation method - Google Patents
Blood supplementing iron supplementing medicineal preparation and its preparation method Download PDFInfo
- Publication number
- CN1323687C CN1323687C CNB2005101011786A CN200510101178A CN1323687C CN 1323687 C CN1323687 C CN 1323687C CN B2005101011786 A CNB2005101011786 A CN B2005101011786A CN 200510101178 A CN200510101178 A CN 200510101178A CN 1323687 C CN1323687 C CN 1323687C
- Authority
- CN
- China
- Prior art keywords
- treatment
- preparation
- fine powder
- iron
- blood
- 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.)
- Active
Links
Landscapes
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a medicinal preparation of iron-deficiency anemia, which discloses a medicinal preparation prepared by using Chinese herbal medicines as principal raw materials. The present invention contains the following raw materials of (by weight portion) 149 to 224 of suberect spatholobus, 91 to 136 of milkvetch root, 25 to 38 of fructus, 29 to 44 of largehead atractylodes rhizome, 18 to 27 of angelica, 8 to 12 of dried tangerine peel and 23 to 34 of ferralia. The present invention also discloses a preparation method of the medicinal preparation. The medicinal preparation of the present invention has the efficiency of blood replenishment, qi benefiting, spleen strengthening and stomach warming, and is used for iron-deficiency anemia caused by alimentary tract hemorrhage, bleeding from hemorrhoids, profuse menstruation, pregnancy, monophagia, etc. In addition, the present invention has the advantages of little side effect and slight symptoms of adverse reaction.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation for the treatment of iron deficiency anemia, being specifically related to a kind of is the pharmaceutical preparation that primary raw material is prepared from the Chinese herbal medicine.The invention still further relates to the preparation method of this medicine.
Background technology
Iron deficiency anemia shows as shallow complexion, cardiopalmus, weak, dizzy, tinnitus, indigestion and loss of appetite etc., belongs to the traditional Chinese medical science " sallow ", " asthenia " category.Medicine has chalybeate as the ferrous sulfate tablet of the 726th page of record of 2005 editions pharmacopeia II portions etc., but untoward reaction such as that oral ferrous sulfate has is nauseating, abdominal distention, digestive tract hemorrhage, constipation, diarrhoea." points for attention " under " ferrous sulfate " item that " Chinese medicine complete works " (Western medicine volume) is the 165th page are indicated: " this product can cause GI irritation reaction symptom (as stomachache, diarrhoea etc.), and one after each meal can reduce its untoward reaction.Stool can be black, but takes chronic poisoning for a long time, the careful usefulness of ulcer patient." open in the 171st page of " child blood generating syrup treatment iron deficiency anemia 50 routine observation of curative effect " literary composition of " modern combination of Chinese and Western medicine magazine " (in January, 2005,14[2]): " and the untoward reaction ratio is respectively after taking the ferrous sulfate electuary: loss of appetite 72%, feel sick 62%, vomiting 32%, diarrhoea 48%, refusal take medicine 40%." all there is malabsorption in various degree when having the patient of digestive tract disease to state oral drugs in the use, even can't adhere to taking medicine, thereby affect the treatment.Side effect such as anaphylaxis, myalgia are arranged during the intramuscular injection chalybeate.Therefore, people are to better efficacy, and still there is demand in the medicine of the blood-nourishing and iron-replenishing that side effect is lower.
Summary of the invention
The objective of the invention is at the problems referred to above, providing a kind of is the pharmaceutical preparation that primary raw material is prepared from the Chinese herbal medicine, to solve the deficiencies in the prior art part.
Other purpose of the present invention has provided the preparation method of this pharmaceutical preparation.
The prescription main component of said preparation is the Radix Astragali, Radix Angelicae Sinensis, Caulis Spatholobi, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Fructus Jujubae, chalybeate.Studies confirm that the Radix Astragali, Radix Angelicae Sinensis have certain effect to hemopoietic function, Caulis Spatholobi has the blood-supplementing blood-nourishing effect, Rhizoma Atractylodis Macrocephalae qi-supplementing, blood-engendering, but share qi and blood tonifying with the Radix Astragali, Fructus Jujubae is rich in vitamin A, B etc., can improve the metabolism of the nutriture and the ferrum of ferrum.And the Rhizoma Atractylodis Macrocephalae still can strengthening the spleen and stomach, and Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen fortune stomach is so oral back side effect will be little and good effect.Add chalybeate such as Melanteritum, ferrous sulfate etc. in the prescription and replenish ferrum element fast, the rising hemoglobin is improved Anemia.Chinese medicine in prescription plays integrally-regulated effect, vigorate qi and replenish the blood, strengthening the spleen and stomach.Chalybeate content is lower than chalybeate in the folk prescription in the compound recipe, untoward reaction, few side effects.
Each amounts of components of pharmaceutical preparation of the present invention all has better curative effect in the following weight parts scope:
Caulis Spatholobi 149-224 Radix Astragali 91-136 Fructus Jujubae 25-38
Rhizoma Atractylodis Macrocephalae 29-44 Radix Angelicae Sinensis 18-27 Pericarpium Citri Reticulatae 8-12
Chalybeate 23-34.
Be preferably:
Caulis Spatholobi 186.5 Radixs Astragali 113.5 Fructus Jujubaes 31.5
The Rhizoma Atractylodis Macrocephalae 36.5 Radix Angelicae Sinensis 22.5 Pericarpium Citri Reticulataes 10
Chalybeate 28.5.
Above-mentioned chalybeate is preferably the combination of any or both in Melanteritum, the ferrous sulfate.
