Revitalisasi Obat Generik: Hasil Uji Disolusi Obat Generik Tidak Kalah Dengan Obat Bermerek

The government through the Ministry of Health is very serious about revitalizing the use of generic medicines by issuing a policy that stipulated in the Regulation of the Minister of Health No. HK. 02.02/Menkes/068/1/2010 about duty to use generic medicines in government health care facilities. To maximize the use of generic medicines, it is very important to improve the understanding and trust of society that the quality, safety and effectiveness of generic medicines are similar to branded medicines. In addition, if there many researchs and the studies of generic medicines, they would increase the knowledge of health professionals, especially doctors, they may not hesitate to prescribe generic medicines. Since the quality as a basis of reference to establish the truth of the eficacy and safety, while the availability of certain products can be demonstrated in vitro. Studies of medicines dissolution, can give the same indication with medicines bioavailability. Ideally, in vitro medicines dissolution correlates bioavailability in vivo. The researchs results of dissolution test generic medicines of Amoxiciline 500 mg tablets, Isosorbit Dinitrat 5 mg tablets and Omeprazole capsules show that generic medicines have a better dissolution test results when compared to branded medicines

Optimasi Formula Tablet Salut Enterik Natrium Diklofenak Dengan Bahan Penyalut Kollicoat 30 D

Diclofenac sodium is an analgetic and antiinflammation drug and commonly used by oral administration. Because of it's side effects that can cause stomach irritation, nausea and vomiting, it's made in the form of enteric-coated. Enteric-coated formulations developed used organic solvent having toxicity and flammability risks. The aim of this study is to develop diclofenac sodium enteric-coated tablets with a water-based coating material. Coating material used is Kollicoat 30 D which is a derivative of acrylic polymer that can dispersed in water. Optimalization of the formula is done by the weight gain 4%, 6% and 8%. The result showed that enteric coated tablets used coating material with weight gain 8% gave the best result with all parameters meet the requirements of the test, there was no change in acid medium for 2 hours and stable released active ingredien

Formulation of Peperomia Pellucida (L) Kunth Extract Tablet by Modified Filler

Background: Peperomia pellucida has been widely used in traditional medicine. Recently, its existing forms are still conventional such as juice and infusum; therefore, it needs to be formulated more practically and in uniform weight such as tablet form. The objective of this research was to get the optimum formula of P. pellucidaextract tablet. Methods: P. pellucida extract tablets were produced with variation of microcrystalline cellulose (MCC) PH 101 – lactose by wet granulation method in three formulas, formula I (100% MCC PH 101), II (lactose 100%), and III (MCC PH 101: lactose = 50%: 50%). Granules were evaluated their physical characteristics including their flow rate, water absorption and compactibility to obtain the optimum formula by using simplex lattice design and total response. The optimum formula was used to make tablet and tested its physical characteristics (uniformity weight, hardness, and friability and disintegration time). Results:Lactose significantly influenced by its flow rate, whereas MCC PH 101 influenced the compactibility and water absorption. Based on the granules physical characteristics and their total responses, the formula combination of MCC PH 101 80% and lactose 20% was concluded to be the most optimum one for tablet filler. This optimum formula tablet had the best physical characteristics with weigth uniformity of 620.84 ± 1.04 mg, hardness of 8.54 ± 0.68 kg, friability of 0.26% ± 0.04 and disintegration time of 4.58 ± 0.17 minutes. Conclusion: The proportion MCC PH 101 80% and lactose of 20% obtained the best optimum formula and passed requirements of the tablet physical characteristics. (Health Science Indones 2013;1:32-6

Effect of Purified Gambir Leaves Extract to Prevent Atherosclerosis in Rats

Background: Atherosclerosis is a risk factor for coronary heart disease (CHD). Catechin have highantioxidant activity that can prevent atherosclerosis. Gambir (Uncaria gambir, Roxb.) leaves extract havehigh catechin content thereby potentially inhibiting atherosclerosis. This research was aimed to examineeffect of purified gambir leaves extract to prevent atherosclerosis in rats.Methods: The experimental laboratory study was conducted in Pharmacy Laboratory and Animal Laboratory,National Institute of Health Research and Development, Ministry of Health, Republic of Indonesia in 2014.Gambir leaves extract were purified to gain optimum catechin. Afterwards, antioxidant activity was testedusing 2.2-diphenyl-1-picrylhydrazyl (DPPH) method, with ascorbic acid as positive control. Thirty six whitemale Sprague Dawley rats aged 2.5 months were randomly divided into six groups, i.e. normal control group,negative control group (aquadest), positive control group (atorvastatin 2 mg/200 g bw),extract dose I (20mg/200 g bw), dose II (40 mg/200 g bw) and dose III (80 mg/200 g bw). The rats were given high fat diet andtreatment according to their group for 60 days, except for normal control group.Results: Catechin content in the purified gambir leaves extract was 92,69%. From antioxidant activity test, IC50 wasfound to be 11,76 μg/mL. Anti-atherosclerotic activity study shown that compared to negative control, all three dosesof purified gambir leaves extract were able to prevent atherosclerosis through inhibition of aortic wall thickening andfoam cell formation due to high fat diet (p<0.05). Anti-atherosclerotic activity increased with increasing dose.Conclusion: Gambir leaves purified extract had the effect of preventing the thickening of the walls andfoam cell formation rat aorta. (Health Science Journal of Indonesia 2015;6:105-10