Above-mentioned medicament is the peroral dosage form on any pharmaceutics.
Medicament mixed powder of the present invention can add the required various conventional adjuvant of preparation different dosage form, be prepared into any oral Pharmaceutical dosage forms commonly used as disintegrating agent, lubricant, bonding agent etc. with the method for Chinese medicinal of routine, as capsule, pill, tablet, granule, drop pill, soft capsule, powder, unguentum, oral liquid etc., be preferably capsule.
The preparation method of said medicine preparation comprises following steps:
1) Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, the Pericarpium Citri Reticulatae with proportional quantity is ground into coarse powder, gets coarse powder one;
2) chalybeate with proportional quantity is ground into fine powder, gets fine powder one;
3) Caulis Spatholobi with proportional quantity decocts with water, and filters, and filtrate is condensed into thick paste, and drying is ground into fine powder two;
4) Radix Astragali, the Fructus Jujubae with proportional quantity decocts with water filtration, and filtrate is condensed into thick paste, adds coarse powder one, mixing, drying, is ground into fine powder, fine powder three;
5) fine powder three adds fine powder two and fine powder one mixing, preparation cost invention medicament mixed powder.
Chalybeate is preferably Melanteritum and/or ferrous sulfate in the above-mentioned preparation method.
Above-mentioned 3) Caulis Spatholobi decocts with water secondary in the step, 3～5 hours for the first time, 1～3 hour for the second time.
Above-mentioned 4) Fructus Jujubae decocts with water secondary in the step, each 1～3 hour.
Above-mentioned 3) Caulis Spatholobi decocts with water secondary in the step, is preferably 4 hours first time, 2 hours for the second time.
Above-mentioned 4) Fructus Jujubae decocts with water secondary in the step, preferred each 2 hours.
In 306 routine clinical trials, untoward reaction case 9 examples appear, and incidence rate is 2.94%, mainly shows as symptoms of digestive tract such as nauseating, slight abdominal pain diarrhea, and symptom is slight, and the persistent period is short, does not deal with, and can die away.Do not see liver function, renal dysfunction reaction.
The present invention has the effect of blood yiqi, invigorating the spleen and regulating the stomach, is used for the iron deficiency anemia due to the reasons such as digestive tract hemorrhage, bleeding hemorrhoids, menorrhagia, gestation, monophagia.Clinical research shows, pharmaceutical preparation of the present invention can improve indexs such as patient blood hemoglobin, erythrocyte number, serum levels of iron, serum ferritin, improves obviously that the anemia patient nervous breathes hard, loss of appetite, spiritlessness and sparing of words, body are tired, spontaneous perspiration, disease sign such as dizzy.Along with the increase of the course of treatment, this effect is more obvious.And few side effects, the untoward reaction symptom is slight.
The specific embodiment
Embodiment 1:
Radix Angelicae Sinensis 2.25kg, Rhizoma Atractylodis Macrocephalae 3.65kg, Pericarpium Citri Reticulatae 1kg are ground into coarse powder 6.76kg; Ferrous sulfate 2.85kg is ground into fine powder 2.79kg; Caulis Spatholobi 18.6kg decocts with water twice, adds 8 times of amounts of water for the first time, decocts 4 hours, adds 6 times of amounts of water for the second time, decocts 2 hours, filters, and merging filtrate is condensed into thick paste, and drying is ground into fine powder 0.93kg; Radix Astragali 11.35kg, Fructus Jujubae 3.15kg decoct with water secondary, add 8 times of amounts of water at every turn, and each 2 hours, filter, merging filtrate is condensed into thick paste 2.32kg, adds above Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae three flavor coarse powder 6.76kg, mixing, drying, is ground into fine powder 8.63kg; Add Caulis Spatholobi dried cream fine powder 0.93kg and ferrous sulfate fine powder 2.79kg mixing, make medicament mixed powder 11.73kg.
Embodiment 2:
Change the ferrous sulfate 2.85kg among the embodiment 1 into Melanteritum 2.85kg and feed intake, other steps are with embodiment 1.
Embodiment 3:
Radix Angelicae Sinensis 2.25kg, Rhizoma Atractylodis Macrocephalae 3.63kg, Pericarpium Citri Reticulatae 1kg are ground into coarse powder 6.4kg; Ferrous sulfate 2.88kg is ground into fine powder 2.60kg; Caulis Spatholobi 28kg decocts with water, and filters, and filtrate is condensed into thick paste, and drying is ground into fine powder 1.68kg; Radix Astragali 17kg, Fructus Jujubae 4.75kg decoct with water filtration, and filtrate is condensed into thick paste 3.0kg, add above Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae three flavor coarse powder 6.4kg, mixing, drying, are ground into fine powder 8.93kg; Add Caulis Spatholobi dried cream fine powder 1.68kg and ferrous sulfate fine powder 2.6kg mixing, make medicament mixed powder 12.55kg.
Embodiment 4:
Radix Angelicae Sinensis 2.25kg, Rhizoma Atractylodis Macrocephalae 3.67kg, Pericarpium Citri Reticulatae 1kg are ground into coarse powder 6.57kg; Ferrous sulfate 2.83kg is ground into fine powder 2.55kg; Caulis Spatholobi 12.42kg decocts with water, and filters, and filtrate is condensed into thick paste, and drying is ground into fine powder 0.62kg; Radix Astragali 7.58kg, Fructus Jujubae 2.08kg decoct with water filtration, and filtrate is condensed into thick paste 1.16kg, add above Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae three flavor coarse powder 6.57kg, mixing, drying, are ground into fine powder 7.34kg; Add Caulis Spatholobi dried cream fine powder 0.62kg and ferrous sulfate fine powder 2.55kg mixing, make medicament mixed powder 10kg.
Embodiment 5:
Get the mixed powder 250g among the embodiment 1, add magnesium stearate 2.5g, mixing incapsulates, and makes 1000, and every dress 0.25g is oral, one time 2,3 times on the one.
Embodiment 6:
Get mixed powder 7.15kg among the embodiment 1, use refined honey 2.85kg, add the suitable quantity of water pill, drying is made water-honeyed pill 10kg, the heavy 0.07g of every ball.Oral, each 0.7g (about 10 balls), every day 3 times.
Embodiment 7:
Get the mixed powder 250g among the embodiment 2, add magnesium stearate 2.5g, mixing incapsulates, and makes 1000, and every dress 0.25g is oral, one time 2,3 times on the one.
Embodiment 8:
Get the mixed powder 250g among the embodiment 3, add magnesium stearate 2.5g, mixing incapsulates, and makes 1000, and every dress 0.25g is oral, one time 2,3 times on the one.
Embodiment 9:
Get the mixed powder 250g among the embodiment 4, add magnesium stearate 2.5g, mixing incapsulates, and makes 1000, and every dress 0.25g is oral, one time 2,3 times on the one.
Implement 10:
Get Radix Angelicae Sinensis 22.5g, Rhizoma Atractylodis Macrocephalae 36.5g, Pericarpium Citri Reticulatae 1g, ferrous sulfate 28.5g is ground into fine powder; Caulis Spatholobi 186.5g, Radix Astragali 113.5g, Fructus Jujubae 31.5g decocts with water twice, filters, and filtrate is condensed into thick paste (relative density 1.25); Get Icing Sugar 1125g, with above-mentioned Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, ferrous sulfate fine powder mix homogeneously, add above-mentioned Caulis Spatholobi, the Radix Astragali, the stirring of Fructus Jujubae thick paste again, granulate, packing is made 250 bags, and every bag of 5g is oral, and each 1 bag, every day 3 times.
Below with evidence the present invention such as hematology's contrast tests before and after curative effect statistics and the treatment.
1, test method: tried case 306 examples, finish jointly by 4 tame hospitals such as the attached Zhujiang Hospital of Nanfang Medical Univ, Wuhan Union Hospital, Guangzhou No.2 People's Hospital, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Med.Be set at for 6 weeks the course of treatment, respectively at following up a case by regular visits in 0 week, 3 weeks, 6 weeks.
2. case is selected: " new Chinese medicine clinical research guideline " with reference to the Ministry of Public Health promulgation drafted.
2.1 iron deficiency anemia diagnostic criteria
2.1.1 anemia diagnostic criteria
Adult male Hb＜120g/L, adult female Hb＜105g/L;
Clinical manifestation: shallow complexion or pale be main, often breathe hard physical fatigue and lassitude of spirit etc. with nervous.
2.1.2 iron deficiency anemia diagnostic criteria
(1) the iron deficiency medical history is arranged, chronic blood loss (as Peptic Ulcers, hemorrhoid, menorrhagia etc.) need the ferrum amount to increase and intake deficiency (as fecund, suckling etc.), or chalybeate absorbs medical histories such as obstacle.
(2) serum ferritin＜14ug/L
(3) serum levels of iron 9umol/L
(4) total iron binding capacity＞64.44umol/L
(5) transferrins saturation＜0.15
(6) the former fore-telling quinoline of free erythrocyte is measured (FEP)＞0.9umol/L
(7) bone marrow iron stain shows that the bone marrow granule can dye ferrum and disappear sideroblast＜15%
(8) microcytic hypochromic anemia (MCV＜80fl, MCH＜26pg, MCHC＜0.30)
(9) the chalybeate treatment has significant curative effect
Possess (2)～2 above persons are diagnosable in (7) is iron deficiency, iron deficiency adds that anemia person is diagnosable and is ischemia anemi.(1), (8) are must inspection item in the above-mentioned iron deficiency anemia diagnostic criteria.
2.2 anemia severity (hemoglobin standard) classification
Slightly: Hb man 91-120g/L woman 81-105g/L
Moderate: Hb man 61-90g/L woman 61-80g/L
Severe: Hb man 31-60g/L woman 41-60g/L
Extreme severe: Hb man＜31g/L woman＜41g/L
2.3 Chinese medical discrimination standard
2.3.1 syndrome of deficiency of blood
(1) Mian Se Koushi is white or sallow;
(2) dizzy, dizzy (rising dim immediately at the moment);
(3) lip, pale tongue;
(4) thready pulse;
Possess above-mentioned wherein three persons, diagnosable is syndrome of deficiency of blood.
2.3.2 syndrome of deficiency of QI
(1) spiritlessness and weakness;
(2) the lazy speech of few speech;
(3) spontaneous perspiration;
(4) enlarged tongue or tooth seal is arranged;
(5) deficient pulse unable (weak, soft, moisten etc.)
Possess above-mentioned wherein three persons, diagnosable is syndrome of deficiency of QI.Assertive evidence and syndrome of deficiency of blood exist for deficiency of both QI and blood simultaneously.
2.4 the test case is included standard in:
(1) meets the dialectical standard person of traditional Chinese medical science syndrome of deficiency of blood or deficiency of both QI and blood.
(2) meet doctor trained in Western medicine iron deficiency anemia person.
(3) every necessary inspection of voluntary accepting is ready to add this experimenter.
(4) age is 18～65 years old.