Optimasi Formula Mikroenkapsulasi Ekstrak Rimpang Temulawak (Curcuma Xanthorrhiza Roxb.) Dengan Penyalut Berbasis Air

Java turmeric (Curcuma xanthorrhiza Roxb.) is a native plant of Indonesia which has been proved as anti-inflamation, antioxidant, antimicrobial, antitumor, hepatoprotective and antihyperlipidemic agent. The bitter taste with pungent aroma of java turmeric, improper storage that decreasing essential oil and curcuminoid level can be prevented by coating java turmeric as microcapsule. Recently, many microcapsule formulation is made based on organic solvent which have high risk on toxicity and also flammable. The study aimed to produce microcapsule using water based coating material from mixture of tapioca starch and carboxymethylceIlulose (CMC). There are 3 formulas of coating material that were used in this study, with proportion (w/v) of tapioca starch and CMC in formula I (3% : 1 %), formula II (2% : 2 %), and formula III (1% : 3%). The results showed that microcapsule with coating material made from formula III was the best, regarding to the measurements of physical parameter (recovery, water content, absorption efficiency, flow rate and particle size) and chemical parameter (curcumin content) compared to formula I and II. The higher CMC concentration on coating material compotition, the better microcapsule will be produced

Pengaruh Penyalutan terhadap Karakteristik Fisika Kimia dan Stabilitas Tablet Fraksi Etil Asetat Daun Gambir sebagai Agen Antidislipidemia

Gambir (Uncaria gambir, Roxb) with the main content of catechin compounds is a major comodity that is efficacious as an antidyslipidemia agent and reduce lesion atheloschlerosis. Catechins are found most often in gambir leaf extract, but are hygroscopic in order to increase the content and its stability is made in the fraction form and formulated in the film-coated tablet preparation. Coatings will protect the gambir from environmental influences. This study aims to find out the best formula of core tablets and film-coated tablets of ethyl acetate fraction of gambir leaf extract. The granulation method used using wet granulation. Optimization of the tablets coating formulation was carried out through three different formulas with the addition of 4, 6, and 8% coatings. The core tablet and the coat were tested for physical characteristics such as weight uniformity, crushed time, hardness, and tablet fragility, chemical characteristics of active substance content and accelerated stability test. The chemical physics evaluation of tablets shows all tablets meeting physical and chemical requirements. Accelerated stability test result obtained catechin content in the core tablets and coat membrane in the absence of loss potency more than 5%. The coated tablet has loss in potency smaller than core tablet. The greater the composition of the coating material used of coating the smaller the loss in potency of catechin content in tablets

Perbandingan Abbott Real-time High-risk HPV dan Cobas 4800 HPV Test untuk Deteksi Molekuler HPV pada Sampel Indonesia

Based on the results of 2013 National Basic Health Research (Riskesdas 2013), as many as 10.3% of female death due to cancer in Indonesia caused by cervical cancer of Human Papillomavirus (HPV) became the main risk factor that was 99.7%. The incidence of cervical cancer can be prevented through early detection of HPV infection moleculary. This study aims to evaluate the ability of Abbot Real-time High-risk HPV (AR) and Roche Cobas HPV (CB) techniques to detect HPV DNA from Indonesia‘s Stored Biology. Furthermore, the results from both techniques are confirmed by using genotyping method using Linnear Array (LA). A total of 74 speciment of stored biological materials (BBT) of cervical swabs stored in Phosphate Buffered Saline (PBS) media were extracted using a special isolation kit from Abbott Real-time High-risk HPV, Cobas 4800 Human Papillomavirus Test and Linear Array. Concentration and purity of HPV viral DNA extraction results were measured by spectophotometry method. The amplification of the extraction results was carried by using a specific primer segment of the L1 gene as a target for detecting HPV DNA. The quality of HPV DNA extraction results using AR technique was 10-30 ng/μL concentration in average, the result was higher when compared to the CB technique which only range from 10-20 ng/μL, but the results using the LA technique had a concentration ≥ 30 ng/μL in average. The purity of HPV DNA extraction using AR and CB technique was similar more or less. The examination of 74 samples had found HPV 16, HPV 18, and other HPV type in each technique, which were 14 positive (9, 4, and 1) in AR technique, 5 positive (3,2, and 0) in CB technique, and 14 positive (8, 4, and 2) in LA technique. AR technique is more accurate and optimal than CB technique in detecting HPV virus and identifying HPV virus types. Both AR and CB technique have their own advantages and disadvantages, although they have uses an automated system of isolation and readout results analysis. It could be concluded that AR technique has better performance in detecting HPV when compared to CB technique