2.5 test case exclusion standard (comprising inadaptation or rejecting standard):
(1) age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution and to this medicine allergy sufferers.
(2) suffers from Anemia and the iron-free deficient patients.
(3) do not meet the Patients with iron deficiency anemia that Chinese medical discrimination is syndrome of deficiency of blood or deficiency of both QI and blood.
(4) merge cardiovascular, cerebrovascular, liver, kidney and other serious primary diseases of hemopoietic system, psychotic.
(5) anemia due to the primary disease not control as yet, continuous bleeding.
(6) extreme severe iron deficiency anemia person, the anemia that the cachexia companion sees.
Accepted treatment of blood transfusion or accepted the chalybeate therapist in 1 month in (7) 2 weeks.
(8) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is incomplete, and particularly lab testing does not have treatment cross-reference etc. and affects the treatment or safety judgement person.
3 therapeutic processes
Medicament capsule of the present invention is pressed the preparation of embodiment 5 preparation methoies and is got, for clinical trial.
Oral, each 2, every day 3 times.3 weeks were 1 course of treatment, took for 6 weeks continuously.
The regulation of 4 drug combinations
Duration of test is prohibited and is added with all Pharmaceuticalss identical with trial drug effectiveness.
5 therapeutic evaluation index and methods
5.1 hematological examination: hemoglobin, RBC number, hematid specific volume, microcytic hypochromic anemia (MCV, MCH, MCHC), serum levels of iron, serum ferritin, total iron binding capacity, transferrins saturation.
5.2 tcm symptom and sign: nervous breathe hard, loss of appetite, spiritlessness and sparing of words, tired, the spontaneous perspiration, dizzy of body.
Tcm symptom quantizes hierarchical table (seeing Table 1).
Table 1 related symptoms quantizes hierarchical table
| Symptom | Gently (+) | In (++) | Heavy (+++) |
| The tired spontaneous perspiration of palpitation and short breath anorexia spiritlessness and sparing of words body is dizzy | Step on that appetite to occur behind building or the heavy physical labour poor, appetite does not subtract lassitude, it is easily tired not like polylogia, can adhere to the little tide of the motionless then skin of light physical labor, moving slightly then appearance more very once in a while | No appetite appears after walking along the street or the general physical exertion; appetite minimizing 1/2 is tired with interior spirit; drowsiness lazy speech asthenia more very; supporting daily routines motionless reluctantly is the little tide of skin; sweating while acting often occurs slightly, and movable back obviously | No appetite appears during tranquillization; appetite reduces more than 1/2 spiritual extremely tired; idol speech myasthenia of limbs; can not adhere to that daily routines are sweating usually; sweating while acting; frequent as water stain shape, also send out during tranquillization |
Annotate: normal person represents with (-).
6 safeties are observed:
(1) general health check-up project;
(2) blood, urine, just conventional;
(3) liver function (ALT, AST); Renal function (BUN, Cr);
(4) electrocardiogram;
(5) untoward reaction that may occur: as dizziness, erythra, feel sick, diarrhoea, stomachache etc.
7 curative effect judging standards:
Efficacy evaluation grade: clinical cure, produce effects, effective, invalid.
Clinical cure: (1) clinical symptom disappearance;
(2) male Hb＞120g/L, adult female Hb＞105g/L;
(3) male RBC＞4.0 * 10
12/ L, women RBC＞3.5 * 10
12/ L;
(4) serum levels of iron, serum ferritin, total iron binding capacity etc. recover normal.
Produce effects: (1) clinical symptoms is clearly better, and severity of anemia improves person more than 2 grades;
(2) more than the hemoglobin rising 25g/L;
(3) serum levels of iron, serum ferritin, total iron binding capacity etc. are near normal level.
Effectively: (1) clinical symptoms takes a turn for the better, and severity of anemia improves person more than 1 grade;
(2) more than the hemoglobin rising 10g/L.
Invalid: clinical symptoms and the classification of the anemia order of severity do not have improvement, or below the hemoglobin ascensional range 10g/L.
8 statistical procedures
Utilization SPSS10.0 statistical software carries out statistical procedures.(1), with before the treatment of every index, 3 week of treatment back, 3 assembly after 6 weeks of treatment match T check (Paired-samples T Test) respectively to the measurement data value; (2), whole patients are divided into syndrome of deficiency of blood group and deficiency of both QI and blood group, the non parametric tests (Two-Independent Samples Tests) of carrying out grade/frequency table data two groups of curative effect differences relatively.(3), the curative effect of different severity of anemia of patient or tcm symptom is made the sum of ranks or the X of grade/frequency table data
2Check.
Result of the test
1. tried analysis of cases:
306 routine patient ages all between 18～65 years old, male patient's 118 examples wherein, female patient 188 examples, M-F is 59: 94; The age minimum is 18 years old, is 65 years old to the maximum, and the mean age is 44.98 years old; The course of disease is the shortest to be January, and the longest is 120 months, average out to 5.2 months.
Seen Table 2 1.1 try the distribution of case protopathy.
Table 1 protopathy distribution situation
| Sequence number | The protopathy title | The example number | Remarks |
| 1 2 3 4 5 6 7 8 9 10 11 12 | Peptic ulcer chronic gastritis gastrointestinal dysfunction colitis UGB hemorrhoid functional uterine bleeding menopausal syndrome is because of other total of lactation fibroid | 82 20 12 16 19 55 67 5 7 7 16 306 | (comprising chronic nephritis, rheumatoid arthritis, cervical spondylosis etc.) |
1.2 tried severity of anemia situation in the case: slight 173 examples, moderate 104 examples, severe 27 examples, utmost point severe 2 examples.
1.3 tried Chinese medical discrimination typing in the case: syndrome of deficiency of blood person 135 examples, deficiency of both QI and blood person 171 examples.
2. health giving quality is observed
2.1 curative effect statistics
Among the 306 routine patients, clinical cure 87 examples account for 28.43%; Produce effects 101 examples account for 33.00%; Effective 86 examples account for 28.10%; Invalid 32 examples account for 10.46%.Total effective rate 89.54%.
1. by the protopathy branch, its iron deficiency anemia curative effect statistics sees Table 3.
Table 3 iron deficiency anemia (by the protopathy classification) curative effect statistics
| Sequence number | Name of disease | Total routine number | Clinical efficacy | |||||||
| Clinical cure | Produce effects | Effectively | Invalid | |||||||
| The example number | ％ | The example number | ％ | The example number | ％ | The example number | ％ | |||
| 1 2 3 4 5 6 7 8 9 10 11 12 | Other total of peptic ulcer chronic gastritis gastrointestinal dysfunction colitis UGB hemorrhoid functional uterine bleeding menopausal syndrome lactation fibroid | 82 20 12 16 19 55 67 5 7 7 16 306 | 28 2 2 2 4 21 22 1 3 2 0 87 | 34.15 10.00 16.67 12.50 21.25 38.18 32.84 20.00 42.86 28.57 0 28.43 | 24 11 0 2 10 23 24 0 3 3 1 101 | 29.27 55.00 0 12.50 52.63 41.82 35.82 0 42.86 42.86 6.25 33.00 | 24 5 7 9 4 11 18 2 1 1 4 86 | 29.27 25.00 58.33 56.25 21.25 20.00 26.87 40.00 14.29 14.29 25.00 28.10 | 6 2 3 3 1 0 3 2 0 1 11 32 | 7.32 10.00 25.00 18.75 5.26 0 4.48 40.00 0 14.29 68.75 10.46 |
2. press the severity of anemia branch, its iron deficiency anemia curative effect statistics sees Table 4.
Table 4 iron deficiency anemia (pressing the severity of anemia branch) curative effect statistics
| Sequence number | Severity of anemia | Total routine number | Clinical efficacy | |||||||
| Clinical cure | Produce effects | Effectively | Invalid | |||||||
| The example number | ％ | The example number | ％ | The example number | ％ | The example number | ％ | |||
| 1 2 3 4 5 | Anemia anemia anemia utmost point anemia adds up to | 173 104 27 2 306 | 58 28 1 0 87 | 33.53 26.92 3.70 0 30.07 | 47 42 10 2 101 | 27.17 40.38 37.04 100 33.01 | 55 24 7 0 86 | 31.79 23.08 25.93 0 28.10 | 13 10 9 0 32 | 7.51 9.62 33.33 0 10.46 |
Curative effect between the different severity of anemia has been compared significant difference (P＜0.001), and the curative effect of anemia group obviously is better than other two groups, sees Table 4.
3. press the Chinese medical discrimination typing, its iron deficiency anemia curative effect statistics sees Table 5.
Table 5 iron deficiency anemia (pressing the Chinese medical discrimination typing) curative effect statistics
| Sequence number | The Chinese medical discrimination typing | Total routine number | Clinical efficacy | |||||||
| Clinical cure | Produce effects | Effectively | Invalid | |||||||
| The example number | ％ | The example number | ％ | The example number | ％ | The example number | ％ | |||
| 1 2 3 | The syndrome of deficiency of blood deficiency of both QI and blood adds up to | 135 171 306 | 45 42 87 | 33.33 24.56 30.07 | 45 56 101 | 33.33 32.75 33.01 | 30 56 86 | 22.22 32.75 27.45 | 15 17 32 | 11.11 9.94 10.46 |
Syndrome of deficiency of blood is compared there was no significant difference (P＞0.05) with the deficiency of both QI and blood curative effect
2.2 hematological examination changes before and after the treatment: every observation index all has significant difference before and after the treatment, sees Table 6 and table 7.
2.2.1 blood routine examination (see Table 6, table 7)
The comparison of phase blood routine examination minimum and peak before, during and after table 6 treatment
| Project | Before the treatment | Treatment 3 weeks of back ★ | Treatment 6 weeks of back ▲ | |||
| Minimum | Peak | Minimum | Peak | Minimum | Peak | |
| Hb(g/L) RBC(×10 12/L) HCT(％) MCV(fl) MCH(pg) MCHC(g/L) | 25 1.11 10.0 51.8 14.7 200 | 107 5.15 45.0 101.0 36.5 358 | 50 1.78 15.2 60.0 14.9 219 | 130 5.31 44.0 99.4 37.7 387 | 63 2.57 18.1 60.0 22.5 240 | 148 5.74 50.8 104.0 39.2 461 |
Blood routine examination variation before and after table 7 treatment (x ± s)
| Project | Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back |
| Hb(g/L) RBC(×10 12/L) HCT(％) MCV(fl) MCH(pg) MCHC(g/L) | 79.98± 16.09 3.08±0.56 31.57±9.04 76.01±9.37 24.95±3.51 298.48± 33.31 | 89.88±16.20 ★ 3.53±0.52 ★ 33.91±6.49 ★ 78.54±7.94 ★ 26.03±3.00 ★ 305.86±32.82 ★ | 102.83±21.18 ▲ 4.12±0.74 ▲ 37.40±5.23 ▲ 82.79±7.66 ▲ 27.61±2.93 ▲ 314.56±33.82 ▲ |
Annotate: relatively preceding with treatment
★P＜0.01; Compare with treatment 3 all backs
▲P＜0.01.
2.2.2 serum levels of iron, serum ferritin, total iron binding capacity, transferrins saturation (seeing Table 8)
The change of serum levels of iron, serum ferritin, total iron binding capacity, transferrins saturation before and after table 8 treatment (x ± s)
| Project | Before the treatment | Treatment 6 weeks of back |
| Serum levels of iron (umol/L) serum ferritin (ug/L) total iron binding capacity (umol/L) transferrins saturation (%) | 6.95±2.48 9.97±6.69 82.68±9.34 14.35±5.48 | 16.77±10.68 ★ 34.78±27.28 ★ 69.17±10.66 ★ 27.45±9.60 ★ |
Annotate: relatively preceding with treatment
★P＜0.01.
2.3 the variation before and after the tcm symptom treatment
Tcm symptom improves mainly to occur in treats the 3rd week and the 6th week of back, and various doing well,improvings are all than there were significant differences before the treatment.
2.3.1 nervous variation of breathing hard sees Table 9.
The variation of the nervous symptom of breathing hard before and after table 9 treatment
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 35 80 154 37 | 58 ▲ 155 ▲ 89 ▲ 4 ▲ | 194 ★ 84 ★ 27 ★ 1 ★ |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
Nervous having clear improvement in symptom 3 weeks after treatment of breathing hard, the 6th week improved more remarkable.Its mild or moderate, moderate patient's curative effect are better.
2.3.2 the variation of spiritlessness and sparing of words sees Table 10.
The variation of spiritlessness and sparing of words symptom before and after table 10 treatment
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 36 75 170 25 | 89 ▲ 131 ▲ 75 ▲ 11 ▲ | 196 ★ 81 ★ 23 ★ 6 ★ |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
The symptom of spiritlessness and sparing of words 3 weeks after treatment have clear improvement, and the 6th week improved more remarkable.Its mild or moderate, moderate patient's curative effect are better.
2.3.3 the variation that body is tired sees Table 11.
The variation of the tired symptom of table 11 treatment forebody-afterbody
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 24 83 179 20 | 65 ▲ 160 ▲ 71 ▲ 10 ▲ | 227 ★ 62 ★ 11 ★ 6 ★ |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
There is improvement in tired symptom 3 weeks after treatment of body, and the 6th week improved significantly.Its mild or moderate, moderate patient's curative effect are better.
2.3.4 dizzy variation sees Table 12.
The variation of dizzy symptom before and after table 12 treatment
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 29 78 170 29 | 64 ▲ 156 ▲ 78 ▲ 8 ▲ | 197 ★ 85 ★ 20 ★ 4 ★ |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
Dizzy symptom 3 weeks after treatment have clear improvement, and the 6th week improved more remarkable.Its mild or moderate, moderate patient's curative effect are better.
2.3.5 the variation of spontaneous perspiration sees Table 13.
The variation of spontaneous perspiration symptom before and after table 13 treatment
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 184 95 27 0 | 228 ▲ 66 ▲ 12 ▲ 0 | 269 ★ 37 ★ 0 ★ 0 |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
The symptom of spontaneous perspiration 6 weeks after treatment have clear improvement, and wherein moderate patient curative effect is better.
2.3.6 the variation of loss of appetite sees Table 14.
The variation of loss of appetite before and after table 14 treatment
| The curative effect classification | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal (-) slight (+) moderate (++) severe (+++) | 76 87 103 20 | 112 ▲ 102 ▲ 76 ▲ 16 ▲ | 199 ★ 82 ★ 21 ★ 4 ★ |
Annotate: with compare before the treatment
▲P＜0.05,
★P＜0.01.
The symptom of loss of appetite 3 weeks after treatment have clear improvement, and the 6th week improved more remarkable.Its mild or moderate, moderate patient's curative effect are better.
2.3.7 the variation of complexion sees Table 15.
The variation of complexion before and after table 15 treatment
| Complexion | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Normal pale sallow | 38 156 112 | 168 ▲ 43 ▲ 95 ▲ | 247 ★ 38 ★ 21 ★ |
Annotate: with ratio before the treatment
▲P＜0.05,
★P＜0.01,
Patient's complexion takes a turn for the better and also begins obviously during the 3rd week in treatment, and the 6th week is more obvious.
2.3.8 the variation of color of the lip sees Table 16.
The variation of color of the lip before and after table 16 treatment
| Complexion | Number changes | ||
| Before the treatment | Treatment 3 weeks of back | Treatment 6 weeks of back | |
| Ruddy light red light white | 44 151 111 | 134 ▲ 129 ▲ 43 ▲ | 199 ★ 94 ★ 13 ★ |
Annotate: with ratio before the treatment
▲P＜0.05,
★P＜0.01,
Patient's color of the lip takes a turn for the better and begins obviously during the 3rd week in treatment, further improves after the 6th week, but compares there was no significant difference (P=0.316) with the 3rd week.
2.3.9 the variation of pulse condition, picture of the tongue
Through treatment, most of patient's pulse condition is transferred to normal by thin, heavy or weak etc., and body of the tongue is ruddy, especially in the 6th all backs obviously.
2.3.10 skin, fingernail, lymph node, stomatitis change:
Skin, fingernail appear in part patient, lymph node changes or stomatitis, glossitis etc. take place, and all obtains improvement in various degree after the treatment.
3 safeties are observed
3.1 the hepatic and renal function inspection sees Table 17.
The variation of hepatic and renal function check result before and after table 17 treatment (x ± s)
| Project | Before the treatment | Treatment 6 weeks of back |
| ALT(U/L) AST(U/L) BUN(mmol/L) Cr(umol/L) | 25.15±7.43 26.54±8.75 5.80±1.01 82.92±20.36 | 24.95±6.54 25.89±7.85 6.24±4.88 82.45±17.35 |
Annotate: compare P＞0.05 before and after every index treatment.
As seen from the above table, treat front and back liver function, kidney function test there was no significant difference as a result.
In addition, 306 routine patients all find to play body and reach changing function unusually because of taking this guiding drug in general health check-up project, routine urinalysis, stool routine examination and Electrocardioscopy.
3.2 untoward reaction (clinical symptoms) is observed
Untoward reaction patient 9 examples occur, incidence rate is 2.94%.6 examples are slight abdominal pain diarrhea, and no nausea and vomiting symptom continues to die away without any processing after 2 days; Vomiting appears in 1 example feels sick, and only gives observation and does not deal with, and disappears after 1 day; 2 examples, the 2 week backs of taking medicine occur feeling sick and do not have vomiting, also give observation and do not deal with, after the not goodbye untoward reaction that continues to take medicine.
This clinical research shows, medicament capsule of the present invention can improve indexs such as patient blood hemoglobin, erythrocyte number, serum levels of iron, serum ferritin, improves obviously that the anemia patient nervous breathes hard, loss of appetite, spiritlessness and sparing of words, body are tired, spontaneous perspiration, disease sign such as dizzy.Along with the increase of the course of treatment, this effect is more obvious.
Untoward reaction patient 9 examples occur, mainly show as symptom of digestive tract, all give and observe and do not deal with or drug withdrawal, can die away.
Medicament capsule of the present invention treatment iron deficiency anemia total effective rate reaches 89.54%, and adverse reaction rate only 2.94% illustrate determined curative effect, and untoward reaction is little, worth clinical application.
Claims (7)
1, a kind of blood-nourishing and iron-replenishing pharmaceutical preparation is characterized in that making the raw materials of effective components medicine and consists of by weight:
Caulis Spatholobi 149-224 Radix Astragali 91-136 Fructus Jujubae 25-38
Rhizoma Atractylodis Macrocephalae 29-44 Radix Angelicae Sinensis 18-27 Pericarpium Citri Reticulatae 8-12
Melanteritum and/or ferrous sulfate 23-34.
2, blood-nourishing and iron-replenishing pharmaceutical preparation according to claim 1 is characterized in that making the raw materials of effective components medicine and consists of by weight:
Caulis Spatholobi 186.5 Radixs Astragali 113.5 Fructus Jujubaes 31.5
The Rhizoma Atractylodis Macrocephalae 36.5 Radix Angelicae Sinensis 22.5 Pericarpium Citri Reticulataes 10
Melanteritum and/or ferrous sulfate 28.5.
3,1 or 2 arbitrary described blood-nourishing and iron-replenishing pharmaceutical preparatioies as requested is characterized in that described medicament is the peroral dosage form on any pharmaceutics.
4, pharmaceutical preparation according to claim 3 is characterized in that described dosage form is a capsule.
5, the preparation method of the described pharmaceutical preparation of claim 1 is characterized in that, comprises following steps:
1) Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, the Pericarpium Citri Reticulatae with proportional quantity is ground into coarse powder, gets coarse powder one;
2) chalybeate with proportional quantity is ground into fine powder, gets fine powder one;
3) Caulis Spatholobi with proportional quantity decocts with water, and filters, and filtrate is condensed into thick paste, and drying is ground into fine powder two;
4) Radix Astragali, the Fructus Jujubae with proportional quantity decocts with water filtration, and filtrate is condensed into thick paste, adds coarse powder one, mixing, drying, is ground into fine powder, fine powder three;
5) fine powder three adds fine powder two and fine powder one mixing, preparation cost invention medicament mixed powder.
6, preparation method according to claim 5 is characterized in that 3) the step Caulis Spatholobi decocts with water secondary, and 3～5 hours for the first time, 1～3 hour for the second time, 4) the step Fructus Jujubae decocts with water secondary, each 1～3 hour.
7, according to claim 5 or 6 described preparation methoies, it is characterized in that 3) the step Caulis Spatholobi decocts with water secondary, and 4 hours for the first time, 2 hours for the second time, 4) the step Fructus Jujubae decocts with water secondary, each 2 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101011786A CN1323687C (en) | 2005-11-16 | 2005-11-16 | Blood supplementing iron supplementing medicineal preparation and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101011786A CN1323687C (en) | 2005-11-16 | 2005-11-16 | Blood supplementing iron supplementing medicineal preparation and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1785279A CN1785279A (en) | 2006-06-14 |
| CN1323687C true CN1323687C (en) | 2007-07-04 |
Family
ID=36782948
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005101011786A Active CN1323687C (en) | 2005-11-16 | 2005-11-16 | Blood supplementing iron supplementing medicineal preparation and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1323687C (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953943A (en) * | 2010-09-21 | 2011-01-26 | 王兴启 | Traditional Chinese medicine for treating chronic aplastic anemia |
| CN103720748A (en) * | 2012-10-11 | 2014-04-16 | 中国科学院上海生命科学研究院 | Regulation and control of caulis spatholobi on hepcidin and application of caulis spatholobi |
| CN103549419A (en) * | 2013-10-30 | 2014-02-05 | 四川大学 | Qi tonifying and blood nourishing micro-nano particle health-care granules and preparation method thereof |
| CN104771485A (en) * | 2015-03-18 | 2015-07-15 | 兰晓光 | Traditional Chinese medicine composition for treating iron-deficiency anemia having symptoms of deficiency in qi and blood |
| CN109481470A (en) * | 2019-01-08 | 2019-03-19 | 广东海洋大学 | A kind of preparation method of fish blood source iron supplementary |
-
2005
- 2005-11-16 CN CNB2005101011786A patent/CN1323687C/en active Active
Non-Patent Citations (3)
| Title |
|---|
| 中药及口服铁剂治疗缺铁性贫血的疗效观察 林梅英，医学文选，第24卷第5期 2005 * |
| 用铁剂有"规矩" 陈志春，医药与保健，第3期 2003;中药及口服铁剂治疗缺铁性贫血的疗效观察 林梅英，医学文选，第24卷第5期 2005 * |
| 用铁剂有"规矩" 陈志春，医药与保健，第3期 2003 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1785279A (en) | 2006-06-14 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1457829A (en) | Chinese medicine composition for curing chronic atrophic sastritis and its preparing method and quality control method | |
| CN100337662C (en) | Medicinal composition for treating hyperlipemia and its preparing method | |
| CN1323687C (en) | Blood supplementing iron supplementing medicineal preparation and its preparation method | |
| CN1263494C (en) | Granule for treating puerperal galactozemia and its preparation method | |
| CN1565552A (en) | Chinese traditional medicine for treating immune hypofunction and disfunction | |
| CN1212134C (en) | Compound Chinese medicine prepn for treating urinary system infection and prostatitis and its prepn process | |
| CN1191082C (en) | Chinese medicinal composition for treating fatty liver and its preparation method | |
| CN1284587C (en) | Preparation of Chinese traditional medicine for treating trmor in alimentary canal | |
| CN1698878A (en) | Kidney replenishing medicinal composition and its preparation process and novel use | |
| CN100346817C (en) | Chinese medicine composition for preventing and treating hypertension, hyperlipemia and hyperglycemia | |
| CN1559495A (en) | Deer's fetus granular Chinese madicinal preparation and its production technology | |
| CN1548138A (en) | Chinese medicine composition for treating consumptive disease and its quality control method | |
| CN1308028C (en) | Medication for treating hepatic fibrosis, and preparation method | |
| CN1304735A (en) | Medicine for curing chronic colitis | |
| CN100344304C (en) | Chinese medicinal preparation for treating consumptive disease and its making method thereof | |
| CN1287827C (en) | Blood-supplementing traditional Chinese medicine preparation and its production method | |
| CN1211111C (en) | Antilipemic Chinese medicine | |
| CN1283300C (en) | Chinese traditional medicine composition for treating diabetes and preparation method thereof | |
| CN1222305C (en) | Chinese medicine for treating liver-kidney insufficiency, qi and yin vacuity and its preparation method | |
| CN1559493A (en) | Medicine for treating hapatitis | |
| CN1990022A (en) | Traditional Chinese medicine composition, its preparation and quality controlling means | |
| CN1162177C (en) | Medicine for curing fatty liver | |
| CN101062374A (en) | Method for preparing Chinese traditional combination capsule for treating cancer and the product thereof | |
| CN1872321A (en) | Composition of Chinese traditional medicine for treating alcoholic hepatitis, and preparation method | |
| CN1562272A (en) | Medication for curing secondary anemia, iron deficiency anemia and preparation method |
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 | ||
| C56 | Change in the name or address of the patentee |
Owner name: GUANGZHOU CHENLIJI PHARMACEUTICAL FACTORY CO., LTD Free format text: FORMER NAME: GUANGZHOU CHENLIJI PHARMACEUTICAL FACTORY |
|
| CP01 | Change in the name or title of a patent holder |
Address after: 510290 No. 1688, Guangzhou Avenue, Haizhuqu District, Guangdong, Guangzhou Patentee after: Guangzhou Chenliji Pharmaceutical Factory Co., Ltd. Address before: 510290 No. 1688, Guangzhou Avenue, Haizhuqu District, Guangdong, Guangzhou Patentee before: Guangzhou Chenliji Pharmaceutical Factory |
|
| C56 | Change in the name or address of the patentee |
Owner name: GUANGZHOU BAIYUNSHAN CHENLIJI PHARMACEUTICAL FACTO Free format text: FORMER NAME: GUANGZHOU CHENLIJI PHARMACEUTICAL FACTORY CO., LTD. |
|
| CP01 | Change in the name or title of a patent holder |
Address after: 510290 No. 1688, Guangzhou Avenue, Haizhuqu District, Guangdong, Guangzhou Patentee after: GUANGZHOU CHENLIJI PHARMACEUTICAL FACTORY Address before: 510290 No. 1688, Guangzhou Avenue, Haizhuqu District, Guangdong, Guangzhou Patentee before: Guangzhou Chenliji Pharmaceutical Factory Co., Ltd. |
|
| CB03 | Change of inventor or designer information |
Inventor after: Xu Zhaodong Inventor after: Lin Qingyi Inventor after: Yang Nengying Inventor after: Guo Zhonghui Inventor after: Xiong Lusha Inventor after: Luo Weimin Inventor after: Li Jiaqing Inventor after: Shi Hongchao Inventor after: Peng Fuquan Inventor after: He Fenglei Inventor after: Wang Bing Inventor before: Xu Zhaodong Inventor before: Guo Zhonghui Inventor before: Xiong Lusha Inventor before: Luo Weimin Inventor before: Li Jiaqing |
|
| COR | Change of bibliographic data |